PRESIDENTIAL ADVISORY COMMITTEE
ON GULF WAR VETERANS' ILLNESSES
PUBLIC MEETING
September 5, 1996
Loews L'Enfant Plaza Hotel
480 L'Enfant Plaza, S.W.
Washington, D.C.
Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway #160
Fairfax, Virginia 22030
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TABLE OF CONTENTS
Page
Follow-up on Stress Panel Meeting 1
Staff Briefing and Committee Discussion: 11
Stress as a Risk Factor
Staff Briefing and Committee Discussion: 53
Access to Care
Followup on Persian Gulf Investigation Team/ 93
risk factors panel meeting
Staff briefing and Committee discussion: 96
Chemical and biological warfare
agent investigations
Current efforts and implementation of Interim Report
recommendations
The Honorable Kenneth W. Kizer 135
Department of Veterans Affairs
The Honorable Stephen C. Joseph 143
Department of Defense
The Honorable Philip R. Lee 156
Department of Health and Human Services
Committee and staff discussion: Next Steps 164
P R O C E E D I N G S
[9:37 a.m.]
DR. LASHOF: Good morning. We are going to resume the deliberations of the committee this morning, and as I indicated yesterday, we have changed the order a little bit and we are going to start with a discussion of stress as a risk factor.
We are going to first have the follow-up on the stress panel meeting, and then go on with the staff briefing and a committee discussion on stress as a factor. Dr. Cassells will present, Dr. Hamburg will lead the discussion and summary of the panel meeting.
Dr. Hamburg, do you want to start with sort of reviewing the panel meeting, and then Dr. Cassells will review the staff recommendations.
Agenda Item: Follow-up on Stress Panel Meeting
DR. HAMBURG: I will be happy to do that. Let me say first that I think that I can speak for all the members of the committee and certainly of the panel that met in Cincinnati that we have a strong sense of empathy for the veterans and concern about the risk factors associated with their war experience.
We are keenly aware of the anguish of the families. These hearings and the panel meetings have been important for us in learning what the experience was actually like, being aware of the stressful aspects of it, and we come out certainly with a strong sense of the need for this country to sustain an ongoing search for understanding in scientific, medical, and human terms of what the combat experience is really about and thereby to improve opportunities both for current and future veterans.
The staff with some help from us has organized a very thorough examination of the biology and psychology of stress and clinical implications for stress-related disorders. I think we have also bumped up against the limits of existing scientific knowledge, and also bumped up against the inherent near chaos of war. This is not a controlled laboratory experiment. It is very difficult to sort out what actually happened and the impact of events on individuals.
Certainly, from all that we have learned, the veterans of the Persian Gulf War had many stressful experiences before, during, and after deployment. They encountered many difficult distressing experiences - threat, danger, high uncertainty, unknown yet looming risks, and with that, the inherent responses of the human organism or responses of human biology of apprehension, anxiety, hypervigilance. There are many people at many times on high alert. That is, we looked at a very fundamental set of human biological responses to hypervigilant condition.
The process involved review of the scientific literature by the staff and with the help of consultants over the past year or so, a staff consultation meeting with experts from all over the country in April, and then a panel meeting with additional experts of international stature in Cincinnati in July.
We are leading scientists in a number of fields and clinicians. We looked at basic research, we looked at clinical research, we looked at a lot of new research which has in some ways been counterintuitive and in some ways has been surprising in the scientific community, for example, the effect of stress on the immune system.
We tried to cover causes, prevention, treatment, and to be future oriented about lessons that could be learned from this experience that would be useful in the future deployments.
Let me try to summarize the essence of the core biological response to stress as we heard it laid out for us and read about it in the scientific papers that were generated by the committee.
As I said, the brain under conditions of stressful experience goes on high alert to cope with the danger and to learn about avoiding or coping with similar dangers in the future. It is a very complex process of information processing in the brain which is only partly understood, but certainly leads to an appraisal of the threatening situation - what is it, what is happening, what can I do about it, and that coordinated response in the brain in turn stimulates a very massive coordinated response throughout the body, in effect a preparation for intensive activity classically called the fight or flight syndrome.
It is more complicated than that, but it certainly involves the physiology and biochemistry of preparation for high exertion, for intensive activity, and this coordinated set of responses is guided by the brain.
It involves a major secretion of a set of hormones, particularly those of the adrenal, the adrenaline type hormones of the adrenal medulla and the cortisol type hormones of the adrenal cortex, two parts of the same gland that sits on top of the kidney, and also the brain sets in motion the so-called autonomic nervous system which has wide ramifications throughout the body. So, between the brain's effect in controlling secretion of stress hormones and stress responses in the autonomic nervous system, you get this mobilization.
The net of it is it is a mobilization of energy resources, fuel from the depots, fuel from the storage places into the circulation and into the tissues for burning, fuel for burning during exertion, and oxygen, that is essential to do what is needed in the face of what may be a life-threatening situation.
This involves a reorganization of the circulation of the blood to get where it is most needed, which mainly means the muscles, get it there in anticipation of the period of intensive exertion. That involves increasing the pumping of the heart, the rate and the stroke volume, and also elevation of blood pressure that ensures adequate circulation in exertion.
But by the same token, the other side of the coin is a decrease in blood flow where it is not needed, for example, in the gastrointestinal tract or where it could be harmful as in the skin, where excessive bleeding, of course, could be dangerous, and there is also increase in the mechanisms having to do with blood clotting during the stress as a kind of biological preparation for injury.
The hormones of the adrenal gland are very powerful. They affect virtually every cell and tissue in the body. Adrenaline is vital for the rapid alert, it increases blood pressure, it eases the flow of air into the lungs, the handling of oxygen in the lungs, so it is actually vital, and yet, it is interesting to observe that the body treats adrenaline almost like a poison, that is, it clears it very rapidly as if it were a highly toxic substance which it is. So, you need it in the short run very badly to adapt to particularly life-threatening stress, but you also need to get rid of it rapidly, so that it doesn't make you sick over the longer term.
The acute response is a wholly coordinated set of central nervous system, endocrine, peripheral nervous system, cardiovascular, and other responses is highly adaptive. Without that coordinated set of adaptive responses, we, as a species, couldn't be here today, couldn't have survived, but on the other hand, that powerful alarm bell can be very troublesome if it rings too often. It is a costly response.
Each one of those biological mobilizations costs a lot, physiologically, biochemically, it costs a lot, and if you keep ringing that alarm bell over and over and over again, then, the stress responses can become risk factors for a variety of disorders.
There are consistent individual differences in how much and in what ways we as individuals respond to this stress alarm. Part of that is genetic, for example, genetic factors influence the production and distribution of the various stress hormones, and part of it has to do with earlier experience through which people may become sensitized to a stressful experience or may become relatively invulnerable to certain kinds of stressful experience, so both early experience and genetics have a bearing on the individual differences in response to a threat in adult life, it sets in motion this biological mobilization.
So, that in a short sketch is an attempt to summarize the better part of the day or at least half a day of information about basic stress biology.
We also heard a lot about the connections of chronic or prolonged or recurrent stressful experiences, not only with physiological changes, but with symptoms and clinical disorders, and I believe over all that we will be able to say that this evidence, much of it quite recent, increases the biological plausibility of some symptoms and disorders being stress related, but in my judgment at least it is not likely to permit a conclusive precise statement of what percent of Persian Gulf illness is stress related, and certainly would not permit the exclusion of other potentially causal factors, in other words, it comes out as an important part of the mix in relation to the clinical problems of the Persian Gulf War, but by no means a sort of dominating or overriding consideration.
It is likely to be a major contributing factor to the broad range of illnesses that are currently experienced by Persian Gulf War veterans. There is no reason to believe that stress would cause a single unique syndrome, a Gulf War syndrome. It might exacerbate a number of different conditions, it might be an important causal factor in some, but not likely to create a single unique syndrome.
We have also learned on the clinical side that the old stigma remains. There was a time up to and through World War I when there was a large amount of belief that these stress-related disorders were simply malingering and a lot of the critical comment.
To some degree that lasted to World War II, but World War II brought a great leap forward in understanding that every person has a breaking point, that stress is ubiquitous and powerful, and that no one is immune to it even though we respond in somewhat different ways, and there has been in recent times a considerable lessening of stigma, but it is still strong. That came out in a number of testimonies and studies.
We will need, as we go down to the wire with this, to see ways of sustaining the recent intensification of effort in stress research, not only by the Department of Defense and the VA, but also by the Department of Health and Human Services, especially through the National Institutes of Health, and also through the National Science Foundation.
We have to consider besides policy recommendation maintaining an adequate level of complexity. It has not been a terribly well supported field in the past. To some degree, research itself suffered from the stigma associated with stress-related clinical disorders, and that has to be overcome, and I think it is in the process of being overcome.
We also need to consider how the Department of Defense can spread much more widely and promptly the stress reduction efforts that we heard about, which are very thoughtful and constructive, based on the best evidence, but particularly with respect to deployed troops, stress management programs need to be considered.
We heard, very compellingly I think, evidence that fits with the studies done during World War II and the Korean War particularly on leadership and unit cohesion as being important in managing stress. As a group, sustaining the solidarity within a group and the mutual aid within a group is an important factor in offsetting the stress of combat and near-combat situations, and that means it is helpful to find ways of engaging senior commanders and senior noncommissioned officers in stress management programs.
With reference to the stigma problem, there really is a need for various government departments to conduct ongoing public education about to go for, but not just to go for, in terms of major stress responses and ways of overcoming the stigma problem.
We also need to consider how to respond to the pervasive concerns that we heard in Cincinnati and before on a number of occasions about VA compensation, that is, how to get periodic review of criteria and procedures including an updating in light of research and clinical experience. These things don't stand still, but as they evolve, the criterion and procedures for compensation need to be updated in my judgment.
Finally, we have heard in Cincinnati and before that recurrent concerns and complaints and suggestions about the medical care offered to veterans and also the organizational process through which veterans have to go to get various kinds of help.
That has involved both the VA and the Department of Defense, and we are going to have to do the best we can to clarify ways in which the VA and DoD can respond in a caring and constructive manner. There is certainly a ferment going on about ways to improve the organizational processes and medical care, and that deserves all the reinforcement we can give it.
Those are some of the highlights that occur to me largely from a review of the stress-related literature and the Cincinnati meeting, but also to some extent from similar themes that have come up in other meetings.
I think it would be good, Dr. Lashof, if we had a staff to augment, and if necessary, correct what I have said, and be sure that we have the facts as straight as we can get them with respect to the stress-related problems.
DR. LASHOF: Thank you very much, Dr. Hamburg. It was greatly appreciated. In your book, you do have a fairly detailed summary that staff have prepared, so let me now turn to Dr. Cassells and ask him to go through and highlight additional factors that he feels are important, or walk us through the rest of this most complex area.
Agenda Item: Staff Briefing and Committee Discussion: Stress as a Risk Factor
DR. CASSELLS: Thank you, Dr. Lashof, and I certainly won't be correcting anything Dr. Hamburg had to say, but I will try to reinforce some of the things that he has said. I think it is important to put some context on this question.
The mind-body debate that exists today actually began, as Dr. Hamburg said, about a hundred years ago when people began to attempt to distinguish neurological from psychiatric disorders.
At that time, there were two perspectives concerning this. One perspective, pretty much championed by Babinski, was that these were malingerers, and then there was Janet, a French psychiatrist, who very strongly believed that there were a host of biological changes that were responsible for these reactions in individuals.
The view that these people were malingerers took precedence, though, around the time of the first World War, and veterans with curious mixtures of psychological and biological complaints were compared to hysterical women. After World War I, the Germans named the complaint "Willenskrankheit," which means a disease of the will.
Throughout the 1920s, experts and policymakers worldwide believed that the sick men were just not good fighting material. They dismissed the idea that war could make men sick. It was not until the 1940s when World War II veterans experienced many of the same symptoms that the full spectrum of what had happened to the minds and bodies of veterans came into prominence. Psychiatrists finally described psychosomatic symptoms as normal extensions of fear and fright reactions and recognized the relationship between intense emotion and bodily changes.
The Gulf War veterans, as Dr. Hamburg mentioned, experienced and encountered many stressors. They included short notice of deployment, uncertainty about the length of the deployment, the hostile environment they were going into, marginal living conditions, prolonged work hours -- and shift work hours at that -- decreased income and worries about job retention, isolation and separation from family, fear of SCUD missile attacks, fear of chemical and biological warfare, threats of high casualties and torture, frequent chemical alerts, and observations of casualties and dead bodies.
They also experienced post-deployment stressors on their return from Southwest Asia, including financial difficulties, unresolved military pay, the rapid resolution of the conflict, which didn't allow appropriate debriefing, the identification of cases of leishmaniasis, and the resulting temporary ban on blood donations, a basis distrust of government and the beliefs and concealment and deception that we have heard so much of in our public testimony, and the incidence and reports of unexplained illnesses and the lack of any definitive diagnosis to explain them.
I won't repeat what Dr. Hamburg had to say about the physiological responses to stress in the human body. They have been demonstrated in animals, and also humans express the same sorts of physiological reactions.
It is important, however, to note that the mind and the body are not separate, unconnected entities. Stress produces demonstrable physiological effects which are mediated by the psychoneuroimmunological system, and these effects involve all organ systems of the body and may manifest themselves in an extraordinarily broad array of health problems, and we see full evidence of that.
The Persian Gulf Veterans Coordinating Board, which has reported to us on a couple of occasions, have identified two related types of research that are germane to this issue of stress. One is what was the prevalence of various psychophysiological stressors among Persian Gulf veterans, and is that prevalence different from that of an appropriate comparison population, and do Persian Gulf veterans have a significantly higher prevalence of psychological symptoms and/or diagnoses than do members of an appropriate control group.
Most of the government stress-related studies focus on risk factors for the development of psychiatric conditions, and a few also examine the protective roles or the protective factors that may ameliorate this. These studies examined preexisting conditions or characteristics that could be associated with the onset or the exacerbation of psychiatric disease.
The diverse variety of psychological stressors and environmental exposures during the Gulf War are being examined, for example, actual combat exposure, the use of chemical warfare protective gear. In addition, stressors during readjustment after the war are also being assessed - financial difficulties or adjustment problems with family and children.
A few studies are evaluating the potential protective factors, for example, educational attainment or the degree of social support that is available that might cushion an individual from developing a psychiatric problem in and after a highly stressful situation.
Two other major topics that are relevant to the consideration of the government's response are the treatment of Gulf War veterans with psychiatric diseases and the prevention of stress-related problems in future military conflicts, and I will go a little bit further into those two aspects.
Nineteen percent of the first 10,000 veterans in the CCEP had a primary psychiatric diagnosis, while approximately 37 percent had one or more psychiatric diagnoses as a primary or secondary diagnosis. These numbers and percentages have remained stable over time.
In DoD's recent report on 18,598 veterans in the CCEP program, 18.4 percent have primary psychiatric diagnosis, and 36 percent had a primary or secondary psychiatric diagnosis. While the VA considers its Registry to be a treatment program, not a research protocol or tool, some useful data can be obtained.
Based on the first 52,000 participants, the Registry data reveals about a 15 percent prevalence of primary psychiatric diagnosis, and that prevalence is consistent when it is compared across Active Duty, Reserve and Guard. Anxiety disorders are diagnosed in less than 2 percent of individuals, and chronic PTSD in about 3 percent.
What treatments have been made available to Gulf War veterans with stress-related illnesses? It is important to recognize that stress-related illnesses are real, often debilitating, illnesses for which treatment interventions are available.
Treatment for stress-related disorders is, by necessity, case-specific and symptom-oriented. No one treatment regimen is appropriate for the overlapping range of problems, from tension headaches, chronic fatigue, fibromyalgia, depression, and anxiety disorders.
Despite some variability in therapeutic approaches to depression and anxiety disorders, as well as other psychiatric conditions, there is a relatively narrow range of treatment options. However, in testimony before the committee, and from the results of our site visits which you will hear about later, there clearly remains a significant stigma attached to psychiatric diagnoses, which often interferes with the veteran receiving or accepting adequate care.
In many instances, veterans report meeting command resistance to granting the necessary time off to maintain an adequate treatment program. This is true of all chronic illnesses, but especially so for veterans with psychiatric diagnoses, despite the fact that since 1986, service members with certain chronic diseases that require medical monitoring have been allowed to remain on active duty.
Frank PTSD is particularly difficult to treat, and the numbers with that diagnosis are small in both the CCEP and the VA registries.
The basic treatment regimen for PTSD consists of three phases, the first one, which is establishing trust and safety; the second one is a therapy that focuses on the trauma, what happened, and how one deals with it and makes sense of what happened; and, third, moving from the past into the present by reintegrating into society, disconnecting from the trauma and reconnecting with the present.
Several additional types of psychotherapy ranging from peer counseling to marital counseling to long-term dynamic therapy exist as well. Some are long term, and some are designed to be short term only.
There are also some pharmacological treatments that work for certain veterans of psychiatric disorders or stress-related disorders like the use of Prozac or Zoloft, and there is research now underway looking at the possibility of developing drugs that can act on various elements of the neurobiological systems that are most associated with stress-related disorders.
Let me focus now on the preventive actions that the government has taken and may in the future take, and what this may mean to us in future conflicts and deployments.
It is axiomatic that preventing war would also prevent combat and combat-related stress disorders, but other stressors associated with modern daily life will continue and result in their own stress-related reactions. Thus, preventive and educational efforts become particularly important. When possible, education can prepare people for what they might encounter and it can be a buffer against stress. For example, debriefing by gathering people together after a major trauma and discussing what happened and how they are adapting to it emotionally serves to normalize the reaction, and it is important to remember that normalization of this reaction is important to its relief.
The realization that others are experiencing the same things can greatly reduce the level of stress. Screening instruments that have been shown to be useful in the diagnosis of some psychiatric conditions can be used along with psychiatric consultations to exclude from military service those individuals who exhibit psychiatric illness at the time of testing. Frank psychosis and clinical depression are examples.
Some people have also suggested the use of psychological screening as a mechanism to identify individuals at particularly high risk for adverse reactions to future stress, but no single instrument has sufficient predictive value to make it useful, even leaving aside the issue that selecting out individuals on the basis of test results of unproven value carries huge emotional baggage.
We heard at the Cincinnati meeting -- and Dr. Hamburg briefly mentioned it -- the Army's program to deal with combat related stress in a proactive way, building on research that they had conducted among Vietnam, Korea, and Gulf veterans. The DoD has instituted a human dimensions research program for use in the Bosnia peacekeeping mission and as a prototype for future deployments, and it is based on the important observation that strong leadership and unit cohesion are very much associated with reduced severity of stress reactions.
Combat stress control detachments have been established, six in the Active Army and nine in the Reserve, consisting of a psychiatrist, a psychologist, a social worker, a psychiatric nurse, a clinical nurse specialist, an occupational therapist, and two enlisted technicians.
One of these detachments is now deployed to Bosnia. These detachments provide predeployment briefings that address all the known health hazards including stress that individuals might face during the deployment. During the deployment, members of the detachments are instructed to be highly visible to the commanders and to the troops.
These detachments provide briefings for the units who are newly arrived. They provide special training in stress management techniques, and most important, they conduct unit survey interviews throughout the deployment.
Unit interviews are a systematic way of gathering information from the troops and then reporting to the command what is troubling the troops and how well leadership is functioning.
When critical events occur, particularly of a highly stressful nature, these trained individuals are responsible for debriefing the personnel directly involved as soon as possible to provide consultation to the leaders and chaplains, and to provide any special education that could be needed.
At the end of a deployment, all units, including those in which no critical events have occurred, receive an end-of-tour briefing. Those units exposed to particular events receive special attention to see that unit members have a chance to talk through and reach appropriate closure prior to returning home.
Follow-up plans for the Bosnia deployment include follow-up studies six months after return. Plans are also under discussion to have these individuals followed over the long term.
Tertiary prevention programs, such as the veterans centers within the VA, can help minimize psychiatric conditions before they become too severe. These vet centers were established after the Vietnam War to provide support for Vietnam veterans of PTSD and other mental health disorders. There are 205 of these centers located around the United States.
Since 1991, more than 66,000 Gulf War veterans have availed themselves of these centers in over 210,000 visits. Based on our staff consultation in April, our meeting in Cincinnati, and our review of the literature and interviews, the staff suggests that the committee make three findings and adopt three recommendations.
Finding 1. Stress is likely to be a major contributing factor to the broad range of illnesses currently being reported by Gulf War veterans.
2. Stress does not cause a single unique Gulf War syndrome.
3. Stigmatization of psychosomatic illness seriously interferes with some veterans seeking care.
Recommendations.
1. The Department of Defense should continue and intensify its efforts to develop stress reduction programs for all troops with special emphasis on deployed troops.
2. Since leadership and unit cohesion are so important in managing stress, the Department of Defense should specifically involve senior commanders and senior noncommissioned officers in stress management programs.
3. Since the stigmatization of mental illness continues to be a problem for society at large, the Department of Health and Human Services should place a priority on developing public education outreach programs that note the indissoluble association between the mind and the body.
The Department of Defense and the Department of Veterans Affairs should make a special effort on addressing and targeting such needed educational outreach to their populations, as well.
That concludes my remarks.
DR. LASHOF: Thank you very much, Dr. Cassells.
Before we take up the individual findings and the individual recommendations, let me open it for questions that any member of the committee have for either Dr. Hamburg, Dr. Cassells, or members of the staff.
John.
MR. BALDESCHWIELER: It seems to me that the compelling point of both David's presentation and the staff report is that there is a physiological response to stress, and one can treat stress in some sense as just another kind of trauma, and to which there is a physical response, and much of the pathway of that response is now understood and under investigation.
It seems to me that it very much complicates getting that message across to call it mental illness, and I wonder if one can't divide this problem into two pieces, one which is a physical response to the trauma of stress, and then another whole discussion, quite important but I think a very different, are those kinds of mental illnesses associated with all kinds of things.
