1 UNITED STATES OF AMERICA + + + + + PRESIDENTIAL ADVISORY COMMITTEE ON + + + + + GULF WAR VETERANS' ILLNESSES + + + + + PUBLIC MEETING + + + + + TUESDAY AUGUST 15, 1995 + + + + + WASHINGTON, D.C. + + + + + The Avisory Committee met in the Congressional Room of the Capital Hilton, 16th and K Streets, N.W., Washington, D.C., at 9:00 a.m., Dr. Joyce Lashof, Committee Chair, presiding. COMMITTEE MEMBERS: JOYCE LASHOF, Chairperson JOHN BALDESCHWIELER ARTHUR L. CAPLAN DONALD CUSTIS FREDERICK M. FRANKS, JR. DAVID A. HAMBURG JAMES A. JOHNSON MARGUERITE KNOX PHILIP J. LANDRIGAN ELAINE L. LARSON ROLANDO RIOS ANDREA KIDD TAYLOR 2 DESIGNATED FEDERAL OFFICIAL: CATHERINE WOTEKI STAFF PRESENT: ROBYN NISHIMI THOMAS McDANIELS ALSO PRESENT: KARL T. KELSEY DIANE J. MUNDT GERARD BURROW KELLEY BRIX 3 A G E N D A PAGE I. OPENING REMARKS 4 II. BRIEFING: INSTITUTE OF MEDICINE, NATIONAL ACADEMY OF SCIENCES A. COMMITTEE TO REVIEW THE HEALTH 4 CONSEQUENCES OF SERVICE DURING THE PERSIAN GULF WAR B. COMMITTEE ON THE DOD PERSIAN GULF 12 SYNDROME COMPREHENSIVE CLINICAL EVALUATION PROGRAM III. DISCUSSION OF ADVISORY COMMITTEE 57 GOALS/OBJECTIVES/STRATEGIES IV. FUTURE MEETINGS 161 V. PUBLIC COMMENT 173 4 1 P-R-O-C-E-E-D-I-N-G-S 2 9:04 a.m. 3 CHAIRPERSON LASHOF: I believe we are 4 ready to begin this morning. I think we had a very 5 full day yesterday. We heard a great deal, both from 6 the Departments and from the Gulf War Veterans. 7 This morning, we are going to have a 8 briefing from the Institute of Medicine, the National 9 Academy of Sciences. They have had two studies 10 ongoing. One, the Committee to Review the Health 11 Consequences of Service During the Persian Gulf War. 12 And then, the Committee on the DOD Persian Gulf 13 Syndrome Comprehensive Clinical Evaluation Program. 14 And I would like to ask the people who are 15 going to present to come forward at this point. Take 16 their places at the table. 17 Dr. Kelsey, will you be starting off? 18 DR. KELSEY: Yes. 19 CHAIRPERSON LASHOF: Okay. Please 20 proceed. 21 DR. KELSEY: Thanks, Dr. Lashof. 22 I first want to thank the Committee for 23 inviting me and send greetings from John Bailar, who 24 is the chairman of the committee, who couldn't be here 25 today. 5 1 What I am going to do is very briefly give 2 you an overview of the Institute of Medicine process, 3 which is familiar to many of you. And then, describe 4 the workings of our committee, touching primarily on 5 the points from our first report. 6 As many of you know, the Institute of 7 Medicine is a part of the National Research Council. 8 And the members who serve on these committees serve as 9 volunteers. It was established congressionally and 10 operates as an independent body. 11 Our committee was established by public 12 law, a law passed in November of 1992, which was about 13 the time the oil fires were a very large part of the 14 Congressional mind. The law requires the VA and the 15 Department of Defense to enter into a joint agreement 16 with medical follow-up agency, the Institute of 17 Medicine, to fund a study to end in 1996. 18 The funding level is $500,000.00 a year, 19 as you can see, equally split between the two 20 agencies. The study really began with money arriving 21 in October of 1993. And the first meeting was held 22 then, in January of 1994. 23 We issued our first report on January 4th 24 of 1995, with the final report due approximately some 25 time around the summer of 1996. 6 1 We have an 18-member committee. And we 2 have -- I've got the members of the committee listed 3 here, with John Bailar, as I mentioned, the chair. 4 The committee has met nine times. And we are 5 scheduled again to meet in September. 6 We have members with various expertise, 7 including epidemiology, toxicology, biostatistics, 8 infectious disease and vaccination, reproductive 9 health, psychiatry, respiratory illness, immunology -- 10 the areas, broadly speaking, needed to touch on the 11 health consequences of service during the Persian Gulf 12 -- in a very broad sense. 13 We have obtained information through a 14 wide variety of means, including presentations from 15 members of the government. Some of the members of the 16 panel have presented information to us. 17 We have also had an excellent staff that 18 have made inquiries broadly, and looking also through 19 the open literature, much of which has been found to 20 be actually quite lacking. 21 The public law that established the 22 committee then, really had three direct points. The 23 first one was to assess the effectiveness of actions 24 taken by the Secretaries of the Veterans 25 Administration and the Department of Defense to 7 1 collect and maintain information useful in assessing 2 these health consequences. 3 That was specifically the first point. 4 The second one was to make recommendations on the 5 means of improving collection and/or maintenance of 6 this information, again aimed at the data base issue. 7 And then finally, to make recommendations 8 as to whether there was a sound scientific basis for 9 an epidemiological study or studies for the follow-up 10 of the veterans' health. And we were also mandated to 11 discuss or recommend the nature of such study or 12 studies. 13 So that, explicitly, is our mandate. As 14 I have mentioned, we released a report on January 4th, 15 an interim report, so to speak, which was motivated by 16 the committee's sense that there were some 17 recommendations that we wanted to make prior to the 18 end of the three years, primarily because we felt that 19 there was some immediate recommendations that could be 20 utilized by the VA and the Department of Defense in 21 moving forward with some of these important and 22 pressing issues. 23 We really stress three areas, data and 24 data bases, coordination, and study design needs. 25 Specifically then, in addressing what we recommended, 8 1 we talked a little bit about the registry, which you 2 have heard quite a bit about. 3 We stressed that this was a self-selected 4 population. That the population itself was not 5 designed for research. And so, while it should be 6 reviewed and updated regularly to monitor sentinel 7 events, which really was its chief purpose. That is, 8 to monitor for sentinel events. 9 We also stressed that it would be useful, 10 certainly, for following up the Persian Gulf Veterans, 11 and definitely for future conflicts, to take a very 12 strong look at the data systems and try very hard to 13 link them. 14 This currently is very difficult, as I am 15 sure you are aware. And it's instances like this that 16 led us to believe that considerable effort might be 17 made to make the data available in linkage systems. 18 Again, we also recommended that the 19 Department of Defense Unit Location Registry be 20 completed with a high priority since, in fact, that 21 could give us both denominator information as well as 22 potential to look at exposure information. 23 We also touched on coordination and 24 recommended that funding be based on scientific merit 25 for any studies that were deemed useful while the 9 1 committee was ongoing. 2 We strongly urged that all activities 3 undergo external peer review and that they be based on 4 scientific merit. This was something that we felt was 5 very important. And there were examples of how this 6 had been lacking in the past. 7 We also recommended that active 8 coordination of the activities of various agencies be 9 undertaken to reduce redundancy. There was a 10 considerable amount of duplication in efforts early 11 on. And we felt the need to stress that coordination 12 was important in this endeavor. 13 The third point then involved study design 14 needs. What we recommended was that we define really 15 what is needed for research. We recommended a 16 population-based epidemiologic study using what we 17 have deemed really data which will be, if it is not 18 currently, available with the completion of some of 19 the work of the Department of the Defense and the VA. 20 We also stressed that information derived 21 from cluster or outbreak investigation was minimally 22 useful. And while it was important in a sentinel 23 sense, this was not the goal of future studies. 24 The mortality study that the VA was 25 conducting -- we also agree it should be extended to 10 1 observe any excess from chronic disease. 2 We use the example of lead to illustrate 3 that many of the possible events that have been tied 4 to chronic disease have not been fully investigated. 5 And certainly, lead deserves a closer look in future 6 studies. 7 We also recommended that the various 8 agencies continue their work looking for appropriate 9 models to evaluate potential interactions in terms of 10 compounds to which the troops were exposed. That is, 11 Deet, permethrin, insecticides, and vaccines, 12 pyridostigmine as well. 13 And then, we further recommended that 14 leishmania tropica be a subject of intensive research 15 as this had been a hypothesis for a considerable 16 amount of disease and represented a very serious 17 research challenge. We felt that it was very 18 appropriate to intensively study this particular 19 problem. 20 We also then addressed some of the 21 putative outcomes associated with servicing the 22 Persian Gulf War. I list here for you some of the 23 things that we have heard about from veterans and 24 which we have considered as part of our list of 25 putative outcomes associated with service. 11 1 And I won't read the list for you. I only 2 show it in an effort to let you know that the list is 3 considerable and is something that we have wrestled 4 with. We also likewise have thought about a number of 5 putative exposures. And the committee has expertise 6 in all these areas. 7 And we looked very closely then at any 8 associations between these putative exposures and the 9 outcomes. And again, I show you the list to 10 illustrate the areas that we are looking at. 11 Finally then, my last overhead really 12 involves our future plans. We continue to look at the 13 evaluation of data collection and the ongoing 14 research. We are continuing, as I have indicated, to 15 look closely at the health problems in general, not 16 just the unexplained illness associated with the 17 Persian Gulf service. 18 Our committee is charged with a broad 19 range of health consequences. And we continue to look 20 at them closely. And finally, we are also continuing 21 to look at potential exposures and outcomes for our 22 research recommendations, as part of our mandate. 23 Thank you. I will be happy to address any 24 questions that you have as well at any point. 25 CHAIRPERSON LASHOF: Thank you very much, 12 1 Dr. Kelsey. 2 I think we will proceed to hear the second 3 annual report. We'll hear from Dr. Burrow, and then 4 open it up for questions from the panel for both 5 reports. 6 DR. BURROW: Thank you. I'm Gerard 7 Burrow, the dean of the Yale University School of 8 Medicine and chairman of the Institute of Medicine 9 Committee on the DOD Persian Gulf Comprehensive 10 Clinical Evaluation Program. 11 The committee was formed in October of 12 1994 at the request of Dr. Stephen Joseph, the 13 Assistant Secretary of Defense for Health Affairs. 14 In the brief time allotted, I'd like to 15 address three topics: a description of the charge to 16 our committee since we have two IOM committees, a 17 summary of the major findings included in our first 18 report on CCEP which was released on December 2nd, 19 1994, and a summary of the major findings included in 20 our second report which we released to your Committee 21 and to the general public yesterday. 22 The charge to our committee was to 23 evaluate the protocol for the Comprehensive Clinical 24 Evaluation Program or CCEP for short, to comment on 25 the interpretation and the results that have been 13 1 obtained so for, to make recommendations relevant to 2 the conduct of the program in the future, and to make 3 recommendations on the broader program of the DOD 4 Persian Gulf health studies, if appropriate. 5 The IOM committee was comprised of 12 6 individuals with a distribution not unlike the other 7 committee, with Dr. Kelley Brix as the study director. 8 We will have held four meetings and produced three 9 reports by the end of the project on September 30th, 10 1995. 11 You have heard about the structure, as Dr. 12 Kelsey has addressed, of the selection and procedures 13 of that IOM committee. Let me simply state that the 14 goal is to make these IOM scientific reports 15 independent, authoritative, and objective. 16 The first report of this committee was 17 released on December 2nd, 1994 based on the 18 information on the CCEP that was available from the 19 DOD in October of 1994. And remember again that it 20 started in June of 1994, so this was very early. 21 The committee at that time concluded that 22 the CCEP design represented a serious attempt by the 23 DOD to evaluate and treat the health problems of 24 military personnel who were on active duty in the 25 Persian Gulf. 14 1 The committee suggested at that time that 2 attention be paid to three issues: the division of 3 labor and other resources between the local medical 4 treatment facilities and regional medical centers and 5 between Phase I, the beginning phase, and Phase II, 6 the referral phase, in the CCEP in light of the 7 enormous large numbers of CCEP patients, and in the 8 light of the apparent use of CCEP by patients to 9 obtain timely, high-quality medical care which would 10 otherwise not be as readily available. 11 We thought there should be attention to 12 the relationship between the clinical care aspects of 13 CCEP for which it was designed and research functions 14 and commented on the prominence of stress and 15 psychiatric disorders as diagnosis and/or as 16 contributing factors in the CCEP findings. 17 The purpose of the second report is to 18 comment upon an unpublished confidential draft DOD 19 report entitled "Comprehensive Clinical Evaluation 20 Program For Gulf War Veterans Report on 10,020 21 Participants." 22 That report was dated June 7th, 1995. I 23 believe you have the report that was issued on August 24 1st which was a revised report. Although the DOD had 25 not seen the IOM's second report, the final DOD report 15 1 which was released on August 1st contained several 2 revisions compared to the June 7th draft. 3 These revisions in the final DOD report 4 address some of the concerns expressed in our second 5 report, even though the IOM committee had no 6 opportunity to review the August 1st report before it 7 was published. So that -- you will see some 8 dissynchrony. 9 The IOM committee reviewed several 10 documents relating to illnesses among Persian Gulf 11 Veterans. These were authored by the Department of 12 Defense and others. 13 I would emphasize that the committee has 14 not performed its own independent research, nor 15 examined individual patients. 16 Second, the committee's second report was 17 based on the following: review of two published and 18 one unpublished report by the Department of Defense 19 which described the results of the program, three IOM 20 committee meetings that included presentations by DOD 21 CCEP physicians, review of several reports which are 22 listed in the appendix of our second report, and 23 attendance by the Institute of Medicine staff at a 24 number of meetings organized by the DOD and Department 25 of Veterans Affairs. 16 1 The CCEP has developed -- has been 2 developed as a thorough, systematic approach to the 3 diagnosis of a wide spectrum of diseases. DOD has 4 made a conscientious effort to build consistency and 5 quality assurance into the CCEP at the many military 6 medical facilities across the country. 7 The protocol has resulted in specific 8 medical diagnosis or diagnoses for most patients. The 9 signs and symptoms of many patients could be explained 10 by well-recognized diseases that are readily 11 diagnosable and treatable. 12 The committee concludes that this is a 13 more likely interpretation -- that a high prevalence - 14 - than the interpretation that a high prevalence of 15 CCE patients are suffering from a unique previously 16 unknown mystery disease that has a very large number 17 of supposedly pathognomonic symptoms. 18 A major DOD conclusion in their report of 19 June 7th, quote: 20 "To date, the CCEP has identified 21 no clinical evidence for a unique or new 22 illness or syndrome among Persian Gulf 23 Veterans." 24 The committee -- our committee urged 25 caution or more justification for this statement. As 17 1 members of the committee are aware, it is always 2 harder in epidemiology to prove that a new disease 3 does not exist than to prove that it does exist. 4 If a new or unique illness were either 5 mild or only affected a small proportion of veterans 6 at risk, the illness might go undetected even in a 7 large case series. 8 On the other hand, if indeed there were a 9 new, unique Persian Gulf-related illness that could 10 cause serious disability in a high proportion of 11 veterans at risk, it would probably be detectable in 12 a population of 10,020 patients. This pattern has not 13 been detected. 14 Dr. Stephen Josephs and other DOD 15 physicians have discussed the likelihood that at least 16 a few CCE patients had developed illnesses that are 17 directly related to the Persian Gulf service. 18 It is also likely that some CCE patients 19 had developed illnesses that are coincidental and 20 therefore unrelated to their Persian Gulf illness. 21 And in some cases, they had predated their Persian 22 Gulf service. These possibilities should have been 23 mentioned in the DOD report. 24 In summary, our overall conclusions were 25 that the program was designed primarily as a clinical 18 1 program to evaluate and treat the health problems of 2 individuals who have served their country during the 3 Persian Gulf conflict. 4 As a secondary goal, the DOD has published 5 a series of reports which describe and interpret the 6 symptoms and diagnoses of the entire group of CCE 7 patients. 8 Overall, our committee is impressed with 9 the quality of the design and the efficiency of the 10 implementation of the clinical protocol. The 11 committee has been particularly impressed with the 12 dedication and commitment of the DOD physicians who 13 actually care for the Persian Gulf Veterans. 14 The committee is also impressed by the 15 considerable devotion of resources to this program and 16 the remarkable amount of work that has been 17 accomplished in just now, a little over a year. 18 Thank you again for the opportunity to 19 address the committee. And I would also be delighted 20 to try and answer any questions that you might have. 21 CHAIRPERSON LASHOF: Thank you very much, 22 Dr. Burrow. 23 The panel is now open for questions. And 24 we can move around our group and -- 25 Andrea, any questions? 19 1 (No response.) 2 CHAIRPERSON LASHOF: Rolando, any 3 questions? 4 (No response.) 5 CHAIRPERSON LASHOF: Elaine? 6 DR. LARSON: Several quick questions. 7 First of all for Dr. Kelsey, we heard 8 testimony yesterday about a couple of things I'd like 9 to ask you about. First of all, we heard testimony 10 that there were long months of waiting for 11 examinations. And I am wondering if the committee is 12 going to address anything about timeliness of data 13 collection because that has not only clinical 14 implications, but certainly research implications. 15 And one related question about what we 16 heard yesterday. That is, concern about if there is 17 a Persian Gulf-related syndrome or illness that is 18 characterized by a multiplicity of signs and symptoms. 19 And I understand from yesterday that the data 20 collection is cut off after six symptoms. Is that 21 correct? 22 DR. KELSEY: You know, Dr. Burrows may be 23 a more appropriate person for the question. Certainly 24 the issue of timeliness is critical in a lot of ways. 25 The committee certainly considered that 20 1 issue in trying to determine how to use the registry 2 information because it bears on interpretation of that 3 data. And I think that's part of our recommendation 4 that the data be treated in a certain fashion. With 5 respect to -- 6 DR. BURROW: The question of timeliness 7 was why we made that comment after the first meeting. 8 I mean, they were -- the process was simply being 9 overwhelmed by individuals coming in and attempting to 10 see them. And everyone was getting a very complete 11 protocol. And that was altered in that they have 12 processed a very large number of patients. 13 The number of both symptoms and diagnoses 14 are cut off after seven, I think. If one looks at 15 these, there are a multitude of diagnoses, but they 16 vary so that there is a wide variety and -- 17 DR. LARSON: Two other questions. What 18 has been the response of the DOD to your 19 recommendations from the report in December of 1994? 20 It's been seven and a half months. 21 DR. BURROW: They have been responsive, 22 have changed the direction in the way that the 23 patients are being used. In a more recent -- in the 24 first draft that we saw of the Defense Department 25 report in June, that they had gone on at some length 21 1 about environmental threat. 2 We question whether that was -- should be 3 in there. And that has been modified in the new 4 report. So that -- in fact, I think that they have 5 been responsive to the committee. 6 DR. LARSON: And last question, what's the 7 interface between your two committees? How do you 8 interact and communicate? 9 DR. BURROW: The two people on either side 10 of me are the probably major interactors. 11 CHAIRPERSON LASHOF: Phil? 12 DR. LANDRIGAN: Yes. Good morning. I'd 13 like to -- one of the recommendations that was made in 14 the report "Health Consequences of Service" -- is that 15 -- is that yours, Karl? 16 -- was a report that the Vice President 17 should chair a committee. I guess this committee is 18 an approximation of that. And that one of our tasks 19 should be to devise a plan to link data systems on 20 health outcomes with standardized forms and an 21 organized system of records. 22 One of the things that we heard repeatedly 23 yesterday were tales of lost records, records that 24 didn't get from the DOD system to the VA, records that 25 were lost in transfer from one hospital to another. 22 1 Basically a system that seems to be still operating 2 largely on paper and not in electronic form. 3 And I wondered if you -- this 4 recommendation is good, but it's also rather brief -- 5 if you had any plans to further elaborate upon that 6 recommendation and spell out in more detail your 7 thoughts. 8 DR. KELSEY: Certainly. I think you've 9 hit upon a -- what we view as a very important 10 recommendation. It's something that's crucial to the 11 endeavor we're all about. 12 The word "denominator" has come up I know 13 in your meeting and obviously, if you are interested 14 in following up any of the health consequences of 15 anything like this, the absence of a denominator is a 16 big problem. 17 Our view is that in fact the linking of 18 the data systems between the Department of Defense and 19 the VA is critical in follow up of any soldiers 20 anywhere. And in our view that is very much lacking. 21 It obviously also is going to take major effort to 22 link these systems. 23 But the committee I think in its first 24 report was very much trying to say -- given the amount 25 of effort and the amount of money that has been spent 23 1 to date on this problem, it might be best to think 2 about prevention. 3 And the best way we know of to prevent 4 this type of thing is to get systems in place where 5 denominators are a little more forthcoming. 6 And obviously we feel data systems and 7 data bases exist to computerize this and to make the - 8 - not only the record, but potentially, then, 9 caregiving improved by swift and easy flow of 10 information. 11 So the Vice President's name was there, I 12 think, because of the importance we felt due to this 13 problem. And I think we'll revisit that. I have no 14 doubt that it is still an important problem. 15 DR. LANDRIGAN: Right. It would seem to 16 me that it has implications for the future too. The - 17 - I mean, the world is unfortunately -- remains an 18 unsettled place. 19 And there are likely to be further 20 deployments of American troops overseas to 21 environments that are less than friendly. And these 22 problems in one form or another are going to recur I 23 am afraid in the years ahead. And it would be nice to 24 have the system in place beforehand the next time. 25 DR. KELSEY: I mean, I think your point is 24 1 a very good one. And I'm glad you've raised it. And 2 I think you've hit upon something the committee feels 3 very strongly about. 4 DR. LANDRIGAN: One more question. I -- 5 this may go beyond the purview of your committee. And 6 if it is, you'll tell me. But we heard yesterday an 7 interesting point that I had not been previously been 8 aware of. 9 And that is that the Veterans 10 Administration doesn't compensate veterans for 11 service-related disease if the disease first becomes 12 manifest more than two years -- I don't know if it's 13 more than two years after discharge from the service, 14 or more than two years after the exposure has taken 15 place. 16 But in either event, it's an approach that 17 basically cuts off from consideration within the 18 workers comp. -- the VA compensation system -- any 19 disease with long latency. 20 This is an approach, of course, that some 21 state workers compensation systems used to have. And 22 most of them dropped it in the 1950's, recognizing 23 that diseases like the diseases caused by asbestos can 24 develop as long as decades after the exposure takes 25 place. 25 1 And I wondered if you folks had given any 2 consideration -- if either of the two committees had 3 given any consideration to that point. 4 DR. BURROW: Dr. Brix just informed me 5 that we believe it's two years after leaving the Gulf 6 for individuals with unexplained illness. I mean -- 7 but our committee didn't really deal with that at all. 8 DR. KELSEY: And we are really not dealing 9 with compensation issues, although it's an interesting 10 point. 11 CHAIRPERSON LASHOF: Marguerite? 12 DR. KNOX: Was there any data related to 13 that about identifiable diseases that are diagnosed 14 after the two-year periods? Do you know anything 15 about that, patients who have diagnosable diseases 16 after the two years? 17 DR. BURROW: I have no information on it. 18 DR. KNOX: I wondered if there was -- 19 after your recommendation to DOD -- 20 DR. BURROW: I'm sorry. Dr. Brix just 21 said that we do not think there is any limit on that. 22 It was just for the unidentified diseases. I mean 23 that is our understanding. In other words, if you 24 have a specific label, then that time limit doesn't 25 hold. 26 1 DR. KNOX: Still, I think veterans are 2 having to prove that the disease was related. And 3 without any patterning and aggregating of certain 4 health diseases, that's very difficult to prove. 5 So I hope there will be some long-term 6 studies looking at patients who have been diagnosed 7 with neoplasias, either benign or malignant, that have 8 occurred in Gulf War Veterans. And I don't think that 9 we've really looked at that very well. 10 DR. BURROW: I feel like a puppet. 11 DR. KNOX: Sorry. 12 DR. BURROW: Both the DOD and the Veterans 13 Administration have information on that. 14 CHAIRPERSON LASHOF: I have no problem 15 with Kelley Brix and Diane Mundt also contributing and 16 speaking and not having to puppet through. We are 17 informal. And we certainly -- it's within our 18 protocol to -- please, I welcome Kelley and Diane to 19 freely speak for themselves. 20 Yes? 21 DR. BRIX: Dr. Knox, you said you were 22 interested in neoplastic activities in particular? I 23 believe that both the Department of Defense and the 24 Department of Veterans Affairs have data on both -- 25 particularly this have malignant cancers. 27 1 And they have tables in their -- in the 2 materials that they passed out in the August 1st 3 report, as well as the DVA's most recent report has a 4 list of all the known patients diagnosed with cancer. 5 And all the different types. 6 DR. KNOX: Could you tell me if the exam - 7 - veterans who did not receive the recommended 8 Comprehensive Clinical Evaluation -- I guess, could 9 those veterans go back and have that comprehensive 10 evaluation? Those that did not receive it early on? 11 DR. BURROW: There are two kinds of 12 veterans: one, people who served in the Persian Gulf 13 and are still on active service, and others who have 14 been discharged. If they have been discharged, it 15 would be done through the Veterans Administration. 16 DR. KNOX: So it would be available, is 17 your understanding? 18 (No response.) 19 DR. KNOX: Could you tell me about the 20 environmental toxin, the serum assays that maybe were 21 recommended for that evaluation? 22 (No response.) 23 DR. KNOX: Were there any? 24 (No response.) 25 DR. KNOX: For instance, lead poisoning or 28 1 depleted uranium for those patients that complained of 2 that? 3 DR. KELSEY: Yes. We -- the issue of lead 4 and depleted uranium were both addressed in our first 5 report. And we're -- we recommended that, I think, a 6 little bit more work be done around those issues. 7 The lead levels that were initially drawn 8 clearly indicated that there needed to be some follow- 9 up, certainly of some individuals. And that was one 10 of our recommendations. 11 In addition, the depleted uranium issue 12 also left a small cohort, but albeit a defined cohort 13 that could be followed. And we recommended that as 14 well. 15 There is a serum bank -- that you referred 16 to serum. There is a serum bank. And obviously, this 17 can provide a resource for a lot of research. Areas 18 that we touched on where that might be useful include 19 leishmaniasis and other infectious disease. Exactly 20 what's ongoing at the moment, I think, is unclear to 21 me as I sit here. But I'm certain that that's a 22 resource that many people are thinking about. 23 DR. BURROW: Perhaps it's worth explaining 24 -- the initial in the program -- the initial -- if 25 somebody identifies himself and wants to be cared for, 29 1 that there is a physical -- this Phase I, the primary 2 care treatment, which is probably equivalent to a very 3 thorough executive physical. 4 If then things are identified in problems 5 or areas -- it is -- they are referred on to regional 6 centers where it's really case finding so that it is 7 not necessarily screening for every environmental 8 toxin. 9 But if there were evidence that the 10 individual might have lead poisoning or have a uranium 11 slug, it would be looked for. So it was really case 12 finding rather than screening. 13 CHAIRPERSON LASHOF: Dr. Hamburg? 14 DR. HAMBURG: I wonder whether there are 15 plans for a continuing role for the Institute of 16 Medicine in relation to the Gulf War health problems? 17 And if so, what the nature of that role is likely to 18 be? 19 DR. BURROW: As far as our committee is 20 concerned we are in negotiation with the Department of 21 Defense to continue our committee and we should know 22 then -- obviously by the end of -- that when it ends. 23 DR. HAMBURG: Thank you. 24 And the other committee? 25 DR. KELSEY: We're to issue our final 30 1 report in 1996. And at that point this committee will 2 be disbanded. With respect to other activities of the 3 Institute of Medicine -- Diane? 4 DR. MUNDT: None. 5 DR. KELSEY: As far as I know, there's 6 none planned. 7 DR. HAMBURG: I wonder if there has been 8 any consideration of the areas not covered in the 9 mandates given to the two committees? There've been 10 occasions when there has been concern that the IOM was 11 not really in a position to look into an important 12 problem because it didn't fall within the mandate of 13 either committee, implying that perhaps there should 14 be some new initiative or conceivably even a broad 15 gauge board to address these problems over the longer 16 term. 17 DR. BURROW: Well, I think in answer, I 18 mean, our study is really in response to a contract 19 with the Department of Defense so that we are limited 20 in those areas. 21 CHAIRPERSON LASHOF: Dr. Mundt? 22 DR. MUNDT: To my knowledge, there is no 23 information or no plans for such a board, although it 24 is an excellent idea. 25 DR. HAMBURG: Well, I raise the question 31 1 because it seems to me that this Committee is going to 2 have to think about the question of whether some kind 3 of independent scrutiny of the highest level of 4 objectivity and penetration can be created to go 5 beyond the life of this Committee. 6 These problems are not likely all to go 7 away any time soon. We heard about long latency 8 diseases and so on. I think we will have to address 9 that. And obviously the IOM is an institution that 10 comes to mind as suitable for that role. 11 I suspect -- at least while speaking for 12 myself, I think there will be a continuing need for 13 independent non-governmental scrutiny of the highest 14 caliber over an extended period of time. And that's 15 why I raise the question of an IOM board as one 16 possibility. 17 CHAIRPERSON LASHOF: Well, I would like to 18 ask Dr. Burrow -- the Comprehensive Clinical Protocol 19 Exam -- these are done at DOD facilities on active -- 20 people who are still actively in service? Or, those 21 who have been discharged, the veterans who have been 22 discharged, are they included in this common protocol 23 or not? 24 DR. BURROW: No. They are not. I mean, 25 this is specifically a DOD protocol. And I meant to 32 1 correct something because I may have left that 2 impression -- is that if it's a veteran who has been 3 discharged, they could go to the VA hospital, but it 4 would not be part of the CCEP protocol. 5 DR. KNOX: So let me just say that of the 6 700,000 veterans who served in the Persian Gulf, 7 according to the data that they have given us in our 8 notebook, 587,000 have separated from the military. 9 So you are looking at a huge population that has 10 medical services unavailable to them. 11 CHAIRPERSON LASHOF: And it also raises 12 the question of the selection of this population being 13 those that are still on active duty when it is 14 somewhat logical that many of those that would be ill 15 have already left service. Can you tell me how 16 representative you feel this eventual 20,000 will be 17 of the total group that served in the Vietnam War? 18 DR. BURROW: Of the Persian Gulf -- 19 CHAIRPERSON LASHOF: Of the -- sorry. The 20 Persian Gulf. Apologies. 21 DR. BURROW: I think that you raise the -- 22 one of the issues that the committee raised when they 23 start making comparisons. I mean, this is a self- 24 selected group of individuals who have felt that they 25 -- who were on active duty and felt that they had 33 1 problems and called to do this. 2 So it is a self-selected sample. And it 3 makes it difficult in terms of what the control would 4 be. The issue of others -- I don't -- yes -- I'm 5 saying that the VA has a similar program, but that's 6 not the question. 7 CHAIRPERSON LASHOF: Well, that -- I'll 8 ask that question to accommodate Diane. In the VA 9 program, are they following the same protocol? And do 10 you have any information of where they are in theirs? 11 How many they have done and whether the data looks 12 similar or dissimilar? 13 DR. BRIX: Yes. There's a similar 14 protocol. And in fact, it is my understanding -- 15 someone from the VA or the DOD should speak up if this 16 isn't correct -- is that they worked together to 17 develop the protocol that we have been examining for 18 the CCEP. And the VA has a similar protocol. They 19 even call their protocol Phase I and Phase II. 20 I think you heard yesterday something 21 about the Persian Gulf Registry Exam. That's also -- 22 that's called Phase I. So they have a similar Phase 23 I. And there are many thousands of people who have 24 been through that program -- is my understanding. 25 They also have a Phase II. Only a small 34 1 handful have been through their Phase II as far as I 2 understand. But again, I'm not as familiar with the 3 VA program as the DOD program. But they are eligible 4 for care. 5 CHAIRPERSON LASHOF: Those that have gone 6 through the Phase I -- if this is beyond you we can 7 just ask staff to get us further information, 8 obviously, direct from VA -- does it appear similar 9 that the pattern of illness and symptom diagnoses -- 10 similar among those that have gone through the VA 11 protocol to the DOD protocol? 12 DR. BURROW: I don't think we really know 13 enough to comment. 14 CHAIRPERSON LASHOF: Okay. Fine. 15 Dr. Custis? 16 DR. CUSTIS: I would like the Committee 17 not to be -- not to have the impression that the VA 18 healthcare system is a paper system. It's highly 19 automated. The patient treatment file is only one of 20 many computerized systems. The DHCP, the 21 Decentralized Hospital Computer Program got started 22 something like 30 years ago and today compares 23 favorably with the private medical sector as far as 24 computerized data is concerned. 25 CHAIRPERSON LASHOF: Do you have any 35 1 questions to -- 2 DR. CUSTIS: I have no questions for the 3 panel. 4 CHAIRPERSON LASHOF: Dr. Caplan? Art? 5 DR. CAPLAN: I guess I would like to -- I 6 would like to get clearer about making sure that the 7 information that needs to be collected about this 8 problem is getting collected. 9 In some ways our charge is to make sure 10 that things are going well and that all that can be 11 done is being done to identify the nature of Gulf War 12 illness and problems, and set up infrastructure to do 13 things about it, both in the future and to compensate 14 those who may have been injured or become ill now. 15 And one of the things I find troubling is 16 this confusion that's broken out just over the past 17 couple of days about well, is there, is there not Gulf 18 War Syndrome? 19 And I'm looking at the response to the 20 report that you issued yesterday, the August 7th 21 report, in which you commented on the fact that there 22 was not enough evidence for the statement that there 23 was not unique illness or syndrome among Gulf War 24 Veterans. 25 My first question to you is: This report 36 1 appears to have come out after you saw an earlier 2 draft. Could you have seen a second draft? Is there 3 some reason you didn't see that before this one came 4 out? What led you to have to comment after the fact 5 on this second version of the DOD report? 6 DR. BURROW: Our comments were directed to 7 the first version. And the DOD -- I can be corrected 8 by the people next to me -- wanted their report -- I 9 mean, it was a contract -- early so that they would 10 have this -- so that we did not see the second report. 11 And the IOM has a review process it goes 12 through so that, in fact, the IOM by the time we had 13 issued our report, they had already issued the second 14 report without either of us seeing the issue. Is that 15 -- 16 CHAIRPERSON LASHOF: John? 17 DR. CAPLAN: I -- 18 CHAIRPERSON LASHOF: Oh, I'm sorry. If 19 you have another question, please, Art? 20 DR. CAPLAN: Is there a need then to make 21 sure that that sort of situation is rectified? In 22 other words, if we'd had an advisory board out there 23 trying to watch the protocol, and we're getting 24 announcements that X doesn't exist, and then we have 25 to have retractions that say well, maybe X exists. 37 1 And there are various methodological 2 reasons to think that X might exist, that doesn't seem 3 to be an optimal situation. 4 DR. BURROW: I think for an ethicist 5 that's a fair statement. 6 (Laughter.) 7 DR. BURROW: Let me go on and add. I 8 mean, you are reading the first sentence that was 9 lifted out of the paper. I mean, we do go on in that 10 report to say that if there were, as I mentioned 11 earlier -- as I said, a disability with a high 12 proportion of veterans at risk, it would probably be 13 detectable. 14 I mean, it was the need to couch the 15 statement that the DOD -- in some terms that would 16 leave it open. And it would certainly have been 17 better to be able to work that out because I think a 18 lot of it was simply a matter of wording. 19 DR. CAPLAN: Let me just ask one more 20 question about the protocol because this is important. 21 Again we want to make sure that people are clear. I 22 think we owe it to the veterans and to all Americans 23 that we not give impressions that are false about what 24 does or doesn't exist with respect to the illness and 25 the disease. 38 1 And it plays to my philosophy interest a 2 bit. We've got claims we made about who is ill, 3 what's a syndrome, what's a disease, what's a cluster 4 of diseases. And all of these things swirl around 5 this thing called Gulf War Syndrome which is a lot of 6 things -- a lot of balls up in the air. 7 My question is: When you looked at this 8 protocol, in particular the Defense Department one, 9 we've heard one comment that it may be a sampling 10 problem to talk about Gulf War Syndrome in general. 11 We want to be careful that we always 12 qualify that and say on active military. There 13 doesn't appear to be a description adequate to say we 14 have a single disease going on. 15 But what I am asking is: Are you 16 confident, even within that protocol for the active 17 military personnel, that the reporting by soldiers -- 18 they're going to feel comfortable identifying 19 themselves to go in for the physicals? 20 Are you satisfied that the comparison 21 group that was used was adequate? In other words, can 22 you tell us a little bit more -- I don't mean for you 23 to rehash the whole report -- might be improved upon 24 in terms of methods for this DOD study? 25 DR. BURROW: Well, it would have been at 39 1 the beginning to really have a comparable control 2 study. And I tried to -- we emphasized in the report 3 and the committee felt that -- we felt that in terms 4 of case finding, I mean, a responsibility to take care 5 of individuals who had reported themselves not well, 6 if you will, who had been on active duty -- that the 7 Department of Defense had merely set up a system of 8 good quality controls and delivering the best possible 9 care in an attempt to make a diagnosis of specific 10 diseases. 11 Where one gets into less firm ground -- 12 and I think the questions that our co-committee talks 13 about when you talk about the comparison groups 14 because then you have to decide who are these 15 comparison groups. 16 And I think one has to look at this as a 17 protocol primarily to deliver care to that group of 18 individuals. Hopefully that answers some of the 19 things you've mentioned. 20 CHAIRPERSON LASHOF: John? 21 DR. BALDESCHWIELER: I think it's 22 important to bear in mind that -- the potential for 23 causative factors that perhaps have not yet been 24 identified. And typically in assays that one performs 25 you only find those things that you look for. 40 1 That is, with the extremely sensitive 2 types of immune assays, for example, you only find 3 those things that you choose to look for. So it's 4 crucial, it seems to me -- the process of postulating 5 potential things to look for is a crucial part of the 6 process. 7 Do you have some thoughts as to how one 8 composes the list of things to look for? Or how well 9 that has been done in fact in this search? 10 DR. KELSEY: Well, I think that's well 11 put. And one of the goals of our work is to look 12 exactly at how questions are asked. Because as you 13 say, you only find what you look for. 14 If you look well, you are likely to find 15 the things that can be repeated and the things that we 16 want to be concerned about. If you do a poor job of 17 looking, you are likely to find things that may not be 18 so important to go after. 19 So I think one of our real concerns, and 20 in particular, one of the motivations for issuing a 21 first report was to stress that people think very hard 22 about how they are going to look. 23 We were impressed with the poor job, if 24 you will, that had been done with coordination and 25 with initial research. And this is why we felt the 41 1 pressing need to issue some recommendations for 2 ongoing work. 3 And I think your questions are good ones. 4 And they are ones that we are very concerned with. 5 And our committee has tried to cast the net broadly. 6 But the mandate is really about the health 7 consequences of the war. And I don't know if you can 8 get any broader than that. 9 So we're -- we're trying to cast the net 10 broadly and begin by really hoping that as research 11 goes forward the quality can be maintained so that, in 12 fact, we can really uncover that which we need to 13 follow up. 14 DR. BURROW: I would just simply say that 15 -- to go back to my earlier statement -- that it's 16 easier to find a disease that is there than a disease 17 that isn't there. And part of the issue that Dr. 18 Caplan is raising is exactly this question. 19 I mean, can we say that there isn't 20 something there that we haven't found. No. And so -- 21 that we haven't been able to find it with as complete 22 a study as, I think, that they could do. That needs 23 to remain an open question. And it's part of the 24 research. 25 DR. BALDESCHWIELER: But quite 42 1 specifically, does there exist an operational list of 2 things that are being tested for? And what's on that 3 list? I mean, a list of pathogens? Of potential 4 environmental factors? 5 DR. BURROW: No. Let me repeat that this 6 was self-reported individuals who said they were 7 unwell, who had an initial screening, a very thorough 8 screening. And if one could not make a diagnosis, 9 they were referred on in that at that time it was case 10 finding. 11 In other words, if they complained of 12 musculoskeletal disease, that they were thoroughly 13 evaluated for anything that was wrong in the 14 musculoskeletal system. There was not a screening of 15 any -- of the whole panel of pathogens or viruses or 16 environmental toxins. 17 DR. CAPLAN: But what -- would that be a 18 useful component of a future program? 19 DR. BURROW: I think it would be a better 20 -- part of a research program, I mean, set up to 21 specifically screen, looking for this unit 22 identification. There a number of ways of getting at 23 this. 24 DR. BRIX: I could add one thing about the 25 way the CCEP is designed. In the referral phase, if 43 1 the person has not been able to reach a diagnosis by 2 the time they have gone through the initial 3 examination, they go to a regional medical center. 4 And there is a set of tests that is 5 mandated for a variety of symptoms. And those 6 symptoms were chosen because they are the types of 7 symptoms that people are frequently complaining of. 8 So, for example, for fatigue there is a 9 list of mandated tests that anybody who goes through 10 the regional medical center, who has fatigue gets 11 those tests and those specialty -- subspecialty 12 consultations. 13 Likewise, if a person has headaches, they 14 get a mandated neurological consultation and a CAT 15 scan of the head and so on. So there is a protocol 16 that's laid out very specifically for those symptoms 17 that are very common in this group. 18 CHAIRPERSON LASHOF: Further follow-up 19 questions? 20 DR. LARSON: Yes. A follow-up question. 21 Really, I don't know if there is anybody on the panel 22 who can answer this, maybe Dr. Stoto or somebody from 23 the Institute of Medicine in the audience. 24 From Dr. Hamburg's question, the Institute 25 of Medicine for years has been the repository of the 44 1 data base called the Medical Follow-up Study, which 2 includes data from several wars. I think from World 3 War II, the Korean Conflict, Vietnam. 4 And I think there are some limitations, as 5 I understand it. In the past it has been a data base 6 of primarily, if not completely, white males. 7 And given that that's fixed, and that the 8 data base is expanded to be more representative of who 9 is in the wars, is that a potential source of -- or a 10 repository for data on the Persian Gulf Conflict that 11 could be used for long-term follow-up? 12 I'm not even sure what's in that data 13 base. Maybe you could give us some information. 14 DR. MUNDT: We -- I am, in fact, staff in 15 the medical follow-up agency. We do studies in 16 veteran populations on cohorts of data that have been 17 assembled over the years for various purposes. 18 And you are correct. They are primarily 19 in white male veterans. There are projects being 20 conducted in atomic veterans and in veterans exposed 21 to microwaves, etc. 22 The cohorts are formed primarily to do a 23 specific study. 24 There are several hundred cohorts. We 25 have no cohort data related to Persian Gulf Veterans 45 1 and Persian Gulf service at this point in time. 2 DR. LARSON: But you could? 3 DR. MUNDT: Potentially, yes. 4 CHAIRPERSON LASHOF: David? 5 DR. HAMBURG: I want to ask about the 6 possibilities for a beneficial interplay between IOM 7 committees and the government agencies, particularly 8 the DOD. In part, my question articulates with what 9 Arthur Caplan raised a few minutes ago. 10 The question is on the one hand 11 stimulation by IOM committees -- for the committees 12 from the agencies that have problems and bring the 13 problems to the IOM and say please help us figure this 14 out. 15 But on the other hand particularly 16 focusing on the feedback from the IOM committees to, 17 let's say, the Department of Defense, not only with 18 respect to procedure as we heard -- is this curious 19 disjunction in procedure in the past couple of months 20 about the latest version of the DOD report, which I 21 find puzzling and troubling frankly, but putting that 22 to one side -- substantive issues, for example, in 23 your report, Dr. Burrow, your very interesting report, 24 on page 13 and 14, committee comments having to do 25 with the likely -- say that it's likely that at least 46 1 a few CCEP patients have developed illnesses that are 2 directly related to their Persian Gulf Service. 3 And it gives some categories. And your 4 third category is psychological stress during or 5 immediately after the war. 6 And you go on to say the basis for 7 research in many fields, of course -- it's important 8 to understand that such stressors produce adverse 9 psychological and physical effects that are as real 10 and as potentially devastating as chemical or 11 biological stressors. 12 And you comment that the psychological 13 stressors of the Persian Gulf war have been 14 insufficiently examined by the DOD. That seems to me 15 a very important issue, a very constructive suggestion 16 that you make. 17 There is by now a vast body of research on 18 the biology and psychology and severe stress that it 19 appears not to have been adequately taken into account 20 recently. Although I may say the DOD has a 21 distinguished tradition of research in this field. 22 For example, the Walter Reed Army 23 Institute of Research going back to the 1950's. But 24 it seems to me that's an example. There are other 25 examples in here of a possible connection between the 47 1 IOM's work and the DOD. 2 Is it possible in real time to give them 3 feedback perhaps in more depth beyond the printed page 4 that would help the DOD to address the stress problem 5 or other currently neglected problems that are really 6 salient and should be addressed? 7 DR. BURROW: I think a great deal of that 8 interchange went on at our committee meetings, which 9 really involved interacting with the physicians that 10 were carrying out the program and a number of 11 individuals from Walter Reed and -- specifically in 12 regard to psychological stressors. 13 So I think that this is going on. I mean, 14 the committee disjunction, if you will, or committee 15 report disjunctions, needs to be resolved. 