Is this a useful way of looking at the problem?
DR. HAMBURG: I think it is. The broad term stress-related disorders probably is useful here because those disorders could manifest themselves in so many ways and may have primarily expressions in terms of, let's say, pain or other somatic complaints, or may have expression primarily in terms of anxiety and depression. The mind-body linkage is so intimate that I personally think it is useful to use some broad designation like stress-related disorders.
That is not to say that stress is unrelated to overt mental illness, but on the other hand, it is not to say that everything that happens in stress is in the mental health category. So, we need in some way to make that distinction.
I would like to add, if I may, another point. The recommendations we will discuss later, but I just hope we won't forget about the science policy aspect of this, and I think we should end up recommending something like intensification of support for research on the fundamental nature of human stress responses and their implications for stress-related disorders.
There has been a response in the scientific community to these problems as a function of the Gulf War, but I think, as a long-term, ongoing proposition, this would be an important additional recommendation to make.
DR. LASHOF: Yes. Let me, David, also follow up on the question that John had because I was wondering even in the writing up of this material when the term psychiatric disorder is used and when the term stress related is used, and I know it is a problem in terms of acceptable psychiatric diagnostic code or ICDM.
For example, somatoform disorders, what is the definition of somatoform disorder, and are we muddying the water to call that a psychiatric diagnosis, or is it really a physiologic response or body response to stress?
DR. HAMBURG: There is over a period of 20, 25 years a group of psychiatrists has worked out increasing specificity as far as possible to the diagnostic categories, and somatoform disorder is a difficult one because it refers to a variety, a rather large extensive variety of somatic complaints for which, at the present time, no physiological or biochemical basis can be ascertained.
Now, at some future time it may be possible to do that, but it is an attempt to categorize something that is meaningful clinically, but I think the more important point for our purposes is that I believe most experienced clinicians and clinical investigators would agree that stress-related factors are an important part, not only in the practice of psychiatry, but of medicine and in pediatrics and indeed of most of the specialties. This is not something you kind of neatly wall off, but it enters into a great deal of suffering that people have, and regardless of how they are categorized, by specialty or by diagnosis, at least the exacerbation of ongoing difficulty by stress is just a pervasive part of medicine.
So, I don't think we are going to solve that problem here, but we certainly ought not to be too quick to categorize stress-related disorders as psychiatric ones unless it is clear. If it is clear, then, there shouldn't be a stigma attached to that either. I mean if it clearly falls in the domain of psychiatric competence, that ought to be faced and dealt with constructively like anything else.
But I think for our purposes, a somewhat narrower construction of what falls in the psychiatric category would be useful.
DR. LASHOF: Other questions? This is a minor technical one, I guess, for you, Joe. You mentioned among the stressors in post-deployment, military pay problems or unresolved military pay. What does that refer to, do people not get paid?
DR. CASSELLS: People not getting paid or not being paid in a timely fashion, that kind of difficulty, facing a gap in income for whatever number of reasons there might be during the time of post-deployment.
DR. LASHOF: Is that a fairly common or correctable problem?
DR. CASSELLS: It is a stressor, but it is correctable.
DR. LASHOF: Further questions?
DR. LANDRIGAN: Joe, one of your conclusions here, and I imagine that David concurs, is the first one, is that stress is likely to be a major contributing factor to the broad range of illnesses that are currently being reported by the Gulf War veterans.
Are you in any position or do you have any plans to move forward and to try to further quantify that phrase "major contributing factor," is there any way in which you could calculate that 20 percent or 50 percent or 70 percent of the illness in the veterans is due to stress, or would you prefer to just leave it like that?
DR. CASSELLS: I think we need to leave it like this. We can't be any further definitive in the quantitation of that, and I think Dr. Hamburg made the similar point in saying that we don't know how much is stress related, but we certainly know that stress is likely to be a contributing factor to a broad range of these illnesses.
DR. LASHOF: One other question I have is that on page 7 of your write-up, you give some data from the CCEP on lost work days due to psychological conditions, and you have three points. The average was 3.7 work days lost.
Over what period of time, is that a year, two years?
DR. CASSELLS: That was over a year's time.
DR. LASHOF: Over one year. And it sounds like a very small amount of time.
DR. CASSELLS: It was a small amount of time. This was data from the CCEP based on the first 10,000.
DR. LASHOF: Do we have similar data from the VA on this or not?
DR. CASSELLS: Not in any more detailed data than what I have given you.
DR. LASHOF: Are there any other questions that others have before we focus our attention on the specific findings? Please.
DR. CAPLAN: Just one for Joe about the definitional question. We go around and around this issue of whether there is a Persian Gulf War syndrome or illness at different times, and now it has since come out saying, well, there is a cluster of illnesses, but there is no real syndrome here.
My understanding was that a syndrome is a cluster of illnesses, and if we are going to say that stress plays a strong role in this cluster of illnesses, are we going to say that there is a syndrome, a lot of it having to do with stress, or are we going to wind up saying there is a cluster of illnesses, but they don't make up a syndrome, and you understand as well as I do the sort of politics of all this, but --
DR. CASSELLS: We are talking about a cluster of illnesses as opposed to a single syndrome in this particular instance, but the popular literature has climbed onto the term "Gulf War syndrome" as a single illness with a single cause, and that is not stress.
MR. RIOS: Joe, does the VA presently allow compensation for stress-related illnesses? Do they have a rating chart?
DR. CASSELLS: The VA rating compensation system certainly compensates for certain psychiatric disorders, and compensates for other kinds of disorders, and for Gulf War veterans there also is compensation for unexplained illnesses.
MR. RIOS: Did you find any serious problem with the way they do that?
DR. CASSELLS: We have not been involved in looking at the compensation side of this issue. This has not been part of our mandate.
DR. LASHOF: That is one issue that wasn't on our plate.
DR. CUSTIS: There is a high percentage of compensation by the VA for the diagnosis of PTSD. As a matter of fact, it was the VA that persuaded the acceptance of that diagnostic term in standard nomenclature.
DR. LASHOF: Thank you. Other questions?
If not, let us focus then on page 10 in your book where we have the specific findings. The first deals with stress is likely to be a major contributing factor to a broad range of illnesses.
We think there is pretty unanimous agreement on that. Is there any further modification of that finding or any change in the wording of that finding that anyone would like to recommend?
If not, we will accept it as it appears.
Now we come to the one we have just discussed with Rolando, and the way this is written, we say, "Stress does not cause a single unique Gulf War Syndrome."
"Gulf War Syndrome" there is capitalized I think very specifically to sort of set it apart as if that were a diagnostic term itself.
Would that be correct? I mean if it didn't have caps, it would sort of fall in this category it could be any group or cluster of illnesses that people were referring. Why not refer to it as syndrome?
DR. CASSELLS: Why not refer to it as an illness?
DR. LASHOF: Several illnesses.
DR. CASSELLS: Does not cause a single unique Gulf War illness.
DR. LASHOF: Would that be preferable to the committee, or do you think it is important to make the point that since it is talked about generally as a syndrome, that we make the point that it is not? I mean it may sound like splitting hairs, but it is a question of how, as we discussed yesterday, how you communicate and get your message across in the clearest, most unambiguous way, and I am not sure.
Let's open it to discussion.
DR. LANDRIGAN: The broader reality is that, number one, stress does not cause a single Gulf War syndrome, and number two is that stress-related illnesses are not the only syndromes that have occurred in the Gulf War veterans. It is a multifaceted reality. I am not sure we need to say all that here. I this is accurate as far as it goes.
DR. CASSELLS: That is correct.
MR. RIOS: Let me ask you, are we suggesting that there is no such thing as a Gulf War syndrome?
DR. CASSELLS: As far as stress is concerned, yes, we are.
DR. LASHOF: Well, let's put it in the terms, I think that means broadly from our discussion, we would be moving certainly in the direction that we would have to come to grips with at one point, if not at this meeting.
The next is to whether we say there is no unique Gulf War Syndrome as compared to a series of illnesses related to Gulf War service.
DR. HAMBURG: I think you have to be very careful. Is what you are trying to say here that stress does not cause a single unique illness, because that I think that we can all accept.
DR. CASSELLS: Yes. The Gulf War modifier is in there because we are dealing with the Gulf War. It is equally true when removing Gulf War.
DR. HAMBURG: But, in fact, stress can give rise to a variety of symptoms which are remarkably close to those reported by our veterans' cohorts.
DR. CAPLAN: That is what I meant when I said there may be a syndrome.
DR. LASHOF: Well, let's take the two findings or the first finding and the second together. The first one says it is likely to be a major contributing factor to a broad range of illnesses currently being reported, and it seems to me that the second is related to that, whether they need to be highlighted as separate statements almost or whether they really aren't two ways of saying the same thing.
DR. LANDRIGAN: Could I propose a little different formulation of the second one? The way it is written it is almost written in code, and maybe we should decode it and just spell it out in plain language and say that stress causes a variety of different illnesses or symptoms in different veterans. These include -- and then list four or five of the most prominent, and save the other issue, which in a sense is a broader issue that our committee has to resolve. Save that for separate resolution.
DR. HAMBURG: But you would have to say stress could cause.
DR. LANDRIGAN: Could cause what?
DR. LASHOF: I think rather than just say "could cause," I think we are very comfortable from everything that we have looked at to say it is a major contributing factor to a series of illnesses and symptomatology maybe, because part of the problem, there are some illnesses that have been diagnosed, like fibromyalgia is a diagnosed illness, chronic fatigue syndrome is a diagnosed illness, and we think stress could well be related to the onset of fibromyalgia - not the only factor maybe, I mean we don't know the cause of fibromyalgia, but we do believe that stress could well contribute to the development of that.
So, that is why the statement that it is likely to be a major contributing factor to a broad range of illnesses currently being reported, some with given known diagnoses and some undiagnosed, and maybe we need to add that phrase, you know, something to the effect a contributing factor to both those illnesses with definitive diagnoses as well as to many of the undefined and undiagnosed illnesses.
DR. HAMBURG: Could we just leave the second bullet out altogether?
DR. LASHOF: We could leave the second bullet out at least here and come to grips with that after we have looked at our total issue.
DR. CUSTIS: I think the second bullet adds considerable to the first. What about stress does not cause a single discrete and unique Gulf War syndrome?
DR. LASHOF: That is all right with me. Does anybody have any problem with that, adding the term "discrete"?
DR. CUSTIS: There has been a lot of debate about is there or is there not a syndrome, and if we fail to reference that debate, it seems to me we leave something out.
DR. LASHOF: I think we have to reference that debate in the total report after we have summarized all of our risk factors and everything we know about the various diseases and review of the CCEP, and all of that.
The question is whether we need to reference it here under "Stress," or maybe that is just going to be a formatting problem of where we end up.
MS. GWIN: The way the outline for the final report reads right now, there is a chapter that we are calling, "The Nature of Gulf War Veterans' Illnesses," which is where I would think a finding, an overall finding there is or is not a Gulf War syndrome would appear.
We are going to be giving you briefings in October that will pull together a lot of this information, data that is available from the clinical programs, data that is available from the epidemiologic studies, and the summary of our risk factors, and you may want to postpone a decision about how to address stress as a cause of a single Gulf War illness until that later date.
DR. CAPLAN: I was just going to come around one more time and say it seems to me illnesses and diseases have clear-cut etiologies and clear-cut symptoms that present themselves, and syndromes have clusters of things, and you may not have all the illnesses or manifestations, but you still might have the syndrome. It is more like if you have six out of 10, or eight out of 10, at some level you decide to do it.
I would be happy here if we said, "Stress does not cause a single illness," because I think that is what we are saying, that you might have anxiety, you might have chronic fatigue, you might have many things, but there is no illness that it causes. Whether we are going to come down and say something about is there a Gulf War syndrome, I am looking forward to, but here I think we have stress doesn't cause an illness, because I think there is a cluster or them.
DR. LASHOF: A single discrete illness. I think you could sort of blend those into the finding that it is not really separable from the statement that it is likely to be a major contributing factor to a broad range of illnesses, but does not cause a discrete single illness.
MS. NISHIMI: If I can recap, I hear three elements. First, Phil's, to make the positive statement that stress does cause a wide range of illnesses, such as -- list. Number two, stress does not cause a single unique discrete illness, and then number three, stress is likely to be a major contributing factor.
Are those the elements that the committee is comfortable with?
DR. LASHOF: I would be if both Dr. Hamburg and Dr. Cassells and Dr. Brix, and those who have looked at this, feel comfortable in the one thing that says stress does cause --
MS. NISHIMI: -- a broad range of symptoms including --
DR. LASHOF: Can we say it causes those or is it a contributing factor?
DR. CASSELLS: I prefer to say a major contributing factor.
DR. LASHOF: I am having trouble with whether we yet have the scientific data to say it causes these symptoms or whether it is a major contributing factor to them.
David?
DR. HAMBURG: I spoke about contributing factor, major contributing factor.
DR. CASSELLS: I prefer contributing factor.
DR. HAMBURG: Not as a straightforward cause.
MS. NISHIMI: Phil, do you want to --
DR. LANDRIGAN: I am content.
MS. NISHIMI: Then, that is fine. Then, let me just for clarification for staff and the committee, we will have two parts. The first one is essentially as you see it with an elaboration, such as.
The second part is, "Stress does not cause a single unique discrete illness," and that the committee's discussion on whether there is or is not a Gulf War Syndrome (in caps) will be taken in the context of the entire analysis that will be discussed in October.
Is that everyone's understanding?
DR. LASHOF: Is that satisfactory? Fine.
The third one is this issue of stigmatization of psychosomatic illness seriously interferes with some veterans seeking care.
I think my only suggestion of addition there is any stigmatization of both psychosomatic and psychiatric illness. They are different, and both of them create problems in my mind for the veteran.
Any other thoughts or hesitations or additions, corrections? John.
DR. BALDESCHWIELER: What I wonder is -- once again the point I raised previously -- whether it is possible to perhaps divide this whole discussion into two parts - one part where one has the relationship of stress to measurable physiological response, and the second part which deals with the psychiatric factors, so that one could perhaps make this part of the report more acceptable.
For example, throughout the text everywhere, there is a psycho, if one could put a stress induced, and then reserve discussion of responses, such as depression, and so forth, to another part of the report.
DR. LASHOF: Well, stress clearly is a factor in both. It is clearly a factor in some --
DR. BALDESCHWIELER: Physiologic.
DR. LASHOF: -- physiologic. Well, you know, psychiatric is physiologic, too. I mean it is unfortunate that historically, we have this separation of mind and body, and we think of psychiatric disease as different from, quote "somatic" disease, and they really are so --
DR. BALDESCHWIELER: But one really has measurable response of the immune system, for example, and it seems to me these are matter which I think are measurable and potentially quite acceptable, whereas, the stigma is related to those things that are psychiatric, or at least it seems to me one could move the discussion in that direction.
DR. LASHOF: Any thoughts on how one could do that, David? I appreciate John and I have the same feeling as I read through this, that the use of psychiatric illness so many times and somatic illness, and the two are so interrelated. Stress clearly contributes to psychiatric illnesses, it clearly contributes to illnesses that are not usually considered psychiatric under a psychiatric diagnosis, but have related physiologic response to stress.
DR. HAMBURG: Stress is also -- it really relates to the limits of our knowledge. It is partly what John is asking is a social question of how we can phrase what we say in a manner that is really sensitive to the concerns of the veterans and their families, and avoids further stigma.
At the same time, I think the facts as presently understood are that you have this wide range of physiological biochemical perturbations associated with repeated and sustained stress response, and because, let's say, one important class of conditioning factors is genetic, that somebody who has been unlucky enough to inherit a gene that predisposes to hypertension, they come out of the stress-related situation, the highly stressful situation with hypertension as the point of contact with the medical system, and is therefore in some sense legitimate.
Somebody else who has an inherited defect of some enzyme that has to do with processing information to the brain, they come out of the same stressful experience with a terrific anxiety reaction or other "mental" disturbance, that has more stigma associated with it. It is no less human, it is no less biological, it is no less legitimate in fundamental terms, but it has more stigma connected with it.
So, in that sense, the person that gets hypertension is luckier than the person who has panic reactions, they are both stress related.
DR. LASHOF: Even if the hypertension is more apt to be fatal than the anxiety reactions.
DR. HAMBURG: Exactly. It is probably better off to have the panic than to have the hypertension, but nevertheless, it is more legitimate. That is a social problem.
I think we want to be very sensitive about avoiding unnecessary stigma like it has some hint of the old malingering about it. That is certainly not what we intend. I would personally, as I said earlier, not be inclined to apply the psychiatric label unless there is a clear reason to do so, but I think we have got to keep in mind that if that is the way the problem expresses itself, in a panic or in depression, that something can be done about that, a lot can be done about it. A medical response is very appropriate, and we don't want to let that drop out of sight either.
So, I think it is mainly a drafting problem. I am not sure we can draft it in committee here, but to the extent that we can narrow it somewhat the explicitly psychiatric categories, I suppose there would be an advantage in that, so long we don't inadvertently cop out of our responsibility to deal with psychiatric problems when they are clear-cut.
These things change over time, too. A lot of this is just operational, where does the person come for treatment, where is the particular specialized expertise at a given time to deal with it. The category of psychiatry operationally might be broader or narrower.
There was a time when there were very few labeled psychiatrists, there were not psychiatry departments in medical schools, there were no institutions to support psychiatric research, and so they were handled as "medical disorders" and mainly in internal medicine, and I may say generally not handled very well.
So, this is a tough problem. I think we can handle it in the drafting as long we are careful to meet our responsibilities to the different sectors of medical responses to stress and as long we keep in mind repeatedly emphasizing the powerful biological responses to stress that channel into many different functional systems and therefore many different kinds of symptoms and disorders.
DR. CASSELLS: We have to keep in mind also that -- following up on John's point -- that there is not a single assay at our present level of knowledge that says stress. Stress is manifest in a number of different ways.
DR. LASHOF: Yes. I mean we can't do a blood test that comes out with -- you know.
DR. CASSELLS: There is not a blood test for equal stress.
DR. BALDESCHWIELER: But, in fact, you can measure degradation of the cardiovascular system, and you can measure responses of the immune system.
DR. LASHOF: There is no way to quantify and say this has happened because of stress and only stress, and there are so many other --
DR. BALDESCHWIELER: But those classes of responses are clearly quite acceptable, and it seems to me zero stigma attached to it. I mean, for example, when you use the word psychoneuroimmunological system, if you take the psycho off, it seems to me it makes that discussion completely nonthreatening.
DR. LASHOF: But not scientifically accurate, John, because the hormones also are found in the brain as well.
DR. BALDESCHWIELER: But that is what the neuro means.
DR. HAMBURG: You can use other terms. I said you want to avoid something like psycho as a derogatory terminology, however, there is a major discipline in psychology, and let's face it, folks, this is fundamentally psychological. It is an interpretation of events by an individual, and the same event is interpreted quite differently by different people, by the same person at different times, so you can't exclude that fact.
You can use terms as I did earlier, like appraisal and alert and hypervigilance, and so on, and those normally in the world of knowledge are thought of as psychological functions, and which are at the same time very tightly coupled, an expression of brain activity, an expression of the domain of neuroscience, so we can minimize the use of terms that could be misinterpreted as being derogatory or stigma-eliciting, but we can't avoid the biological properties of the way the brain processes information in response to difficult circumstances.
DR. BALDESCHWIELER: I think I am not proposing to eliminate that, but just to somehow divide the discussion into two parts, one where we address frankly the psychiatric issues, and in such a section I would think stigmatization of psychiatric illness seriously affects veterans seeking care.
That would be, it seems to me, a clear and present finding associated with psychiatric section.
DR. LASHOF: Well, maybe also we could, in the findings, say something about stigmatization of psychiatric illness, but also say something about the stigmatization of undiagnosable -- I am not sure how to word it again, and as you say, we really can't draft the wording -- but the concept that there are numerous illnesses that manifest themselves with somatic symptoms that are stress related, that aren't easily diagnosable and fall into known diagnostic categories.
DR. CASSELLS: We have to be very careful that we don't appear to be buying into the stigma for the psychiatric arm of that.
DR. LASHOF: That is right, that we are concerned that both types have been stigmatized and that we need to clarify and not stigmatize either.
MR. RIOS: Let me ask John, since we are concerned with the separation of the mind and the body, and maybe people say, "well, it's all in your head," your suggestion to separate it that way, wouldn't that play into that, maybe hurt us in the long run, as opposed to trying to make this an evaluation of the whole body, the damages that are being caused to the human being?
I am just suggesting, would that be contributing to that?
DR. CUSTIS: Let's create a new term, neuro --
DR. LASHOF: As I say, we can't change terminology.
DR. HAMBURG: Operationally, one way to respond in part to John's concern would be to take a core set of secondary diagnostic categories, as reflected in the diagnostic manual of the American Psychiatric Association, you know, it is far from perfect, but it is the best that has ever been done, and it is the best that can be done in light of the present knowledge probably, and say a certain percentage of these stress related disorders fall into those core diagnostic categories that have relatively explicit criteria, and a certain percentage is just related disorders, and this would have to be a rough approximation, I think, a certain percentage fall into other diagnostic categories that operationally are today mainly in internal medicine or in orthopedics or in other medical specialties.
You could do that provided you recognize that the stress factor was important to cross that whole range and that this is a very legitimate and deeply human part of biology. We could find a way to handle that as long as we are extremely careful that in trying to correct stigma one way, we don't load it another way. It is going to take some drafting.
DR. LASHOF: It is a challenge to you. Why don't we leave it at this point. You have got the sense of where we are thinking and would like to go. So, let me move to the recommendations and let us see whether we concur with the three recommendations that appear before you. Let me take those up, and then we will discuss the research one that Dr. Hamburg added.
The first deals with DoD's efforts to develop stress reduction programs. I can't imagine anyone would not concur that that is an important recommendation. I think we were quite impressed yesterday with the presentation of what is going on in Bosnia and their efforts in this direction. I guess one can always say intensify. I don't know that we are in a position to know how much more they have to do, we recognize that they are doing by saying they should continue.
DR. HAMBURG: I do think it is a sound recommendation, and I think it is important to point out -- it is an aside, but it is perhaps a useful aside -- that the Army has really a distinguished tradition, a long distinguished tradition of supporting research on stress-related problems even in the most difficult times, going back at least to World War II and since, the major source of support for research for the basic and clinical on these matters, it has adopted a public health point of view.
When it developed the Walter Reed Army Institute of Research, here, during the Korean War, it started out with an extraordinary group of scientists in a range of fields working together, and all the way from studies in the field in Korea to basic mechanisms of processing information in the nervous system, for which one of those original founding scientists later won a Nobel prize, so that is an institution of which we can be very proud, and the Army's tradition of trying to understand stress-related problems and find ways to cope and even to prevent is something that we should reinforce. It probably, I would guess, has waxed and waned in its support within the Army. I don't know that to be of recent years, I am not so close to it, but I think it is a very valuable tradition, and we should reinforce it.
DR. CUSTIS: Shouldn't we also commend it?
DR. LASHOF: I was wondering whether maybe back in the findings, we might say something about a finding that they have done, and are doing, ongoing research if we are then going to recommend they continue, and are going to recommend further research, it might be that we would want to add another finding to the fact that we do find that they have been responsive, concerned about this, and have had an active program to deal with the issues.
Would anyone think that would be a worthwhile addition to the finding? The findings and the recommendations are the things most people are going to read in this report, not an awful lot of everything else we say, since the executive summary will be primarily findings and recommendations.
The next one deals with unit cohesion, and we have heard a great deal about that, and we heard some of that yesterday again in Bosnia. I think this recommendation to involve the leadership and stress management programs is very sound.
Does anyone have any problem, any addition to that recommendation?
DR. BALDESCHWIELER: I would be curious as to just what the policy, for example, in the Gulf was and in Bosnia with regard to the rotation of troops, as whether troops are rotated as units or whether they are individual or refilled into units. It seems to me those kind of personnel logistics are really at the heart of some of these unit cohesion issues, aren't they? That is, if you are a replacement that is suddenly sent up to the line, and have to fit in with a company of troops that has been fighting together, that is very different than if the whole company is withdrawn and a new company is moved in.
DR. CASSELLS: These combat stress detachment teams are supposed to address the individual unit replacement coming in as part of their modus operandi, in addition to meeting and debriefing the units themselves if they go in, in that kind of capacity.
DR. LASHOF: It is your impression, though, that most replacements do go as units --
DR. CASSELLS: Are unit based.
DR. LASHOF: -- are unit based, and there isn't much of this pulling one guy out and sending one guy in.
DR. CASSELLS: That's right.
DR. LASHOF: I guess if several people in a unit are badly injured, and the unit is down, there would have to be unit replacements and trying to work on that unit cohesion might be an ongoing problem.
DR. BALDESCHWIELER: But in the Second World War, for example, individuals, I think there was a much more general policy of replacing individuals.
DR. CASSELLS: That is true in a conflict. There is no question about that as opposed to withdrawing and rotating on a regular basis.
DR. BRIX: There was a lot of problems during the Vietnam War where people had differing links of deployment to Vietnam, and there was a policy of individual replacement as opposed to unit replacement.
I think this was well recognized as a problem, and the doctrine during the Persian Gulf War was that they would do unit replacement whenever they could, and, in fact, people were supposed to realize that they were there for the duration, as long as the war lasted, that is how long they were going to stay there. They weren't told that right away, but they were told that by November or December of 1990, that they were going to be there for the duration, and not that they were going to rotate out in a month or two.
DR. LASHOF: Thank you.
The next recommendation deals with the one we were discussing, about stigmatization, and the problem in society at large is urging special outreach and educational efforts in this regard. I think our own discussion certainly would endorse that. Does anyone want to add, subtract, or modify in any way the recommendation as it appears?
DR. BALDESCHWIELER: Again, in the spirit of wondering if one can succeed in addressing at least part of the problem, could one envision a recommendation where stress-related illnesses that have physical symptoms might be separated from the mental illness category?
DR. LASHOF: I don't know whether that would lead to more contribution to the stigmatization. I think it would backfire myself.
DR. HAMBURG: You could have a broader statement about understanding of human stress responses and stress-related disorders, and that would cover both mental and physical manifestations, if you want to put it that way.
DR. BALDESCHWIELER: The word "mental illness" is the worst of all from the standpoint of stigma, so could one use perhaps David's language?
MS. NISHIMI: I think we know how we can broaden that.
DR. LASHOF: I think David's last statement, we got it down on the transcript, we can go to it, and try to get that might help.
MS. NISHIMI: And then I would note we also are aware of Dr. Hamburg's recommendation in terms of the broader science policy questions, which we would address most likely in the context of the research agenda. Again, that will be discussed in October.
DR. CAPLAN: I have a question about this. When we talk about a public education outreach, what do we mean, looking for reflection of this in advertising, and calls for people to avail themselves of services, or are we talking about general public outreach?
DR. CASSELLS: We are talking about general public outreach.
DR. LASHOF: Well, I think we are talking about both. We have HHS doing -- I am not sure of the phraseology of public education outreach --
DR. CAPLAN: I am not sure I am gung ho about assigning DoD the task of destigmatizing stress-related illnesses to society is what I am not all that happy about.
DR. HAMBURG: The only thing about that is that, at least to my knowledge, the single most effective destigmatizing experience is war or the threat of war. In World War II, transmission was really profound. We went into that war with a very denigrating attitude about combat reactions and came out of it with considerable respect for what soldiers go through, and so on. For example, Manger(?) had this perhaps cliche, but a very useful one, that every man has his breaking point -- he wasn't talking about women in those days -- but every man has his breaking point.
In some way, whether the Department of Defense is the operational arm is another question, but in some way, the experiences of war make clear and vivid something about the nature of human stress response and there is the kind of shared humanity in that, and would tend to therefore offset the stigmatization, you want to preserve that regardless of what the operating agency is, I think.
DR. LASHOF: In this recommendation, we really do call on HHS to do the broader public education and move in this area, and then we call on DoD and VA to make a special effort to their populations.
DR. CAPLAN: I am not fighting the matter extensively. It just seems to me an assignment to the artistic community or the movie or the cinematic industry, I can't even imagine what they would do with this.
DR. LASHOF: That is up to HHS to approach them to do something because our recommendation is segmentary, and I don't think I will try to tell Warner Bros. what to do, but HHS could call in the movie guys and the screenwriters, and work with them to do a better job.
Are there other recommendations that anyone wishes to add, recognizing that the research one will be dealt with in our chapter on Research, and it will be taken up in October, are there other recommendations that relate specifically?
David, you had another one?
DR. HAMBURG: No, it was just to check on the mechanism. It may be adequate, I just don't know enough about it, to make sure that there is a clear-cut mechanism for updating the criterion procedures for compensation in light of new research and the clinical experience. That is a long-term, ongoing process, and we want to be sure it is there, and not something that only happens if there is a war.
DR. LASHOF: Is that agreeable with everyone?
We are going to take a 15-minute break at this point, and come back. At the time we come back, we are going to deal with the access to medical care issues.
[Brief recess.]
Agenda Item: Staff Briefing and Committee Discussion: Access to Care
DR. LASHOF: We will move on to the access to care issues. Again, Dr. Cassells, Tom McDaniels, and Holly Gwin of the staff have prepared the material, and Dr. Cassells will walk us through the staff summary and recommendations.
DR. CASSELLS: Thank you, Dr. Lashof.
This is essentially a report on site visits, but let me go on. Beginning with the first meeting of this advisory committee, public commentators have frequently testified that they had had difficulty accessing health care for themselves in the Department of Veterans Affairs, Medical Centers, and to a somewhat lesser degree, in the DoD medical facilities, for health problems that they felt were associated with their service in the Gulf.
They complained of inadequate information, delays in scheduling appointments, insensitive personnel, and inadequate follow-up. The committee determined that those complaints needed further investigation, and a series of interviews and site visits were undertaken.
VA established its Gulf War Registry, as you know, in August of 1992, and the DoD established its Comprehensive Clinical Evaluation Program in June of 1994. Both of those clinical programs consist of two phases. Phase 1 examinations may be conducted at any medical center in either system. Phase 2 examinations are conducted at one of four referral centers in the VA, in one of 14 regional medical centers in DoD.
Site visits were made to four medical facilities within the VA, and four DoD medical facilities, and they are listed on this overhead. The facilities were selected to vary geographically and represent both initial evaluation sites and referral centers.
The site visits included interviews with medical facilities commanders and chiefs of staff, registry or CCEP coordinators, medical and nonmedical staff assigned to the program, and veterans undergoing evaluation at the time of our visits.
Walking tours of the dedicated facilities and a review of randomly selected medical records were also performed. Although each site was quite distinct, there were no major differences in the handling of the VA Registry Program or the CCEP.
The remarks that I am going to make now are based on an overview of what we observed and what we learned.
The clinical evaluation programs have been described to you in great detail on more than one occasion, and I won't do that again today except to say that they have been determined by other groups, as well as by the staff, on these site visits that evaluations themselves are quite complete and will produce diagnoses of illnesses when carried out.
Let me take the next step and discuss the parameters of our evaluation, and I will walk you through each of these elements. As far as appointment scheduling is concerned, when the VA Registry began in 1992, veterans often encountered significant delays in scheduling appointments throughout the system chiefly because of the large number of veterans requesting examination, the newness of the program, and the need to reassign space and personnel within facilities.
With the passage of time, the development of streamlined procedures and the decreasing number of veterans entering the registry have largely eliminated major delays in scheduling the initial examinations, however, delays can occur in scheduling Phase 2 evaluations if specialist resources are heavily burdened. These delays currently are generally less than 30 days.
For an evaluation at one of the VA's four referral centers, there are administrative delays associated with necessary medical records preparation and consultations with referring physicians.
The referral centers follow a more rigorous protocol that requires a greater commitment of time and specialty resources, and limits the number of participants that can be seen at any one time. Delays of three months or more are not uncommon.
The committee has heard fewer complaints about initial appointment scheduling in the CCEP program, and delays in scheduling Phase 2 referrals seldom exceeds two weeks. The specialized care center at Walter Reed is a different case in point. It is a rigorous 30-day program which requires advance scheduling and consultation, but at the time of our visit, we heard no complaints regarding scheduling delays.
At the time of our visit, they had processed 35 individuals through that specialized care program, and in speaking to the current director this morning, Dr. Engel, they have now processed 47 people through the specialized care center.
Moving on to personnel and space, by the time the committee members and staff undertook these site visits in November of 1995, all of the facilities had a designated Gulf War veterans program coordinator and support staff who were responsible for scheduling patient visits and conducting the evaluations.
Interviews revealed that all of these individuals were knowledgeable about the VA Registry or the CCEP program and their individual responsibilities. Current staffing is sufficient to conduct the Phase 1 and Phase 2 evaluations although differing numbers of available specialists to conduct portions of the Phase 2 evaluations causes some delays in a few of the facilities we visited. Psychiatry is particular overloaded at some sites.
A very large number of soldiers at Fort Knox, for example, who had registered in the CCEP program threatened to overwhelm the resources of the internal medicine department. A large backlog of patients awaiting initial evaluation existed in February 1995, when DoD Health Affairs mandated that all requested workups nationally would be completed by April the 22nd of that year.
Because there were only three internists at Fort Knox at that time, CCEP registrants consumed all of the clinic time. In response to this situation, two physicians from Wright Patterson Air Force Base were detailed to Fort Knox to assist with the evaluation. Contract arrangements were then made with the University of Louisville to conduct Phase 1 evaluations from Fort Knox, and that began in July of 1995.
Patients requiring Phase 2 evaluations formerly were referred to the U.S. Air Force Hospital at Wright Patterson Air Force Base in Dayton, Ohio. The Phase 2 evaluations are now also conducted at the University of Louisville.
Most of the facilities we visited did not designate a separate clinics base for the Phase 1 evaluations, seeking to mainstream these patients as much as possible and reduce the possibility of symptom sharing. Some facilities, for example, the VA Medical Center in Durham, North Carolina, have set aside specific clinic hours for the Gulf War evaluations, and they have reported no evidence of symptom sharing among that group of veterans.
With a significant reduction in numbers of Gulf War veterans seeking evaluation currently, all clinical spaces are more than adequate to handle the current demand.
As far as the effect on other clinical functions was involved, the Fort Knox example that I just gave you was the most extreme example of disruption. Eligible beneficiaries other than Gulf War veterans who requested appointments in the Fort Knox internal medicine clinic in the spring of 1995 were referred to civilian care under the CHAMPUS program. All other facilities visited maintained that they had extended hours and worked harder to avoid interfering with the usual hospital routine.
In conversations with staff at these facilities, however, it was noted that there had been some disruption in the early part of the programs, but they had not been severe. The most frequently mentioned effect was the pressure on the staff to complete the evaluations in a timely manner, particularly at the DoD facilities during January to May 1995.
Staff education. At the time of these site visits, all the staff specifically assigned to the Registry or the CCEP programs were knowledgeable about those protocols and understood their individual roles. Some staff at the VA medical facilities complained that they were receiving less information about the program from VA Central Office than they felt they needed.
While recognizing the educational outreach concerning the Registry program which had been undertaken by the Central Office, they wanted more information concerning the results of the Registry evaluations and more information regarding research being undertaken. Staff at DoD facilities expressed general satisfaction with the feedback they were receiving.
The knowledge level of staff members not specifically assigned to the Registry or the CCEP at both the VA and DoD medical facilities was much more problematic. It was astonishing in one instance to find that a physician treating Gulf War veterans in his VA posttraumatic stress disorder research was unaware of the VA Registry itself, and perhaps less astonishing to find ignorance about the existence of the CCEP program rather widely within the VA facilities.
There have been scattered continuing medical education programs for medical facility about the government's Gulf War programs, but these are intermittent, usually limited to a single department, and anecdotally, have been said to be not well attended.
Staff attitudes. The committee has heard much testimony citing insensitive attitudes on the part of the staff in both the VA and DoD. The most frequent complaints are of the dismissive or cynical approach to the veterans' problems, that the problems are not real, and that the problems are all in your head.
These complaints were most prominent among those veterans seeking care after the Gulf War, but before the establishment of the VA Registry and the CCEP. However, we continue to hear these complaints at each committee or panel meeting that we have held.
In our interviews with staff at the eight medical facilities we visited, there clearly was a very mixed reaction to the problems being experienced and reported by Gulf War veterans. Some VA and DoD staff members expressed the belief that the thorough structural evaluations in Registry and CCEP were overkill and were exacerbating any problems that existed by reinforcing a sick role. Others felt constrained about the rigidity of the evaluation protocols, that it did not allow for flexibility of clinical judgment and felt that this was "not the way I practice medicine."
No VA or DoD staff member that we interviewed stated that they believe that these veterans were not actually ill. They all recognized that they were ill.
At each facility, the staff reviewed a 10 percent sample of randomly selected medical records of Gulf War veterans at each of these facilities. The records were reviewed for completeness, for adherence to protocol, and particularly, documentation of diagnoses by specialty consultation and/or laboratory reports.
The records of the Registry and CCEP participants at each facility are maintained separately from other patient records, and there is a final common pathway for determining when the records are complete, and this completion is certified by a physician's signature. When completed, the patient data is reported to either VA Central Office or to DoD Health Affairs.
In our review, staff found only minor deviations from completeness and adherence to protocol. In a couple of instances, missing documentation for a discharge diagnosis was noted, but in each instance, facility staff was able to locate the necessary documentation. Based on our random review, staff concludes that the medical records for these veterans are complete.
Follow-up treatment. After the completion of the Registry or the CCEP evaluation, Gulf War veterans are in most instances returned to their local medical facility for follow-up care. Despite the general medical adequacy of the VA and DoD evaluation programs, follow-up treatment, particularly where mental health visits are involved, are problematic.
Staffing constraints often occasion long delays in scheduling appointments in some specialties, particularly in psychiatry. Follow-up treatment of Active Duty veterans also is made more difficult by command resistance to granting the necessary time off to maintain an adequate treatment program. This is true for all chronic illnesses, but especially so for psychiatric diagnoses.
Based on these site visits and our interviews, the staff suggests that the committee consider making two findings and adopting several recommendations.
Finding 1. VA and DoD educational outreach to clinical staff not directly involved in the Registry and CCEP has not been effective.
Prior to moving on into the findings, I am going to call on Tom McDaniels here who had a personal experience with the VA Registry program. He is a Gulf War veteran.
MR. MC DANIELS: Having served in the Kuwait theater of operations during the summer of 1991, I was eligible for a VA Persian Gulf Health Registry examination. On January 26 of this year, I contacted the Persian Gulf coordinator at the VA Medical Center in Minneapolis to set up the examination. The viewgraph shows the dates of the subsequent events.
The exam began with a medical history questionnaire. The examining physician then queried me about every illness or condition, all of which were relatively minor, I had since leaving the Gulf. Following this, I went through the examination which included among the standard physical exam items, an evaluation of hearing, reflexes, and joint mobility.
I was told that I would be referred to specialists to determine whether any of the illnesses or conditions I experienced since leaving the Gulf were service related. The examining physician then explained to me the purpose of these exams in studying illnesses among Gulf War veterans.
The examination was thorough, yet, there was confusion on the part of the VA staff about if the referrals would be free of charge. Following the exam, I was told by phone by the Compensation and Pension Department which conducted the physical examination that I would have to call the Billing Department about fees for the referral appointments.
The Billing Department said that I would be charged if the conditions were not related to my service in the Gulf. The problem here is that I was being referred to specialists, so that they could determine if the condition was service related.
This supports Dr. Cassells' finding about VA staff education, particularly those who are not designated particularly to deal with Persian Gulf issues, and I would be happy to answer any questions you have about the examination.
DR. LASHOF: Well, what happened next? When they informed you that they didn't know whether you would have to pay if it wasn't service related, what did you do about that, did you educate them that it was their referral and their responsibility?
MR. MC DANIELS: No, I filled out the financial worksheet for April, and referrals came during the month of May for the summer, and those, because of conflicts, I couldn't make, but I did receive referrals, and so we never resolved the question of whether I would pay or not.
DR. CASSELLS: Did you ever receive a bill?
MR. MC DANIELS: No, I never received a bill for the initial examination.
DR. LASHOF: But you never did have the referral exam.
MR. MC DANIELS: Right.
DR. LASHOF: So you don't know what would have happened if you had gone ahead with the referral exam.
MR. MC DANIELS: I was surprised about the referrals, though, because these conditions were relatively minor. I would expect that the primary care physician could have made the determination during the first exam about whether it was possibly related to service in the Gulf.
DR. LASHOF: Were you seeking service connection?
MR. MC DANIELS: No, I was just going just because I was eligible.
DR. LASHOF: That is part of your staff job more than anything else?
MR. MC DANIELS: That's right.
MS. NISHIMI: Which is why I didn't want to send him to a specialist if he was going to have to pay for it, because that means I was probably going to have to pay --
[Laughter.]
DR. CUSTIS: Do you think maybe they recognized you as a spy?
MR. MC DANIELS: No, no, I don't think so.
MAJOR CROSS: What was your overall impression of your visit there?
MR. MC DANIELS: I thought it was very efficient. As the viewgraph said, I was done -- I got there around 8:00 or 8:30, and I was done by lunchtime, and everything went according to plan. The attitudes were good.
I asked a few questions about exposures and what those exposures could mean or could result in, and the physician told me that there was research underway to determine that, he didn't really want to go into detail about the possible results of exposures in the Gulf, but I thought it was very comprehensive and very fair.
DR. KIDD-TAYLOR: And they were sensitive to your concerns about service in the Gulf, they didn't brush it off as being --
MR. MC DANIELS: That's right. The physician just went through the exam. His attitude was this is the protocol, I am just following it. He didn't speak much.
DR. LASHOF: Other questions for Tom? Thanks.
DR. CASSELLS: I should point out that when we embarked on these site visits, we knew that we were going into these site visits four years after the beginning of the VA program and two years after the beginning of the CCEP program, and expected that whatever problems had existed early on would probably have been addressed by the time we got there.
The first finding -- to return -- the VA and the DoD educational outreach to clinical staff not directly involved in the Registry and CCEP has not been effective.
The second finding. Follow-up treatment, particularly when mental health visits are involved, is problematic both within VA and DoD. Staffing constraints occasion long delays in scheduling appointments, commanders are sometimes resistant to making sufficient time off available in order for Active Duty veterans to maintain an adequate treatment program.
Recommendations. Aimed at the first finding. VA and DoD should, in their educational outreach programs, specifically target staff members not directly involved in the care of Gulf War veterans.
2. Continuing Medical Education programs sponsored by DoD and VA should include updates on the Registry or the CCEP programs at least semiannually. VA and DoD should regularly brief their staffs on the Gulf War research portfolio and on the results of research studies as they become available.
Recommendations relative to Finding 2. VA and DoD should examine staffing needs particularly in mental health and increase recruitment and retention of adequate numbers of medical professionals to satisfy the patient need and demand.
Staffing review should consider that despite increased medical surveillance and better preventive measures, future deployments also will generate a significant number of veterans with undiagnosed illnesses who will need care.
Recommendation 2. Since 1986, service members with certain chronic illnesses, for example, asthma and diabetes, have been allowed to remain on Active Duty when regular medical monitoring is necessary. Veterans of the Gulf War with chronic illnesses are no different. Troop commanders should be reminded that adequate time off for follow-up medical appointments is a necessity and a priority.
DR. LASHOF: Thank you very much.