16 But I think that my -- a personal comment 17 -- that they were trying very hard to look for 18 physical causes and to attempt not to focus as 19 strongly on the psychological stressors though they 20 were aware that those were there. 21 CHAIRPERSON LASHOF: I'd like to ask Dr. 22 Kelsey whether -- we heard yesterday that there a 23 number of different epidemiologic studies going on. 24 And we did quiz the panel as to the comparability of 25 those different studies and the ability to pool the 48 1 data from all of them. 2 Certainly you've been looking at that 3 issue and at the whole -- how scientific and solid the 4 epidemiology is. I wonder if you would comment upon 5 that, and how you feel about the fact that there are 6 multiple epidemiologic studies, and how comparable 7 they are, and how well that agencies are really 8 working together to make them more comparable. 9 DR. KELSEY: Well my -- chiefly what I 10 would say is we've been provided protocols for many of 11 the ongoing studies. And we're looking at the 12 questions that they specifically want to ask. 13 It's obviously part of our mandate. And 14 I think we've urged that these things be done in a 15 coordinated fashion, subject to peer review. And I 16 think that issue is important. 17 And it's something we look at. And 18 obviously something very important for you to look at. 19 Beyond that I don't think I can comment on specifics. 20 CHAIRPERSON LASHOF: I guess part of my 21 question is: You made a series of recommendations. 22 And we clearly are going to have to look at whether 23 your recommendations are being followed. And if you 24 have any insights or ideas at this point about how 25 well -- or any suggestions for us as we look at that, 49 1 it would be helpful. 2 DR. KELSEY: Sure. And I think we'd be 3 happy to be in contact with the committee at any point 4 as well. For us, obviously, it's an ongoing process. 5 And it's -- those questions are very important. And 6 we are actively searching for and asking for protocols 7 and any information that you can provide. 8 And I think the presence of this Committee 9 has made a lot of information available to us more 10 rapidly than it might otherwise have. So it's been 11 useful for us as well. But I think that Dr. Mundt 12 would be happy to provide anything that we have that 13 you can use. 14 CHAIRPERSON LASHOF: Thank you. 15 Elaine? 16 DR. LARSON: It's pretty safe to say, I 17 think, that the resulting -- could be acute 18 musculoskeletal disease, stress, and infectious 19 disease from the indigenous area. 20 That's pretty safe. And that is part of 21 any war. What's missing here is any specific comment 22 about the testimony that we heard yesterday related to 23 autoimmune symptoms and immune dysfunctions of various 24 sorts. And I assume that's what some people refer to 25 as the Gulf War Syndrome. 50 1 You haven't commented that in your report. 2 Did you hear testimony on that? Did you see evidence 3 that that's being examined or looked for? 4 DR. BURROW: Well, I can only go back and 5 repeat that the people who had complaints -- and they 6 are listed -- were examined and if not satisfied by 7 the physician, were again looked at. 8 And what came out were specific diagnoses 9 and not large numbers of any particular autoimmune 10 disease or anything else. So the -- that in that 11 structure, nothing of this sort surfaced in any number 12 that was different than one would expect. 13 And by saying that, let me say there were 14 people who had lupus arimethrotosis, but may have had 15 it before. I mean, if you examine that many people, 16 you are going to get people with illnesses. But there 17 wasn't anything that was particularly out of the 18 ordinary. 19 CHAIRPERSON LASHOF: Dr. Custis? 20 DR. CUSTIS: In connection with Dr. 21 Lashof's question, I wonder, Dr. Mundt, would you 22 repeat your definition of the term "coordinated 23 effort?" 24 DR. MUNDT: I think that the term 25 "coordination" is something that our committee 51 1 discussed at length. And I believe that the committee 2 has looked at coordination in terms of coordinate the 3 activities and the interactions and the participation 4 of the various agencies on particular projects. 5 The word "coordination" -- it's become our 6 understanding -- relates more to the knowledge of or 7 the awareness of various activities. So I think that 8 the word "coordination" may need to be defined 9 explicitly, both in terms of how our committee 10 understands its use as well as how the various groups 11 that we are dealing with are defining the word 12 "coordination." 13 CHAIRPERSON LASHOF: Would it be correct 14 to say that we are talking about coordination and not 15 integration, and maybe we need some more integration 16 of the efforts? Or not? 17 DR. MUNDT: That's really not my place to 18 answer. 19 CHAIRPERSON LASHOF: That's our job, I 20 guess. 21 Any further questions for the -- 22 Yes? Phil? 23 DR. LANDRIGAN: Karl -- for Dr. Kelsey -- 24 Karl, on page 12 of your report you make the very 25 sensible recommendation that the VA and the DOD should 52 1 determine the specific research questions that need to 2 be answered and should develop methodologies etc. to 3 pursue those questions. 4 It sort of follows up on Dr. 5 Baldeschwieler's question. Have you given any thought 6 to what additional items ought to be on the list? 7 We've obviously heard about some: depleted uranium, 8 leishmaniasis, lead. Any others that you would like 9 to offer specifically? 10 DR. KELSEY: Well, I can comment that I 11 think our mandate is broad. And so that this second 12 report will be much broader than the first. This 13 really was an attempt to direct hypothesis-driven work 14 in the interim. And to the extent that we've done 15 that, we've accomplished our goal with that report. 16 I can -- I can't give you specifics other 17 than to tell you that clearly our second report will 18 be much more broad and address other health 19 consequences. 20 DR. LANDRIGAN: Yes. We learned yesterday 21 that there were -- there either has started or will 22 shortly be starting in the state of Iowa an 23 examination of 3,000 veterans, half of whom were 24 deployed in combat areas, and half of whom were in the 25 service at the same time, but not in combat areas. 53 1 And it seems like a nice start in that 2 direction. It would also be good, though, if that 3 effort were energized by specific hypotheses before it 4 began in fact. 5 CHAIRPERSON LASHOF: Other -- 6 DR. KNOX: I just have one more question 7 as to whether you made a recommendation, maybe, about 8 the predeployment physical, now that you've looked at 9 exit physicals from being deployed? 10 DR. BURROW: Well, I think actually it's 11 an -- if I understand the question -- it's an 12 interesting -- because clearly, I mean, there was a 13 war going on. And it's a bad way to set up an 14 experiment. 15 But if, in fact, one really thought about 16 this kind of thing before going in, there were ways in 17 terms of unit identification -- who got vaccinated, 18 when, medications that would be enormously helpful 19 later. So I think that's an area of interest. We 20 have not dealt with that. But it certainly is an 21 area. 22 DR. KNOX: One of the problems that I 23 recognize -- when you look at this study and you look 24 at the number of illnesses that the reserve components 25 complained about, their physicals on active duty 54 1 reserve are only every four to five years unless they 2 are over the age of 40. So that may be some of the 3 reason for the increased number of illnesses in that 4 group. 5 DR. BURROW: Very good. 6 CHAIRPERSON LASHOF: Art? 7 DR. CAPLAN: This is for Dr. Kelsey. In 8 your sort of overall examination of the issues -- one 9 of the things that came up yesterday in the testimony 10 we heard is that people face tremendous problems if 11 they are discharged in terms of insurance coverage and 12 follow-up. 13 I just had two questions for you. One, 14 are you looking at all at the ability of the 15 investigators to protect subject privacy and 16 confidentiality in the various inquiries that are 17 being made? 18 And, two, are they doing a good job 19 warning people about what may happen to them if they 20 get identified as having a problem or syndrome or 21 chronic condition that -- at discharge. 22 In other words, are they -- can you make 23 some recommendations not only about what's there, but 24 about the protection of the subjects of the 25 populations that are involved in some of these studies 55 1 since there clearly are consequences that aren't 2 always beneficial if you are identified as being ill? 3 DR. KELSEY: An excellent point. The 4 overarching fragmentation of healthcare really does 5 not lend itself to endeavors like the epidemiologic 6 examination of this cohort of 700,000. And I think 7 insurance is but one of the many enormous problems. 8 We have discussed at length -- and there 9 is -- it's obviously important both for the individual 10 patient and for caregiving, as well as for data 11 gathering and integration of the resources so the 12 economics of healthcare play a very big role here. 13 In addition -- and that's from our 14 standpoint. It will come out in the report because 15 that's a very important part of this. The other issue 16 of informed consent, if you will, for participating in 17 studies is a concern. And it's one that we have to 18 take into account when we advocate linking records. 19 It's, as you know, a complex problem. At 20 this point, I think we are advocating linking medical 21 records and then dealing with these problems in the 22 way that epidemiologists deal with medical records. 23 That's, I think, the model. And that's what, at this 24 point, we are really thinking about. 25 Going beyond that would require, 56 1 certainly, a rethinking of how one deals with this 2 data because it is a massive data base. And to the 3 extent that a massive data base is being put together 4 with identifiers, that's a critical question. 5 And it's further a critical question when 6 you deal also with the armed services because their 7 confidentiality has an entirely different meaning. So 8 I think your point is a good one. It's one that we 9 have thought a lot about. It certainly will be in our 10 report. 11 CHAIRPERSON LASHOF: Are there any other 12 questions? 13 (No response.) 14 CHAIRPERSON LASHOF: If not, I want to 15 thank you all very much. This has been helpful. And 16 there is no question that we will be in touch. And 17 our staff will be working closely with Kelley and 18 Diane. And any further suggestions you have for our 19 work are certainly welcome. Thank you very much. 20 The committee would like to take a stretch 21 just right here just for a couple minutes. 22 (Whereupon, the proceedings went off the 23 record at 10:14 a.m. and went back on the 24 record at 10:22 a.m.) 25 CHAIRPERSON LASHOF: Can I ask the 57 1 Committee to take their places again? 2 Well, I think we've had a very thorough 3 briefing now for a day and a half. Now we have to 4 face that task of deciding just what our job is and 5 how we are going to do it. And develop some type of 6 time line for accomplishing our goal. 7 What I'd like to do is start first with a 8 discussion of the elements of the charter. Each of us 9 has reviewed the charter ourselves. And each of us 10 discussed it at the time we agreed to serve on this 11 Committee. 12 But we haven't had a chance to discuss it 13 as a Committee, as a whole, and make sure that we all 14 interpret the charter in the same way. Or, if we have 15 differences in views about the charter and our 16 responsibilities, we need to air those and hopefully 17 reach a consensus as to what we need do. 18 If you'll turn in your briefing book to 19 tab B -- the charter is in tab B. And we might all 20 just take a look at it at this point. I think item C 21 is clearly where we are at, at which the duties of the 22 Committee are solely advisory. That, I think we all 23 understand. 24 We have no implementing authority. But I 25 think the weight of our advice -- it will carry a 58 1 great deal of weight. Let me put it that way. I 2 think there is no question that the President, the 3 First Lady, the heads of the departments, are looking 4 to us for advice. And I think they will be 5 responsive. 6 The areas at which we are supposed to look 7 are the research, which we have heard a fair amount 8 about this morning; the coordination efforts we also 9 discussed briefly and again this morning. 10 We are to look at medical treatment. In 11 that regard we have heard primarily from the veterans 12 and their families. We are to look at the outreach 13 issues, which we have had some brief questions about 14 and have been touched on. 15 And we are to look at the external reviews 16 and the -- which really refer to the IOM and others 17 and whether those have been implemented. Look at the 18 NIH reviews and the Health Technology Assessment 19 reviews. 20 We are to look at what possible risk 21 factors. We are again to look at the question of 22 chemical and biological weapons. My view of how we 23 look at those -- well, how we look at them will be the 24 subject of our major discussion. 25 I think that really covers a broad range 59 1 and leaves out only one thing. And I think it's 2 important to note what it does leave out. And it 3 leaves out the issue of compensation. It is not the 4 responsibility of this Committee to look at issues of 5 compensation. 6 And it's also my understanding of the 7 charge that as we look at each of these issues, we 8 will not be undertaking any new research. But rather, 9 we will be reviewing everything that is ongoing and 10 make recommendations about new research. 11 But within a year and a half, which is the 12 life of our Committee, it's clear that we could not 13 launch new research activities in the traditional 14 sense of research. 15 Digging into and researching what has been 16 done in that sense of research is obviously 17 appropriate. Listening and hearing and asking 18 questions and searching, rather than researching, may 19 be the way to put it. Well, that's enough said from 20 me. 21 Let me ask any of the members of this 22 group to raise any questions, feelings, their 23 interpretations of the charter itself. 24 Elaine? 25 DR. LARSON: Two comments. First of all, 60 1 it -- one of the other things that is missing is any 2 consideration about the sort of, if you will, ethical 3 or social implications of all this and whether there 4 are processes in terms of the way people were handled 5 or treated that need to be considered. And we might 6 want to talk a little bit about whether we are 7 interested in making any comments about that. 8 Secondly, obviously, we were reminded 9 several times yesterday that we are the fifth group -- 10 and there is a clear mood of discouragement if not 11 questioning about whether any of these are going to be 12 that useful. 13 The first thing we've got to do is make 14 some kind of a chart and figure out who has done what 15 in each of these areas, collect the information, 16 collect the committee reports. That's a staff 17 function. 18 We have some of them. I don't think we 19 have all of the information. And then see where it is 20 that we really can have an oversight function and make 21 some statements that will be of benefit. 22 CHAIRPERSON LASHOF: That's correct. 23 Others? 24 Art? 25 DR. CAPLAN: One of the things that has 61 1 come up a bit in our somewhat sparse comments -- but 2 it's probably the time to bring it up now -- is I 3 think it's not clear to me, although I know which way 4 I lean about this, that it's part of our mandate to 5 make suggestions about what Phil was talking about 6 earlier, the future deployments, repeating the same 7 problems in that we may want to say things about 8 either research or structure or infrastructure that 9 needs to be said. 10 And I lean toward thinking that that would 11 be important and should be part of what we are up to. 12 But it's not clear to me as I look at this that 13 anybody asked, so to speak. 14 CHAIRPERSON LASHOF: I think I can respond 15 to that in the positive. In my discussions with the 16 National Security Council and the representatives of 17 the Agency in assuming this role, that was one of the 18 things that was stressed, that they do look to us to 19 make recommendations as to how future issues of this 20 kind can be addressed so that we don't find ourselves 21 in this situation this long after a deployment of 22 troops. 23 Are there any other questions that come to 24 mind on the Committee on just reading the charter 25 itself and understanding what our responsibilities 62 1 are? 2 (No response.) 3 CHAIRPERSON LASHOF: I suspect there is 4 just one other thing that needs to be said to that. 5 And it's only fair to the veterans that they 6 understand that. We heard so much yesterday of their 7 need to have answers. 8 We are not in a position, probably, to 9 give a definitive answer for all people's individual 10 problems at the end of this time. What we hope we 11 will be able to do is to say whether or not the 12 studies that are ongoing will provide those definitive 13 answers. 14 If studies that are ongoing during the 15 course of our time give us answers, we certainly will 16 act on that and state that. But epidemiologic studies 17 take time. And what we must be sure of, I think, is 18 that everything that should be done is being done. 19 Everything that can be done is being done. 20 And if not, to identify those and 21 recommend that they be done. That is, I think, our 22 final goal. And we need to be clear to ourselves and 23 to the community at large that that's our goal. 24 Phil? 25 DR. LANDRIGAN: Yes. I think in that 63 1 vein, we heard testimony yesterday from many veterans, 2 their families, members of veterans' groups, laying 3 out a long series of diseases and syndromes and 4 symptoms that are bothering them. 5 And we saw a similar list up on the slide 6 a while ago during the IOM presentation. It behooves 7 us to look very carefully at that list and look at the 8 minutes that will be provided us to make sure that 9 we've got all the details of the testimony that was 10 presented. 11 And make sure, as you say, that each of 12 these points is being addressed, at least to the 13 extent it can be, by either the various committees 14 that are already going on, the various studies that 15 are underway. 16 And if they are not, it -- I think it's 17 our job to make suggestions as to how any gaps can be 18 filled so that, indeed, no stone is unturned. 19 CHAIRPERSON LASHOF: All right. 20 Art? 21 DR. CAPLAN: Just following up on the 22 issue of coming up with the answers. 23 I think you put it very well, Madam Chair, 24 about our inability to answer some of these questions, 25 that it's going to have to fall to those actually 64 1 doing the studies to answer some questions. 2 But we did hear yesterday as part of the 3 testimony claims about difficulties in getting 4 physicals, chilling effect if one reported complaints, 5 problems about fears of retribution, and what happened 6 in terms of loss of benefits or coverage for people 7 who are discharged and so forth. 8 And I think it might be appropriate for us 9 not again to try and solve every problem and 10 difficulty that has come up, but at least to look at, 11 again, structural means as part of the research to see 12 that those sorts of things -- what's going on and what 13 could be done to attend to some of that as well. Not 14 just, in other words, the biology, but some of these 15 administrative problems that we hear about. 16 CHAIRPERSON LASHOF: Andrea? 17 DR. TAYLOR: I guess I wanted to follow up 18 with that as far as active duty versus those who have 19 been discharged who are no longer in service -- 20 whether they are receiving the help that they need. 21 And I guess that was we heard over and over again. We 22 definitely have to address that. 23 CHAIRPERSON LASHOF: I think the last 24 couple of remarks lead us right into the next things 25 I wanted to take up as we run through, which is a 65 1 discussion of our first day and what issues came out 2 that we feel are burning that we need to look at. 3 But before I move on to that, let me ask 4 whether there are any other questions or 5 interpretations of the charter that anyone wants to 6 make any further comments on before we move into -- 7 what I planned to do was -- the structure of our 8 discussion this morning will be around, after the 9 charter, to discuss the first day and what things came 10 out and then to go systematically through what the 11 thrust of our report will eventually look like. 12 How we are going to go about -- staff, 13 what kind of staff we are going to need, and then how 14 the Committee and staff are going to function. What 15 will be staff functions, what kinds of things the 16 Committee is going to have to address as a Committee, 17 a whole, and some of the operational issues. 18 And we -- I think that will follow 19 naturally from this discussion. 20 Anybody have any other suggestions about 21 how we go about this task at this point? 22 (No response.) 23 CHAIRPERSON LASHOF: Okay. If not, then 24 let's launch into further discussion of issues that 25 people feel came up yesterday that they want to 66 1 explore further, either by getting staff to get 2 further information, or by further testimony at future 3 times. Whatever. 4 Andrea? 5 DR. TAYLOR: I wrote down a few things. 6 I've heard a lot of information regarding chemical 7 environmental exposure, or some. I am interested -- 8 one of the persons who testified yesterday talked 9 about the kerosene exposure, kerosene use. 10 So I am really interested in following up 11 on that as far as the contents of kerosene, what was 12 being actually used at the point -- in the tents for 13 heating -- whether that had any effect, along with 14 some of the other issues around, the chemical warning 15 signals that constantly went off. 16 And although we've been told that there 17 was no chemical warfare, then why would the chemical 18 warning signals go off and react? And people would be 19 asked to don their equipment as well as take the 20 tablets, the nerve tablets? 21 And that's something that I think we have 22 to investigate further, to make sure that the correct 23 studies are being done. 24 The other thing that came up -- and I am 25 sure we've talked about it before -- is the mycoplasma 67 1 incognitas. I think that's the name that we heard. 2 I've never heard of that before. 3 And I think we need some more background 4 information on that illness or disease. Actually what 5 it is. Who is getting it. How many people are 6 affected. And I think that's what I have. And also 7 the inoculations, whether that had any impact. And we 8 have had a lot of researching done on that. 9 CHAIRPERSON LASHOF: Rolando? 10 DR. RIOS: That's one of the issues that 11 came up to me yesterday -- that loomed in my mind 12 yesterday -- is to try to establish the facts, what 13 actually happened, what kind of elements were the 14 troops actually exposed to. 15 And I think that a significant part of our 16 report should be where we address every claim and what 17 the government's response to it is. We have some 18 pretty important group made up of citizens that 19 believe that the Department is hiding something or -- 20 there is this kind of suspicion that is -- I think 21 there is a broad perception that it's difficult to 22 imagine that all this happened over there and that 23 there was no exposure to chemical war agents. 24 And I think that's why people are worrying 25 that there must be something going on here, but the 68 1 government doesn't want to tell us. 2 I do think that an important part of our 3 report must address each claim and what the response 4 of the government is, and what we have been able to 5 determine -- whether or not we agree or whether or not 6 we disagree, or whether or not we, you know, we can't 7 conclude one way or the other. 8 So we've got to address the issue of what 9 are the facts, what were they exposed to. Were 10 chemical war agents there? The government has agreed 11 that they inoculated everybody. So we know that they 12 were exposed to that. 13 We all know that there was a lot of 14 kerosene, a lot of the fires from the wells. That's 15 there. Those are facts that they admit to. So I 16 think that we do need to focus on what we can conclude 17 insofar as what our troops were exposed to. 18 And I think that's going to be an 19 important part because it underlines a lot of the 20 suspicions that people have about what the government 21 is saying these days. 22 CHAIRPERSON LASHOF: Andrea? 23 DR. TAYLOR: I just thought of one other 24 thing regarding the chemical warning signals. We need 25 to know what kind of equipment was used, what was the 69 1 actual equipment, why it -- that was the one thing 2 that I wanted to ask. 3 CHAIRPERSON LASHOF: Elaine? 4 DR. LARSON: Well, first I have to make a 5 comment about the signals going off. That -- it 6 doesn't bother me as much as I think it does other 7 people. 8 And that's probably because in the past, 9 as a nurse I worked in critical care units where 10 monitors are always going off because you have them 11 set so that they go off for muscle movement and 12 everything else just so that you will check. 13 And it's very common in healthcare that 14 you have monitors for everything, EKG's and I.V. 15 lines. And they're buzzing and sort of burping all 16 the time. But anyway, it is something. 17 I think the main thing, again, is that 18 we've got to get the facts straight. Yesterday we 19 heard conflicting information. I don't know what's 20 true. There are some things that we can determine are 21 true, and not true. 22 And I think we may need some more hearings 23 specifically about the infectious diseases, the 24 microsporidium, the mycoplasma. And leishmaniasis, 25 and Q fever to a lesser extent because those are 70 1 expected. And those are endemic in the area. But 2 particularly the new things. 3 We may need some expert help in addition 4 to what's on the panel with the chemical exposures and 5 what the implications of that are. What people were 6 actually exposed to and what the implications are. I 7 think we need some expert help with the vaccine and 8 the potential for the kinds of side effects or that as 9 an exposure. 10 And then we need someone to give us more 11 information about teratogenicity and some of the 12 congenital issues that came up yesterday. That 13 factual information we need. 14 Lastly, I think we need to know what's 15 actually lost and what -- by virtue of whatever you 16 want to call it, inefficiency or whatever -- versus 17 what is available in terms of data on who got what. 18 And we may, again, want to make some 19 recommendations on what data need to be kept in the 20 future for long-term follow-up. 21 CHAIRPERSON LASHOF: Phil? 22 DR. LANDRIGAN: No. 23 CHAIRPERSON LASHOF: Any further comments 24 from yesterday? 25 Marguerite? 71 1 DR. KNOX: I just have a couple of things. 2 I think it's very important, again, that we look at 3 the predeployment physical that veterans have, 4 especially for the Reserve and Guard components. 5 Active duty army has a physical every 6 year. But that's not so. And I think some of the 7 that patients we saw with GI bleeds and myocardial 8 infarcts during the war were because people were not 9 screened well. They really were not physically fit. 10 The other thing is I want to comment on 11 the VA system. I think for the largest healthcare 12 system available, that it is a very good one. VA 13 employees do their very best to meet the needs of 14 veterans. But because of federal funding, it is 15 difficult. 16 I will admit that the VA has problems with 17 records because of the transfer from one facility to 18 the other. And that might be something that we could 19 address to the VA for an administrative purpose. 20 CHAIRPERSON LASHOF: Thank you. 21 David? 22 DR. HAMBURG: Well, our colleagues have 23 already raised a whole series of major questions that 24 came up yesterday that we should clarify. I certainly 25 agree that getting the facts straight is the most 72 1 important task we have. 2 I have to say, having been through many 3 similar exercises on other subjects, that it's easy to 4 say and very hard to do. It's very complex. We heard 5 yesterday vivid and poignant and moving accounts of 6 the suffering and the concerns and hope for our 7 veterans and their families. 8 And we have to take those very seriously 9 into account, do everything in our power to see to it 10 that those are matched up with the best available 11 scientific and professional resources of the country. 12 And that will be our ongoing and fundamental task. 13 But it is hard to do. I think we mustn't 14 be presumptuous. That is, the extent to which we can 15 mobilize the capacity throughout the country will be 16 very important. How much we an do ourselves, a 17 relatively small group -- and these issues are very 18 complicated. 19 We will need to think not only about our 20 own staff, about our own members, but I think -- how 21 do we get, for example, people who are doing the best 22 ongoing research on these thorny questions, either 23 directly vis … vis the Persian Gulf War, or in other 24 contexts, chemical agents and so on. 25 There are a number of different sources of 73 1 information that we are going to have to try to tap 2 quite systematically in the relatively short time 3 available to us. So I am not going to make 4 suggestions about that at the moment. 5 But I think, in effect, the mobilization 6 of the relevant scientific and professional 7 communities and the relevant knowledge bases is a 8 really big job. It's got to go way beyond what we and 9 our staff will actually be able to do ourselves. 10 We'll have to stimulate a lot throughout the country. 11 CHAIRPERSON LASHOF: Thank you. 12 Don? Any comments at this point? 13 DR. CUSTIS: I know it's difficult to deal 14 with anecdotal information. But on the other hand, it 15 seems to me that we possibly could make some use of it 16 by taking some samples, some examples of individuals 17 who are suffering from certain illness and follow 18 through, find out exactly what had been done for them, 19 and perhaps what is left undone, on a sample basis. 20 I think to -- we can't afford to ignore some of this 21 anecdotal information. 22 CHAIRPERSON LASHOF: Okay. 23 Art? 24 DR. LARSON: Joyce, could I just comment 25 on that -- 74 1 CHAIRPERSON LASHOF: Sure. 2 DR. LARSON: Because this is a technique 3 that the Institute of Medicine uses with some success 4 quite often. And that is the case study approach. 5 Now there's, you know, pros and cons and ups and 6 downs. 7 But it's not a bad idea to look at some 8 representative cases and follow through the system of, 9 you know, sort of a systems approach to what happened 10 to people. And I don't think that that's been done in 11 any way before. 12 CHAIRPERSON LASHOF: Okay. Let's save 13 that for when we get into the actual discussion of how 14 we are going to do the job. Right now we are 15 discussing what we need to cover, and then we will dig 16 into exactly how we are going to go about doing it. 17 Art? 18 DR. CAPLAN: One of the things that I 19 think we ought to try and cover is something about how 20 the response was mounted to this particular episode 21 and the attempt to muster information. I -- we have 22 the outcomes, if you will, the four committee reports 23 and so forth. 24 But I'm interested in knowing literally as 25 much as we can without turning it into a complete 75 1 history project. But who asked for what when, how 2 quickly, what sort of memos and requests went back and 3 forth. Because I think that would help us know what 4 are options and what's, to follow David's suggestion, 5 what's really practical. 6 I mean, it may take a year to roll 7 something forward or 18 months to get a study up and 8 put our for peer review and so forth. And that may 9 just be a reality. 10 But if you are looking at it from the 11 point of view of someone who is ill and waiting for an 12 answer, it looks like an obfuscation or a plot. 13 And I think it's our -- in some sense our 14 responsibility to get information so that we can 15 explain to people why sometimes these responses take 16 some time, and that's just going to be the way it is. 17 So I'd like to see us at least be able to 18 pull maybe some information about how we got to the 19 reports that we have with memos or documents or 20 whatever there is there. 21 The two other things that I'd like some 22 information on came up yesterday actually in the first 23 panel testimony. What are other countries doing? And 24 what were the illnesses there? And discussions to the 25 extent they've had them and so forth? I'd just like 76 1 to find out what we can about that. 2 And the third thing that occurred to me is 3 I'd like to get some information about actually -- I 4 guess what Marguerite is talking about -- what really 5 is done in terms of base line and standard information 6 collection. 7 I don't know that everybody's physical is 8 kept in a giant megacomputer somewhere. So what is it 9 that's -- what do we know, as we begin the process of 10 sending troops into war, about their health status? 11 What do we know about the indigenous risks 12 that are believed to be out in any area, from 13 intelligence reports or whatever it's going to be? So 14 what do we know when we start? 15 And then maybe we can say something 16 interesting about what we might want to try to learn 17 next time when we start. 18 CHAIRPERSON LASHOF: Fine. 19 John, do you have anything at this point? 20 DR. BALDESCHWIELER: On the basis of 21 yesterday's presentations, I would again recommend 22 that we consider carefully two specific things. One, 23 the mycoplasma incognitas, and the microsporidial 24 species that were mentioned. It seems to me that 25 those are specific things that we can follow up on. 77 1 And that would be a good use of our staff. 2 Also, one other specific issue. I must 3 say I found the descriptions of the environmental 4 exposures unconvincing, and particularly the exposure 5 to the plumes from the oil well fires. It seems to me 6 that there is an enormous amount of release of toxic 7 material in those plumes. 8 And what I thought I heard was that the 9 analysis of serum levels of specific hydrocarbons was 10 used as the measure. It seems to me this may miss an 11 important point. It meant, in particular, the -- it 12 seems to me the major risk is from particulates with 13 carcinogens that are potentially condensed on them. 14 And so it may be that the most important 15 effects of exposure are yet to come in the sense of 16 long-term, long-latency carcinogens. So it seems to 17 me that's an important one to follow up on. 18 Other observations from the presentations 19 -- it seems to me that the reports on the performance 20 of the VA system are very uneven. And long waits, 21 lost records, and so forth. 22 And here I think the case study approach 23 should be very useful, as I think tracking down, you 24 know, what happened in a few individual cases will be 25 very useful. We may find that some hospitals perform 78 1 very well, others do not. And all of that would be 2 useful input. 3 Finally, it seems to me that it's 4 essential to get some sort of credible background 5 measures of incidents of symptoms of the kinds that 6 we've -- that have been reported. Background measures 7 from control groups that are really as comparable as 8 they can be made. 9 CHAIRPERSON LASHOF: Thank you. 10 Okay. Well, I think all of those are good 11 points of things we need to follow up. If we look 12 specifically at the headings in the charter, it might 13 be one way to try to look at the broad areas of 14 inquiry and look at what kind of staffing and what 15 kind of efforts we want to carry out. 16 I mean, the first thing we were to look at 17 was the research. And it's clear that we are going -- 18 I mean, we have in our binder the research plan of the 19 -- pulled together by the VA and DOD and HHS. At 20 least all signed off on it. It's a fairly extensive 21 research plan. 22 I think there's no question that we need 23 to do an in-depth -- we need staff to do an in-depth 24 review of that research plan, to understand its 25 status, to look at how comparable the various -- the 79 1 issues I raised about comparability of that area. I 2 think that's a lot of staff work that needs to go on. 3 I guess one of the questions for us is how 4 do we as a Committee address that versus what we have 5 staff try to do and what things you would like to have 6 further Committee meetings specifically address? 7 Phil? 8 DR. LANDRIGAN: Yes. I think there's a 9 basic principle here. And it was enunciated by the 10 folks from the IOM this morning. And I'd like to 11 underscore it. And that is that the results of the 12 various registries that were presented to us yesterday 13 by DOD and VA are nothing more than that. They are 14 registries. 15 In other words, these are tabulations of 16 symptoms in a lot of people, but a relatively small 17 and self-selected fraction of the total population 18 who, for whatever reason, have come forward. There is 19 no -- nobody concedes for a moment that these -- that 20 these registries constitute prospectively designed 21 hypothesis-driven epidemiologic studies. 22 So I think that we have to distinguish 23 carefully between the results of those registries 24 which throw up clues, but are really almost totally 25 unequipped to answer definitive questions. 80 1 We must distinguish those from true 2 epidemiologic studies such as the one we were told is 3 about to be undertaken in Iowa, where a serious effort 4 is going to be made to compare exposed and unexposed. 5 I don't know if that's a perfect study or 6 not. I simply haven't seen the protocols. I have 7 heard that some folks have concerns about it. I don't 8 know those concerns. 9 But I think those are issues that we need 10 to keep clear as we proceed, as we develop lists of 11 exposures that we think ought to be subjected to 12 epidemiologic study. 13 We have to do the testing of those 14 exposures in properly designed epidemiologic 15 protocols, and not merely rely upon the registries to 16 throw out the answers. 17 CHAIRPERSON LASHOF: Any further -- I 18 agree. And I want to caution us -- further thoughts 19 about how we go about evaluating the ongoing research 20 projects and whether, since the key question we'll 21 have to address is: Are these research projects ones 22 that will give the answers? Are there new research 23 projects that need to be done? 24 Certainly we need a lot more briefing from 25 staff. This book is pretty extensive. And I don't 81 1 know how many of you were able to go through the 2 reports in it. But we need to do that. But there are 3 lots more reports that we didn't put in the book that 4 we need yet to digest. 5 Marguerite? 6 DR. KNOX: Apparently Dr. Brix was under 7 the impression that the information already existed 8 about the patterning and aggregating of certain 9 diagnosed diseases and the undiagnosed illnesses in 10 the Gulf War Veterans that were not mentioned in the 11 DOD report. And so maybe that would be easily 12 obtainable as well. 13 CHAIRPERSON LASHOF: David, you raised a 14 lot of questions about the psychological stressors. 15 Do you have recommendations about -- in this -- under 16 the heading of research, if you will, how we might 17 address learning more about what we need to know on 18 this score. 19 DR. HAMBURG: Well, operationally we 20 probably need someone on staff who is a specialist in 21 that area. I understand that there are bound to be 22 concerns that stress will not be treated in a proper 23 scientific and rigorously medical public health way, 24 but rather as a way of dismissing the difficulties 25 that veterans and their families have. 82 1 At the extreme, and some times past, there 2 has been -- had the implication that well, there is 3 just a kind of malingering. You know, it's kind of 4 made up. It's invented. It's not real, etc. 5 And that of course is a depreciatory 6 stance which evades responsibility on the part of the 7 officials or institutions who are coping with the 8 problem. That is not what I am talking about. 9 There is a very serious question of how 10 severe stress affects the endocrine system, for 11 example, the cardiovascular system, possibly the 12 immune system, and so on. It's a very extensive body 13 of research over about half a century which has been 14 coming to fruition in the past decade. 15 And I think it just simply has to be taken 16 into account. And it's one of the technical areas we 17 need to cover, being mindful of the distortion to 18 which that area is always susceptible as a kind of a 19 cavalier dismissal of serious problems, which is 20 obviously not the way in which we would treat it. 21 CHAIRPERSON LASHOF: In that regard 22 certainly we would want to add someone on staff. 23 Would you see that as an issue that we ought to have 24 some further panel and hearing about? Bringing in 25 some experts in that field? 83 1 DR. HAMBURG: Well -- 2 CHAIRPERSON LASHOF: We can wait on 3 deciding that. But -- 4 DR. HAMBURG: To the extent we -- it's 5 part of a part of a kind of systematic even coverage 6 of major problem areas. I wouldn't give it a higher 7 standing with let's say the sorting out of possible 8 chemical agents. But it's in that same ballpark. 9 CHAIRPERSON LASHOF: In the same category? 10 DR. HAMBURG: Yes. 11 CHAIRPERSON LASHOF: Fine. 12 Don? Any further thoughts on this aspect? 13 DR. CUSTIS: I think you've pretty well 14 covered it. 15 CHAIRPERSON LASHOF: Art? 16 DR. CAPLAN: One set of information that 17 I think it might be useful to have -- I don't know 18 that everybody has to get it -- but clearly for many 19 of these protocols, when we heard testimony yesterday 20 there were claims made about nonstandardization or 21 incomplete interview things. 22 We have been asking about standardization 23 for information. I would just like to see us 24 archivally get some staff person who could read, 25 store, collate, tell us what's in the basic protocol 84 1 documents. We need somebody who is savvy to be able 2 to read them and call them up and just tell us whether 3 they look comparable or not, or incomplete or even 4 incomprehensible, Lord only knows. 5 CHAIRPERSON LASHOF: Fair enough. 6 John? 7 DR. BALDESCHWIELER: One additional 8 thought. There has been so much previous work and 9 layers of study and analysis upon study and analysis. 10 And I think we saw some of the problem this morning. 11 That is the distinctions between what was 12 literally in the IOM and DOD reports and what was said 13 about what was in the DOD and IOM reports and those 14 seem to be completely orthogonal sets of statements. 15 And so, you know, I think we will have to play some 16 role in sorting all of this out. 17 CHAIRPERSON LASHOF: I think that's a very 18 important point. It was an issue that was raised with 19 me early by the White House group -- is the importance 20 of our thinking through how we communicate with the 21 public about the issues as we do our work, not just at 22 the end when we have a report, but as we go along to 23 be sure that we think through what's the best means of 24 communication beside being on C-SPAN or the newspaper 25 articles, what we want to do in a more proactive way 85 1 ourselves. And that's an issue we'll take up. 2 All right. Well, from that I would say 3 that, you know, in the research area we would 4 certainly want on staff epidemiologic expertise and 5 environmental risk assessment expertise. 6 I think, John, you've raised a lot of 7 questions about the environmental risk. There has 8 been at least one fairly scientific or technical study 9 on risk assessment that I don't pretend that I have 10 completely digested, or frankly, completely 11 understood. 12 But I think we do need some people to do 13 that and obviously I would look to -- the members of 14 the committee have different expertise. I would hope 15 they would concentrate their efforts in that area and 16 take a look at that and make specific recommendations 17 to staff. 18 And if they can help us identify not only 19 people to put on staff, but consultants that we could 20 call in, people that -- the contracts that we might be 21 able to give for consulting efforts. We can go both 22 ways. We have funding for staff as well as for 23 consultants. And we can commission reports to us 24 analyzing reports, if you will. 25 Don? 86 1 DR. CUSTIS: You know, it occurs to me 2 that the statements that were made that the people who 3 put out the fires that were complaining of no illness 4 -- in what depths that has been pursued. 5 That category of people remind me of the 6 ranch handers in the Agent Orange group who were in, 7 you know, were studied with some intensity. I would 8 think that the people who put out the fires would be 9 a very important source of information. 10 CHAIRPERSON LASHOF: Okay. 11 DR. LANDRIGAN: May I -- 12 CHAIRPERSON LASHOF: Yes. Sure. 13 DR. LANDRIGAN: I think that's an 14 excellent suggestion. And it sort of goes back to 15 what I was talking about yesterday, with the need to 16 use our common sense, our instinct, and our ears to 17 find subgroups within this enormous population of 18 700,000 people who might have had particularly intense 19 exposures. 20 And sometimes it's much more fruitful to 21 look at a few hundred people who are heavily exposed 22 than many thousands who were minimally exposed. And 23 I wonder if there is some systematic way that we can 24 seek to learn about such groups. 25 There is usually somebody who knows about 87 1 those groups, but you have to find that somebody. And 2 that might be worth some thought. It's a detective 3 process. 4 CHAIRPERSON LASHOF: Okay. I think that 5 would be a good detective process for one of the staff 6 people. It's also one of the reasons that I raised 7 the question of how much longer it's going to take 8 them to do that geographic identification. I really 9 don't understand why this long after, we don't know 10 who was where, and when. 11 All right. Let's move into the clinical 12 care area. It's obviously a major issue that came up 13 from yesterday and how we might tackle looking at the 14 clinical care. 15 One is to consider one of our panel future 16 meetings -- be a panel of physicians who have been 17 caring for veterans, both at the VA and some of the 18 other sources of care that veterans have sought out. 19 But I am open to any idea and suggestions along that 20 line. 21 Elaine? 22 DR. LARSON: Here I think Don's suggestion 23 about case studies is relevant. And if we are going 24 to do panels, I'd like to see not just physicians 25 there, but also -- there's no such thing as a typical 88 1 patient, but somebody who's been a client in the 2 system and perhaps some of the nurses as well because 3 there's a different perspective from those delivering 4 care, outpatient care in the system. 5 CHAIRPERSON LASHOF: Marguerite? 6 DR. KNOX: I think it might be beneficial 7 for the panel as well to get some kind of 8 understanding about how the VA works. 9 CHAIRPERSON LASHOF: Yes. 10 DR. KNOX: Any Gulf War Veteran or any 11 veteran of any kind can go into the VA system for an 12 emergency. If you are not a service-connected 13 veteran, not just coming for a physical, the rules and 14 regulations are very different. 15 So I think it would behoove us to educate 16 ourselves, those of us that are not as familiar to 17 know what the differences in that care is. 18 CHAIRPERSON LASHOF: Okay. Fine. 19 DR. RIOS: I know that I have been 20 contacted by a couple of doctors in Texas who have 21 some Gulf War Veterans who are their patients and have 22 indicated that they would like to present information 23 to this Committee by way of a panel -- 24 CHAIRPERSON LASHOF: Yes. 25 DR. RIOS: With their patients and give 89 1 you their perspectives. And I think that would be 2 worthwhile. 3 CHAIRPERSON LASHOF: Okay. You give that 4 kind of detailed information to staff. 5 Art? 6 DR. CAPLAN: That might be a good 7 opportunity for the Committee to maybe think about 8 going to the VA and doing it there. 9 CHAIRPERSON LASHOF: Yes. 10 DR. CAPLAN: My school has a -- at Penn. 11 there is a pretty extensive program now on 12 rehabilitation. And they are interested -- made an 13 offer that maybe we might want to come and both listen 14 and look. 15 CHAIRPERSON LASHOF: Okay. 16 David? 17 DR. HAMBURG: The VA system is not the 18 whole story by any means. But it is an important part 19 of this. And so there are at least two things that 20 occur to me that might be a useful way for us to get 21 an overview. 22 One is that there have been periodic 23 really major reviews of the VA care system by one or 24 another part of the National Academy of Sciences. I 25 don't know if there has been a recent one in the past 90 1 few years. Some of them in the period of 15 or so 2 years ago were really well done, very thoroughly done, 3 enough that they created some flurry of resistance in 4 various circles. But if there is a recent one, we 5 ought to find that out. 6 Secondly, Dr. Kizer, who appeared here 7 yesterday, has been given, I think, the lead role in 8 pushing a major extensive reform. And we probably 9 should find out about that insofar as it's likely to 10 affect Gulf War Veterans and their families and maybe 11 many aspects that go far beyond that. 12 Obviously there will be. But at least 13 that -- how it would impinge would -- for example, 14 it's conceivable that a reform which in general would 15 be very invigorating for the VA might have some 16 adverse side-effects for Gulf War Veterans. I haven't 17 the foggiest idea. But I think since that is 18 perceived at the moment as a major undertaking, we 19 ought to learn what is the nature of that reform. 20 CHAIRPERSON LASHOF: Okay. 21 DR. LARSON: Joyce, obviously -- 22 CHAIRPERSON LASHOF: Yes, Elaine? 23 DR. LARSON: It goes without saying that 24 we want to do an analogous thing on the active duty 25 side. 91 1 CHAIRPERSON LASHOF: Pardon? 2 DR. LARSON: I think we want to do an 3 analogous effort on the active duty side as well. 4 CHAIRPERSON LASHOF: Yes. 5 DR. LARSON: In terms of medical care. 6 CHAIRPERSON LASHOF: The DOD is also -- I 7 think Steve Joseph has been ordered to do -- or, 8 ordered is probably the incorrect term, but is 9 undertaking a review of the total medical service at 10 DOD and looking at whether that needs to be 11 reorganized or not. And so I think we can get an 12 update. 13 I think we have to be careful we don't get 14 into too broad in those areas and confine it to the 15 issue, as you point out, that what will be the impact 16 of how they are looking at on the Gulf War Veteran and 17 not try to put ourselves as another panel to critique 18 the reevaluation in the VA and the DOD, but focus on 19 that in relation to the Gulf War Veterans. 20 Any other thoughts about the clinical 21 care, diagnostic treatment? I think we need to know 22 more about the VA registry. I mean, we've gotten this 23 detailed report on the DOD registry. 24 But we don't know whether the data are 25 similar for the VA registry yet and how soon that data 92 1 will be available. And to understand how those 2 examinations are being done, I think we need more on 3 that. 4 DR. BALDESCHWIELER: In the spirit of the 5 case study, it might be interesting to try phoning 6 some of the 800 numbers and see -- 7 (Laughter.) 