Let me open up the discussion first to the background material as presented, and ask if any of the committee have further questions they want to ask Dr. Cassells or Tom or Holly before we proceed to look at the findings and recommendations.
Marguerite.
MAJOR KNOX: I just have a question on some of the panel meetings and the public testimony. Did we do any follow-up on specific VA sites that were named in public testimonies and certain incidents that occurred?
DR. CASSELLS: We did not as a matter speaking of the Charlotte panel meeting that we had and some of the information that we got there. We went to the Durham VA, which was the subject of some of the testimony in Charlotte, and found that the Durham VA operation at the time we visited it was certainly very efficiently run, and the staff devoted to the program itself was very knowledgeable, and since that is a research-oriented institution, they felt that there was no such thing as too much information and they were delighted to perform as many evaluations as could come through the door.
MAJOR KNOX: But that was the only facility on public testimony that we followed up?
DR. CASSELLS: That is right. We did interview individual veterans of each of the facilities that we visited when they were available, when they are undergoing their evaluations, and most of the complaints had not to do with the Phase 2 evaluations that they were undergoing at the time.
Most of their concerns about scheduling appointments and delays in receiving care in their view were related to earlier in the programs, either before the VA Registry began in some instances, or with difficulty making the transition from Phase 1 spots into a Phase 2 evaluation site.
This is when we heard the most complaints about medical records, and medical records not being able to follow the individual patient in any kind of routine way. In looking at that even further, we found that none of the records were complete at the facilities we looked at when we went through the records, but very often medical records were lost in going to compensation hearings and disability hearings of various and sundry sorts, because the records were handled differently in those circumstances, but the records for the veterans themselves were in good order.
MS. NISHIMI: I think also in San Diego we heard some public testimony surrounding that facility and then you visited that afterwards, so I would say it was both those, yes.
DR. LASHOF: I think as a general policy -- correct me if I am wrong, Robyn -- that when we had specific complaints at the testimony, those were referred back to the facility and to a social worker or someone who was contacted and notified about the testimony, but we felt it was probably not appropriate for us to individually follow those, but make sure that they got back into channels.
MS. NISHIMI: Right. What we did was we referred it to a central contact point, and then they were referred out, back as a casework.
DR, KIDD-TAYLOR: When you interviewed veterans, were there any problems with cost or having to pay for care?
DR. CASSELLS: None of the ones that we interviewed had had that problem although we have heard in public testimony that some individual veterans have had that.
DR. LASHOF: Did we do any other follow-up on the situation that Tom faced, that the referral to the specialist might be billed, did we hear that complaint from others?
DR. CASSELLS: We didn't hear the complaints at any of the facilities we were at or any of the veterans we interviewed. We have heard that at testimony particularly in Kansas City, I believe was when we heard it most.
DR. LASHOF: Other questions?
DR. LARSON: It would also be unlucky to hear the testimony from those who are in the system, because obviously, if there is a problem with payment, they are more likely to be not receiving care than being available.
DR. CASSELLS: Also, these individuals were in the process of being evaluated, and may have not yet received a bill if they were going to get one. But there was not general agreement from facility to facility what was a billable service, and that has to do with staff education outside of the CCEP and the programs themselves.
MAJOR CROSS: Joe, do you know if the VA does checks like you did just for their own housekeeping to make sure that their programs --
DR. CASSELLS: They do patient satisfaction surveys at each of the facilities that we visited, both DoD and the VA, and the satisfaction surveys come back with better than an 85 percent positive rate, and this was certainly true of the Gulf War veterans that were going through at the same time.
DR. LASHOF: Other questions?
MAJOR KNOX: I would just add to that, Tom, that most VA facilities have a person that is responsible for following up on that.
DR. CASSELLS: There is a patient ombudsman in most instances.
DR. LASHOF: Any other questions?
Let us go, then, to that first finding concerning outreach to clinical staff. Can you elaborate a little bit -- I am a little concerned with the finding just saying "has not been effective" -- in what sense, whether we can modify that a little more to hasn't been effective in accomplishing this or has reached only a minority, or something.
DR. CASSELLS: In talking with staff other than those associated with the programs themselves, there was a general lack of information about the individual program within that institution and certainly a lack of information about any findings that had come up relative to the Registry exams or the CCEP exam, or any of the research that was underway.
DR. CUSTIS: The way this is stated, this includes every hospital in the system.
DR. CASSELLS: It only applies to those that we visited.
DR. CUSTIS: Would it be considered not consistently or not universally effective? Do you mean for this to be a blanket?
DR. CASSELLS: It certainly has not been effective in the institutions we visited.
DR. CUSTIS: Then, how about saying in the institutions visited?
DR. CASSELLS: Fine, if the committee would prefer that.
MAJOR KNOX: I think that deletes public testimony about all the VA facilities that veterans complained about.
DR. LASHOF: I would be happier if it explained a little bit more about what we meant not effective, not effective in, or put the other way, a finding that we found that clinical staff not directly involved were not knowledgeable about -- the other way, it just leads me wondering not effective in what.
Since, as I pointed out, the findings tend to stand alone, it would be better, I think, unless you have a problem with that --
DR. CASSELLS: I don't have a problem.
DR. LASHOF: -- if everyone else agrees, that people didn't know what they should know, and be kind of specific.
MAJOR KNOX: I would just add I think that some of the problem was that they came about so late after the war, that it was ineffective because people were already discharged or spread around, and didn't get the information.
DR. LASHOF: That is to the veterans. Here, he is talking to the clinical staff.
DR. CASSELLS: Right.
DR. LASHOF: The other we will cover in the outreach when we talk about how to reach the veterans.
Here, I think we just want to say that the clinical staff who were not directly involved were not knowledgeable about the Registry and the process.
MS. NISHIMI: Can we revisit the general versus specific in terms of facilities visited?
DR. LASHOF: I think it can be general. I mean you visited a sample, and we heard it from others, and I don't think we have to say in our specific facilities, wouldn't you think?
DR. LARSON: Right, because you have already clearly specified the actual observation you made, I don't think we need to say that it was in certain facilities.
MS. GWIN: Do you want to make a preliminary statement in the finding that it is based on the site visits and public testimony? It clarifies.
DR. LARSON: I don't think we need to. We haven't done that in the -- I mean everything is based on public testimony and the information we have been able to gather.
DR. LASHOF: We have to draw a conclusion based on where we are. I mean we can say we found, if you want.
Don, do you have any problem with this one?
DR. CUSTIS: I will stick to my original concern. I would add in some qualification. I can picture, for example, the director of a VA Hospital who has made a special effort to educate clinical staff, and he reads this, and he said, well, that is not true, it is not universally true. That is what I am trying to avoid.
DR. LASHOF: So, you would like this worded, so that it is not accepted as universal.
DR. CUSTIS: Right, simply because we don't know that it is universal. We may suspect it, I don't know. Maybe it is insufficient to say of those facilities visited. Maybe we want to say more than that, I don't know.
DR. LARSON: Could you say that clinical staff interviewed were unaware of -- I mean that is the same thing.
DR. CUSTIS: That's all right.
MS. NISHIMI: That doesn't address Marguerite's point about the other sources of information evaluated and analyzed to reach the finding.
DR. LARSON: Well, maybe we need to discuss it more, but I think that everything is based on the information we have been able to gather, and I would not at this point feel convinced that we need to make this recommendation any different qualitatively than the others in terms of how general it is. It is the case that based on the evidence we found --
DR. LASHOF: It was uniform among those you spoke with?
DR. CASSELLS: In the facilities we visited, yes, we found this every place.
DR. LASHOF: In all those involved.
DR. CUSTIS: I don't think we need to belabor the point.
DR. LASHOF: Okay. Since we are not going to say the educational outreach wasn't effective, but just really that the clinical staff not involved didn't know, that's it. You know, the guy may have run a good program, but nobody listened, he can go back and check his own institution out and see.
Shall we move on, then. In the others, we have done the findings and recommendations, but since you separated them, let's do it this way here.
Let us look at the three recommendations you have that really do relate to that finding.
First, it is to target the staff members not directly involved. That seems clear-cut in everything we have just said.
The second deals with CME programs sponsored should include updates on the Registry.
Does anyone have any problem with that recommendation?
DR. LARSON: Oh, I had a little problem with the second recommendation. Are we on the second one? To recommend, which may turn into a mandate, who knows, CME semiannually for an unspecified period of time is a little bit of a concern to me. For how long, forever? I don't know.
DR. LASHOF: As long as it is an issue. I mean no one expects you to keep doing it for -- I don't know.
DR. LARSON: It is a sweeping recommendation to have CME by both DoD and the VA semiannually.
MAJOR CROSS: Starting when, starting and ending? I agree with Elaine, what she is saying.
DR. LARSON: I am not sure that adding an ending date is the right answer, I am not suggesting that, but it could turn into something that would be quite mechanistic, and we need to be clear what we are asking for here.
DR. LASHOF: Who all goes to the CME?
DR. LARSON: Right. CME, in some places that means docs, in other places that means all health care personnel.
DR. LASHOF: And they all have to do CME semiannually or quarterly, or what are their requirements now?
DR. CASSELLS: It is usually more often than semiannually. CME programs go on within institutions regularly.
DR. LASHOF: But what are their requirements? There is a difference between saying CME programs in their offerings should include this, and people selected in CME programs versus saying everyone ought to be required to go to a CME program, that covers this item, and it is not clear to me which we are saying here.
MAJOR CROSS: Maybe just turn it around and say CME programs should include issues of Gulf War veterans.
DR. LANDRIGAN: Could I offer a suggestion? We have a model in New York State. I mean most of us in academic medicine do CME all the time, grand rounds and other teaching activities, in many cases several times a week, that cover a huge array of topics.
But every three years, each physician who is licensed in the State, and I think it applies to other health care providers, such as nurses and physician assistants, as well, is required to do one session a couple of hours in duration on the recognition of battered children. That was a state law that was passed a couple of years ago. And we are required to do a separate session of two hours duration on how to prevent infections and needle sticks in the hospital among health care personnel.
What they do is they log you in, you have to have a piece of paper that certifies that you attended the session when you next apply at three-year intervals for your State Medical License. So, I think the model is there. I think mandating that something happen twice a year, every year, runs the real risk of making a joke out of it, because it will become one of those things that you have to do, and everybody will treat it light-heartedly and it won't go down well.
I would suggest once a year or once every other year is probably enough. You are dealing with bright people. You just need to make sure they understand the basics.
DR. LARSON: How about something like assuring that timely information and updates on the Registry and CCEP are incorporated into CME programs? Maybe that is too loose, but the point is timely.
DR. LASHOF: I prefer that.
DR. LARSON: Rather than mandating a specific period of time, that there are mechanisms to assure that timely information and updates are incorporated into the current CME strategies and programs.
DR. LASHOF: Yes. In that case, it might be much oftener.
DR. LARSON: Because what we are looking for is not necessarily a specified time, but the timeliness qualitatively of what is communicated.
DR. LASHOF: Any other suggestions, comments? Any problem with that, Joe?
Did I hear an acceptance from staff, is that okay?
MS. GWIN: Yes.
MR. MC DANIELS: Yes.
DR. CASSELLS: Yes.
DR. LASHOF: The next one is on briefing staffs on the research portfolio and the results of research studies as they become available. That is logical, obvious. I would be pretty disappointed if they weren't doing that.
Are there any other recommendations that you feel should come out of this particular finding that the clinical staff didn't know what they ought to know?
We will deal with the other recommendations after the other finding, and then any other recommendations.
Hearing none, then, let's move to your next finding, which deals with the follow-up treatment, staffing constraints, delays, appointment scheduling.
Is there any problem with the way that finding is stated?
DR. LANDRIGAN: Is there a problem with recommending increased staffing or at least potentially increased staffing, and not recommending that funds be appropriated to sustain that?
DR. CASSELLS: That is why we used the word "examined" deliberately as opposed to mandating anything.
DR. LASHOF: Before we get to the recommendation, does anybody have any trouble with the finding? If not, we will move right on to that first recommendation that is dealing with staffing needs.
DR. CUSTIS: The VA and also the military, for that matter, are losing FTEs, more specifically, target that as a problem?
DR. LASHOF: Well, it is not something that we took up as an issue for us to look at, what the streamlining or reduction of forces are. We did look at what the staffing needs were in relation to this, and have concerns, and I think we can only address that.
Now, whether they address the staffing needs we suggest by moving people from something else, and then causing shortages somewhere else, that is going to be a problem to them, but I am not sure we can get into looking at total staffing needs.
DR. CUSTIS: I am talking about downsizing.
DR. LASHOF: Yes. What I am saying is I don't think as a committee we can comment on the whole approach to downsizing, whether it is appropriate or not appropriate. We can say where we think staffing needs aren't adequate in a specific area. How they correct that and whether it is a reflection of their problems with downsizing or not is something they have to address. I think it is beyond the scope for us to deal with broad staffing.
Does anyone have any problems with the way that first recommendation is worded, Don, except for your concern about the total downsizing?
Hearing none, we will accept that one.
The last recommendation --
DR. LARSON: Oh, wait. Did we skip the first one? I am sorry.
DR. LASHOF: Which one?
DR. LARSON: On the recommendation.
DR. LASHOF: On the first recommendation, under Finding 2, is the one I am on.
DR. LARSON: A couple of minor --
DR. LASHOF: We had three recommendations on Finding 1 that we all settled on, and we are now on the first recommendation on Finding 2. Any problems with it?
DR. LARSON: Yes, a couple of issues. First of all, I have a little concern about suggesting changing staffing patterns based on patient need and demand, because we had the same discussion yesterday about genetic counseling.
There are a lot of people who would like it, and there is no indication for it. So, I would wonder if we might want to just say based on patient need.
DR. CASSELLS: And drop demand?
DR. LARSON: Yes, and also I would change the medical professionals to health professionals, because frequently the person who needs to be seen might be a genetic counselor or someone else. Now, you probably meant medical in the generic term, but it might be read as physicians, and the staffing needs might not be for physicians, it might be for other health professionals.
DR. LASHOF: Okay. I accept both changes.
DR. LARSON: And in the second sentence, when you said, "Despite increased medical surveillance and better preventive measures," I assume you mean predeployment, during deployment -- okay -- what do you mean by "increased medical surveillance," because I don't think that is something -- we have talked about improved surveillance, not necessarily increased.
DR. CASSELLS: We have been dealing with the draft directive on medical surveillance as it goes to future deployments, generally speaking, and it is an increased surveillance.
DR. LARSON: Okay.
DR. LASHOF: The presentation on Bosnia and later today when you hear response from the principals, they have increased their medical surveillance significantly.
DR. LARSON: Thanks.
DR. LASHOF: I don't know whether "despite" -- this is sort of a thing with words -- increased medical surveillance may increase the demand, so it wouldn't be despite it. It would be despite better preventive measures, future deployments, but increased medical surveillance also might increase demand.
DR. CUSTIS: I think it depends on how you interpret demand.
DR. LASHOF: Well, since we dropped demand to satisfy patient needs, consider that increased medical surveillance --
DR. LARSON: Why don't we just take that out and say that staffing review should consider that future deployments also will generate -- I mean it is just true, we know that in the future, there will be predictably in other wars --
DR. LASHOF: I understand what staff is trying to say there, though, because they are making a big point that the prevention ought to decrease the demand, and that they are putting in so much better surveillance and preventive measures.
DR. CASSELLS: It is not necessarily the case.
DR. LASHOF: So that there may not be demand.
Is it a question of examining staffing needs now or being sure that they have a mechanism to really review them on an ongoing basis and that they are able to be responsive to increased demand? It might be better to rework this recommendation.
DR. CASSELLS: That is what I meant by "examine."
DR. LASHOF: By being in a position to -- because if you end up saying, you know, despite surveillance, despite prevention, there is going to be still lots more, well, we don't know that, there might indeed be less, but what you want to do is be sure they have a mechanism in place to regularly review staffing needs and make sure the staffing pattern is adequate to meet the demand.
MS. NISHIMI: I think that staff know, that we can rework this and we will bring it back to the committee.
DR. LASHOF: You get the sense.
DR. LARSON: And I would consider making that a separate recommendation, because it is two things. One is for future deployments, to anticipate the potential need for additional staffing for veterans with undiagnosed illness, and the other one is the current needs in particular areas.
It seems like two separate recommendations.
DR. LASHOF: Okay. I think staff can take a look at that and come back to us.
The next recommendation relating to chronic illness, being allowed to stay on.
MAJOR KNOX: Joyce, can I just speak to this one?
DR. LASHOF: Please.
MAJOR KNOX: I think that this leaves out -- it talks about Active Duty service members, but I think it leaves out Guard and Reserves, and for those veterans who were in the Guard or still are, who they want to send, for example, to Walter Reed for a month, they are expected to go there without pay and may have problems in their civilian job even though they need to go for Phase 2 or Phase 3 of their treatments.
I think it may leave out the component of Guard and Reserves even though it says veterans of the Gulf War. I don't know that we could do anything about --
MS. GWIN: We have a real hard time addressing civilian employers. Are you suggesting a recommendation about Guard or Reserve pay for those periods of time?
MAJOR KNOX: That may be something that we can't change, but it certainly has been a complaint. You know, when you come back from the Gulf War, your civilian employer is pretty much mandated by law to give you that job back, but if you are ill now and you need to go for a month of treatment at Walter Reed, that doesn't necessarily mandate that employer to hold onto your job while you do that.
So, I think that is a problem for veterans who are sick, who were Guard and Reserve, and who are not Active Duty. If you are on Active Duty and you need to do that, of course, you can go and you can be paid while you receive treatment.
MS. GWIN: But that is going way beyond what we have suggested here, and that would be a big step toward recommending major --
DR. LASHOF: I wonder if there should be a finding dealing with the fact that National Guard have specific problems, members of the Guard who are no longer on Active Duty have problems in receiving ongoing care for chronic illness.
DR. CASSELLS: Within the direct care system.
DR. LASHOF: The current care system. That might be a finding, and then a recommendation might be that the VA look into possible opportunities, remedies, I don't know what they could do, consider whether there are any mechanisms to deal with that problem.
MS. NISHIMI: Why don't we have the staff flesh out a finding and recommendation, just have the committee keep this in mind you would be making a directive again to private employers in this regard, but we will take a run at it and have the committee come back and look at it.
DR. LASHOF: All right. Any other recommendations? There are ombudsmen and patient bill of rights at all facilities?
MS. NISHIMI: Yes.
DR. LASHOF: Did we make any effort to assess the effect on this of the ombudsmen and how frequently they are used, and whether veterans always know? I am just thinking about so much of the testimony we heard here from veterans, and it didn't sound like they knew what to do when they were getting the runaround.
At least I didn't hear anyone say, well, I have gotten to this problem, and I went and saw the ombudsman, and the ombudsman did this, that, or the other. I mean what we heard were people who had a great deal of difficulty.
DR. CASSELLS: The people we saw at the site visits themselves, we did not have that kind of testimony from them. There was somebody who received them when they came into the facility, there was somebody there to assist them in finding their way about and to answer whatever questions they could, and there was a veterans' representative, not a medical person, also available within the VA system to assist them with any problems of getting information.
MS. NISHIMI: I think a lot of this, Joyce, has to do with the timing of our experience versus many of the things that we have heard, not to say that there obviously aren't existing difficulties.
DR. LASHOF: Apparently, they have corrected, they have listened.
MS. NISHIMI: I think there are still obviously some current difficulties, but by and large, staff's experience is reflected in this memo, and a lot of this is timing.
MR. JOHNSON: Should there be a positive finding, then, in that regard? That is rather a strong statement that you have made, that all of the facilities that you mentioned or visited were, in fact, set up with ombudsmen capable of processing the people who came.
DR. LASHOF: Our problem has been -- and this goes throughout all of our reports on findings and recommendations -- we tend to point out as findings those things that we are going to make recommendations around, so it appears like we are only doing negative findings.
The body of the material covers a tremendous amount of information, much of it positive, and when we format and write the report, many of those are highlighted in the margins as our interim report was, but we tend not to make findings that we are not going to have recommendations around.
Am I correct? Am I right or wrong, Holly? You have gone through the formatting and all of this.
MS. GWIN: We pull out the findings specifically to support the recommendations. So, if we don't intend to recommend a change in a program, we don't tend to make findings about that.
DR. LASHOF: We don't highlight as a finding. The facts are in there and speak for themselves.
MR. JOHNSON: It may be appropriate to make a general comment explaining that methodology. It would seem to me that places, as was pointed out earlier, who are doing a good job, who have stepped up to the task, should not feel as though they have not been acknowledged in some way in the report.
MS. NISHIMI: I think as a drafting matter, I know where we can take this.
DR. LASHOF: I think we did in the interim, and I think we can handle this.
Any others?
DR. BALDESCHWIELER: One minor nitpick.
DR. LASHOF: By all means, John.
DR. BALDESCHWIELER: If we can go back to the first block of recommendations, the first bullet, we say, "VA and DoD should in their educational outreach program specifically target staff members not directly involved in it."
Shouldn't we just -- this should specifically target those people who are involved in the care of Gulf War veterans --
DR. LASHOF: No, because they are knowledgeable. It is the other group who aren't that run into them, that aren't knowledgeable. That is our problem. It was the clinical staff who aren't directly involved, who may have a Gulf War veteran come in for something else, that aren't knowledgeable and don't know.
Those who are specifically working on the CCEP or in a Phase 1 or Phase 2 are knowledgeable, unless I misunderstood you.
DR. BALDESCHWIELER: No, I would say include rather than specifically target. But you mean specifically target?
DR. CASSELLS: Yes, we do.
DR. LASHOF: Are there any others?
If not, we will break for lunch and resume at 1:45.
[Whereupon, at 12:15 p.m., a recess was taken until 1:45 p.m. that same day.]
A F T E R N O O N S E S S I O N (1:47 p.m.)
Agenda Item: Follow-up on Persian Gulf Investigation Team/Risk Factors Panel Meeting
DR. LASHOF: We will resume our discussion. We're proceeding on now for a discussion of the panel meeting dealing with risk factors and the Persian Gulf Investigative Team Report that was held in Denver. It was a subcommittee or panel meeting held in Denver on August 6. Andrea Taylor chaired that meeting and will present the summary of that panel meeting. We will then go on for discussion.
DR. KIDD-TAYLOR: Thanks, Joyce. Our meeting in Denver was sort of a followup meeting to our meeting in Chicago where we talked about conclusions about risk factors of depleted uranium and oil well fire smoke. We had a continuing meeting with PGIT, the Persian Gulf Veterans Illnesses Investigation Team. Regarding depleted uranium, Dr. Voltz, an occupational health physician and former head of the Health Defects Division of Los Alamos National Laboratory briefed the panel about health effects of uranium. He reported that natural uranium and depleted uranium have low levels of radioactivity and that their principal hazard is their chemical effect on the kidney.
We also had discussions about the oil well fires and smoke. I think at our last meeting in Chicago, we weren't certain of why there were no levels or high levels of polycyclic aromatic hydrocarbons. We got more information, received more information from Dr. Jack Huller(?) of the U.S. Army Center for Health Promotion and Preventive Medicine and Dr. Joe Moderly(?), Director of Inhalation Toxicology and Research Institute. Both of them made presentations regarding the presence of particulate matter and how that is measured. We had other information given regarding the Persian Gulf Veterans Illnesses Investigation Team.
This was the second, I think, report that we had, or briefing from them regarding chemical weapons and the use of chemical weapons during the Gulf War. Based on what we learned there, we do know now that at least 1,100 U.S. troops were in the vicinity of Khamissiyah when chemical agents were released. We also know that the CIA's report that was just introduced in August, that a 25 kilometer downwind hazard area based on their modeling of Khamissiyah did exist. We heard from veterans that were in the area that they felt that they felt that they had possibly been exposed to chemical weapons.
We feel that the veterans deserve the benefit of any doubts concerning possible exposure, and we should presume, based on the CIA's report, that soldiers within the 25 kilometers of Khamissiyah were exposed to the agents that we released.
PGIT's description of its investigations at Denver is kind of puzzling in that we still don't have a lot of information on the investigations that are ongoing. They mentioned at our meeting in Denver that only three investigations have been completed and the progress has been very slow. Information has not been released promptly, and we feel that this sort of leads to some sort of -- well, it feels like for many of the veterans that there's something that's being covered up. There is possibly not anything being covered up, but it leaves that impression that the whole story is not being told. That is a problem in communication and getting the veterans to really trust and the confidence in PGIT and what they're doing. Basically that was our report.
DR. LASHOF: Okay. Thank you very much Andrea. Are there other panel members who have any questions for Andrea at this point?
If there are no questions for Andrea on her report on that meeting, we will proceed on to have the staff present their staff memo summary of their investigation into the whole issue of chemical and biological warfare agents and the efforts to learn more about it. Mark, are you going to or Jim Turner --
DR. BROWN: I'm going to turn it over to Jim Turner.
DR. TURNER: Thank you, Dr. Lashof. In July, the committee staff, Dr. Brown to my left, presented the staff's findings and recommendations with respect to the potential health effects of chemical and biological warfare agents. Today, we are addressing two related but separate issues that are more directly related to possible exposures, not effects, but possible exposures of these agents. At the committee's direction, staff has maintained a separation between these two issues in our analysis and that's why we're presenting these two issues separately.
In the area of exposures, we have looked at two basic major issues. The first is what is the evidence of possible chemical or biological warfare agent exposure during the Gulf War. The second is what is the adequacy and inadequacy of governmental investigations of issues related to potential chemical or biological agent exposure.
To give you a nutshell capsule summary at the outset, the evidence of possible exposure to chemical and biological warfare agents is mixed. With respect to some agents, biological agents in particular, there is little if any credible evidence that would suggest that there was exposure during the Gulf War. The evidence is less unequivocal, however, with respect to chemical warfare agents, and in particular with respect to potential low level exposures to chemical agents. We now know of one incident in southern Iraq at Khamissiyah where there is a credibly, if not comprehensibly documented instance where the nerve agent sarin and cyclosarin were released while U.S. were in the vicinity. There are other detections and evidence of other possible releases that cannot be dismissed out of hand.
If I could have the first slide please. Gulf War veterans and independent researchers have suggested three potential exposure scenarios for chemical or biological warfare agents that could have transpired during the Persian Gulf War. The first is an intentional Iraqi attack which would take the form of either rockets, artillery shells or mines. The second is collateral fallout from bomb storage sites in Iraq during the coalition air war. The third is what could be termed accidental or incidental exposures at contaminated sites where U.S. or other coalition forces happened to be.
With respect to the intentional Iraqi attacks, a hypothesis, the evidence that has been gathered to date, including the representations of Iraqi military officials upon debriefing and the on site inspections by the United Nations and our own intelligence assets, do not support a conclusion that there were any intentional Iraqi attacks with chemical weapons or that there were widespread exposures by U.S. personnel in the Persian Gulf as a result of any such intentional attack.
With respect to collateral fallout from the air war, three key factors, evidentiary factors that we can identify with some certainty today, strongly suggest that collateral fallout that would affect soldiers throughout the Kuwait theater of operations is highly unlikely. Those factors are the apparent ineffectiveness of coalition air strikes in actually hitting sites and releasing or damaging or destroying chemical munitions that were stored at sites in Iraq. The second is of the sites that were actually hit and munitions were damaged or destroyed, the quantity of chemical warfare agent that was released was limited, approximately 20 metric tons. And finally, the location of these sites was remote. The distance from U.S. troops was substantial and based on downwind modeling that the CIA conducted at very low trace level thresholds, it does not appear that it is a significant possibility that agent would have reached U.S. forces.
With respect, just to summarize once more, with respect to the Khamissiyah site-specific type of exposure, there is evidence which I will discuss later -- if we could have the next slide please, John.
These are the 11 sites in Iraq where UN inspectors and Iraqi declarations confirmed that chemical warfare agents were stored during the Gulf War. If you will note, only two of those, An Nasiriyah and Khamissiyah are below the 31st parallel, which was defined as the Kuwaitee theater of operations. U.S. ground forces did not go north of the 31st parallel. That's why that definition is there.
At these 11 sites, UN inspectors located approximately 700 metric tons of chemical warfare agents and those stores of agents were by and large destroyed at a deposition facility that was set up at Al Muthanna. In addition, a complicating factor in all of this is the reliance on Iraqi representations. One of the representations that they made that complicates an assessment of the likelihood of collateral fallout is that instead of keeping everything at their major storage facilities, once the air war started, the Iraqis say that they moved chemical warfare agents and munitions out of those sites and hid them in other locales. So there is still some uncertainty about how comprehensive the information about exactly where agent was during the air war is. But this is the best information that we have been able to compile for the committee to date.
Next slide please, John. Again, based on the UN inspections and Iraqi declarations of where agents were during the air war, the best evidence is that only two sites contained munitions with chemical warfare agents that were damaged during the air war. Those are Muhammadiyat and Al Muthanna.
These sites were bombed in early February of 1991. Another complicating factor is we do not know the precise date in February when those sites were hit. At the committee's request and working with staff, CIA did a worst case analysis of downwind footprints or hazards that would be caused by the bombing of those two sites for the days in February when the winds would present the greatest hazard southward towards where U.S. forces were at Rafha in Saudi Arabia. Approximately 15.2 tons of mustard was damaged at Muhammadiyat, approximately a little less than 3 metric tons of sarin and cyclosarin mix. At Al Muthanna, approximately 16.8 metric tons of again the sarin/cyclosarin mix that the Iraqis used was apparently damaged.
And again, so that the committee has a feel, this is based on the UN going into those sites and actually observing evidence of damaged munitions there, in additions to the Iraqis representations.
Based on the CIA's modeling, which was I believe transmitted to all the committee members with the CIA's August 2 report, the furthest downwind hazards to the south from these bombings were approximately 300 kilometers. As you can see from the viewgraph, the closest U.S. troops are 400 kilometers away, so that's roughly 60 miles, 100 kilometers between what is the projected best science estimate of what the downwind hazard would be.
If I can just digress for a second, the CIA has been very responsive to concerns about possible low level exposures and modified both its modeling assumptions and its parameters to reflect low level general population limits for chemical warfare agents. Although the model that they used was developed for battlefield levels of agent that would affect the units, the competence to continue with war(?) activities, they were adapted and modified to reflect the concerns that have been raised and to answer questions about possible low level exposures.
So again, to summarize the three key pieces of evidence with respect to theater-wide low level fallout from the air war. There were only two sites hit. There was only about 20 metric tons of sarin and 15 metric tons of mustard released. Those sites were remote from U.S. troops. Those three factors combined to lead staff to conclude that the likelihood of low level theater-wide contamination or exposure is remote.
If I could have the next slide please. With respect to the third scenario, site specific releases of information, Khamissiyah, as I'm sure everyone here knows, is perhaps the best documented instance where that did occur. Khamissiyah represents a large bunker area -- that's about 100 bunkers up there where it's identified as bunker #73. After the air war, and actually after the conclusion of the ground war during the cease fire period, U.S. forces had captured this site. To deny the Iraqis the ability to rearm with munitions of all sorts that were there, undertook demolition activities that resulted in the release of sarin and cyclosarin from bunker #73.
United Nations inspectors first visited this site, I believe, in October of 1991. And at that point, they found evidence of chemical weapons at three sites within the Khamissiyah area. Six thousand intact mustard rounds were found approximately five miles to the west of the bunker complex. At a pit area a couple of kilometers to the southeast of the bunker complex, a number of damaged one to two millimeter rockets were found which contained sarin and cyclosarin in combination. The UN confirmed with respect to this site here, the bit area, that those rockets contained chemical warfare agent using chemical agent monitors and other actual tests in the field.
At the bunker #73, there were remnants of the same kind of one to two millimeter rockets found by the UN. Iraqi officials at that point in time told the UN in October of 1991 that approximately 1,000 sarin/cyclosarin filled rockets had been destroyed by U.S. demolition operations at bunker #73.
Today, after the UN has made two more visits to the Khamissiyah, the latest in May of 1996, these are the facts as we've been able to piece them together. First, it appears that from bunker #73 there was a release during demolition operations on March 4, 1991 of approximately 8.5 metric tons of sarin/cyclosarin mix. When I say there was a release, that's the amount of agent that was in the rockets, the total amount that actually got out is substantially less and is modeled accordingly.
The CIA modeling, again at the low general population exposure limit, indicates that there is a 25 kilometer downwind hazard that one would expect from the destruction of those kinds of rockets and that kind of bunker.
If I could digress for just a second, there were at Dougway(?) proving grounds, actual field tests done by our Army of similar rockets, burning in a bunker. The CIA's assumptions about the release from bunker #73 are predicated upon our actual data from what happens in a bunker when there is a release in a demolition like that.
With respect to the second area, the pit area, in May of 1996, the Iraqis for the first time told UN inspectors that U.S. forces had destroyed sarin filled rockets at the pit area. That allegation is under investigation still. There is corroboration for that allegation however on the basis of first hand testimony from soldiers who were in the field. Determining the actual number of sarin/cyclosarin filled rockets that were involved in the demolition activity in the pit area is very difficult. There are conflicting stories, so that modeling has not been completed on that yet. My understanding is that the modeling and the information collection should be completed in time for our October meeting and we should be able to brief you more completely about the pit area at that time.
In addition to the Khamissiyah events, the committee has been briefed on detections that were made by Czech units in northern Saudi Arabia prior to the air war. These detections are regarded as credible by the Department of Defense, but they have not been verified. In addition to the Czech detections, there are other detections that were made in Saudi Arabia and Kuwait and Iraq during the ground war with detection systems that are substantially more reliable than the automated alarms that we've heard so much about. The MT56 kit(?) detections, there are at least nine that we know of that have been indicated in logs and other documentation, and there are a number of fox vehicle detections where mass spectrometers corroborated nerve agent or mustard at specific areas.
So that's the thumbnail sketch of the evidence to date on potential exposures to chemical warfare agents during the Gulf War. I would now like to turn, if I could, to the internal investigations that the government has conducted to date on these issues.
At the outset, I would like to note that CIA analysts have been aggressive in pursuing both classified and open sources in their investigative efforts in support of the committee's work and independently in response to their director's mandate. They have been responsive in terms of taking an active approach that reflects legitimate concerns about possible low level exposures. The modeling has been modified and offers a substantial margin of safety in my estimation.
The picture is not as rosy, however, with respect to the Department of Defense's internal investigations. To fulfill the government's obligation to tell the truth about chemical warfare agent exposures to veterans and the American public, DOD's investigations must be timely, thorough, independent, credible and public. This means devoting adequate resources, targeting investigative efforts appropriately, developing objective standards for evaluating possible low level exposures, and informing veterans and the American people of the results of the investigations. On each of these counts, staff must rather reluctantly report that DOD's efforts have fallen short of the mark.
Since the first concerns were raised about possible chemical warfare agent exposures, the Department of Defense's official position has remained essentially unchanged. That can be kind of summarized in three nos. There was no use, there were no exposures and there was no presence. The inflexible reassertion of this position in the face of growing evidence that there were possible low level exposures, there were chemical munitions in the Kuwaitee theater of operations and there were releases has served to gravely undermine the credibility of the Department of Defense's internal investigations.
The second issue I would highlight for the committee is a staffing one and a resource allocation one. Only one of 12 professional staff members on the Pentagon's Persian Gulf investigative team is a trained investigator. Reflecting the staffing decisions, the team has engaged and devoted a substantial portion of its resources to literature reviews and scientific studies that could perhaps be more appropriately delegated to other components of the Department of Defense. This is a major mistake in our estimation. The Persian Gulf investigative team was in a unique position to pursue investigative leads through personal interviews, primary documentary analysis, assessments of logs, the review of operational intelligence and the analysis of other direct evidence.
A third factor that I would point to for the committee is the use of the inappropriate standard. When the issues of low level chemical warfare agent exposures arose, the Persian Gulf Investigation Team told this committee that it had no basis for assessing low level exposures. Later, the standard that was enunciated is the same standard that is used for purposes for prosecuting a war crime or for determining whether significant national level retaliation is in order. This standard presupposes physical symptoms, yet that very presupposition that there will be physical symptoms from chemical warfare agent exposure is inconsistent with the allegations that were made by Gulf vets that they were exposed to low level of agents that don't cause physical symptoms. Again, the inflexible use of this inappropriate standard has also served to gravely undermine the credibility of the Department of Defense's internal investigations.
Finally, the slow reluctant on again, off again release of information to the public by the parallel body to the Persian Gulf Investigation Team, the senior level oversight panel, has served to also undermine credibility and confidence in the DOD's efforts.
There are still many legitimate leads and concerns about chemical warfare agent exposures to be thoroughly investigated. I would note the Department of Defense has assets that cannot be replaced in pursuing those investigations. DOD has to play a critical and active role in investigating possible exposures.
But staff has been again forced to the rather reluctant conclusion that a credible review of these allegations and concerns cannot be accomplished internally by the Department of Defense. To be credible amongst veterans and the American public in general, there is a need for outside independent oversight, review and involvement in these investigative efforts.
Based on these observations, staff would suggest three key findings by the committee, accompanied by three corresponding recommendations. First to the findings. One, the evidence of chemical agent release at Khamissiyah is overwhelming and exposure to troops with 25 kilometers of the demolition activity should be presumed. Second, other site-specific exposures of U.S. troops to low levels of chemical agents cannot be ruled out. Finally, DOD has conducted a superficial investigation of possible chemical and biological agent exposures which is unlikely to provide credible answers to veteran's questions.
Based on these findings, staff would suggest three recommendations. First, all personnel assigned to units within 25 kilometers of the Khamissiyah demolition activity should be notified and encouraged to enroll in the Veterans Administration's Persian Gulf Health Registry or the Department of Defense's Clinical Evaluation Program.
Second, investigation of all reports of positive M-256 kits and fox(?) detections should continue. Where unit logs record positive detections by either type of equipment, members of that unit should be notified and encouraged to enroll in the Veterans Administration's Registry or the Department of Defense's Comprehensive Clinical Evaluation Program.
Finally, any further investigation of possible chemical or biological agent exposures during the Gulf War should be conducted by a group independent of DOD.
That completes the staff summary of its work on the CBW exposure issues and we would be pleased to discuss any particular area or findings with the committee.
DR. LASHOF: Thank you very much, Jim, very thorough and very carefully done. But let me start the questioning by taking another look at another way to look at what we're dealing with. You made the point very clearly that we've looked at exposure and effects as two separate. I almost really think we're looking at three stages. We're looking at was there release, then if there was release, was there possible exposure, and third, what are the health effects.
From my perception of what we've been hearing from PGIT is that they've started at the health effects and worked backward. That is in the absence of any health effects, they've not felt compelled to go after looking for exposures and release. Our point, to resummarize what you're saying, is that that is probably not the appropriate way under these circumstances to deal with the veterans' concerns. That we really need to first determine where there was possible release, then if there was a release, who was exposed and what that exposure was, and then deal with the question of health effects. By our discussion today, we're going to limit ourselves to the release and possible exposure. The issue of health effects we have discussed at length before and will take up again in October. Is that correct?
DR. TURNER: Yes, that's correct. I would not quibble with the recasting of that, except to point out that in addition to release data, there are also some detection data where you do not have a source. So to characterize that as a release when you don't know -- the check detections are what I'm referring to -- there is a complicating factor in it, which is why staff has somewhat compressed the two into exposures on one side and effects on the other. But that is a shorthand, and your elaboration is an accurate one.
DR. LASHOF: Okay. Let me open it to the committee to ask questions.
DR. LANDRIGAN: I would like to second what the chair just said about focusing on the releases. The reason, the biological reason that I would put forth to support that argument is the whole notion of subclinical toxicities. Subclinical toxicity, of course, refers to the notion that there are low dose effects of exposure to toxic chemicals which do not produce the clinically evident overt effects that you see from high dose exposure. It's a notion that first arose out of work on lead poisoning. We knew that kids that ate paint chips and had high blood lead levels had convulsions and sometimes went on to die. We subsequently learned that low dose chronic exposure to lead can produce mental retardation and other adverse effects in children. What we're looking for here, what we're presuming might have occurred here among exposed troops is that there are a variety of perhaps not very well defined subtle effects. I think the chair is absolutely right that we not hang our argument on the search for health effects, because that search might require some very subtle and specialized tools that are beyond the reach of anything that's on the table here today, that the obvious way to cut to the heart of this is to go after the exposure and the release.
DR. TURNER: It may be throwing yet another term into the mix that's unhelpful, but one way that I've conceptualized it myself is that if you think about detections and releases together, what you have is actually the presence -- there's some evidence that an agent is present in an area. That may be, rather than using a release, it's a shorthand term for the first tier of your analysis that may actually be one that encompasses also the concept that I raised about possible detections.
DR. LASHOF: I think the only reason I was making the point of the other is that we found some sites, I mean if you take Khamissiyah, we first found the site, and we knew there was release. Then the question of exposure was looked at by the fact that we had to do the modeling, find out downwind. The mere fact that there's a release somewhere doesn't necessarily mean that one was exposed. That was the point you made at -- I can never pronounce this -- Al Muthanna.
DR. NISHIMI: Al Muthanna and Muhammadiyat.
DR. LASHOF: I keep working at it. What is your understanding of the other 50 odd reports that yet have not been looked at. As I understand it, in the Denver meeting, we were told that there are some more 50 odd ones that could be looked at, but PGIT has only looked at four. Where do we stand on all that?
DR. TURNER: The best information that I have today is that of the 54 matters under investigation, PGIT has completed and published, posted reports on the Gulf Link Internet site for five of those. Those matters under investigation are not all chemical and biological warfare agent issues. There are a number of other matters that PGIT is reviewing, conducting literature reviews, scientific studies, referring matters to outside consultants that are included within those 54 matters. There are, however, a number of chemical and biological warfare agent issues subsumed within that 54.
With respect to what staff views as the most salient, the M-256 kit detections that are logged and the other fox detections that we've heard about, our understanding is that PGIT's current plan is just to include those in what they are terming a time distance analysis, essentially a scattergram and factor analysis of alarms, geographical locations, known releases and troop locations. It seems to us that that is not a prudent or responsible course to follow that where one has direct log entry evidence that is not rebutted that chemical warfare agents were detected, those should be pursued on a case by case basis through thorough investigative legwork, personal interviews with the soldiers who were in the area, analysis of collateral, operational intelligence from that time frame, so that real in depth answers can be given not, oh there's no evidence that there's a theater-wide concern.
DR. LASHOF: As I understand, maybe Andrea you can answer this for me, at the Denver meeting PGIT was asked about this issue. What is their point of view as to why they feel that's not necessary as compared to staff's point of view that it is necessary?
DR. KIDD-TAYLOR: What I remember is that for some it's hard in contacting some of the individuals who might have been involved. I think they mentioned that that some had not been contacted or knowing where they were. That was what I remember.
DR. LASHOF: Jim, please.
DR. TURNER: To some degree it's so you have a logged entry, what more can you do than note that it's a logged entry. If the unit did not take additional action and they aren't temporally down line additional indications of chemical agents in the area, there's nothing really to investigate. That again is an appropriate application of a methodology for battlefield acute levels of chemical agent. When we're talking about possible low level exposures, we think that's not a wise approach.
DR. LASHOF: So our real difference between our view or staff's view that they're recommending to the committee and PGIT's does deal with this question of a standard. If there's no illness, they don't think it's worth the time, effort, energy and go after it. We're saying if there's any detection, we had better go after it and worry about whether we have a health effect when we know more and have done more research on health effects. That's sort of a brief summary.