8 CHAIRPERSON LASHOF: To see what happens 9 when you call. 10 DR. BALDESCHWIELER: To se what really 11 happens. 12 CHAIRPERSON LASHOF: All right. Well, one 13 thing we could certainly do is have staff supply all 14 the Committee members with 800 numbers and ask every 15 one of us to make a few calls and find out what 16 happens. 17 DR. BALDESCHWIELER: As an 18 experimentalist, I think this is often very 19 illuminating. 20 CHAIRPERSON LASHOF: That'll be our own 21 original research. 22 DR. LARSON: Actually I was going to do 23 that last night. But I ran out of time. Seriously. 24 CHAIRPERSON LASHOF: Okay. Outreach is 25 another area. I mean, I'm sort of running down our 93 1 charter area as you can see. Outreach was the next -- 2 certainly the panel we heard yesterday was our first 3 effort at outreach. 4 And Tom McDaniels, who was at my side 5 during that, is the staff person -- we've brought 6 aboard staff to work on the outreach -- and was 7 instrumental in contacting and getting that group up. 8 We have to admit that, you know, he has not been on 9 board very long. 10 And we weren't able to do the kind of 11 outreach we ought to be able to do in the future. For 12 our very first meeting, we had to pull this one 13 together very quickly. 14 DR. RIOS: Along those lines, are we 15 planning to have hearings out in the field? 16 CHAIRPERSON LASHOF: That's open for 17 discussion. I would like to hear how people feel 18 about hearings in the field, whether those ought to be 19 numerous, limited, whole committees, subcommittees, 20 specific areas, how we decide where -- 21 DR. RIOS: I don't know what's out there, 22 but I think the idea of getting away from Washington 23 and hearing from people out in the field might be of 24 some benefit because out there that have something to 25 say about this. 94 1 CHAIRPERSON LASHOF: I agree. 2 Don? 3 DR. CUSTIS: One option we might consider 4 would be to contract for some focus group sessions on 5 the part of -- contract with people who know how to 6 handle a focus group, you know, organize focus groups. 7 CHAIRPERSON LASHOF: Yes. 8 DR. CUSTIS: And get a sampling of 9 patients who have been treated. 10 CHAIRPERSON LASHOF: I think that's -- 11 DR. TAYLOR: I missed something Donald 12 said. He was saying contract with -- 13 DR. CUSTIS: There are commercial outfits, 14 you know, that do nothing but handle focus groups. 15 CHAIRPERSON LASHOF: Don? 16 Phil? Sorry. 17 DR. LANDRIGAN: Yes. I think -- I think 18 field hearings might be useful. I think that maybe 19 two topics where they could most fruitfully 20 concentrate would be on medical care and outreach. I 21 think research is probably less likely to be 22 illuminated by those. 23 CHAIRPERSON LASHOF: Elaine? Did -- 24 DR. LARSON: Well, just a point of 25 clarification. My understanding of outreach here is 95 1 not to discuss how we are going to communicate or go 2 out, but it's to evaluate government-sponsored 3 outreach efforts. 4 CHAIRPERSON LASHOF: That's true. 5 DR. LARSON: So we're -- 6 CHAIRPERSON LASHOF: That's right. Yes. 7 DR. LARSON: To do that two times a year. 8 CHAIRPERSON LASHOF: That's right. You 9 are right. 10 DR. LARSON: But related to the -- related 11 to the topic or our assignment -- 12 CHAIRPERSON LASHOF: Assignment. 13 DR. LARSON: In addition to checking out 14 the 800 numbers I think it would be very useful if 15 anybody has any information about when they started 16 and the extent to which they have been used. It 17 probably isn't possible to get a good sense. 18 But you asked a question yesterday about, 19 okay, we've got these numbers. Do people know about 20 them? How many veterans use the Internet? How many 21 people use a computer? And we need to kind of -- my 22 sense is our mandate is to look at that. Are the 23 appropriate mechanisms being used? 24 I thought the panels yesterday were very 25 responsive. They said, "we are using multiple 96 1 methods" etc., etc., which is what you would want to 2 hear. But we need to get some sense of what media 3 campaigns there have been. 4 Has there been anything on the -- on 5 television? On radio there has. But the question is: 6 Is it appropriate? And is it occurring only at 2:00 7 a.m.? Or, what's going on? 8 CHAIRPERSON LASHOF: Yes. And also 9 newsletters. You know, what newsletters are going 10 out? What kind of mailings? We ought to archive all 11 of those and analyze them. 12 Art? 13 DR. CAPLAN: That's a great area for a 14 contract. One of the things I have been interested 15 over the years is working on tissue donation. And 16 there are, again, firms that just do a nice job in 17 tracking. 18 They can answer the question for you about 19 who knows about the 800 numbers. And does anybody 20 ever read newsletters that go out. And that sort of 21 thing. 22 That's a great place to get somebody with 23 good expertise on media outreach and let them look at 24 this. And they'll call other veterans' samples and 25 find out who has been looking at what and do they know 97 1 about the numbers and that sort of stuff. 2 CHAIRPERSON LASHOF: Yes. That's a very 3 good point. We can look into that. 4 DR. TAYLOR: Are there government support 5 groups at all in relation to Gulf War Veterans 6 illnesses? Is there any kind of support group 7 network? Does anyone -- 8 CHAIRPERSON LASHOF: That's a good 9 question. 10 Yes? 11 DR. RIOS: Down in San Antonio there's a 12 group called the Gulf War Veterans Support Group 13 Network. 14 CHAIRPERSON LASHOF: There is a national 15 organization of -- 16 DR. TAYLOR: But are they government- 17 sponsored? Or are they on their own with funding from 18 the outside? 19 DR. RIOS: The one in Texas is on its own. 20 DR. TAYLOR: Okay. 21 CHAIRPERSON LASHOF: The one I was 22 contacted by is on its own. 23 DR. TAYLOR: Okay. 24 CHAIRPERSON LASHOF: Do you know one, 25 Marguerite? 98 1 DR. KNOX: My experience has been most of 2 them are on their own. However, I would commend them. 3 They have a great network. They got the information 4 to everybody about this meeting. 5 CHAIRPERSON LASHOF: With the Internet 6 coming up on line I think we ought to look at, in more 7 detail, where those computers are going to be, how 8 useful they are to the vets, how many of them know 9 about it, how user friendly they are, whether they are 10 the difficult ones or the easy ones to get into and so 11 on. 12 DR. CAPLAN: One other thing I was going 13 to comment on about outreach -- if you talk to some of 14 the schools of communication in addition to Internet 15 things, it's possible to put on location things like 16 video disks and other technologies which some people 17 hope are going to start showing up in the library 18 system and in other places where people could find 19 them and know that there's some hope. 20 That maybe -- in Pennsylvania that there 21 is going to be this commitment to put a computer 22 terminal and a CD ROM type player in every library. 23 And that's the sort of place where people could go and 24 get a CD ROM disk that has information about this and 25 who to report to and that sort of stuff. 99 1 So I think we should think very broadly 2 both about what's out there now and what might 3 reasonably be out there that people could really use 4 that may not own a computer or know anything about 5 them or some of these other information technologies. 6 But a lot of cable stations, a lot of 7 technology coming out there -- it may be that in five 8 or ten years if we recommend it there could be some 9 effort to put that into play. So it's not just the 10 Internet, there's a lot of other tactics out there to 11 get information out. 12 CHAIRPERSON LASHOF: So our charge in 13 outreach really is one to look at what is going on in 14 outreach now, what we would recommend ought to be in 15 the outreach, as well as the other aspect that I had 16 started off on and -- how we outreach. So we've got 17 three aspects of outreach there that we'll need to 18 address. 19 DR. CAPLAN: We'll have to get an 800 20 number. 21 (Laughter.) 22 CHAIRPERSON LASHOF: Do we have an 800 23 number? 24 DR. CAPLAN: No. 25 CHAIRPERSON LASHOF: Okay. We'll talk 100 1 about that. 2 The next thing I had listed down to take 3 a look at was the question of the implementation of 4 past recommendations. As we know, there have been 5 others' reports and there have been recommendations. 6 I don't know that there's been any 7 systematic review of all the recommendations that have 8 been made and what's happened to those recommendations 9 and what is the status of the implementation of those 10 recommendations. 11 And Robyn Nishimi and I have been 12 discussing, you know, what maybe our first focus might 13 well be. And it seems to me that that's a logical way 14 to get at this to start. 15 Any thoughts about that? 16 Andrea? 17 DR. TAYLOR: I guess all of the 18 recommendations -- there are so many that have been 19 listed. And I guess it goes back to the agencies -- 20 the DOD versus the VA system. 21 I guess -- is it our responsibility to 22 accomplish where these recommendations are and try to 23 investigate the implementations from that end? And 24 how will that be accomplished? I mean, I have a hard 25 time with OSHA doing follow up on inspections. So I 101 1 am just -- 2 CHAIRPERSON LASHOF: I think to the extent 3 that it is possible -- and, you know -- for some 4 recommendations it's going to be easy to find out 5 whether they are being followed. 6 Specific recommendations on clinical care 7 and every physical exam will be very difficult for us 8 to know whether they are being implemented in the 9 field. All we can do is look at whether the 10 information got out to the field and so on. 11 Others in terms of the epidemiologic 12 studies that have been recommended by IOM -- whether 13 they have been started and where they stand should be 14 easy for us to find now. 15 And I do think the President and the White 16 House are looking for us to take a look at the 17 recommendations that have been made and let him know 18 whether they are being implemented or not being 19 implemented. 20 DR. TAYLOR: And make suggestions -- 21 CHAIRPERSON LASHOF: And make suggestions. 22 DR. TAYLOR: And make suggestions on how 23 to get them implemented. 24 CHAIRPERSON LASHOF: Yes. That's within 25 our charge. 102 1 David? 2 DR. HAMBURG: Yes. I think that's very 3 important to do. That's why I raised with some of the 4 government people about what mechanisms of 5 implementation they had or could construct to pursue 6 the thought for recommendations it could put out 7 there. 8 I think we could ask every relevant agency 9 their response to perhaps a defined set of 10 recommendations that have made by serious bodies that 11 have looked into this up to now. 12 And their reaction, their commentary -- 13 probably to a considerable extent they have already 14 reacted. They may have reason, basis, for rejecting 15 some of the recommendations. But the most treacherous 16 territory is where the response is essentially, "Yes. 17 We agree some day, some how we are going to do this." 18 And I think we need, therefore, to press 19 them for rather specific steps being taken and -- and 20 questions about mechanisms of implementation. I asked 21 twice about this coordinating board yesterday. And I 22 have to say the responses, though earnest and in good 23 faith and pleasant, were not very informative. 24 I -- it may be that this coordinating 25 board has real potential to move the agenda of serious 103 1 recommendations toward implementation. But that isn't 2 obvious to me from what we heard yesterday. 3 So I would want to know not only about 4 their response to major recommendations, especially 5 converging recommendations, but also about the 6 mechanisms they have in place or they are thinking of 7 constructing through which they would be likely to 8 respond effectively one way or another. 9 Not assuming that they accept all. But 10 yes or no. But if no, why. And if yes, what concrete 11 steps are being taken. 12 CHAIRPERSON LASHOF: John? 13 DR. BALDESCHWIELER: There's a significant 14 danger in asking a large agency such as DOD for their 15 response to a set of recommendations because they will 16 assign a staff officer to write you something, which, 17 you know, typically is not going to be very helpful. 18 A much more powerful approach, I think, is 19 to look at the end point. And to literally once again 20 look at some cases and see what is happening. I mean, 21 see what's really happening at the -- at the point of 22 care, for example. 23 And if you find some, you know, outrageous 24 inconsistency there, that will certainly elicit a 25 response through the system, I think, much more 104 1 effectively than asking for a bureaucratic response to 2 a set of recommendations. 3 CHAIRPERSON LASHOF: I -- pardon? 4 DR. CUSTIS: So little faith. 5 (Laughter.) 6 CHAIRPERSON LASHOF: I think that does 7 vary with the kind of recommendation. I think the 8 point is very well taken. There are some 9 recommendations that they will tell you, "Oh, yes. We 10 are doing this." But you have to go out in the field 11 and find out whether they are. 12 There are other recommendations like we 13 are going to do this study, and here's where we are in 14 the study and so on. And we'll work with the protocol 15 and so on. So, yes. I think both those points are 16 well taken. 17 Anything else on the implementation of 18 past recommendations? 19 (No response.) 20 CHAIRPERSON LASHOF: Okay. Moving ahead 21 to the hazard exposure assessment, including the 22 chemical and biological weapons. Well, we have talked 23 about that as an important issue that came up 24 yesterday. And clearly, it's one that we are going to 25 have to look into. 105 1 We have on staff, or pending to be on 2 staff very shortly, someone who has military 3 background in the area of chemical and biological 4 weapons who will have the clearance necessary to dig 5 into the records and review all of that. 6 There have been previous studies. Our 7 first thing is to review those, find out the validity 8 of those, see if there are areas that we feel that 9 haven't been looked into that need to be looked into 10 further. 11 And we have to be careful that we don't 12 start from scratch on all of these, and that we look 13 first at what's been done, and then try to analyze 14 those and see whether more needs to be done. 15 Yes? 16 DR. RIOS: On that, I noticed yesterday 17 when we asked them about bombing patterns and what 18 approach the military used on how to decide where to 19 drop their bombs and where not to drop them, 20 apparently a lot of that information is still 21 classified. 22 Whoever we bring in would have to be 23 somebody that knows everything about military planning 24 and what the ramifications are -- dropping bombs in 25 certain areas. I would assume that -- is that -- do 106 1 you have somebody in mind already? 2 CHAIRPERSON LASHOF: Yes. 3 DR. RIOS: In mind already? 4 CHAIRPERSON LASHOF: Yes. And he does 5 have that kind of background. We'll get the CV's for 6 all these people. I haven't wanted to put out the 7 CV's until they were processed and aboard. But we'll 8 get them as soon as they have been cleared and we'll 9 be on to all of you. 10 And keep in mind that what we aren't able 11 to -- the expertise that we are not able to obtain as 12 full-time staff here we can bring on as consultants on 13 a part-time basis. 14 So as we proceed through our process and 15 we put staff on -- and you'll get the detailed CV's -- 16 and then if you feel that there are areas that there 17 are gaps -- and we can identify consultants to bring 18 in to do those. But we have looked at someone that we 19 think will fit the bill for -- in that area. 20 DR. KNOX: Do you mind if I -- 21 CHAIRPERSON LASHOF: Certainly. By all 22 means. 23 DR. KNOX: I think we need to look at a 24 point that someone made yesterday. And that is about 25 the chemical and biological warfare that cannot be 107 1 accounted for, that Saddam had. So I think that's 2 something that we need to look at. 3 CHAIRPERSON LASHOF: John? 4 DR. BALDESCHWIELER: A useful field trip 5 might be to Aberdeen, Edgewood, to have a look at the 6 various sensors and detection systems. I think that 7 would -- for those who haven't seen that, that would 8 be a potentially useful trip for the Committee. 9 And one other aspect in this category. 10 There have been, I think, so many concerns raised 11 about the prophylactic drugs, about the pyridostigmine 12 bromide and the vaccines that it would be useful to 13 have a thorough review of what's known from the 14 standpoint of the original FDA files on these 15 documents. 16 And also from the standpoint of the 17 anthrax vaccine, the British troops of course I think 18 were all vaccinated. And I don't know if the source 19 of the vaccine was the same. I suspect it was not. 20 But -- that is that the U.S. troops 21 received vaccine from the Michigan state origin. And 22 some from the British origin as well. But I think a 23 comparison in that regard would be extremely 24 illuminating. 25 CHAIRPERSON LASHOF: I think that maybe 108 1 another area where we would have a panel present to 2 the full Committee -- I mean, we would get staff to 3 get background information, but this is something that 4 deserves a panel presentation. 5 And a little further down the line after 6 we get all this on the table, we will sort of go back 7 and try to figure out what panels we want at the next 8 meeting and the following meeting, and some kind of 9 time line on that. 10 DR. BALDESCHWIELER: Are the -- the 11 botulinum toxin has not been mentioned. 12 CHAIRPERSON LASHOF: Yes. 13 DR. BALDESCHWIELER: But that one was also 14 distributed to a limited number. I think -- of the 15 order of 8,000 U.S. troops received that. And it 16 seems to me that that would be an important part of 17 that review as well. 18 CHAIRPERSON LASHOF: Yes. Okay. Fine. 19 Other thoughts on this one? 20 Elaine? 21 DR. LARSON: Yes. I was going to concur 22 that the most efficient way for us to deal with this 23 factual information about vaccines and these chemicals 24 is with expert panels. 25 But when I am looking at charge number 7, 109 1 I guess I do need a little clarification on what we 2 are supposed to be doing. It just says regarding 3 chemical and biological weapons, we are to: 4 "review information related to 5 reports of possible detection of chemical 6 or biological weapons during the Persian 7 Gulf Conflict." 8 Well, what are we supposed to do with it? 9 And hasn't that been done? I am not exactly clear 10 what we are supposed to do with that information. 11 CHAIRPERSON LASHOF: I think what we are 12 supposed to do is look at the previous studies about 13 that and the response and why they've been passed off, 14 and see whether we think there is any stone unturned 15 or whether we are satisfied that it has been 16 adequately addressed. 17 DR. TAYLOR: Because we did hear yesterday 18 that there was no chemical warfare used. Right? 19 CHAIRPERSON LASHOF: Right. 20 DR. TAYLOR: So -- 21 CHAIRPERSON LASHOF: I guess we can read 22 the newspapers and see when the defector from Iraq is 23 going to testify before the U.N. on their chemical and 24 biological warfare. We may get some information. 25 He's going to testify soon. So stay tuned. 110 1 David? 2 DR. HAMBURG: I think there is a general 3 principle there. I think you are absolutely right, 4 Joyce, that we need to start with the existing 5 reports, the serious ones that are science based to 6 the extent possible. 7 But then we also need to look for updates. 8 In the case we were just talking about now, there are 9 some conceivable updated. One was raised yesterday 10 about this U.N. technical group, I guess the group 11 that's headed by Rolf Ichaeus. They've been in and 12 out of Iraq quite a bit since the prior reports were 13 published. 14 And it may be that there is something of 15 importance there. I think you are absolutely right 16 about these recent defectors -- may well be a source 17 of information. 18 In any case, the principle is in each -- 19 in each case, we build on what's there, but we ask 20 about updates. Is there new information? Or are 21 there approaches that have never been taken that are 22 feasible to take? It should be built upon the 23 previous reports. 24 CHAIRPERSON LASHOF: Okay. 25 Don? 111 1 DR. CUSTIS: I think we ought to find out 2 if the American Legion has a source of information 3 that is not generally known. 4 CHAIRPERSON LASHOF: Pardon? Could you -- 5 DR. CUSTIS: I think we ought to find out 6 whether the American Legion has a source of 7 information that is not generally known. They make 8 some pretty categorical statements. 9 CHAIRPERSON LASHOF: Well, all the 10 testimony we heard yesterday, you know, much of it was 11 abbreviated. We will have full records from all the 12 people who testified, and we can have staff follow up 13 and get additional information on any points that were 14 raised that we feel are not adequately covered. 15 And it will be quite a research task. All 16 right. Moving on then to the bioethics and humans and 17 subjects protection area. 18 Why don't we let you, Art, kick that one 19 off for us -- and what you think we need to do and 20 look at in that area. 21 DR. CAPLAN: I think there's really two 22 divisions there to look at that occurred to me as I 23 was listening to the testimony. One is sort of the 24 research ethics question: What can we do to protect 25 those who are asked to take experimental or innovative 112 1 things? 2 The drugs, the vaccines, that whole issue 3 should be looked at in terms of what they were told, 4 risks that they were going to face, what's practical, 5 what's silly in the context of active or imminent 6 conflict. 7 I think there's some questions about how 8 we are doing now in terms of protecting subjects as we 9 try to understand what happened. 10 And that's what I was asking of the last 11 panel in terms of identified information, loss of 12 insurance, the information going back to employers, 13 other third parties, that sort of thing. 14 So there are a set of issues about the, if 15 you will, research or innovative things that might 16 have been done to troops -- or during or just before 17 the conflict. 18 And then as we try to assess what they are 19 exposed to and what the ability is of these studies to 20 figure out what happened, how well do we do in making 21 sure that their welfare is protected? 22 And then there's the ethical issues on the 23 clinical side. How well does the system deal with 24 them? Are they informed? Do they get humane and 25 respectful treatment when they go into the VA or not? 113 1 Do they get dealt with well within the context of the 2 military health system with their complaints? Are 3 they basically getting the kind of care that we think 4 is ethically acceptable? 5 So that's roughly the visions I would be 6 looking at there. I think there's a bigger issue that 7 I flagged before that I just want to come back to 8 again. It seems to me the best ethics is still 9 prophylactic. 10 So anything we can say about how not to 11 get these problems, again, is going to be very useful 12 in terms of what I think would be constructive for 13 Americans to hear about. How to minimize these 14 problems from coming up again. 15 And I'll tell you what I mean by that. 16 I did go -- and I remember being at a hearing on the 17 vaccines. There's a lot of claims that we didn't have 18 basic science and didn't know about animal safety with 19 these things and that you did the best you could. 20 You tried to use these antibiological 21 warfare weapons, antichemical warfare interventions, 22 just assuming that it would be better to be protected 23 than not. 24 I'm not sure today that we are any better 25 off in answering the question: Would we use them next 114 1 week? And that's not a situation we should be in. We 2 just had a big experiment in the field. 3 And I don't know whether we could answer 4 any more -- that if next week we had to go and deploy 5 in a desert situation and somebody said, "I think 6 there might biological or chemical weapons put into 7 place. So should I take this vaccine or do I take 8 this pill?" -- something is not good about that. 9 That seems to me to be an ethical problem. 10 If we sort of miss the opportunity to figure out the 11 answer to the question, we are going to be back at it 12 again a month or a year or ten years from now. So -- 13 CHAIRPERSON LASHOF: Any thoughts about 14 how we would go about both aspects of that? First, 15 what they were told, the initial ones. And then the 16 more difficult one, I think -- 17 DR. CAPLAN: Some of it's panels again. 18 I think there's some opportunity there for information 19 to be presented to us about what the actual context is 20 of doing -- in wartime situations or in conflict, 21 trying out new medicines, new vaccines, what's policy, 22 getting the documents and then finding out literally 23 from a few people what they think the -- what's 24 reasonable to try and do and what's not reasonable to 25 try and do. 115 1 Postwise, I think some of the testimony 2 we'll collect in terms of care, clinical care and 3 outreach, will cover what we need. I don't think 4 we'll need anything special. We'll just have to ask 5 the right questions in there. 6 CHAIRPERSON LASHOF: Well, again, in terms 7 -- in following up with Don's idea that maybe the idea 8 of some focus groups that could -- 9 DR. CAPLAN: Yes. It would help. 10 CHAIRPERSON LASHOF: Work on all these. 11 DR. CAPLAN: Yes. 12 CHAIRPERSON LASHOF: Get some good focus 13 groups that are representative and not necessarily 14 just the people who come forward, who, you know -- 15 DR. CAPLAN: I think that's a very good 16 idea. 17 CHAIRPERSON LASHOF: Particularly going to 18 be the people who have problems, clearly. 