DR. TURNER: Precisely, it's something of circular reasoning. If you have no effects, you have no release and if you have no release, you have no effects. That is faulty logic. To comprehensively investigate something, you look at evidence of releases and then you look at the people who were in the area who may have been affected by a release. That's our position.
DR. LASHOF: Thank you. Just in terms of process, I want to clarify all the issues in the background material presented and then we will move to the specific findings and the recommendations. So if it's about planning and recommendations, hold it, but let's get the background clear.
DR. LARSON: I just want to get a sense of how many instances or incidents you're talking about with the fox detectors and so forth. How many?
DR. TURNER: I believe under a dozen.
DR. LARSON: Under a dozen, okay, so we're not talking about hundreds.
DR. TURNER: It is not hundreds and the M-256 kits, I know of nine. I have not personally gone through and reviewed all the logs, but I know that PGIT has identified nine specific instances, some of which were brought to our attention by veterans and we pass them on to the DOD.
DR. LARSON: Well, that's very helpful, because in our early meetings, the whole issue of frequent false alarms came up. If we're talking about investigating frequent false alarms, that's one thing.
DR. TURNER: If I did not make the distinction clear.
DR. LARSON: No, you did. I wanted you to give a number because initially the whole idea of the alarm mechanisms was brushed off as something that was so frequent and so common as to be, so insensitive as to be useless, but you're not talking about that, you're talking about these other.
DR. TURNER: No, ma'am, and Dr. Larson, the scientific basis is that the alarms use an ionization process that can respond to many large molecules, whereas the M-256 kits use enzymatic and chemical specific kinds of tests for nerve agent and mustard agent respectively. The fox vehicles use mass spectrometry.
DR. LASHOF: So there are about nine that are M-25 kits and then --
DR. TURNER: That is based on the logs that have been reviewed to date. I don't want to be in a position of there being another 15 out there that we don't know about.
DR. LASHOF: But it's really a manageable number that needs to be looked at.
DR. TURNER: Yes, ma'am.
DR. LASHOF: The staffing of PGIT with only one investigative officer and the others you say were doing literature review and so on, who are the staff? I mean what is the expertise, not who are the people, but what kinds of disciplines and what kind of other background material have they been doing that they have put up on Gulf Link?
DR. TURNER: There are physicians, there are nuclear, chemical and biological officers who are specialists in that area. There's a pharmacist. Please don't mistake me, I don't want to denigrate their efforts for a second. In particular in response to Khamissiyah, there was a major mobilization by PGIT to do exactly the kind of tedious investigative legwork that I outlined needs to be done for these other areas also.
But there is something to be said for having some experience in conducting investigative interviews and reviewing original source documents. PGIT has relied on large part on electronically scanned documents and in some cases optically(?) character recognized summaries of those documents. In my profession, there's a concept of best evidence. To suggest that someone would rely on an imperfect copy of documents to assess questions of this importance would be rejected out of hand. That's just an example of the kind of what I think of as fundamental mistake that can happen when folks with investigative expertise are not involved in conducting what should be a thorough investigative effort, what a body is positioned uniquely to perform is a thorough investigative effort.
Instead, a lot of the work product has been things like rebuttals to particular theories of Gulf War illness, mortality study with basic cross tabs. These are not investigative functions. These are kind of semi-epidemiological analyses that PGIT is not the body that one would nominate to do that normally.
DR. LASHOF: If I'm following you, what you're telling me is that some of their manpower is being used to do things that are being addressed by various other research studies and review of literature for whether there is or is not a health effect of low level, what kind of low level. That's being studied by a number of research centers, specifically asked by DOD to do that. Are we facing here a difference in priority setting and mission and role of the organization's work?
DR. TURNER: Certainly that is part of it. I think that the difference in priority and mission and role also carries over to the staffing decisions or it's a chicken and an egg.
DR. LASHOF: That's what I mean. If you set your priorities differently, you assign your staff differently to do different things. So we have a difference in view as to what the priorities should have been for PGIT and what PGIT has felt its priority was.
DR. TURNER: But also I think that difference in view extends to what should be done prospectively to resolve these very serious questions.
DR. KIDD-TAYLOR: We can't forget also providing information to the veterans in a timely manner of what actually is happening, what's going on. That seemed to be a problem when we were in Denver.
DR. TURNER: Yes, I alluded to the posting of records on Gulf Link that were later removed and that kind of action does just untold damage to the credibility of the entire DOD effort to provide information and answer to veterans and the American public.
DR. KIDD-TAYLOR: And credibility, trust, sort of the feeling of cover-up even if there isn't any.
DR. TURNER: That and the internal memoranda that come out that say before you post anything, send it by the Gulf Investigation Team so we have an answer to whatever the "bombshell" document may contain. Both of those are very damaging events that have happened. You can't put that egg back in the shell.
DR. LASHOF: Further questions.
DR. LARSON: Jim, what was the reason for removal of those approximately 400 documents? Why those?
DR. TURNER: There were legitimate classification concerns in my estimation that were reflected in those documents. The command decision to pull something off the Internet once it's been out there for six weeks or however many weeks it's off there, is one that could be second guessed. The subsequent events have confirmed that that material was not all of it as sensitive as the totality of the material was. DOD at a press briefing just last week released some of the documents to members of the media.
DR. LASHOF: Have they cleared most of those documents to go back on?
DR. TURNER: I have not had an official response to that. The numbers I've seen are that 90 of the 400 pages are back in the public domain. What we were told at Denver was that if an individual requested any specific document, it would be provided, but that if an individual requested all 400 pages of documents, there would have to be an additional classification review for purposes of sources and methods because the totality tells more than any individual document is the argument that was being made.
DR. LASHOF: I see, so that would be the reason not to put them all on Gulf Link.
DR. TURNER: That is the stated reason.
DR. KIDD-TAYLOR: Even with the Freedom of Information Act, if you can request the documents and not knowing what the documents are that you want, it would be hard for anyone seeking that information to get --
MAJOR KNOX: There was not a listing of documents that people could look through.
DR. KIDD-TAYLOR: -- and identify.
DR. LASHOF: Further questions?
DR. CUSTIS: Has there been an actual head count of the number of troops within that 25 kilometer radius of Khamissiyah?
DR. TURNER: The best number I have is 1,100, the number that was provided. And that number has changed. When I first raised the question, I believe it was in Atlanta, Lieutenant Colonel Martin stated it was between 3,000 and 5,000. When the Pentagon released the first confirmations about Khamissiyah, the number was between 150 and 300. There is uncertainty about where troops were and getting a precise number is a difficult task. The 1,100 is the number that has most recently emerged as the working estimate.
DR. LASHOF: Other questions?
DR. BALDESCHWIELER: Once again, on the first finding --
DR. LASHOF: We're not to the findings yet. We will be ready to go to the findings in a minute, but if you have background issues.
DR. BALDESCHWIELER: When you say 25 kilometers, is that considered as a radial distance around the release or is that the downwind?
DR. TURNER: A radial distance, and there are some specific reasons why we believe that that approach is the prudent one at Khamissiyah. There is a substantial uncertainty about the wind direction there. There is data that the CIA relied upon that says winds were going generally in a northeasterly direction. That data is based on a 30 kilometer grid, a 25 kilometer footprint is, if you will, within the uncertainty level inside that grid. The National Oceanographic and Atmospheric Administration publication for that same time frame indicate wind direction is different than that. Eye witnesses on the ground who testified before the committee say winds were blowing different directions, and the low level of winds, it's only three to four knot winds -- three to four miles per hour, not even knots -- three to four mile per hour winds, which are highly variable at those low levels, all those combined on that side of the parameter.
In addition, one of the phenomena that happens in a bunker demolition operation is not only do you get broken emissions that are emitting from a point source but the heat of the demolition activity, because these are live rockets, ignite some of them. So you have what is termed by the military cook-offs, and you will have rockets tumbling out for distances. The best estimate based on our dougway(?) test is that it's roughly a two kilometer radius from that that you get those cook-offs. There are however reports from Khamissiyah that debris was falling at substantially further distances up to 10 kilometers.
None of those standing alone is enough to say yes you've got to draw a circle. If you take all those together, I think the prudent result is you don't really have much option.
DR. BALDESCHWIELER: And the 25 kilometers, that's the contour of what presumed level of --
DR. TURNER: Concentration -- it's a general population exposure limit established by the Army which is 0.013 milligram minutes per cubic meter -- I think I got all those. It has both a time and a concentration component in the numerator.
DR. BALDESCHWIELER: And that's a level which is substantially below what?
DR. TURNER: It is substantially below clinical effects, even threshold clinical effects like runny nose.
DR. BALDESCHWIELER: And below industrial -- I mean if one were working in a plant where --
DR. TURNER: That is correct. There is an eight hour exposure limit, which is I believe on the order of .04, whatever that unit is, milligram minutes per cubic meter, thank you. So we have taken the absolutely most conservative established standard the Department of Defense has put out there as being an exposure limit to give veterans again every benefit of the doubt as to the possible exposure.
DR. LASHOF: Any other questions before we move specifically to our findings and recommendations?
Okay. Findings are on page 10 of Tab H. The first deals with the evidence in Khamissiyah, which is overwhelming. Is there any hesitation or any change or addition or correction anyone wishes on findings #1?
MAJOR CROSS: Jim, I think jumping on what John said, I think in that finding, can we say a 25 kilometer radius?
DR. TURNER: You want radius, yes. We went back and forth. I have no misgiving about being more specific.
DR. LASHOF: Okay. We will insert radius there. The second one?
DR. BALDESCHWIELER: And on the first, if there would be some way of giving a feeling for how those contours literally go with distance. For example, what would be the radial contour for the industrial level of exposure? Would that be half the radius?
DR. TURNER: I believe it's roughly a third. Again, the CIA laid that out. There's a tradeoff between overwhelming people with too much detail in a finding. I tried to, when we kicked this around, to keep it as single note and I think it's highly defensible because you're using this very conservative threshold, sub-threshold level if you will. An accompanying text could certainly lay out in greater detail the various -- there are actually three, there's a threshold level where you might first get myosis and some runny nose. There's also this occupational eight hour standard. Then there's the third general population limit. Whereas I did not brief that in the memo that is before the committee, I would certainly have no objection to providing that detail.
DR. BALDESCHWIELER: But just in the sense, if indeed the radius is only one-third, then that means the aerial exposure is down by a factor of 10 roughly.
DR. NISHIMI: John, if I could ask a question then. Are you objecting to the 25 kilometer radius part of the recommendation or would you just like the outcomes and finding or would you just like more context as to why the staff recommends the 25 kilometer?
DR. BALDESCHWIELER: I guess as a reader of this recommendation, I would like to have I guess a more -- I don't know how you can quite do this --
DR. KIDD-TAYLOR: I think it's based on the CIA report, right?
DR. TURNER: If what you're asking for is in the finding and explication of the general exposure level, we can certainly provide that.
DR. LASHOF: I was going to say, I think it would help not so much to quibble over the 25 kilometer how much, but the statement "and exposure to troops within 25 kilometers", exposure at some level.
DR. TURNER: At that level perhaps.
DR. LASHOF: At whatever level or minimal or low level, non-obvious health effect level.
DR. BROWN: We could use the language that the Department of Defense itself uses to describe that level.
DR. LASHOF: I think we have to say something because the findings are going to be picked up out of context. Not everybody is going to read as thoroughly as we have just read.
DR. NISHIMI: I think we know where to go with that.
DR. BALDESCHWIELER: And perhaps even some more detail in the text or some graphical --
DR. TURNER: A presentation of the footprint, is that what you're suggesting?
DR. BALDESCHWIELER: Yes, I think along with the exposure levels, yes.
DR. LASHOF: Okay. Shall we move to the second finding? Other site specific exposures. I think we've pretty well discussed the background for that. Any problem with that finding?
The third is a statement concerning DOD or PGIT's efforts. Are we more correct or -- I don't know whether it matters whether in the finding the statement is DOD or PGIT or PGIT's --
DR. TURNER: PGIT is part of DOD.
MAJOR KNOX: You could just always label it Persian Gulf Investigative Team of the Department of Defense.
DR. LASHOF: Does anybody have trouble with any of the wording of that statement?
Okay. It stands as it is.
Recommendations? The first one deals with the personnel assigned within 25 kilometers of Khamissiyah.
DR. TURNER: I would note the radius comment that Major Cross made would apply to this also I think.
DR. LASHOF: Are they not all being notified now? Wasn't I under the impression that the DOD is calling everyone of the 1,100?
DR. TURNER: DOD is calling some subset. We cannot say that all within the 25 kilometers are in the process of being contacted. The 1,100 number is not actually the target. What they're looking for are the units that were closest right now. Our suggestion is that any unit, any personnel that were at units within 25 kilometers should be contacted. This is something of an extension from what they're doing already. It is not inconsistent. It is a logical extension.
DR. LASHOF: But it is an extension and not that far?
DR. TURNER: Yes, ma'am.
DR. LASHOF: Okay, that's what I wanted to be sure of. Yes, Phil.
DR. LANDRIGAN: Implicit in this recommendation is the concept that first these people would be identified and a roster would be created of them, yes?
DR. TURNER: Yes.
DR. LANDRIGAN: I wonder if the recommendation ought to be expanded a bit to talk about setting up that roster, making a listing of these people, breaking them down if it's possible according to level of exposure, which is a function of where they were when. What I have in mind, what I'm leading towards is the concept that at some point, hopefully sooner rather than later, there might ought to be systematic medical epidemiologic evaluation of these people looking for the kind of subclinical toxic effects that are not going to be evident unless they're specifically sought.
DR. TURNER: I certainly don't quibble with that. In proceeding with anything like that, it is important, however, that the unit identifier be kept with the individual so that you can say where they were. I would also just add a cautionary note, we've been over and have looked at what the unit locator information is for Khamissiyah and it's not very reassuring. The 73rd Battalion is shown on top of bunker #73, which we know was not the case. The degree of confidence you can put in that data I would want to caveat at the outset just so that no one thought you were going to get hard and fast epidemiological exposures out of it.
DR. NISHIMI: Maybe we can make a stab at it, Phil, and then everyone can --
DR. LANDRIGAN: Yes. I remember similar difficulties back when we were trying to reconstruct exposures to Agent Orange among people who had served in Vietnam. The locators are inherently imperfect because of the fluid nature of the situation. But at least it was a starting point.
DR. TURNER: I'm not suggesting that that's not a worthwhile effort, I just wanted the caveat to be on the table.
MAJOR CROSS: Should we also note that once these people are identified, they should be monitored annually, semi-annually? I don't know if that makes sense.
DR. TURNER: We kicked that around extensively at the staff level. I think that our consensus was the first step is to get them identified and to get them into the CCEP of the VA Registry. What you've suggested may be a very wise second step, but it's a second step. It's premature to make that kind of recommendation now.
DR. KIDD-TAYLOR: But that was based on also what Phil just commented on, to get them listed in a roster. That would be one way once there's more epidemiologic evidence available that you would be able to link.
DR. BALDESCHWIELER: Isn't a simple step along those lines to compare such a list with the list of people who have complained of various symptoms?
DR. TURNER: That approach is already being undertaken by the Department of Defense. I view that approach as a complimentary one that you look at the folks who have already registered with CCEP who may have been in the vicinity and do some analysis from the effects, as well as from the exposure end. But those are complimentary and my understanding is that that's ongoing already. So it did not seem to us to be necessary do recommend.
DR. BALDESCHWIELER: Do we know anything about that analysis.
DR. TURNER: It's too soon. The N is awfully small right now is the short answer.
DR. LASHOF: We just don't have enough information yet. Okay, Phil.
DR. LANDRIGAN: I share your sense that it would be premature in any way to mandate medical examinations with any frequency for these people. I think that would be going way over the top, but I wonder if it would be possible to put in something softer than that in the recommendation that once this group of people have been identified and notified that the possibility of systematic periodic medical follow-up exams be considered or something like that. Basically it's a placeholder. The reason I push you a bit on this is that I think we're in the unique position here in the next few months while this commission still exists to get something like that down on paper.
DR. TURNER: We I believe have something similar to that in some of the recommendations that were made on the health effects that Dr. Brown briefed on. There are human populations where it does make sense to do some clinical and post-exposure evaluations. I believe the door is certainly left open to include in this group and the recommendations that were made with respect to possible health effects of chemical warfare agents and research into those areas.
DR. NISHIMI: I think, Phil, once the information that Mark presented and the information that Jim has presented today get married up in a report, I'm reasonably confident that your general concern will be addressed. Then we will be able at that time to sort of quibble about language.
DR. LANDRIGAN: Okay, fine.
DR. LASHOF: Okay, then we have one final recommendation. It's obviously a difficult one that we should think very carefully about in which we're recommending that any further investigation in CBW be conducted by a group independent of DOD. I think you've given us in the background your reasons for feeling it should be independent of DOD. Could you give me some ideas of the type of commission or type of group that you think is appropriate and whether this has been done before and there's precedent for this kind of an approach?
DR. TURNER: Certainly. The type of effort that is needed is essentially an investigative one, and the government in the past has had a number of independent commissions, which unlike this body have been charged with fact finding investigations. A recent one, which I'm sure everyone here is familiar with, is the Presidential Committee on Radiation Experimentation. Its kind of lineal predecessors are the Feinman(?) Commission that reviewed the Challenger Disaster, the Tower Commission, the Rockefeller Commission. So there are ample precedents for establishing an outside individual department kind of investigative effort when a particularly volatile contentious issue arises that the department in question has lost credibility to investigate itself. Those would be the three anyway that I would point to.
There are other models. There are ad hoc efforts by interagency groups to review and investigate for fact finding purposes. They generally don't have the same kind of credibility as a high level commission does, but those are indeed an improvement so long as there is public oversight, public involvement by private citizens and veterans in any continuing effort.
DR. LASHOF: Would you think it appropriate to add in the wording of the recommendation an indication that to assure credibility, or to gain credibility, further investigations are possible, that we put some statement in there that I think we feel they're capable of doing this at DOD, but at this point, in order to assure the credibility is our major motivation for suggesting that this be an independent group.
DR. TURNER: Credibility and thoroughness are the two criteria that I would suggest are appropriate antecedents. DR. NISHIMI: We can make those changes.
DR. LASHOF: Are there any other? If there aren't, thanks very much for a job very well done. We appreciate the efforts. We will proceed. We're going not to take a break this afternoon and move right into hearing from our assistant secretaries. Phil, welcome. Steve. Okay, we will give people a chance to move around a little bit, get themselves settled in.
First, I want to thank Assistant Secretary Dr. Kizer, Assistant Secretary Steve Joseph, Assistant Secretary Phil Lee for coming here to speak on behalf of their departments as we go into the final phase of the work of the committee. We were anxious to have you review for us the progress that has been made in response to the recommendations and the findings in our interim report and other activities that you've undertaken and proceeded on since we first began our work and you first addressed this committee back last August.
I will ask Dr. Kizer to kick off and present first. What we will do is proceed on, asking each of you to present, and then open it for questions to the panel. The committee can address any of you and feel free to respond, any of you can pitch in in responding to any questions the committee might have. Ken.
Agenda Item: Current Efforts and Implementation of Interim Report Recommendations -- The Honorable Kenneth W. Kizer, Department of Veterans Affairs
DR. KIZER: Thank you. You have, I presume, copies of my comments, as well as answers to a number of questions that were posed. Instead of repeating those and going through them, what I would like to do is just make a few verbal points at this time and then hopefully save, by doing that, save more time for discussion and addressing questions and your comments during the time that we have. I would certainly note that we appreciate this opportunity to be here and to engage in this dialogue with you and the continuation of the ongoing dialogue that has been going on for some time now.
I think as you're well aware, the VA's programs to deal with the illnesses that have become evident in our Persian Gulf War veterans began in 1991/1992 and that has evolved into the four pronged approach that currently exists of providing medical care and conducting research, providing compensation and also providing public education and outreach. We have over the last year continued to provide examinations, the registry examinations. That number now is over 60,000 individuals have been examined pursuant to that program.
Just as a side bar, I would note that of the analysis of the first 52,000 plus individuals who underwent that, 77 percent of them have come away with a diagnosable condition or a diagnosis. There are 23 percent that have not been able to be diagnosed as a result of the findings of that.
We have continued to provide the more in depth referral examinations also, likewise as a result of the special legislation that was enacted a couple of years ago. Our Persian Gulf veterans have continued to receive out-patient and in-patient care in substantial numbers, over 155,000 veterans have been seen in our ambulatory care clinics and 16,000 or so have been admitted to hospitals for a variety of conditions, most of which have diagnoses associated with them.
We also, as you know, pursuant to very specific legislated direction of Congress, initiated a program that allows spouses and children of Persian Gulf veterans to have their health records entered into the VA registry. That legislation and the way that it was set up, we felt created some problems from both a research point of view, as well as a care delivery point of view, did register our concerns at the time, or I should say prior to enactment. It was enacted and we have carried out the legislation, although we feel there are severe limitations from both a research and a provision of care perspective with the way that is set up. As result of that, we certainly questioned the value of continuing that program, at least as it's currently conceived in the law beyond the date that it expires at the end of this month.
We've continued to support a research agenda. Now there are more than 30 individual projects that have been funded at our various environmental hazards research centers, as well as research being conducted through the office here in Washington. You've been previously provided with documents that detail those projects, as well as other projects being sponsored by the federal government as well.
I know that you're aware that we also announced at least my desire to fund and establish a fourth environmental hazards research center that would specifically focus on reproductive outcomes. I think that the shortcomings in efforts in that regard have certainly become evident as a result of the Persian Gulf War concerns, as I think they were evident before. We did issue a request for proposals some time ago. Those requests are all due in a little over a week from now, and we expect to be funding and getting that center going within certainly the next very few months, if not the next several weeks depending on the volume of proposals that come in and the amount of time it takes to rigorously review those.
We do expect that that center will be focusing not only on Persian Gulf War veterans but Vietnam veterans and others because we think there's quite a number of reproductive issues that need to be addressed both from a research perspective as well as an educational perspective and there will be a number of products, if you will, that the center will be tasked in developing things such as education modules that could be provided to our providers on these issues.
In this vein, or while we're talking about research, I might just very briefly mention two other projects that I know you're aware of, but just to update you on them. The first of these is the Persian Gulf Veterans Mortality Study that has been completed and has been accepted for publication in one of the major medical journals in the country and will be coming out in a couple of months. Just in a word, that study did demonstrate a mild excess in mortality among Persian Gulf War veterans due to external causes, injuries, things like automobile accidents, but did not demonstrate an increased death rate due to medical conditions, certainly in the time of the study period. In fact, in some instances, the Persian Gulf veterans had a slightly lower cause specific mortality than non-deployed Gulf era veterans. For example, in the area of cancer, there was a slightly lower rate than was found in other veterans who served at the same time, but weren't deployed to the Gulf.
The other study I would just briefly mention, the National Persian Gulf Veterans Survey, which is a survey that is looked at 15,000 randomly selected Gulf War veterans with a comparable group of veterans who were not deployed. Phase one of that study has been completed. Phase two and three are underway, or are in the process of being completed. It's too early at this time to give specific results, but I did want to let you know that that study is underway. We consider it an important study and it is moving according to schedule.
We have, I think, addressed some of the concerns that have been expressed before as far as the oversight of the research effort by the Research Working Group. That group has been very active this past year and is providing more in depth overview and I think addresses some of the issues that you expressed some time ago as far as the role that it was playing. I think the net effect is that it is strengthening our research portfolio related to the Gulf War veterans issues.
Just in the last couple minutes or so, you did request that I specifically comment on our plans to address the issues raised by the information that has become available recently about Khamissiyah and the exposures that certainly appear to have occurred consequent to that incident. I would just underscore what we have talked about before, that we have certainly remained open to this possibility. I think the Secretary has been quite clear in his comments that this is something that we would at no point discount and have been open to. I know that I have made that comment and have been quoted in the press in that regard to keeping this open as a possibility, although I have received assurances that that did not occur. We have designed protocols to identify clinical signs and symptoms of potentially neurotoxic exposures and our VA Medical Center in Birmingham has focused a part of its research on potential effects in this regard, although in the absence of information to lead us to think that this was a real possibility, our think our research agenda has been oriented more towards other possibilities than it will be in the future.
I would note that certainly the conventional medical wisdom at this time is that readily identifiable long-term sequelae or adverse health effects secondary to any of the agents of concern, the conventional medical wisdom is that those would only occur after acute toxicity was demonstrated. I must note that as a medical toxicologist, I'm familiar with that line of thinking, but I'm also not convinced that enough research has been done to preclude the possibility that there may be some individuals or certain circumstances where the conventional medical wisdom may not apply.
And while I think there are gaps in the research agenda here, we are moving forward to fill those in. On learning about this incident some time ago, I immediately asked our Research Working Group to provide a short-term plan for addressing the issue and their recommended plan of action was to fund some toxicologic research proposals on low level chemical weapons exposure from a pool of the proposals that had already been submitted, to relook at those proposals and cull out those that appeared most promising and to support them. That we should also solicit research on the feasibility of conducting epidemiologic investigations, certainly more investigations of low level chemical agent effects, particularly as the proximate population of concern would be those who potentially were exposed a la the Khamissiyah incident. Then third, they recommended that we review the ability to confirm the identities and locations of individuals in and around that site with the goal of soliciting more detailed and rigorous epidemiologic investigation of that group of individuals.
We are looking at funding some new efforts in this regard. I have also tasked our new chief research officer in developing a strategic plan for research in this area, both in the short and the long-term, recognizing the paucity really of expertise that exists in this whole area. Again, as one who has spent some time and has some background in medical toxicology, this is just not an area that a lot of investigators in this country have focused on. As a result, there is some paucity of expertise. Indeed, a number of the proposals that potentially would be fundable are by investigators that are outside of the United States. So we have to look at both developing a body of experts in this regard, laboratories and other things that would support this effort that currently doesn't exist in the research community that we're familiar with.
I would just conclude these brief comments by noting that we've also tried to expand and enhance our outreach efforts a la some of the discussions that we've had with the committee and some of your comments in the past. We've tried to improve our public service announcements and have an enhanced PSA campaign that is about to be launched. We've established some additional efforts to monitor these efforts and to again provide more information to both the veterans and their families, as well as our practitioners, specifically focusing on those who provide the bulk of the investigation, but also looking at potential avenues where we can enhance the overall level of knowledge and familiarity of these issues among our much larger pool of practitioners who may not be as directly involved but may in the course of their work certainly provide initial access to the system or seeing individuals where these are corollary questions to other things that they're seeking care for.
We certainly appreciate the efforts and the advice that the commission has provided and look forward to continuing to work with you so that we can do a better job in the future.
DR. LASHOF: Thank you very much. Dr. Joseph.
Agenda Item: Current Efforts and Implementation of Interim Report Recommendations -- The Honorable Stephen C. Joseph, Department of Defense
DR. JOSEPH: Thank you, Madame Chairman. It's a pleasure to be here on behalf of Deputy Secretary John White to represent the department. My testimony as submitted is rather voluminous and I did that deliberately because we view this as an opportunity to kind of give you our round-up shot so to speak on where we have been on these issues. I'm going to very sketchily go through that testimony in the hopes that you will address yourself to it in detail. I will go into more detail on those issues that I think are of particular relevance today.
Also, attached to the testimony are a series of attachments bearing on specific issues. One of them that I want to mention specifically, least I leave something out in my overview, is a sort of point by point list of questions from the PAC and our specific replies to them. Of course, I would be happy to go into any of these areas in more detail in the discussion period that you wish.
I also have with me in support a number of subject matter experts from the department and I will answer the easy questions and refer the difficult ones to them.
My testimony begins, after some introductory statements, about our commitment and the President's commitment to the veterans of the Gulf in a description once again of the Comprehensive Clinical Evaluation Program. I really won't say anything about that now. We've talked about it before. I've included our 21,000 patient report. I really have nothing new to say about the findings as they stand at the moment and from that report, except that they really have not changed since the last time that we discussed them.
Similarly, you have a list in the attachments of our research activities and I'm not going to go through them in detail, except to say three things. The first is that we believe our research really is responsive to both the best scientific view of the problem and the committee's recommendations. Second, I think as tough as it is sometimes for agencies to work together, we really feel that the interagency coordination effort on research in this area has been of very high caliber. And third, just to say to the committee something that most if not all of you know, good research takes time. You cannot rush science. Some of these issues on which we have preliminary studies, Ken Kizer mentioned the mortality study, the hospitalization studies, the reproductive outcome studies, we have preliminary information, we've shared that and made it public as it becomes available, but we really -- I think I ought to put this as kind of a plea to the committee as you go towards your report, because it is often hard to remind the public that definitive research answers do take time.
I want to spend a few moments talking about the Senior Oversight Panel. As our clinical and research programs were well underway, in March of 1995, it was felt that we needed a way to have a broader and tighter management view of the broad range of activities in the department. After all, our activities in this area span everything from questions about intelligence activities during the time of the war to current clinical studies. And to that end, the deputy secretary established and chaired what we know as the Senior Oversight Panel in the department. It meets several times a year and it provides this oversight authority. The members of that panel, to give you a sense of the scope, include the Under Secretary of the Army, the principal Assistant Secretary of Defense for Atomic Energy, the Director of the Defense Intelligence Agency, the Deputy Assistant Secretary of Defense for Intelligence and Security, the Deputy Director for Current Operations of the Joint Chiefs of Staff, and myself as the Assistant Secretary of Defense for Health Affairs. There's a full-time staff, a director for that activity. The panel oversees through the year the broad array of the activities.
I want to spend a few minutes on the Persian Gulf Veterans Investigation Team, because I know there's been some discussion about that today. At the same time, the Dep Sec Def established the Senior Oversight Panel, he established the investigation team. Let me call it PGIT, because we love acronyms in the Department of Defense. We set up a separate toll-free telephone line to reach out for reports of incidents or suspicious circumstances or allegations. We've had over 1,000 incidents that have been reported.
I think one of the things that's important to remember in all the discussion about Khamissiyah is that the rediscovery of Khamissiyah really was a function in part of CIA activity, we have to give them credit for that, but in great part of the investigation team. Khamissiyah would not have come back into the focus that we have put it, and in which greater focus that it's taken on in the public view, had we not had the PGIT.
Once learning of a probable presence of chemical agents in Khamissiyah, we initiated several steps, in part but not only through the investigation team, to rapidly assess whether health related consequences may have occurred among service members who demolished the site. Let me take a moment and identify specifically not only the steps we have taken in Khamissiyah, but also where we are in the process of completing them.
The first thing we did was begin a review of the clinical records of service members from those units, and there were several units, who we could identify as being within the area of the Khamissiyah activity. I believe we're using 50 kilometers. I have to double check that that's true, but I believe we're using 50 kilometers as our first ring of focus. There were about 1,000 people in that area. We matched that. It's an example of how fortunate it was that we began the CCEP three years ago. We made a match between everyone that we had in the CCEP, people who had self identified with symptoms who were members of those units who might have been within the Khamissiyah area.
I must add that not everybody in the units that were present at Khamissiyah were actually present at Khamissiyah. In fact, depending on the diameter you use, it may be as small as 150 out of the 1,000 people.
But in any event, we had an inside and external medical clinical review of the clinical records from the CCEP looking for any patterns that might be recognizable. And from a double review, we have as yet found no patterns or no significant connections that we can make. There were actually 46 members of the involved units who are also members of the CCEP. We do not yet know that all 46 were actually in the Khamissiyah area, but they were members of those units.
The second thing we did was begin to contact individuals directly who were assigned to those units, to ask them about any information they have and to make sure they knew about the CCEP and the VA corollary program. In the printed testimony you have, I say that we have contacted telephonically so far some 250. Actually, the number as of this morning is 429 individuals with whom we have had direct contact, or about half the people within those units. And our intention is those that we cannot find telephonically, remember we're talking about an event that took place five years ago now, we will have a letter go out to them to the best known address. We will try to come up with 100 percent, we will see.
The third thing we did was to review the information regarding DOD hospitalizations since the Persian Gulf War using the Health Research Center Hospitalization Study, which we have talked about before. Again, our first cut through that information, I think it's a pretty good cut but it's a first cut, revealed no patterns or no unusual focus in those hospitalizations. Our plan is to go back when we actually know which of the individuals were in the Khamissiyah ring, to go back and repeat that.
Then fourthly, we continued to do preliminary investigations of other sites where there may have been the potential for exposure of U.S. forces to chemical agents. In other words, are there other sites to rediscover as Khamissiyah was. CIA and DIA have identified two additional sites where chemical agents were stored and were destroyed during the war. Both these sites were destroyed from the air in aerial bombing. In correlation with our Geographic Locator Study, we do not identify American forces as having been in the areas of those sites when they were destroyed by the air.
Fifth and the actual report is in your packet, I requested the Armed Forces Epidemiology Board to conduct a comprehensive literature review and critique regarding this issue of is it possible the have chronic or delayed health effects resulting from low level exposure to chemical agents, to nerve agents that do not manifest themselves as acute health effects. The findings of the board are in your packet. They are, to put it succinctly, that there is no evidence that without acute effects in the case of nerve agents, that you would expect to see long-term effects. I will come back to that in a few minutes.
And finally, much as Ken Kizer has said, we revisited our research priorities and resolved to fund as quickly as possible expedited peer review research concerning this subject of without acute, is there chronic. We have already funded three research proposals that were in the pile from formerly for a total of $2.5 million, and we expect to fund another $2.5 million as soon as projects are submitted and identified.
Let me talk a little bit about the Khamissiyah demolition operations and what we're doing to try and determine the possible chemical agent hazard resulting from the destruction of 122-millimeter nerve agent rockets in the pit area south of the bunker complex area which was originally described in Khamissiyah. In October of 1991, the UNSCOM(?) Inspection Team found some 300 122 rockers containing a mixture of the nerve agents sarin and cyclosarin in the pit area. The mostly intact rockets were found in several heaps or piles, but some appeared to have been damaged or destroyed. At that time, the Iraqis told UNSCOM that occupying coalition troops had destroyed chemical weapons at the bunker #73 earlier that year. That's the March incident. UNSCOM reported that the rockets found in the pit area were apparently salvaged from that bunker. Iraqi statements however were viewed with skepticism at that time because of the use of deception by the Iraqis against UNSCOM.
In March 1992, when the UNSCOM inspectors returned to Khamissiyah, they reported that they consolidated and destroyed a total of some 450 plus 122-millimeter nerve agent rockets found in the pit area, including the original some 300 that they had found the year before. Approximately 300 additional intact rockets were found buried in the pit area, which were then sent by UNSCOM elsewhere for destruction.
In May of 1996, UNSCOM inspectors returned to Khamissiyah and were told then by Iraqi officials that some 2,000 122 nerve agent rockets were moved into bunker #73 from Al Muthanna 100 kilometers northwest of Baghdad just prior to the air war. The Iraqis told the inspectors that these rockets began to leak and that they moved approximately half of them from bunker #73 to the pit area and that the movements of these munitions occurred prior to the U.S. forces arrival in early March and demolition in the bunker area. At this inspection, the Iraqis also stated that the occupying coalition forces destroyed those pit area rockets.
As part of the systematic destruction of the Khamissiyah ammunition area, the 37th Engineer Battalion destroyed stacks of crated munitions in the pit area on 10 March 1991 after these stacks were found by the battalion operations officer a day earlier. That's the story you are familiar with. The Persian Gulf Investigation Team will continue to investigate the circumstances surrounding the pit area demolition as well as the bunker area demolition, identify what troops were in the area at the time, determine the amounts of any chemical agents released, and ascertain details required to model any potential downwind hazard area. Using modeled downwind hazard distance and unit location data, as I've described from our geographic information system, units in the Khamissiyah vicinity that were possible affected will be identified as we are doing for further analysis and follow-up.
As I'm sure you can appreciate, going back five years in time and reconstructing the actual events surrounding Khamissiyah is difficult. We will be prepared to provide you, through the investigation team, a fuller and up-to-date report on these developments and our findings in your October hearing.
To date, we have not identified a casual relationship between any post-war illnesses of Gulf War veterans in any of the incidents or theories that the investigation team has been dealing with. We have of course established the need for further investigation and research, which may prove beneficial, or which may lead us to different conclusions. The investigation team, as you know, is placing the results of their work on the Gulf Link Home Page.
With respect to classification, you have in my testimony the various numbers of $20 million and $5 million and 500,000 pages for declassification, et cetera. It's a mammoth job. We think it's going well, and sorting through it, following Sutton's law, looking for what might be the most relevant health related information, the declassification effort led by the Army expects to complete its work at the end of this year.
I have a long session in my testimony, a section in my testimony about what the lessons learned have taught us that we are implementing in Bosnia. I think that's a very good story. I understand you heard about it yesterday. I would be happy to go into any greater detail either about the one off(?0 activities that we have implemented in Bosnia, I think with great success, or the way that we are now turning that into ongoing DOD policy. But I won't spend any more time on it in describing my testimony.
Finally, in closing, I would like, having heard some of the comments and heard of some of the comments about the investigation team and the department's investigations that have been presented by staff at the hearing, I would like to add a very short verbal statement that I think is germane to the point. We understand that the committee has expressed concerns about the department's investigation into the potential causes of Persian Gulf illnesses.
While we are always open to constructive criticism, let me respectfully suggest that this concern fails to recognize and appreciate the department's complete commitment to investigating the possible causes of Persian Gulf illnesses in the context of its support for all Gulf War veterans. We have investigated our own operations, opened ourselves up to independent public review and fully supported the review by an independent Presidential advisory committee. The department has opened itself up on this issue, whether it's declassification, the investigation team, external peer review of research, making clinical databases available or work with your committee.
I should add the one thing I want to say about CCEP is we are now making the clinical databases for CCEP open to scientific investigators in the academic community. All that we need is an IRB approval from an institution and we will make the data available to them.
The Persian Gulf Investigation Team was designed to help the department meet the President's commitment to leave no stone unturned. As an internal investigation into possible causes of Persian Gulf illnesses, it has made a major contribution to the department and the way we look at the world, and I would suggest to the public. It has been a major and positive contributor to the work of your committee to date. It continues to meet with and make its work available to your committee. The investigation team, as I've said, is also moving the results of its work out to the public via Gulf Link. More is coming. If you have specific criticisms or you have found things that they have missed, we need to know as well and we will, as always, respond positively.
We clearly understand that the department's efforts can never fully meet the expectations of those who want an independent external review. That is why the President took the positive step of establishing your committee and why your committee's efforts are so important. In addition to your work, the department itself has called upon other independent bodies to assist our work and yours. I cite the Institute of Medicine, the Defense Science Board, the Armed Forces Epidemiology Board and the external reviewers of our research work who all carried out independent reviews. This work has been made available to your committee and has been incorporated into your review.
As you know, our investigations continue. We welcome your suggestions as to how these efforts can be improved. The department would be happy to sit down with the committee and discuss more intensive or extra(?) intensive investigations or a mutually agreed upon alternative framework for those investigations. Thank you and I would be happy when we get to the questions to relate of these points or the others that are in my more comprehensive written testimony.
DR. LASHOF: Thank you very much, Dr. Joseph. Phil.
Agenda Item: Current Efforts and Implementation of Interim Report Recommendations -- The Honorable Philip R. Lee, Department of Health and Human Services
DR. LEE: Madame Chairman, thank you and members of the committee. I'm testifying on behalf of the secretary and hope to respond to the questions that you addressed to her in the letter of July 31. I would just like to note, as Steve Joseph did, that I am also accompanied by experts who can perhaps respond to your more detailed questions. Mary Pendergast(?), who is the Deputy Commissioner of the Food and Drug Administration, and Henry Falk who is the Director of the Division of Environmental Hazards and Health Effects at the National Center for Environmental Health at the Centers for Disease Control and Prevention.
Let me just begin with a very brief update on the two studies that CDC has been carrying out. The first, the investigation of the Persian Gulf War illness in Pennsylvania and that was at the Lebanon Veterans Administration Medical Center. There were three elements to that study, some of which have been reviewed with you and you've been provided with detailed information. First, the veterans were interviewed, examined and medical records reviewed to verify and characterize the illness. Second, a survey was conducted of four military populations who were deployed to the Persian Gulf War or not deployed to determine relative prevalence of symptoms and develop a working case definition. And then a study of the Persian Gulf War veterans from the index unit was carried out to clinically characterize the illness by further identifying risk factors through both examination and laboratory tests, as had been suggested by this committee.
The results of phase one and phase two were presented to the committee at the end of last year. Since that time, phase three was conducted and CDC is in the process of analyzing that work and hopefully will be reaching some conclusions. The findings from this investigation demonstrated an association between deployment to the Persian Gulf War and a chronic multi-symptomatic condition characterized by symptoms such as fatigue, diarrhea, joint pain, nasal or sinus congestion, muscle pain and memory difficulty. Cases were more likely to demonstrate poor functioning, depression and post-traumatic stress disorder. However, no consistent abnormalities were found by physical exam, routine laboratory tests or tests of several infectious agents endemic to the Middle East.
These findings suggested that the case prevalence was high among Persian Gulf War veterans but was not unique to that population. Further, this strongly suggested that risk factors for this condition were not unique to the Persian Gulf. Again, CDC is in the process of analyzing the final results, and as soon as they are available, they will be shared with this committee. The CDC would also be preparing the results of those studies for peer reviewed journal publication.
The second study was the health assessment of Persian Gulf War veterans at Iowa and this was requested by Senator Tom Harkin. That study was conducted in collaboration with the Iowa Department of Public Health and the University of Iowa. The purpose was to assess the prevalence of self reported adverse health outcomes among Iowa residents who were deployed during the Gulf War. Some of the outcomes that are being examined include chronic fatigue, cognitive dysfunction and post-traumatic stress disorder. There was a randomly selected cohort of 2,421 military personnel who served in the Gulf and another 2,465 who were stationed elsewhere during the Gulf War and they were selected to participate in the study. Because of the large number involved, this study was conducted via telephone survey.
The data from this has been shared with this committee, and the study was initiated last September and it was completed on May 8 of this year. The investigators are currently working on the analysis and interpretation of the data and we hope that we will have the results available in November. And again as soon as those results are available, they will be shared with the committee. The initial report will again be submitted for publication in a peer reviewed journal.
Let me then respond to the four questions. First, with respect to the status of the FDA's interim rule, on the use of unapproved drugs without informed consent during Operation Desert Storm. Dr. Nightingale advised the Advisory Committee in his testimony on May 2 that the FDA appreciates the recommendations made in the committee's 1996 Interim Report, this report, and again, those related to disclosure, record keeping, following and other matters. The FDA is evaluating its approach to these issues and the rule in light of the committee's recommendations, as well as other information that has come to its attention.
The FDA is engaged in intensive internal discussions within the FDA and with the Department of Defense on these issues. The FDA has examined its interim rule. Several areas have engendered significant discussion and debate. The first is that in order to address the waiver of consent issue, the FDA must address and resolve both scientifically, medically and legally the questions surrounding when a product could be approved for use as a prophylaxis or treatment for chemical and biological warfare agents. This again was raised by the committee. It's a critical issue, but not one that is easily resolved. We recognize that you all will be addressing the approval standards for these products in your final report, and we would certainly appreciate any recommendations or suggestions you have with respect to that.
Second, the agency is reviewing the experience in the Gulf War with an eye towards limiting waivers of informed consent to very rare circumstances. The agency is working with the Department of Defense to reexamine the issues surrounding the obtaining of consent in the military context. Those are active discussions going on practically as we speak.