19 DR. CAPLAN: Yes. 20 CHAIRPERSON LASHOF: I mean, that's 21 expected. But if we want a broader, to have focus 22 groups that we could explore a number of these issues 23 with. 24 DR. CAPLAN: I think that's a great idea. 25 CHAIRPERSON LASHOF: Okay. 116 1 Phil? 2 DR. LANDRIGAN: Although I think these 3 issues of the vaccine and the antidotes -- they are 4 basically research questions. And what we need to do 5 is look at the state of the data and the data gaps. 6 Where has the testing been adequate? Where is it 7 deficient? 8 CHAIRPERSON LASHOF: Yes. 9 DR. LANDRIGAN: What do we need to know? 10 CHAIRPERSON LASHOF: On that aspect, I 11 think there's no question we could get it. I was 12 thinking in terms of what people were told, how the 13 felt about it and so on. 14 Elaine? 15 DR. LARSON: Well, actually the 16 interesting about the issues that Arthur raises is 17 that they are not research questions. They are 18 ethical questions. They are questions of values. And 19 they are questions of sort of sociologic perspective. 20 And that's beyond our charge. 21 Although I do think that within the 22 context of our, you know, number 3 charge, if you 23 will, we don't have, unless I am missing it, a charge 24 to deal with the bioethics of and so forth. But I 25 think it does go in number 3. 117 1 CHAIRPERSON LASHOF: I think it goes in 2 number 3. And clearly we are expected to, or Art 3 wouldn't be on this panel. So I think his presence 4 here tells us that we ought to be looking at those 5 kinds of issues. 6 DR. BALDESCHWIELER: Well, a major issue 7 of how you behave under a strategic situation of great 8 uncertainty is the quality of the intelligence 9 information that is available. That is, if one knew 10 for sure what the opposition had and their doctrine 11 for using it, you would behave, of course, very 12 differently. 13 CHAIRPERSON LASHOF: That may or may not 14 be part of the classified material that may or may not 15 get unclassified in time for us to discuss it 16 publicly. But all of us I suspect at some point will 17 have our clearance confirmed. And we will be able to 18 look at those things in closed session, anything that 19 we can't have open. 20 Anything else on that score? 21 (No response.) 22 CHAIRPERSON LASHOF: I think the 23 pyridostigmine bromide issue -- 24 DR. CAPLAN: Joyce, one other comment 25 which I am not sure about how to respond to -- and it 118 1 goes into this problem we got into earlier about 2 trying to comment on the VA or the CHAMPUS program 3 generally, and keeping our focus on the veterans and 4 the Gulf War issue. 5 But clearly some of the problems that come 6 up -- and we were joking about this yesterday -- but 7 it's not a joke from the point of view of access to 8 services. 9 Are problems in the system -- I mean the 10 American healthcare system, not problems -- anybody 11 would have problems who has a preexisting condition or 12 a child with a disability. 13 There are just some problems in the 14 system. An we are not going to review and fix all 15 that. But it seems to me, we may simply have to -- it 16 may be necessary for us to say something about some of 17 the equity or access problems that people face. 18 They are not due to, necessarily, Gulf War 19 experience. They are due to problems that are still 20 unsolved in healthcare. So I don't propose that we 21 review the system again. I think that was last year's 22 project. But we -- 23 CHAIRPERSON LASHOF: We didn't solve it 24 last year. 25 DR. CAPLAN: We didn't solve it. 119 1 CHAIRPERSON LASHOF: So it -- 2 DR. CAPLAN: I think it's been raised 3 again at this year's Congress. But -- 4 DR. CUSTIS: If we did solve it, the 5 solution would have been simple. 6 DR. CAPLAN: Right. But we may need to 7 flag that as -- that some of the things we've heard 8 even yesterday in testimony were problems of the 9 system. They are not VA problems. They are problems. 10 CHAIRPERSON LASHOF: I think that's valid. 11 And I don't see how we can avoid without, as you say, 12 reviewing all the healthcare system inequities, but we 13 need to take cognizance of it. 14 Other thoughts about all this before we 15 now dig into in -- and it's so good we are going to do 16 all of this. Just how are we going to do it? 17 (No response.) 18 CHAIRPERSON LASHOF: As I said, we will be 19 staffing up in each of these areas and have 20 consultants available to us as well. And then the use 21 of scientific panels. So I'd like to move at this 22 point into the strategies for doing this. And that 23 means a number of meetings, kinds of panels, what are 24 the issues, which ones, the priority for doing them. 25 The question of subcommittee formats, 120 1 whether we break up into some subcommittees. And 2 especially if we want to do numerous hearings around 3 the country it may not be practical for all of us to 4 attend every hearing. 5 But it may be that we could develop some 6 subcommittees and hold hearings in different parts 7 without the full Committee. 8 Why don't we start with that issue as a 9 whole? Are -- should all of our meetings be full 10 Committee? We are a relatively small Committee. 11 There are 12 of us. Ten of us were able to make 12 today's. 13 We thought we would have had 11, but 14 something came up at the last minute that -- for 15 General Franks. We will continue to -- and this one 16 was called in very short order after your appointment 17 and did interrupt people's vacations. 18 We'll have enough time to hopefully get on 19 everybody's schedules. But everybody has busy 20 schedules. So what are your feelings about number of 21 meetings, subcommittees, small -- 22 Andrea? 23 DR. TAYLOR: Sometimes I think it's going 24 to be important that we work in subgroups to discuss 25 these issues further and come up with -- and possibly 121 1 come up with a scheme. 2 It might -- you know, for those of us who 3 are interested in exposure assessment, for instance, 4 I think maybe working in a small group to develop a 5 plan and present it to the full body or something of 6 that sort would be good. 7 The same with some of the other areas, 8 healthcare, primary care. Using it as a subcommittee 9 and then bringing back a full report to the entire 10 body to accept or adopt may be useful. 11 CHAIRPERSON LASHOF: Elaine? 12 DR. LARSON: Along those lines I was going 13 to make a similar suggestion. And that is that we 14 have some subcommittees with specific assignments as 15 much as possible related to the seven charges that we 16 have. 17 But also that each of our subcommittees 18 has assigned staff so that we are working in 19 subcommittee with staff who are collecting data and 20 then the group is assigned to collate the data or do 21 whatever with it. 22 CHAIRPERSON LASHOF: Yes. 23 DR. LARSON: We actually -- I was sort of 24 taking notes as we were talking about ideas and 25 processes. And we actually had laid out some plans 122 1 that I think we could move from there on. One is for 2 charges 2, 3, and 4, we talked about case studies, 3 field visits, and focus groups. 4 Now, for those we may or may not want full 5 committee. There may be some where we'll have a field 6 visit that we'll do, you know, something in a region 7 or whatever. For charges 1 and 5 through 7, first 8 before we can do anything else, we need staff work. 9 CHAIRPERSON LASHOF: Right. 10 DR. LARSON: And so we have got to get all 11 of that done. And I liked your previous idea about 12 starting with number 5, the external reviews, and see 13 where we are with that. And sort of look at where the 14 recommendations are in process. That might be a next 15 full Committee meeting that we need to do. 16 And then for charges 6 and 7 which have to 17 do with risk factors and chemical and biological 18 weapons, there you suggested that we need some expert 19 testimony, which again is full committee work, I 20 think. 21 CHAIRPERSON LASHOF: I think that's an 22 excellent summary. I agree with that. 23 Anyone else want to add to Elaine's -- 24 John? 25 DR. BALDESCHWIELER: Let me express a 123 1 concern about credibility. That is to say if we 2 divide the work to -- in too many fine segments, then 3 I guess I am concerned about our individual 4 credibility in those areas where we have a lot of 5 expertise. 6 It seems to me that the issue of 7 credibility would be a highlighted. An important 8 aspect of this Committee is that the Committee as a 9 whole, I think, brings credibility to these issues. 10 That is, if your resident chemist is the 11 only one who speaks to the chemical warfare issues, it 12 seems to me that's somewhat precarious. 13 CHAIRPERSON LASHOF: But I would think -- 14 let me react first before I ask everyone else to 15 react. My interpretation -- and, Elaine, correct me 16 if I am wrong -- would be that the subcommittee would 17 work through with staff on that and present something 18 to the full committee. 19 DR. LARSON: That's right. 20 CHAIRPERSON LASHOF: But as resident 21 chemist, you would have to convince all of us first 22 before we would accept it. Not just we'll just take 23 it. 24 DR. BALDESCHWIELER: A Committee consensus 25 it seems to me is a critical part of our output. 124 1 DR. TAYLOR: And that would be my first 2 comment -- is that if we worked subgroups, which I 3 think is a good idea because of all the material that 4 we have, we would bring it back to the full Committee 5 for any kind of acceptance or otherwise rejection of 6 what the recommendations are. That kind of thing. 7 CHAIRPERSON LASHOF: Elaine? 8 DR. LARSON: Another point is that while 9 I think at least one Committee member should be 10 present at each focus group or case study 11 presentation, just in terms of cost benefit and 12 efficiency and getting more information, we could 13 convene some of these focus groups or case studies, 14 however we decide to do it, in various parts of the 15 country, making it possible for subgroups of us to get 16 together with people who might have more difficulty 17 traveling -- some people who might not be able to come 18 here for a variety of reasons that would like to be 19 heard and need to be heard. 20 CHAIRPERSON LASHOF: Yes? 21 DR. RIOS: I was going to ask John a 22 question. Is your concern that if you have a 23 subcommittee and the chairperson is a chemist, say, 24 and that person makes a recommendation -- you are 25 concerned that there is no objectivity insofar as the 125 1 full Committee being able to hear the information 2 that's presented to the subcommittee? 3 I mean, I understand where you are coming 4 from because I think credibility is very important. 5 Are you saying that it's important that we hear all 6 the evidence? 7 Or maybe it could be taken care of by 8 having the subcommittee chair not make 9 recommendations, and just say here is what I heard, 10 and summarize the information? I am trying to get at 11 what you were concerned about. 12 DR. BALDESCHWIELER: I think credibility 13 is the central issue of this exercise, and that 14 operating as individual experts in our own fields, I 15 think that credibility is likely to be questioned. 16 I would say in epidemiology, for example, 17 the same kind of concern. So that I think enough of 18 us have to hear enough of the story from all of its 19 aspects to, you know -- to give a credible consensus 20 view. 21 DR. RIOS: So you are arguing against a 22 subcommittee type of format? 23 DR. BALDESCHWIELER: Or at least a 24 division into subcommittees so small. 25 DR. TAYLOR: I'm not thinking of just one 126 1 person per subcommittee though. I am thinking a 2 little more -- there are what -- 11 of us -- maybe 3 three in each group and don't have more than three 4 focus groups at a time before we decide to tackle 5 something else, three or four. 6 CHAIRPERSON LASHOF: Phil? 7 DR. LANDRIGAN: There may be a useful 8 model here in the way that the National Institutes of 9 Health review grant applications. A grant application 10 comes in and it's assigned to a study session usually 11 consisting of ten or a dozen people, as many as we 12 have on this committee. 13 And the ultimate verdict on the grant is 14 rendered by the whole study session who vote and 15 assign ratings. But within the study session, usually 16 two people, sometimes three, are assigned primary 17 responsibility on the basis of their expertise for 18 reviewing the grant and informing the rest of the 19 committee about the grant. 20 And then there is a discussion. And the 21 committee may entirely accept the recommendation of 22 the primary reviewers or further aspects may emerge. 23 And maybe that's the way to, on the one hand maximize 24 efficiency, because none of us is doing this as a 25 full-time job. 127 1 It's all -- for all of us it's in addition 2 to something else. And it seems to me cumbersome to 3 think that every one of us can attend in full detail 4 to every aspect of this. 5 And yet, at the same time, it's a way to 6 protect the credibility of the one or two people with 7 particular expertise that take primary responsibility 8 for reviewing a particular aspect. 9 CHAIRPERSON LASHOF: Is that, do you 10 think, responsive, John? 11 DR. KNOX: Well, and I think too, if you 12 are interested in a certain area, you certainly should 13 not be restricted from not seeing what that 14 subcommittee does. 15 If you would like to, you know, be 16 involved in more than one subcommittee, or just sit on 17 one and see what all the information received is, I 18 think you should be welcome to do that. 19 CHAIRPERSON LASHOF: David? 20 DR. HAMBURG: I think that the 21 subcommittee structure should really follow the task 22 requirements that we encounter. I don't see any need 23 to -- in fact, it would be very undesirable to say 24 well, we are going to essentially, arbitrarily have so 25 and so many subcommittees or do everything in the 128 1 first instance by subcommittee. 2 On the other hand, it seems to me almost 3 inevitable that the time we have available and the 4 complexity of the task will call for some kind of 5 efficient working arrangements. 6 And subcommittees would be a part of that, 7 including, by the way, conference calls, not 8 necessarily their meeting all the time. But small 9 subcommittees could move the agenda ahead without 10 having, so to say, voting rights to settle the issue. 11 Now, on credibility, John, I think you are 12 right and wrong. The credibility thing cuts both 13 ways. To have a chemist of your stature gives us 14 credibility that we are not, you know, wandering in 15 the dark with respect to chemical issues. 16 On the other hand, those of a suspicious 17 turn of mind may assume that having somebody who has 18 lived his life in the chemical community gives him a 19 warp, a serious warp, a deficiency -- he knows too 20 much. 21 It cuts both ways, depending in some part 22 on who the audience is. And I think we need both. We 23 need your expertise in chemistry or Phil's in 24 epidemiology. We desperately need that. We also need 25 to put some people at certain times around you so that 129 1 there are multiple perspectives on your expertise. 2 And we can do that. 3 DR. BALDESCHWIELER: I think you have said 4 it very, very well. Were right on target. 5 CHAIRPERSON LASHOF: Okay. In that light, 6 do we need to identify any of the subcommittees at 7 this point? Or do we leave that for staff and myself 8 to be in contact as we try to work through the 9 project? 10 DR. HAMBURG: I think you and staff 11 should, in the next week or two, intensively think 12 about this. 13 CHAIRPERSON LASHOF: We'll be on the phone 14 constantly. But I would -- it's obvious that John and 15 Andrea -- and, Phil, I am afraid we'll have you on so 16 many subcommittees, Phil. 17 We'll be looking at some of the 18 environmental risks and the biological and chemical, 19 as well as wanting you on the epidemiological. But 20 that's a natural grouping. 21 And medical care is a natural grouping 22 with Elaine and Marguerite and Art and Don. You know, 23 there is some natural -- I'll float around. But as 24 you say, we'll work on this as we try to -- but what 25 about the oral briefings for the Committee. 130 1 Well, maybe -- what things could be 2 handled in focus groups with then a report from the 3 focus groups to the full Committee. This being focus 4 groups of consumers or veterans really versus what 5 things you would like to see done on expert panels 6 brought forward. 7 They are quite different. I shouldn't put 8 those one against the other. We really identified 9 some areas that lend themselves to focus groups and 10 then some that lend themselves to expert panels. 11 CHAIRPERSON LASHOF: David? 12 DR. HAMBURG: Yesterday it seemed to be 13 that we heard expressions of anguish in two themes, 14 both of which might be suitable for focus groups to 15 clarify. One had to do with the themes of conversion 16 -- coercion -- sorry. 17 Coercion, involuntary participation as in 18 immunization or prophylactic medication. Begin forced 19 to do something without much information and without 20 a choice to opt out and so on. And to understand 21 those kinds of issues it is conceivable that a focus 22 group would convene. 23 We also heard the theme of neglect. Long 24 waits for VA care. Slow processing of disability 25 applications. Denial of benefits and so on. I think 131 1 the themes of coercion and neglect came up over and 2 over again. And those are kinds of issues that 3 professional focus groups, well designed focus groups, 4 have been able to clarify in other settings. 5 CHAIRPERSON LASHOF: Okay. I think those 6 are -- 7 Yes? Elaine? 8 DR. LARSON: I think we can proceed 9 simultaneously with two things. First of all we can 10 set up for our next meeting, which I assume will be in 11 the fall. Some expert testimony related to the 12 specific of chemical and biologic and environmental 13 potential hazards, etc. 14 We can set those up, and staff can work 15 with the panel and with others to find out the best 16 way to get the information on that. We can also 17 decide how we want to proceed with these focus groups. 18 The focus groups can't be done in full Committee. 19 CHAIRPERSON LASHOF: No. 20 DR. LARSON: The results need to be 21 presented to full Committee. 22 CHAIRPERSON LASHOF: Right. 23 DR. LARSON: So they need to start now as 24 well and be on -- be in process. They probably won't 25 be ready for sort of synthesis and presentation at the 132 1 next meeting in the fall. But in order to have them 2 ready for the one after that, we are going to have to 3 start them now. 4 And so those two things can go on while at 5 the same time, either before or after lunch, we should 6 have some more discussion about whether we or 7 subgroups want to do, in addition to the focus groups, 8 which we don't have to do, except attend. 9 CHAIRPERSON LASHOF: Yes. 10 DR. LARSON: Do we want to do something 11 else in the way of case study panels or in the way of 12 field -- we threw these words around, and we need some 13 more discussion on what we want to do with that. So 14 I think three things going on simultaneously are going 15 to have to occur to get us done in time. 16 CHAIRPERSON LASHOF: Well, you know, I -- 17 Robyn? Please? 18 DR. NISHIMI: I just wanted to say one 19 thing about the focus groups so not to raise your 20 expectation that you would even get this by the second 21 meeting, because obviously this will require a fair 22 amount of planning as to what we want. 23 And then we will have to select the right 24 contractor who will then have to get the proper 25 groups. So I just, you know -- I don't want to -- 133 1 DR. LARSON: No. I agree. Even more 2 reason why we start now thinking about when we want to 3 do that so that we'll have these things lined up and 4 can get the work done. 5 CHAIRPERSON LASHOF: Yes. Well, actually 6 I was going to say if there -- we talk about general 7 principles about this. Then we try to say what should 8 the priorities -- so if we can identify what things we 9 will want to have panels here for the full Committee. 10 What things we have just done on the 11 focus. What we want to do in field hearings where we 12 will hear from veterans in different areas -- separate 13 from the focus groups because I think the focus group 14 is a different kind of structure than the kind of open 15 hearing where anyone, you know, wants to present their 16 position. 17 Do we decide in principle how we feel 18 about those things? Then I think we would try to set 19 up a time line of which are the first ones to do, 20 considering that we have a six-month report due and 21 then a final report that is a year and a half from 22 now. 23 And the six-month report -- I am saying -- 24 we'll fudge a little on six months, the end of 25 February, first of March. 134 1 No? 2 DR. NISHIMI: No. There's no fudging on 3 that date. 4 CHAIRPERSON LASHOF: There's no fudging on 5 that date. 6 DR. NISHIMI: No. No. 7 CHAIRPERSON LASHOF: Mid-February? 8 DR. NISHIMI: February 14th and 15th would 9 be six months. 10 CHAIRPERSON LASHOF: Okay. We have our 11 marching orders. February 14th and 15th we have to 12 have an interim report ready. 13 DR. CAPLAN: Joyce? 14 CHAIRPERSON LASHOF: Yes. 15 DR. CAPLAN: One thing I would like to 16 suggest is that the next meeting be devoted to the 17 compilation of the recommendations about what 18 information to acquire and some initial step by us to 19 assess that. 20 Because if we are going to say something 21 by February 14th, we want to leave ourselves time to 22 both find out what these recommendations are and then 23 ask about them again if we need to, since that is 24 going to become a crucial part, I suspect, of the 25 interim report. 135 1 How well are we doing, given the task 2 that's been put out there to four groups and 3 subsidiary studies to get information? How well is 4 that happening? 5 I think it would be appropriate -- I don't 6 think there is any shift that is going to take place 7 on the biological and chemical warfare area, in terms 8 of what's known, to schedule some expert testimony 9 about that. 10 That simply exists. And the same thing is 11 true about the vaccines and the various prophylactic 12 things that were tried out. We could certainly look 13 to schedule those. 14 It does seem to me we should start to 15 think about the adequacy of care and having some 16 hearings or the ability to collect information out in 17 the field in different locations. I'm not ready yet 18 to say exactly what questions we need to ask. 19 But we certainly need to standardize them. 20 We have been yelling at everybody else to get 21 standardized questions. And if we are going to go out 22 in the field, we have to come with standardized 23 questions to ask to make sure that we can do that. 24 And that's going to be a staff 25 responsibility. And it's going to take a little time 136 1 logistically to set those up. So it does seem to me 2 that for the next meeting, which I gather you are 3 talking October -- 4 CHAIRPERSON LASHOF: We are talking about 5 mid-October or around -- 6 DR. CAPLAN: So that's pretty fast. We 7 might look for the recommendations, try to compile 8 that, see how people are meeting the goals that have 9 been set in terms of getting information, and maybe 10 some of these panel presentations about the areas that 11 at least look like to me they are -- I don't want to 12 say they are settled -- but they are -- the expertise 13 is there. 14 What's known is known. It's not going to 15 change unless we get one of our surprise defector 16 announcements about biological warfare. But short of 17 that, that may be a place to go in the short run. 18 CHAIRPERSON LASHOF: Well -- 19 DR. CAPLAN: I'm concerned when we get 20 going on the recommendations that -- 21 CHAIRPERSON LASHOF: I agree. I mean, one 22 way to look at our priority of deciding what we want 23 at which level is what do we want to try cover in that 24 first interim report? 25 DR. CAPLAN: Yes. 137 1 CHAIRPERSON LASHOF: And one way is to 2 look at as -- well, some things that are easy to 3 handle we can get out of the way, like chemical and 4 biological, the other is to say well, you know, that's 5 not that burning and immediate an issue. We can 6 handle that later. 7 I think we have to balance which way to 8 go. I think, clearly, looking at the recommendations 9 that have been made, because there is no point looking 10 at those a year and a half from now. 11 DR. CAPLAN: Right. 12 CHAIRPERSON LASHOF: We ought to look at 13 those now and focus our interim report around what are 14 the recommendations that have been made, and where do 15 we stand on those? 16 And maybe if we all agree on that, then 17 trying to determine just what are the panels is not 18 necessarily a good idea at this meeting. We may need 19 some staff work over the next month or so. 20 I don't know, Robyn. 21 DR. NISHIMI: I'm sorry. I -- 22 CHAIRPERSON LASHOF: I -- yes. You got 23 distracted too. 24 Well, let's sit on this and mull it at 25 lunch. And -- because I think it's noon. And I don't 138 1 know how all of you are feeling, but we've had a 2 pretty intensive morning. 3 Maybe this is a good point to take our 4 lunch break, think about some of this over noon. And 5 we'll com back after lunch and try to go through a 6 time line, priorities for hearings, staff hearings, 7 and so on. 8 (Whereupon, the proceedings went off the 9 record at 12:01 p.m. and went back on the 10 record at 1:36 p.m.) 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 139 1 A F T E R N O O N S E S S I O N 2 1:36 p.m. 3 CHAIRPERSON LASHOF: I believe we're ready 4 to resume. Dr. Landrigan had to leave to catch a 5 plane. And some of the other Committee members may 6 need to leave before our official adjournment at 3:00. 7 But I would appreciate it if the others 8 could hang in here with us until we complete our 9 business. I think we made a lot of progress this 10 morning in going through the charter, what we hope to 11 accomplish and some of the methodologies we'll use. 12 I think at the break we were up to the 13 point of maybe exploring a little further what are the 14 areas we would like to have full briefings on for the 15 full Committee with scientific panels, not necessarily 16 the time order for them, but just what are the subject 17 areas. 18 And I'd like to go back to that question 19 of subcommittees and get a feeling from each of the 20 members of the areas they would like to be most 21 involved in. 22 Then I think we ought to be at the point 23 where we might try to set some priorities and talk 24 about the frequency of meetings, and at least come to 25 an agreement on the next two or three meetings, not 140 1 the specific dates, but roughly the timing and the 2 subject matter for those meetings. And then we can go 3 from there. 4 So with that in mind, let me just open it 5 up again for discussion of subjects for full panels 6 for the full Committee. We did identify clinical care 7 as one. We identified biologic, meaning the 8 immunizations and -- remind me. 9 Chemical and biological. Oh, biological 10 I already had. And chemical war. Oh, the infectious 11 diseases. We wanted to get some good scientific 12 panelists that would deal with the mycoplasma with the 13 microsporidia issue and with Q fever, leishmaniasis, 14 and any of the other tropical diseases that possibly 15 be clinical or subclinical infections. 16 Are there others that -- psychological 17 stress. Others? 18 DR. LARSON: The viral fighters were 19 mentioned. The smoke. Don mentioned something. 20 CHAIRPERSON LASHOF: Don, was the -- 21 Well, the -- the environmental exposure, 22 certainly. 23 DR. TAYLOR: And that would include, I 24 think, some of the things that we don't necessarily 25 think of environmentally, with reference to their 141 1 living area. The kerosene use, use of the heaters. 2 And I think we should -- 3 CHAIRPERSON LASHOF: Yes. I think living 4 conditions, sand, particulates. 5 DR. TAYLOR: Right. Particulates. All of 6 those should be included. 7 CHAIRPERSON LASHOF: Kerosene. All of the 8 environmental possible exposures we would probably 9 want a scientific panel of experts. 10 Now, some of these -- we're looking at 11 actual members from DOD, VA, certainly in clinical 12 care, but -- well, let's run down them a little bit 13 and talk about the kinds of people we're looking and 14 what would be official and where we would look for 15 other scientific expertise. 16 In the clinical care, we want to hear from 17 the physicians, the VA physicians, and the DOD 18 physicians, who have been actively involved in the 19 care of veterans. But in addition, we wanted to hear, 20 I believe, from some of the other physicians who have 21 been caring for veterans. 22 Rolando, you had some physicians in Texas 23 who wanted to present. 24 We had some referred to yesterday at the 25 hearing. And I would think we would want to hear from 142 1 some of them. 2 Are there other thoughts along that line? 3 Art? 4 DR. CAPLAN: We just wanted to make sure 5 that we had the nursing allied health input. And 6 there are people in rehab now -- 7 CHAIRPERSON LASHOF: Yes. 8 DR. CAPLAN: That are doing that. 9 CHAIRPERSON LASHOF: We would want to hear 10 from some of those of the special referral centers. 11 DR. CAPLAN: Right. 12 CHAIRPERSON LASHOF: That are doing some 13 of that work. So, you know, that could be a session, 14 a day or more in itself just to deal with these 15 various clinical aspects -- be the subject of one 16 whole meeting. 17 Okay. And the biologics, I would think we 18 would want to get some of the national experts in 19 vaccine and the vaccine development. 20 We would want staff to do some background 21 work for us and get as much facts as we can about 22 where the vaccine is manufactured and how it -- 23 whether it's similar to what is used by other troops, 24 a point you raised, John. 25 And then we want some of the infectious 143 1 disease experts in the country to tell us what we know 2 about these vaccines and how they have been used 3 before and so forth. 4 Anything else on that score? 5 (No response.) 6 CHAIRPERSON LASHOF: Okay. On chemical 7 warfare we have discussed the issues that we want 8 there. We are bringing someone on full time on the 9 staff who will be doing thorough review of all the 10 material available and we'll be guided by staff 11 reports to us -- and then decide later, and by the 12 subcommittee work. 13 DR. RIOS: Let me see if I understand 14 this. Is that going to be a different committee or a 15 different set of hearings from the environmental 16 exposure? 17 CHAIRPERSON LASHOF: Yes. I would think 18 that chemical warfare is separate -- well, it's a 19 separate issue from environmental exposure. They are 20 looking at different things. It may be the same 21 subcommittee. They are both environmental. But it's 22 a particular issue in that area. 23 DR. RIOS: Okay. 24 CHAIRPERSON LASHOF: It may well be that 25 we cover both at the same meeting. That would be 144 1 logical. 2 DR. TAYLOR: Right. 3 DR. BALDESCHWIELER: And don't forget the 4 prophylactic drug issue. 5 CHAIRPERSON LASHOF: Oh, yes. 6 Prophylactic drugs. 7 Be sure to push your mic. 8 DR. TAYLOR: Prophylactic drug use goes 9 with the vaccines that they were -- 10 CHAIRPERSON LASHOF: Yes. When we do the 11 pyridostigmine bromide. We can decide how to group 12 these and what's the best ones to do at the same 13 meeting and which ones go with others. But I think 14 maybe we could leave that to staff and myself to work 15 on. 16 Then the infectious disease aspect -- that 17 might be combined with the biologic immunization work. 18 David, how would you like to see us and 19 what kind of panels would you like to see us pull 20 together in the psychological stress factors? 21 DR. HAMBURG: Well, in principle, the same 22 -- use the same kind of criteria as for the other 23 problem areas. There have been -- for example, right 24 after the Gulf War, the National Institutes of Mental 25 Health put out a request for proposals, and they have 145 1 stimulated quite a number of research studies. 2 They are underway around the country. I 3 think we should find out from NIMH who are the leading 4 investigators in this field and get people who are 5 really at the frontier on the different facets of 6 stress response. Plus, we should probably tap into 7 the basic research community on neuroendocrine 8 relations. 9 DR. TAYLOR: The American Public Health 10 Association has a sort of a psychological stress 11 group. And they are planning a big conference. I'm 12 not certain if it's this year or the following year. 13 Bob Karasek, Jeffrey Johnson from Johns 14 Hopkins -- there are quite a few folks in the field 15 who are doing work on psychological stress. So we may 16 want to tap into what they are doing and find out. 17 CHAIRPERSON LASHOF: In all these areas, 18 you know, as you go home and think about them all, if 19 you identify any experts that you personally know in 20 an area that you think would be key for a panel, 21 please let staff know. Feed that back regularly. 22 Art? 23 DR. CAPLAN: This isn't actually about 24 substance, it's about process. And I just wanted to 25 get this in before I leave. Just two comments. 146 1 One is I think we should let people know, 2 when we have expert panels, that we are certainly 3 willing to take written materials in in terms of 4 asking questions about what was said or things for us 5 to ask about. I don't mind being open to what anyone 6 out there wants to raise for us to ask. 7 And I think it should be -- I joked before 8 about an 800 number -- but I think we need some 9 mechanism -- if we say we are going to have a hearing 10 on X and someone wants to send in a question and say, 11 "Why don't you ask them about Y?" -- when you get to 12 the hearing, they should have a place to do that. 13 CHAIRPERSON LASHOF: Yes. 14 DR. CAPLAN: It just seems to me that we 15 can be open. We don't have to be the sole source of 16 every question that is out there. And it seems to me 17 too that it would be useful for us in looking for even 18 comments about themes and topics to be open to 19 suggestions as well. 20 So what I'm saying is as we make the 21 agenda up, I have the correct thoughts, but I don't 22 mind hearing from other people in the world who might 23 have other thoughts. 24 CHAIRPERSON LASHOF: It's a point well 25 taken. And, you know, I think it was clear this 147 1 morning as we identified some of these issues -- they 2 were clearly based on what we heard yesterday. 3 And some areas we intend to explore are 4 merely in response to those comments. And in that 5 same spirit, we will certainly be open. I hope 6 everyone at this point has the address for the office 7 and would urge that all communications be addressed to 8 Dr. Nishimi, who is the chief of staff, the executive 9 staff director for the Committee. The address of the 10 Committee is 1411 K Street, N.W. And the zip is -- 11 DR. NISHIMI: Two, zero, zero, zero, five 12 dash three, four, zero, four (20005-3404). Suite 13 1000. 14 CHAIRPERSON LASHOF: Okay. 15 John? 16 DR. BALDESCHWIELER: I wondered if 17 epidemiology will be on your list of major issues? 18 CHAIRPERSON LASHOF: Well, certainly the - 19 - that's right. We did say that one of the first 20 things we'd be doing would be to look at all the 21 recommendations that have been made and whether they 22 have been implemented. 23 And we'll certainly be having a full 24 hearing around that issue as the staff get that work. 25 And key among that will be the recommendations for the 148 1 epidemiologic studies, the issues we raised this 2 morning and yesterday, the comparability of the 3 different epidemiologic studies that have been 4 started. 5 And I think getting some other 6 epidemiologists to testify after they have reviewed 7 that's planned would be worthwhile. 8 Other things we need to flag for future 9 hearings? 10 (No response.) 11 CHAIRPERSON LASHOF: Okay. Well, I think 12 we've covered that. Now, the question of 13 subcommittees. I wonder if maybe the most efficient 14 way is to -- for me to just go around the table and 15 for each of you to indicate the areas you'd be most 16 interested in working on if we develop subcommittees. 17 And how we develop them and the timing of 18 them and so on will depend on further staff analysis 19 of how fast we get our various staff on and how 20 quickly they can go through the material that's 21 already in existence. 22 But, Andrea -- 23 DR. TAYLOR: My interest, I guess, is the 24 environmental exposure, exposure assessment area 25 regarding -- from chemical warfare to some of the 149 1 other exposures that we've talked about earlier. 2 CHAIRPERSON LASHOF: Fine. 3 Rolando? 4 DR. RIOS: My interest would also be in 5 chemical and biological warfare and the environmental 6 exposure issues. 7 CHAIRPERSON LASHOF: Elaine? 8 DR. LARSON: Infectious diseases and the 9 clinical systems issues. 10 CHAIRPERSON LASHOF: Marguerite? 11 DR. KNOX: Are you lumping the 12 pyridostigmine under the clinical -- the anthrax and 13 that under the clinical? Or is that environmental? 14 CHAIRPERSON LASHOF: That's a good 15 question. It crosses all boundaries, doesn't it? 16 It's involved with both. You are interested in it, 17 clearly. 18 DR. KNOX: Right. And also the ethical 19 issues. 20 CHAIRPERSON LASHOF: And the ethical 21 issues. Fine. 22 DR. HAMBURG: From your list of seven, I 23 guess I would do either research or clinical care or 24 implementation of past recommendations. And -- either 25 one of those. 150 1 CHAIRPERSON LASHOF: Okay. 2 Don? 3 DR. CUSTIS: Clinical care and infectious 4 diseases. Are you going to have the staff handle the 5 implementation of past recommendations? Or is that 6 also -- 7 CHAIRPERSON LASHOF: I think that will be 8 one staff will do most of the initial work on and 9 we'll have complete hearings around. I doubt that 10 we'll do that one in subcommittee. But I don't know. 11 But if so, we'll put it down. 12 DR. CUSTIS: I have some particular 13 interest in some of those recommendations. 14 CHAIRPERSON LASHOF: Right. 15 DR. CUSTIS: I think clinical care and 16 infectious diseases. 17 CHAIRPERSON LASHOF: Fine. 18 DR. CAPLAN: I am interested in the -- 19 wherever the anthrax and prophylactic agents go. And 20 I am interested in clinical care. 21 CHAIRPERSON LASHOF: And, John, you are 22 the natural -- 23 DR. BALDESCHWIELER: I think I would 24 follow all those things with the molecular basis, 25 including chemical and biological warfare, the 151 1 environmental exposures, prophylactic drugs, 2 immunization, and the assays for the infectious 3 diseases. 4 CHAIRPERSON LASHOF: Fine. Thanks. 5 Well, you can see why we were all 6 selected. We really do cover the waterfront. And I 7 think that's a good way to get about. I guess, then, 8 there's the question of what we think the priorities 9 ought to be, the order in which we might be taking 10 these up. 11 For staff, the first priority will be 12 gathering the data on all the previous 13 recommendations, previous reports, getting that 14 analyzed, and beginning to find out, and tracking that 15 material. My guess is they won't be ready to report 16 on that for a couple of months. 17 Robyn, let me turn that part to you. 18 DR. NISHIMI: I would say not in 19 September. But I think we can start, you know, laying 20 out a framework, certainly, by October, put together 21 that typology, you know, have started the interview 22 process of departments as well as the end users. 23 But certainly, the typology could 24 presumably be completed by October and some 25 preliminary information gathering be presented to the 152 1 Committee. 2 CHAIRPERSON LASHOF: Okay. 3 Any questions on that? And we can aim for 4 that for an October session. 5 (No response.) 6 CHAIRPERSON LASHOF: What would be our 7 next priority we would like to see addressed? Does it 8 matter to us? Or should we wait and see how staff are 9 moving on all these areas and -- 10 DR. LARSON: Using your criterion that you 11 discussed before lunch -- and that is, what do we want 12 to put in that first six-month report -- 13 CHAIRPERSON LASHOF: Yes. 14 DR. LARSON: That interim report. Clearly 15 we need to be finished with reviewing the 16 recommendations. And then it -- maybe the next 17 priority might have something to do with if there are 18 problems of access, waiting times, clinical issues. 19 We know that the research studies are 20 beginning to get going. Perhaps the next thing to do 21 is to address some of those things that might hinder 22 the rest of the progress -- 23 CHAIRPERSON LASHOF: Yes. 24 DR. LARSON: Of inquiry. So we might want 25 to focus on getting those focus groups started and 153 1 getting -- looking at the clinical groups. And we had 2 also talked before lunch about the possibility on 3 these panels of patients. Now, that may be a 4 different panel. 5 CHAIRPERSON LASHOF: Well -- oh, that's 6 right. We wanted to come back to the question of 7 hearings around the country. 8 DR. LARSON: Yes. 9 CHAIRPERSON LASHOF: And I think those 10 will be the kind of hearings, like we had yesterday 11 afternoon, that we might hold in different spots 12 around the country. But I think staff will have to do 13 research as to where the concentration of vets are. 14 And I guess the issue for us is whether 15 those need to be the full Committee, or, we hold some 16 regional hearings with two, three, four 17 representatives of the Committee at each one of the 18 hearings. 19 DR. LARSON: Well, that's one issue. And 20 then, the other issue is we talked about doing some 21 case studies walking through the system. 22 CHAIRPERSON LASHOF: That's right. 23 DR. LARSON: For what happens when someone 24 enters the system as an active duty person or as a new 25 veteran in the VA system. And just walking through 154 1 that system with them as a case study. 2 CHAIRPERSON LASHOF: Yes. 3 DR. LARSON: Which is a little different 4 than the focus groups -- 5 CHAIRPERSON LASHOF: Yes. 6 DR. LARSON: And the individual hearings. 7 CHAIRPERSON LASHOF: Right. Right. 8 DR. LARSON: And I would suggest that we 9 might want to do that sooner rather than later to 10 approach some of the clinical systems problems. 11 CHAIRPERSON LASHOF: Is that possible, 12 Robyn? 13 DR. NISHIMI: Sure. I mean, we start on 14 all of these initially. But I think in terms of what 15 one can begin to do immediately in the near term to 16 gather these facets -- 17 CHAIRPERSON LASHOF: Right. 18 DR. NISHIMI: For, certainly, the field 19 hearings because that's the type of thing where you'll 20 be able to get immediate impact. 21 So I do think that if the Committee could, 22 you know, reach some kind of sense of whether they 23 want to do this as a full Committee or whether they 24 feel that subcommittees of some combination or 25 combinations is adequate is an important thing for us 155 1 to settle today. 2 DR. LARSON: Maybe one way to approach it 3 with the case studies is to use the same format and 4 then have it again. 5 We could do more if we did in two or three 6 groups a similar case study in a different -- like at 7 lunch, you were saying, Don, that each VA is 8 different. 9 There is a wide quality and spectrum of 10 care across the VAs depending on whether they are 11 associated with academic health centers or out in a 12 community or whatever. So we might want to select -- 13 DR. CUSTIS: You shouldn't quote me. 14 DR. LARSON: Well, I'll quote myself then. 15 They are different. But anyway, it might be nice to 16 have more than one of those case studies. 17 DR. CAPLAN: One thing we could do is 18 agree, I think, that it would be good to have small 19 groups going out to these hearings because we'll get 20 more information and we'll give more people the 21 opportunity to talk to us. We'll just be able to 22 cover more of a big country. 23 So I would strongly come down on the side 24 of two or three person subcommittees trying to do this 25 in different parts of the country, giving people 156 1 access who can't get to Washington. It's too 2 expensive. They are too sick. Whatever. 3 And I would also like to urge that if we 4 are going to get ready for that, we need one other 5 thing, which is a kind of succinct summary of what 6 people are supposed to be entitled to for clinical 7 care, legally and otherwise. 8 What are they supposed to get? What were 9 they promised? What was supposed to be delivered? 10 That should certainly inform some standard set of 11 questions, whether in a case study format or just -- 12 And I had another thought, which is in 13 addition to doing a case study walk-through. If we 14 could, instead of asking people to simply testify to 15 us, sort of hanging out the shingle and saying, "We're 16 here. We've come to your town. Here we are." If we 17 could come up with a list of questions and say we want 18 you to tell us about A, B, and C, that will move it 19 along for us too. 20 I mean, I don't mean to just limit it to 21 what we want to know about, but we certainly could 22 suggest as part of -- 23 CHAIRPERSON LASHOF: Their testimony that 24 they address certain issues that -- 25 DR. CAPLAN: Their testimony, these are 157 1 key themes that we are interested in. 2 CHAIRPERSON LASHOF: Good point. We'll 3 note that. 4 Okay. Any other -- I sense a consensus of 5 the group that we try to get those going in the fall, 6 maybe use September, October -- 7 DR. LARSON: But we may be talking about 8 two different things. I mean, you are talking about 9 hearings. I was talking about case -- where you 10 actually look at -- okay, here is where you entered 11 the system, and here's how. 12 CHAIRPERSON LASHOF: Yes. 13 DR. LARSON: And then on X date, Y date, 14 here's what happened, here's the test that occurred. 15 CHAIRPERSON LASHOF: Yes. 16 DR. LARSON: Here's the symptoms. You 17 know, just that kind of a walk-through. 18 DR. BALDESCHWIELER: For a specific 19 person? 20 DR. LARSON: Yes. 21 CHAIRPERSON LASHOF: Yes. Yes. We would 22 identify some specific people. We'll have to stave 23 off the work on the logistics. We could combine that 24 with the small hearings at the same time -- that we 25 are having a small hearing somewhere, have a case 158 1 study also from that area, that region, that VA. 2 DR. NISHIMI: I think you have to be -- 3 we'll have to be careful about privacy considerations. 4 CHAIRPERSON LASHOF: Privacy. 5 DR. RIOS: I was going to mention that it 6 -- there may be some privacy problems. Plus it also 7 seems like it could be something done by staff. If 8 you get somebody and you find out what their complaint 9 was, where it started, and what happened. 10 I mean, that's just -- sounds like 11 something that staff could work up. I don't know how 12 many cases you want to look at just to see what 13 happened. It doesn't seem like it's something 14 conducive to having hearings on. I don't know. 15 CHAIRPERSON LASHOF: No. I think it was 16 separate from the hearings. 17 DR. LARSON: Two separate issues. 18 CHAIRPERSON LASHOF: That was the thought. 19 DR. LARSON: And in fact -- 20 CHAIRPERSON LASHOF: Of this whole -- 21 DR. LARSON: I wonder if the hearings is 22 not better served at this point by focus groups. I 23 don't know. I mean, we are talking about three things 24 now. 25 CHAIRPERSON LASHOF: I think they are 159 1 different. They're three different things. 2 DR. LARSON: Right. 3 CHAIRPERSON LASHOF: One would be 4 individual case studies. 5 DR. LARSON: Right. 6 CHAIRPERSON LASHOF: And we'll have to 7 determine -- I think we'll need some staff work to 8 determine how to select those and what the exact 9 specifics. Regional hearings are for those veterans 10 who wish to be heard by this Committee, who have not 11 been able to come here. 12 DR. LARSON: Yes. 13 CHAIRPERSON LASHOF: Focus groups will be 14 an order sample, a more representative sample of Gulf 15 War veterans to explore the issues that have come up 16 as part of the process and the studies. And we will 17 do all three. 18 Is that -- is that the consensus of what 19 I've heard here? 20 DR. LARSON: Right. 21 CHAIRPERSON LASHOF: Okay. Well, to me it 22 sounds like then that by our October meeting we'll be 23 able to get the initial recommendations issues. We 24 would get started on some of the case studies, 25 possibly, and some of the hearings. 160 1 The actual focus groups would not be held 2 by then. That's more complicated until we select a 3 firm and identify that. But we could develop the next 4 meeting -- and we'll have to talk about the frequency 5 of meetings -- but the meeting after the October 6 meeting, around the clinical care issues, and focus on 7 clinical care. 8 Maybe that's as far as we ought to go in 9 trying to set priorities until we see where staff are. 10 There's too much that needs to be done and too many 11 unanswered questions. 12 DR. NISHIMI: Yes. I think so. 13 CHAIRPERSON LASHOF: I think -- 14 DR. NISHIMI: That's all we are going to 15 get done before the report is due, the six-month. If 16 we had an October meeting and then another one in 17 December or whatever, the report's due in early 18 February, right? 19 CHAIRPERSON LASHOF: Mid-February. 20 DR. NISHIMI: So it'll either be December 21 or January. I don't think we are going to get more 22 than two more meetings in before then. So if we've 23 decided those two are our priorities, we can deal with 24 those before February. 25 CHAIRPERSON LASHOF: Well, that brings us 161 1 to the frequency of meetings. Are we aiming for 2 monthly? Bimonthly? I can see everyone voting at 3 different times. And what's realistic? 4 DR. NISHIMI: I think you also have to 5 think about the fact that you are going to have these 6 smaller group field hearings. So, you know, when you 7 commit to a -- either, you know, every four weeks, six 8 weeks, eight weeks schedule, remember that there will 9 be subgroups of you also taking on the responsibility, 10 you know, at some point in between those meetings of 11 convening for a separate small gathering. 12 DR. TAYLOR: On that note -- 13 CHAIRPERSON LASHOF: What is the 14 preference? On that note, what would you like to say? 15 DR. TAYLOR: Bimonthly. Every other 16 month. 17 CHAIRPERSON LASHOF: Every other month? 18 DR. LARSON: Whatever it takes to get the 19 work done. 20 CHAIRPERSON LASHOF: To get the work done. 21 DR. LARSON: Yes. 22 CHAIRPERSON LASHOF: Well, let us see. 23 We've asked you for calendars. Those have been 24 distributed. We'll have a sense by the October 25 meeting. And maybe we'll leave this open to see and 162 1 see what we can do in the -- 2 DR. CAPLAN: What I'd like to suggest, 3 maybe, is that we could presume that we are going to 4 meet at least bimonthly. 5 CHAIRPERSON LASHOF: Yes. 6 DR. CAPLAN: So we could set those in now. 7 CHAIRPERSON LASHOF: Okay. Well, we won't 8 take this time to set the calendar. But staff will be 9 back in touch with you all. 10 DR. CAPLAN: Well -- 11 CHAIRPERSON LASHOF: All of you have in 12 the book a calendar with x's in there already, which 13 are my x's out. Some are wrong. And I've corrected 14 them. 15 DR. BALDESCHWIELER: It's extremely 16 helpful to at least -- 17 CHAIRPERSON LASHOF: Yes. I think as many 18 as we can do ahead -- 19 DR. BALDESCHWIELER: Schedule ahead -- 20 CHAIRPERSON LASHOF: And just say if we 21 could set the bimonthly for the whole year, and then 22 if we need additionals, fit them in and do 23 subcommittees. That would be helpful. 24 Okay. Are there any other -- 25 Robyn reminds me that in the environmental 163 1 that includes the depleted uranium issue as well. And 2 -- okay. I am open now for anything else any member 3 of the Committee wants to raise at this point. Issues 4 we've missed. Additions. Suggestions. 5 Andrea? 6 DR. TAYLOR: Yes. Our next meeting I note 7 thus far is the week of October 16th. So then, we 8 don't have the dates yet? 9 DR. NISHIMI: No. Because we don't even 10 have all the responses in. But that was what was sort 11 of looking good. Although I got a few more yesterday. 12 And so maybe now it's toward -- anyway -- some time -- 13 DR. RIOS: That's going to be here? 14 DR. NISHIMI: Well, that's for the 15 Committee to decide. 16 CHAIRPERSON LASHOF: Yes. That's one of 17 the questions, is how frequently we meet in 18 Washington. How frequently do you want to come to 19 California? And whether we ever meet somewhere else 20 in between. If we do subcommittee hearings around the 21 country, there's less need for the whole Committee to 22 move west. And you are heavily eastern loaded. But 23 John and I do live in California. 24 DR. KNOX: I think most of the Gulf War 25 veterans did come from the east. I don't want to make 164 1 that too big of a statement. But I think a lot of 2 them were from the East because it was closer. 3 CHAIRPERSON LASHOF: Today, I mean for 4 this hearing, but then there are others from around 5 the country. 6 DR. KNOX: Oh, right. Right. 7 CHAIRPERSON LASHOF: That might want to 8 attend the full meeting as well as be present at the 9 hearing. 10 DR. KNOX: Right. 11 CHAIRPERSON LASHOF: So I think we 12 shouldn't have all of the meetings in Washington. We 13 clearly have to have some in other cities to give 14 other people beside the hearings a chance to actually 15 sit through a full meeting. 16 DR. RIOS: Did you say the -- most of the 17 troops that went to the Gulf War were from the east 18 coast? 19 DR. KNOX: I think a majority of the 20 troops that went into the Gulf War were on this side 21 of the United States. And simply because it was 22 easier to transport them from the east coast than it 23 was from the west coast. 24 DR. RIOS: It may have been -- they may 25 have been stationed on the east coast, but they are 165 1 not from the east coast. 2 CHAIRPERSON LASHOF: John? 3 DR. BALDESCHWIELER: I would like to raise 4 what is a complex and confusing issue of economics and 5 ethics. And that is, presumably if this panel and the 6 Administration responds to recommendations to improve 7 the care and the access of this group of veterans -- 8 if one is dealing with the zero sum game, that means 9 that somebody else gets less care. 10 That is, if the system is conserved in 11 terms of resources and facilities. I suppose that is 12 not in our charter, but somehow it seems to me utterly 13 essential that one understand just how the dynamics of 14 the system will respond to recommendations that we 15 make. 16 CHAIRPERSON LASHOF: I think that's 17 something that we may want to talk about when we come 18 to final recommendations, as to costs of 19 recommendations and prioritizing them in some way. 20 But final decisions of how governmental resources are 21 allocated remains in the hands of the President and 22 the Congress, through the appropriation processes and 23 many others. But these are issues that I think we'll 24 have to address downstream. 25 The immediate issues for us are our own 166 1 budget, and that we live within that budget. Which 2 may put constraints on how many hearings where, how 3 much travel and so on. And staff is going to have to 4 struggle with that a little bit with me as we -- 5 DR. BALDESCHWIELER: But the frequent 6 outcome of recommendations of this sort is a, in a 7 sense, an unfunded mandate. The system is asked to do 8 something. And those resources come from somewhere 9 else. And then you succeed in shifting the problem. 10 But not necessarily making an overall improvement. 11 DR. CUSTIS: Unfunded mandates are very 12 popular. It's an imponderable. 13 CHAIRPERSON LASHOF: It's an imponderable. 14 I'm not sure how fruitful it is for us to discuss that 15 at any length, but -- 16 Elaine? 17 DR. LARSON: No. I was just going to 18 suggest that first we need to lay out the issues and 19 see where we are. And then, I agree with you. The 20 final recommendations -- it might be something we need 21 to -- it will be something we will address in terms of 22 prioritization and so forth. 23 In terms of deciding where our meetings 24 are, I am wondering if it might be helpful to first 25 have -- just talk about whether -- where we might, 167 1 what might be logical places to have hearings based on 2 the location of where we might get more information, 3 more vets, and also where we are located around the 4 country. 5 And then maybe a simple way to do it with 6 the Committee is to at least every third meeting, if 7 not every other, reverse coasts or go across and back. 8 I don't know. 9 CHAIRPERSON LASHOF: Well, I -- it's a 10 question of whether that's worth our exploring that 11 more here, or we need staff to do some more work on 12 this -- 13 DR. LARSON: That's fine. Yes. 14 CHAIRPERSON LASHOF: And find out where 15 some key spots -- 16 DR. LARSON: It sounds fine. 17 CHAIRPERSON LASHOF: -- that we need to be 18 and so on. 19 DR. NISHIMI: Yes. I mean, I think 20 because it wouldn't be very fruitful here for us to -- 21 all the data points aren't here. But we also have to 22 have financial considerations, quite frankly, taken 23 into account. 24 CHAIRPERSON LASHOF: It's not only our 25 trouble, it's staff trouble as well. 168 1 David? 2 DR. HAMBURG: Joyce, on the process of the 3 near term, it's been pretty easy for me and others 4 today to say the staff will do this and the staff will 5 do that, except we don't have much staff yet. 6 These kinds of operations begin with a 7 desk and a pencil. When you start from ground zero, 8 it's not as if you had an established institution. 9 You turn to the established institution to do a study. 10 You create an institution in a sense, a 11 transitory one to be blown away at the end of next 12 year. But in the meantime, how do you get up and 13 running expeditiously? 14 And in effect, we are piling on 15 suggestions for a non-existent staff to do. I think 16 we need to focus on how we get a staff in place of the 17 right calibre as rapidly as possible. 18 I think one part of that, quite frankly, 19 is an intensive interaction between the chair and the 20 staff director in the next few weeks. A very 21 intensive one. If you had any thoughts of doing 22 anything else, I suspect they'll soon evaporate. 23 But more than that, I believe we ought to 24 volunteer -- I think every member of the Committee 25 would want to be helpful to the extent you want to 169 1 involve us in identifying people or helping to assess 2 or recruit people to join the staff as soon as 3 possible. 4 You might also want to consider some 5 flexibility, some first-rate people who are not 6 available full time might be available half time in 7 the near future, something of that sort. We ought to 8 be open to that. 9 It's more important to get the right sort 10 of people, with the competence and the integrity and 11 so on, than it is to have them in any particular 12 arrangement, in my judgement. 13 In any event, I am volunteering for the 14 Committee to help the Chair to work this out to get 15 the staff up and running as soon as possible. 16 CHAIRPERSON LASHOF: Thank you, David. I 17 appreciate that. And I welcome that help. Robyn and 18 I have been in almost daily contact since the end of 19 June, I guess, around staffing issues. We are -- I 20 think have made amazing progress for how short. 21 But there are a lot of positions unfilled 22 at this point. It might be helpful for Robyn to run 23 down and give you a brief description of the people 24 who are on board and the areas that we are still 25 searching very hard for and elicit you to help. 170 1 Robyn, would you like to do that? 2 Okay. 3 DR. NISHIMI: There's myself, the 4 executive director. We have a deputy director and a 5 counsel, Holly Gwin, who has been doing all of -- most 6 of the logistics for the meeting. 7 There will need to be some type of senior 8 medical advisor. And I believe we have already 9 identified a person who has familiarity with the 10 policy world, military health, veterans' health, 11 clinical issues, bioethics, a lot of experience. 12 A director of communications, obviously, 13 is important. And we are, I think, close to achieving 14 closure on that. The same with the congressional and 15 public affairs coordinator to work with the director 16 of communications. 17 There will be sort of a medical veterans' 18 military ombudsperson that Joyce has previously 19 mentioned. And we have a couple of people in line 20 there. 21 And then we are looking at, you know, what 22 I would call the policy analysts, senior policy 23 analysts, across a range of issues, clinical care, the 24 ones we've been discussing. Clinical care. Research. 25 Hazard and risk assessment. Outreach. Implementation 171 1 of the past recommendations. 2 And they would fill out the analytic 3 staff. And we have identified people for many of 4 those positions. Some of them are still being 5 interviewed. Some of them -- their papers are being 6 processed. 7 And then a couple of research assistants. 8 The administrative staff is pretty much in place, 9 except for probably a contractor to help with the 10 archival material and things like that. 11 DR. LARSON: Did -- were you clear on -- 12 or, I'm not clear on what our priorities are -- our 13 priority needs are, based on that? 14 CHAIRPERSON LASHOF: Priority needs, I 15 believe, are in epidemiology and -- 16 DR. NISHIMI: Well, in epidemiology we 17 have a strong candidate now identified that we were 18 following up on. On the psychological factors, Dr. 19 Hamburg has, I think, discussed that with Dr. Lashof. 20 CHAIRPERSON LASHOF: He's going to before 21 he leaves today. 22 DR. NISHIMI: Or, he's going to. Clinical 23 care, we have a physician and then another possible 24 part-time consultant physician. But I think it would 25 be also important to look into, as Art indicated, some 172 1 of the allied health professionals, perhaps full time, 2 perhaps not, to assist in going out and evaluating 3 both the DOD and the VA care systems. 4 CHAIRPERSON LASHOF: Did -- wouldn't we 5 feel that we would like to find a nurse who could help 6 us in this area and could look at some of the 7 healthcare and medical care issues? And that's one we 8 haven't identified. And the outreach we have. 9 Otherwise, we are in reasonable shape, actually. 10 We've been hard at work. 11 Okay. Others? Other issues? 12 Suggestions? Things we need to cover before we -- 13 (No response.) 14 CHAIRPERSON LASHOF: If not, we did have 15 a request earlier today that there were some veterans 16 who wished to testify yesterday who did not have an 17 opportunity. And I said that if we had time at the 18 end of today's session before we had to adjourn, I 19 would grant them time. 20 If they would identify themselves? 21 Let me take a five minute break and ask 22 anyone who wishes to so testify to come forward and 23 identify themselves to Robyn? You, or? 24 DR. NISHIMI: No. I am looking for -- 25 CHAIRPERSON LASHOF: Diane's over there. 173 1 DR. NISHIMI: No. Is Mike Kowalek here? 2 Or is he out front? 3 CHAIRPERSON LASHOF: Okay. Let us take a 4 couple-minute break. And we'll have someone to 5 identify anyone who wishes to testify. And we should 6 be able to wrap up in the next 20 minutes. 7 (Whereupon, the proceedings went off the 8 record at 2:16 p.m. and went back on the 9 record at 2:31 p.m.) 10 CHAIRPERSON LASHOF: I think we'll resume. 11 I was approached this morning and informed that there 12 were some people that wanted to testify. But it does 13 not appear that we've been able to -- we have. Okay. 14 We're waiting to try and see if we have 15 identified -- there is one person who wishes to 16 testify. 17 The name is Diane St. Julian, I believe. 18 Will she come forward now to the mic. We'll be happy 19 to hear her. 20 We may need to lower the mic. They 21 clearly need to lower the mic. for you. We'll do 22 that. Just wait one minute. 23 The floor is yours. 24 MRS. ST. JULIAN: Good afternoon. My name 25 is Diane St. Julian. And I am reading a statement on 174 1 behalf of Jeffrey St. Julian. 2 "Members of the committee, I served 3 my country in the United States Army for 4 over nine years, during which time I have 5 been awarded for outstanding service on 6 numerous occasions. 7 "I was ready and willing to defend, 8 fight, or die for my country just so my 9 family or fellow Americans could have all 10 the rights afforded to them under the 11 Constitution. 12 "During Desert Shield and Desert 13 Storm I was assigned to 25th ID, 14 Schofield, Hawaii. I never deployed to 15 Saudi Arabia. 16 "Nevertheless, my unit was briefed 17 for predeployment and predeployment plans 18 and conducted countless training 19 exercises in preparation for deployment 20 with the main focus on NBC training. 21 "In a series of PALMING exercises - 22 - PALMING is done when a rapid deployment 23 unit reaches a unit that can deploy 24 worldwide within 18 hours, going through 25 a series of checklists, such as updating 175 1 wills, insurance policies, to include 2 receiving shots for diseases that are 3 contrary to that region of the world you 4 are deploying to." 5 "Some time before the war began, 6 the 25th ID was placed in a unit on alert 7 to have the unit ready to deploy and act 8 as an escort to the ground troop 9 commander. 10 "At this time, my unit did prepare 11 for deployment to the Gulf Region, to 12 include taking shots that were to protect 13 us from various diseases and threats in 14 that region. 15 "Most of the shots went unrecorded. 16 I was also involved in a mission to 17 support the unit that did deploy to the 18 25th ID to escort the commander. 19 "The mission involved receiving, 20 cleaning as needed, and turning in 21 equipment. Also during this time, I 22 received several investigations of shots 23 and pills. 24 "I was forced to take one of the 25 shots, and it was Japanese encephalitis, 176 1 and a mysterious malaria pill. 2 "I called the pill mysterious for 3 two reasons: first, because after 4 contacting a medic who remembered the 5 pill, I could not find any record of 6 them; secondly, because after questioning 7 numerous doctors about such a pill, none 8 of them was aware of a malaria pill taken 9 in the fashion we took these. 10 "We were -- the malaria pills 11 finished. The pill was white and one was 12 taken after each meal. I took these 13 pills for 60 days. 14 "In the summer of 1991, I had what 15 I now consider my first unexplained 16 medical symptom. My problems have 17 continued and became more and more 18 frequent. 19 "I was lost when my family started 20 having medical problems and conditions 21 that were very similar to my own. In 22 fact, I was referred to mental health for 23 my symptoms, and on several different 24 occasions. 25 "I finally admitted myself into the 177 1 hospital in December of 1994 because the 2 symptoms I was experiencing were coming 3 so often. 4 "After giving my symptoms to the 5 doctor, I was repeatedly questioned about 6 whether I served in the Persian Gulf 7 during the war. 8 "I answered the question no. I did 9 not serve in the Persian Gulf. I could 10 not understand the connection between my 11 symptoms and the Persian Gulf. 12 "After contacting DOD registry, I 13 found that my symptoms that I had been 14 complaining about for the last couple of 15 years were the same as the Persian War 16 illness. 17 "Colonel Jones of Walter Reed Gulf 18 War Registry wanted me seen there. After 19 being informed of my developing 20 situation, my unit told doctors I was 21 faking my symptoms. 22 "I did not receive another medical 23 treatment for over seven days. When I 24 was discharged from the hospital on the 25 21st of December, after contacting the 178 1 center at my home town, I was placed on 2 medical hold to receive medical testing 3 and treatment at Walter Reed. 4 "I was not allowed to receive any 5 medical treatment. I was counseled that 6 I was not due anything but clinic 7 insulation I was assigned to. 8 "I was escorted everywhere I went. 9 In fact, on Christmas day, I was in the 10 hospital receiving a needed medical 11 surgery which otherwise I could not get 12 on a normal duty day. 13 "The doctor who treated me felt I 14 needed to be seen by specialists for the 15 problems I was having and gave me 16 consultation to have problems looked 17 into. 18 "After going on one of the clinics 19 the next day, I was once again counseled. 20 This time I was counseled and warned that 21 if I attempted to get medical attention 22 again, I would be court martialed. 23 "I was then escorted and taken to a 24 separation physical which found me not 25 qualified for separation. Nevertheless, 179 1 I was escorted to continue clearance and 2 ordered to sign a DD-214. 3 "I did as I was ordered. I have 4 attempted to be seen through the VA, but 5 because I am not medically cleared from 6 the service, I have not been seen there. 7 "In addition, I was told because I 8 didn't serve in the Gulf, I am not a Gulf 9 War Veteran. So I am not qualified to be 10 seen by a VA Gulf clinic. 11 "Furthermore, on each visit to the 12 VA, I was sent to the Pentagon and to 13 DODIG regarding errors in the discharge 14 from service. 15 "For this reason, I requested 16 assistance from Senator Thurmond's 17 office, Congressman Jefferson Williams, 18 Senator Robb's office, Senator Moran's 19 office. 20 "While dealing with Senator 21 Thurmond's office, a DOD investigation 22 was conducted. The military furnished 23 false information in regards to the 24 investigation, such as Sgt. St. Julian 25 did not complete a separation physical, 180 1 so there is no reason to retain him on 2 active duty. 3 "I have provided official 4 documentation in response to these false 5 statements, such as a copy of my official 6 separation physical. 7 "The final response from the 8 military was for me to take it to the 9 Military Board of Corrections. I have 10 contacted every source I know for help, 11 to include the Military Board of 12 Corrections. 13 "The bottom line is that my family 14 and my medical problems are caught up in 15 politics. Who is a Persian Gulf Veteran? 16 Who is isn't? I served my country 17 proudly. I wore my uniform proudly. 18 "I want you to realize I was a 19 career soldier, highly decorated. I 20 wouldn't let anything stand in my way. I 21 have a contract with the United States. 22 And today it's not worth the paper it's 23 written on. 24 "I'm not a veteran because I am not 25 qualified for discharge. I am not a 181 1 soldier because I signed a DD-214 after 2 being ordered to do so. How can these 3 be? 4 "What have I done with the last ten 5 years of my life? Today I have to seek 6 medical help the best way I can. I know 7 that I was not in the war zone. 8 "But I know I was prepared to go 9 and I supported a unit going to and 10 coming from the Gulf. That must count 11 for something. 12 "I don't think that I am being 13 unreasonable to want the rights I was 14 told I would receive if I needed them. I 15 have earned them. Jeffrey St. Julian." 16 CHAIRPERSON LASHOF: Thank you very much. 17 Just for the record, I'd like to clarify that you were 18 reading a statement from -- 19 MRS. ST. JULIAN: Jeffrey St. Julian. 20 CHAIRPERSON LASHOF: St. Julian. 21 MRS. ST. JULIAN: Yes. 22 CHAIRPERSON LASHOF: I see. And you are? 23 MRS. ST. JULIAN: Diane St. Julian. 24 CHAIRPERSON LASHOF: And you are Diane St. 25 Julian. 182 1 MRS. ST. JULIAN: Yes. 2 CHAIRPERSON LASHOF: So that you were 3 reading the statement on behalf of your husband? 4 MRS. ST. JULIAN: Yes. 5 CHAIRPERSON LASHOF: I understand that 6 now. 7 MRS. ST. JULIAN: Okay. 8 CHAIRPERSON LASHOF: I wasn't clear on 9 that, and I wanted that clear for the record. 10 MRS. ST. JULIAN: Okay. 11 CHAIRPERSON LASHOF: Thank you very much. 12 MRS. ST. JULIAN: Okay. 13 DR. TAYLOR: One question, Diane? 14 CHAIRPERSON LASHOF: Oh, yes. Questions. 15 DR. TAYLOR: Diane, you said that he 16 received the vaccines? In his statement, he said that 17 he had received a vaccine but never served in the 18 Gulf. So he received some of the similar shots that 19 many of the other veterans -- 20 MRS. ST. JULIAN: Yes. He received all 21 the vaccines. He was even loaded on the plane to go, 22 with bags and everything, and then was told to stand 23 down. 24 CHAIRPERSON LASHOF: Are there any other 25 questions. 183 1 (No response.) 2 CHAIRPERSON LASHOF: If not, thank you 3 very much. 4 MRS. ST. JULIAN: Okay. Thank you. 5 CHAIRPERSON LASHOF: I think before we 6 close we had one request from one of the Gulf War 7 Veterans. Denise Nichols would like to make just a 8 few remarks about her reactions to the day and a half, 9 almost two days. 10 MS. NICHOLS: It's awfully low here. 11 CHAIRPERSON LASHOF: Denise, I will ask 12 you to be brief because we must return promptly -- 13 MS. NICHOLS: It will be brief. 14 CHAIRPERSON LASHOF: And I do have a few 15 more minor business things to cover. 16 MS. NICHOLS: We want to make a couple of 17 statements. First of all, we appreciate the 18 dedication that you've shown. And you've picked up on 19 some of our concerns. We do hope we have some 20 communication with the staff as you go along. 21 I want to mention that we have had quite 22 a few deaths. And we have different figures. And we 23 hope that if you get those death data that you can 24 help facilitate the release of that so recognition for 25 these soldiers and the troops can be started. 184 1 I think they need to be recognized in some 2 way. Col. Kline is one example. And I would like to 3 move that forward so that those families have some 4 recognition. I want to stress again that time is very 5 definitely a factor. 6 A lot of the vets feel like their time is 7 short, that they are dying. And so I hope that even 8 though your final report is not due until quite a ways 9 away, that if you find data that will provide the 10 answers, that you will communicate clearly with the 11 troops. 12 There was one thing that I was taught when 13 I came into the military as an officer. And I am 14 retired now. It was always said if you take care of 15 the troops, they would take care of you. We've done 16 our duty. We would like you to help us find the 17 answers and get them addressed. 18 We hope that you will also consider the 19 base line data that a lot of troops didn't have. Some 20 of us do have base line data from before we went to 21 war, with the physicals. A lot of our records are 22 missing. 23 Some people being reservists guards might 24 be able to provide some of that. And it's never been 25 asked for. But one of the things I've seen is it may 185 1 not be abnormal lab results yet, but they are 2 different from their base line. They have changed 3 over time. 4 And I was always taught as a nurse to look 5 at a base line first. And it may not be abnormal yet. 6 But if it's changing, you need to watch it. And it's 7 an indicator. 8 I want to stress that they have not been 9 doing testing for depleted uranium. And in a 10 sandstorm situation, like we were in over there, with 11 the weather factors and all, that we have great 12 concern for the inhalation, ingestion, of depleted 13 uranium. 14 And we have not had any testing across the 15 board for depleted uranium in our bodies, and heavy 16 metals, and the lead that came out in one of the 17 reports in the past. 18 We also have not had sufficient testing 19 for leishmaniasis and some of the endemic diseases 20 that may be affecting the families and could be 21 addressed quite quickly, I do believe. I think those 22 things that may affect the family we should put on a 23 high priority -- would be our feed in because there's 24 great concern for our family members out there. 25 And in ending this, I would hope that -- 186 1 we heard the figures 58,000 on a registry. I went to 2 the Wall last night, stopped by early this morning -- 3 58,000 and something names on the Vietnam War. And I 4 hope that we are not looking at -- and delayed an 5 expectant category of people that are looking to be 6 not with us. And I hope that that doesn't happen. 7 That would be a real tragedy for our nation. And 8 thank you for your sincerity. And thank you for 9 addressing some of our concerns from yesterday. 10 CHAIRPERSON LASHOF: Thank you very much. 11 We are about ready to close up. I just 12 have a couple of final things to say to the Committee 13 and then to anyone in the audience who wants to 14 approach anything. 15 Over the next few days we'll be getting 16 out to you follow-ups on some of the issues that we've 17 discussed. Robyn will be back in touch with you about 18 dates and we'll try to resolve some of those. 19 Again, the -- I wanted to make clear to 20 any of the audience who wishes to submit any 21 additional material to our office. That is open 22 throughout the duration of our study which runs to 23 December 1996. 24 I would urge you not to submit anything 25 during the last month or two, but the sooner we get 187 1 additional information from you, the sooner we can 2 address your concerns and look into it. 3 This is not like a Congressional hearing 4 where you only have ten days after the hearing to 5 submit material. Our office will be open to 6 submissions from any veterans or any other concerned 7 people who have information or data. 8 Again, I'll give you the address of that 9 office. That's 1411 K Street, N.W., Suite 1000, and 10 the zip code is 20005-3404. 11 Thank you, Robyn. 12 And if there are any other closing remarks 13 any member of the Committee cares to make? 14 (No response.) 15 CHAIRPERSON LASHOF: If not, I will turn 16 the gavel over to Cathy Woteki, who officially opens 17 and closes our meetings. 18 MS. WOTEKI: And as the designated federal 19 official for the Gulf War Veterans' Illnesses 20 Committee, you are now adjourned. 21 (Whereupon, the Public Meeting of the 22 Presidential Advisory Committee on Gulf War Veterans' 23 Illnesses was adjourned at 2:49 p.m.) 24 25