Third, the FDA recognizes that it must consider the role of drugs as prophylaxis or treatment for chemical and biological warfare agents in both the military and the civilian context. We all know the difficulties encountered in Japan when a nerve agent was used against civilians in the Tokyo subway. And we must be thinking through the appropriate approach to take in order to be prepared for this type of terrorist incident in the United States. And as my office coordinates the medical and public health response to those emergency situations just as we do in natural disasters, this is of particular concern to us. We were concerned about the possibilities obviously in Atlanta during the Olympics. We've been concerned in San Diego and in Chicago during the recent political conventions. Fortunately, no untoward incidents occurred, but in fact we were prepared to respond should there have been any such terrorist acts.
One of the questions is should the standards be different for informed consent and approval in the military and civilian contexts when chemical and biological weapons are used, or are they the same. And if they are different, how should the standards differ?
These are very complex and tough issues and they require very, very careful coordination first of all with the Defense Department. So it's impossible at this time to say well we will have this ready, the rule will be published in November or December. But it's an area that is getting very, very active attention and it's one where the recommendations of this committee were very beneficial in moving the process forward.
Second, you asked about the status of external reviews of the Gulf War related studies. In my testimony, I really list and describe the various internal and external review bodies that have been involved in both the Iowa study and in the Pennsylvania study. I would just say that there have been multiple meetings, there have been scientific reviews and I certainly personally am satisfied that the review process is one that is now quite appropriate to the circumstances of those studies. Those are done not only at CDC, but for example at the University of Iowa in the case of the Iowa Study.
In the case of the Pennsylvania Study, that's an epidemic aid investigation. They are human subjects reviewed by institutional review boards and may or may not be required, and in fact that has been reviewed by the CDC institutional review board.
The third was regarding the status of the strengthened Persian Gulf War Veterans Coordinating Board. There I think efforts have been made by all of us to strengthen the coordination functions of the board, coordinating research, determining priorities for funding, ensuring quality of the research and reviewing the results of such research. And we are actively involved, particularly in the research working group, which is most related to our mission and our activities in this effort.
The Research Working Group has participated in the selection process for grant and contract awards focusing their input on the relevancy of the proposed project's ability to fulfill the gaps in knowledge about the illnesses in Persian Gulf veterans. Most recently, the Research Working Group members have addressed the question of research needs related to the study of the long-term effects of low level exposures to chemical agents. Steve mentioned some of the issues involved in that and so did Ken.
The research work plan is currently being updated incorporating the newly funded research activities. And of course, as those research results become available, they will be made available to the committee. We have assigned support staff to the Coordinating Board in an effort to be of further assistance in that process. I think it is not an easy task to accomplish a coordination of this level and complexity of research. The monitoring function and reviewing the recommendations of the external scientific peer review committees have led to some recommendations with respect to the conduct of the particular studies.
In my view, I think it's difficult for the committee, because of the multiplicity of the studies, to perform perhaps all of the kind of coordinating, oversight and monitoring that you all would find perhaps completely desirable. That's my own personal view and I think that it's one that others may or may not agree with. And so I would say that that latter recommendation, we may not be able to fully implement it. But I would say that through that effort we are making a conscientious effort to achieve the kind of coordination that we think you want in terms of the research effort between these three departments.
We will be prepared to respond to questions and Dr. Mary Pendergast and Henry Falk both are available as well.
DR. LASHOF: Thank you very much. Let me open up to the committee any questions they wish to ask to any of our three presenters.
MAJOR KNOX: Well, I guess I will begin. Dr. Joseph, I just have a question for you. You asked for constructive criticism concerning the work of PGIT and the Oversight Panel to declassify information that has been classified. A couple of things that have really been disappointing to us are one, the interoffice memo that came out of the Senior Panel Oversight, which works parallel with PGIT, that alluded to incidents that would occur, maybe reports that might allude to any contamination or exposure of chemical warfare should be run through the PGIT Office initially before they're declassified.
The second one is that the information that you've put out on the Gulf Link to veterans, you took about 300 to 400 documents off the Gulf Link, which we had thought you had reclassified. They had been initially declassified and then were reclassified. However, we have found out that they're not reclassified, that they're still available through the Freedom of Information Act, but veterans have to be able to identify those documents and there's not a listing of them.
So, I just think that those two incidents or actions have been deceptive. I would just ask what your feelings are on that.
DR. JOSEPH: Let me respond to those separately. First of all, I do very strongly object to the word deceptive. I think the department has really gone to great lengths to be anything but deceptive.
With regard to the interoffice memo, I don't know what memo you are referring to. You may have seen a memo that I haven't seen, that sometimes happens. But let me just set the thing straight. The Senior Oversight Panel does not work in parallel with the PGIT. The PGIT is a staff activity that is supervised, as with everything else that we do in the Persian Gulf, ultimately by the Senior Oversight Panel. I don't know the specific wording, I would be happy to respond specifically to you if you give me the memo or cite the memo to me. I find it very appropriate that the Senior Oversight Panel would say if you have turned up an issue in the declassification process that you think may be indicative or focus some attention on CBW issues, make sure it's seen by the PGIT. That after all is one of the major purposes of the PGIT is to find those nuggets in that great big rock pile. And certainly among the nuggets, and again I will use the example of Khamissiyah, among the nuggets we are most interested in finding and that are most important to find is anything that might bear on the question of the use or release of CBW. I don't read that memo at all as an attempt to say give it to the PGIT so they can bury it. The PGIT's function is to dig it out and find out what it represents and then make it public. So that seems to me to be entirely appropriate.
With regard to the issue of the Intel documents that were put on Gulf Link, taken off Gulf Link, et cetera, I'm accompanied by Mr. Charles Wells who is a senior planner for the Defense Intelligence Agency and I think I have to turn to him to answer that question as to why documents went up and then were taken off, et cetera. It's really outside my area of detailed expertise. So if Mr. Wells is here, do you want to respond to that.
DR. PLAXTON(?): Mr. Wells is not here. I took over the job from him.
DR. LASHOF: Could you come forward and speak into the mike just so we can be sure to get everything on the transcript. Welcome, identify yourself. We're pleased to have anybody in the support come forward at any time.
DR. PLAXTON: My name is James Plaxton. I am also with the Defense Intelligence Agency. Mr. Wells is not here this afternoon for reasons I do not know. He could probably provide you a fuller response to that. My understanding is that the initial effort to place as much as possible on Gulf Link resulted in some information that upon further review in the aggregate was felt to cause the possible dangers to intelligence sources and methods and therefore the decision was made to withdraw that information.
DR. JOSEPH: Ms. Knox, I will see to it that a full response from the DIA is furnished to the committee. If you will give me the specific memo that relates to your first point, I will give you what additional information I can on that.
MAJOR KNOX: Okay. And I agree with what you said about PGIT being notified of incidents, but I think that it was the manner in which the memo was written that causes veterans to think deception.
DR. LASHOF: Let me just clarify on that one, Steve. We did have a discussion of that memo and we will get it to you. I think the memo was well intentioned. There was nothing deceptive in the memo per se, except it was badly written and could be easily misunderstood. We had a marvelous panel yesterday on risk communication. I would suggest that there might be some need for further staff training on risk communication and how to word things so they aren't misread. I think everyone of us when we read this memo, and you will take a look at it when we get it to you, all had the same feeling that this was just so misleading and that we just couldn't convince the veterans that it didn't mean what they thought it meant, even though those of us who have been in the business could understand what was being said. It's that issue is an important one for you to be aware of.
DR. JOSEPH: We have also discussed internally at great link this issue of risk communications, a very difficult issue. I certainly think your point is well taken on that. One thing I will not defend for the Department of Defense is the quality of its writing. Paul, was that you that was up a moment ago? Paul Wallner who is the staff director of the Oversight Panel may want to comment.
DR. WALLNER: Because I wrote the memo.
DR. LASHOF: We've had discussions with him about it.
DR. WALLNER: The principal purpose of that memo, as I've told the committee before, regardless of the language which is in it, which I will take the hit for, was to provide a filter of those kinds of reports that could be potentially sensitive and inform our bosses, specifically the Oversight Panel, of those, not to stop them from being released. They all went forward and were released and declassified.
DR. LASHOF: As you know, we understood that very clearly, but it's very hard -- and our point was not so much that you were trying to be deceptive, but that the wording of the memo was such that it was hard for us to convince the veterans that that was the view. I think we accept your explanation quite clearly. I understood it very well, it was just badly written and this is the kind of problem that gives you credibility. And as I say, this is a risk communication problem, take a look at it. I don't think it's worth belaboring it much more here.
DR. WALLNER: If I could comment also please on the declassification --
DR. LASHOF: Yes, go right ahead.
DR. JOSEPH: -- which Ms. Knox raised. The intelligence file at the time it was pulled off contained about 1,000 records. Six hundred of those were subsequently reposted. Four hundred were not. It is the 400 that are in question. In individual documents, they are not reclassified. In the aggregate, they are considered to be sensitive, in fact probably classified at some level, all 400 of them, if you look at all 400 of them together.
We are prepared under current guidance to provide those to anyone who asks for them. Now, the criticism that you have to know what the document is before you can ask for it is a valid one. However, if you come in and ask for everything having to do with Scud attacks in and around Kuwait City, you might find out some hits on that and we would sanitize those if there are any and subsequently them on a case by case basis.
Finally, because of the report that was released on Khamissiyah, we have foregone the FOIA on that particular report and it has been handed out to the press and to anyone else who is interested. It was one that was taken off and not reposted. We are reviewing the policy in the department at the present time, how do we handle others that come up in the future in that same regard. We don't have an answer yet. We will have that for you and provide you with the information.
DR. LASHOF: Is there any reason why you couldn't at least post on the Gulf Link the list of documents that would be available under FOIA with the explanation that the total group as a whole presents some sensitivity, but here are the topics if you wish a specific one, please write.
DR. WALLNER: I think that's possible. I would like to look into that and get back to you. That's possible it seems to me.
DR. LASHOF: Steve, as long as you raised the question of the issues we've raised about the functioning of PGIT, can I ask you to comment further about what you feel are some of the priority areas? I think part of our difficulty here is a question of what is the priority of the areas that PGIT should be looking into. And specifically, the priority that should be given to exploration and in depth investigation of reported detections, detections not from the most sensitive, but from the 256 kit and the fox, whether each of those don't warrant the intensive investigation that was done in Khamissiyah that led us to the information on Khamissiyah.
DR. JOSEPH: I will answer that in two parts, Joyce. I think the appropriate highest priorities for the PGIT remain in essence the ones that led to its creation and there are two. The first is to be a point of information gathering and response to those on the outside, whether they are veterans or anybody else, who have a concern about a specific incident or circumstance that either we don't know about or that they feel has not been properly addressed.
I will give you what's perhaps a trivial example, but I don't think it's trivial. Colonel Conisberg(?) received at the end of one of these hearings a piece of metal handed to him by a veteran. The veteran claimed that this was a piece of a scud rocket which fell on his unit and that it contained traces of chemical warfare agent. We put that through exhaustive testing, and as it turned out, one could not tell whether it was a piece of a scud rocket or not, but it did not by any known chemical analysis have chemical warfare agents attached to it. That was an important way to respond to an individual veteran and also to follow what could have been a very significant finding that was not otherwise available.
The second highest priority was, and I believe remains, to sort through that information that we do have and skim off -- I will use the same analogy -- try to find the nuggets in that enormous ore(?) heap of 20 million pages and whatever else is in people's heads. The best example there I think once again is Khamissiyah.
Now, within those two priorities, I think the obvious focus area of substance, again there's two, one is unexplained or otherwise interesting clinical events, and two is anything that bears on the potential or actual presence, release, exposure of chemical or biological agents. If you look at the way the team has gone about its work, those are the way the priorities have been followed.
Now, with respect to following in depth, this is a kind of tough issue, because you have to be selective in some sense. We have chosen a litmus test which I think was disparaged by the staff testimony earlier, but which I think I would like to defend the logic of. The current best scientific evidence, the current best scientific opinion, the current unanimous scientific opinion in the literature is that for chemical agents, quite different than heavy metals, that for chemical agents without acute health effects, there is no known correlation with chronic health effects. So one of the litmuses we have used, well there are basically two. Given a report of some possible exposure or release is there kind of intrinsic credibility to that report, reconfirmation by other detection testing, corollary information from one source or another, again going back to the declass pile. Then two, is there anything we can match to that from a clinical perspective.
And in contrast to what was said in the staff report, we work those issues in both directions. If we have, as we had at Khamissiyah, credible evidence of release exposure, we work from that release exposure and see are there any clinical correlations. The first thing we did, as I said, is we went back and looked at what unit logs were existent to see if there was any cluster of acute exposures in that time space frame and didn't find any.
On the other hand, if we have a credible or troublesome set of clinical circumstances, we will work back from that to see if we can match that up with any known or reported release potential. I think you do have to work the issue both ways. You have to have some discrimination. If we tried, or if anybody tried -- it's not a matter of throwing more manpower at it -- if we tried to take every first level chemical detection report and do a Khamissiyah type radius, geographic, clinical study on it, it would be impossible to both have enough information to do that and to do that -- so we have to have some discrimination, but those are the two parameters, the persuasiveness of the evidence of release or exposure, and any clinical evidence that might lead you back to think that a release or exposure had taken place. And the team, and all the rest of us for that matter, work in both directions.
DR. LASHOF: Let us say that the committee quite agrees that the best medical knowledge to date is that there is no evidence of chronic illness due to chemical weapons in the absence of acute symptoms. But we have taken the approach of saying that that is one issue that needs to be studied and go forward --
DR. JOSEPH: And we absolutely agree, as I said in my testimony.
DR. LASHOF: -- and I think we agree that the other issue, in view of the frequency with which the veterans have been concerned about the release, that we felt that that developed equal attention looking at release. We also quite agree that looking at every one of the times the alarms went off in the ionization chambers, it's hundreds, that's an impossibility. It is our understanding that there's something like nine to 12 fairly credible, M-250, whatever it is, fox vehicle ones that have not been investigated with the same degree of intensity that the Khamissiyah has and that they deserved a higher priority and that time and effort was spent on things that did not deserve as much.
Now, this is a difference in judgment call on priority. However, that gets interpreted outside in terms of credibility around the approach. I'm not sure how much -- well, how much further we need to go on that at this session, but I think we're willing to have further discourse.
DR. JOSEPH: I think there is a step further that we from our part feel that we can. I quite deliberately in my wrap-up statement said that the department is more than happy to sit down with the committee and see if we can together agree upon an alternative framework than the one that I have mentioned for either more extensive or more intensive investigations of a class of incidents. I gave you what our working -- and it is that kind of working perspective on where we draw the lines. If together we can work out an alternative rule of thumb for which things we should look at at which degree of extensivity or intensity, we are happy to do that with you.
DR. LASHOF: We will discuss it with the committee and staff and get back to you on what's the best approach on how to deal with this kind of issue.
DR. LANDRIGAN: Those are good points. I've had a chance now to look at the report that Dennis Broder(?) wrote for the Armed Forces Epidemiologic Board. Actually, I think it's not absolutely an open and shut issue as he writes it here with regard to the issue of subclinical neurologic effects. What he says -- I'm reading from page 13 the bottom half -- it says some information in humans and animals suggests that repeated low dose exposures to GB, sarin, could result in subtle but measurable changes in the electroencephalogram of exposed animals and men. Then it says a few lines further down on the same page, the similarity in findings between human and animal studies suggests that this may be a true effect. Then on the very last page, last paragraph, page 16, it says well designed studies that examine the neurologic impact of low doses of nerve agents still need to be conducted.
I mean I don't know what's the truth of the matter, but I don't think one can just flatly that there's no effect. DR. JOSEPH: Phil, I was very careful to not say flatly that there's no effect. I said that the best current scientific opinion is that without acute you do not have chronic. If you read further in the report, you will find that those EEG studies were not correlated with clinically discernable symptoms. That's number one.
Number two, the statement in there refers to repeated low level exposure. And I want to say two things about that. First of all, again, best rule of thumb that we can use here is that any exposures that may have occurred were probably of rather short duration and single episode exposures. There's been much made of the famous Stockholm Institute for Peace article, now some 25 years old, alleging chronic without acute. We went back and had that analyzed. It turns out that that's based on work done by a German scientist in the 1930s and 1940s in Nazi Germany regarding factory workers who were exposed chronically over a long period of time to the production of CW armaments. I might also add that those factory workers in the thirties and forties in Germany were probably heavily slave labor and concentration camp inmates and probably had other reasons to be in poor health.
So there really is nothing in the literature that either the AFEB(?) could find or that we have found that supports chronic effects without acute effects in the situation of a short single exposure. We agree entirely that there needs to be more research in this area. It's a very hard area to do research in for obvious reasons. We have already put $2.5 million into that, and intend to put another $2.5 million this year, in addition to whatever the VA will be doing and we agree with that point. But you can only work with the best scientific knowledge that you have, and the best scientific knowledge currently is quite clear, as I think the chairman said.
DR. LANDRIGAN: The syndrome that sort of dances on the edge of perception here is the syndrome that's known by the acronym of OPIDN, the organophosphate induced delayed neuropathy. It's a syndrome that was first recognized in Britain in World War II, at least in the western literature, among women that were making organophosphate agents. They were dosed up with atropine to prevent acute symptoms. Then many weeks, months later they developed this delayed syndrome. Since that time, some of the organophosphate agents have been found to produce this syndrome in people in the general population who have been exposed, granted repeated exposure. My favorite example is a group of veterinarians whom we studied when I was in the Public Health Service who were in the southern states, Georgia, Tennessee, who were dipping animals into an organophosphate flea dip called phenthion(?). They had repeated contact with this stuff. They never developed acute syndromes and then they developed a peripheral neuropathy.
DR. BALDESCHWIELER: The Khamissiyah event has become the subject of growing vocal coverage. One of my concerns is the confusion over the number of people who might conceivably have been exposed. We've heard numbers going from 5,000 to 1,000 to 100. Does that reflect different footprints reflecting the different possible doses of exposure or is it confusion as to where the units might have been?
DR. JOSEPH: I don't think we can say anything substantive yet about doses of exposure. It does in great part reflect difference in geographic footprints. It reflects several things. One, where you draw the ring. As I said, I think we're using a 50 kilometer ring that would include about 1,000 people. Of those, the immediate ring, which I think is three miles -- I believe that's the number that was initially used -- was several hundred people, 150 or 200 people. What we don't know for sure yet, what we will know because we're contacting hopefully all of the people in these units, is of the 1,000 people in those units in the 50 kilometer ring, which people were actually in the ring and in the inner ring on those given days. And until we really can disaggregate that, it's hard to be more precise. We have the 46 people of the engineering battalion who are in the RCCP, but we can't yet disaggregate that 40. It's possible that all those 47 people were somewhere else 100 kilometers away that day, or it's possible, which would be of quite different significance, that all those 47 people were standing on the site when it was blown. We just don't know that yet. We will know that.
DR. LARSON: I would like to set aside the scientific speculation for a minute, because I think we all agree that it's highly unlikely but possible, but extremely unlikely that there were any health effects related to low dose exposure to CBWs. We all know that it's difficult to prove that something isn't an exposure, we appreciate that.
I think the issue though of credibility and risk communication is important here, and there is a nagging sort of doubt on the part of the public, on the part of some veterans, and perhaps among some of us about why Khamissiyah had to be rediscovered. I think that is one of, along with some of the incidents that we've talked about before, that's a concern, because the fact that there was an exposure, we all understand doesn't mean that there was a subsequent health risk. The concern is how did it get lost in the institutional memory. I don't know if you can or want to answer that, but the point is that credibility here, who sends the message and what message is sent is very important to this committee's work and to -- if we're ever going to get the most we can out of the studies that are done.
DR. JOSEPH: I think, Ms. Larson, that there are several reasons one can postulate for the initial submersion of the Khamissiyah information. Let me mention some of them. I think in truth we will never know. Let's remember this was 1991. Very few of the people who are in a position to talk to you today about these issues were there in the department in 1991, but let me try as best I can.
First of all, there was just the information overload, fog of war, the people whose job it is to do task A get a piece of information that's of relevance to task B and because they're task A people, the relevance is missed. I think we can all understand how that can happen, particularly in the kind of situation of enormous amounts of information and high intensity environment, so that's one.
Number two, there were other issues that were of particular interest to the people looking at the information as it came. This is now personal, informed personal speculation. At the time, what was of most interest around those issues was what did the Iraqis have left, where was it and how truthful were they being about where it was and where it had been moved to or where was it being moved to. In that light, the possible connection between coalition forces being in the area and blowing would have a very different relevance, salience than we're giving it today.
Number three, in March of 1991, no one was thinking about a large number of our armed forces coming back and complaining of symptoms and illnesses following their service in the Gulf War. That just was not an issue on anybody's screen. The fact that anybody might preview that issue, that's one of the lessons learned, right, that's one of the reasons for doing the things differently that we're doing in Bosnia now, but at that time, this was not an issue on anybody's screen.
Number four, I'm being a little careful when I say this, there were intelligence reasons as I understand them why the connection between UNSCOM information and activities of the department was not particularly visible. There were differences in channels and there were current intelligence issues that made it unlikely that those things would be connected.
You used the word that it had to be rediscovered. I don't want to say something that sounds foolish or self serving, I think that's a tremendous success story. I can well understand, and I think anybody who has been in a large organization, particularly the largest and most complex organization, can understand how that piece of information, which would have seemed totally irrelevant from a medical point of view at the time, could have dropped from sight. I think it is a terrific success story for the CIA and the DOD that it was resurfaced.
DR. LARSON: Thank you. That helps. I think you can understand too, we heard testimony yesterday that when information appears to have been withheld, that it is perceived as either being purposeful or incompetent and people will always choose if they have to make an explanation the malice. So it's now necessary to do some clean-up of the communications difficulties.
DR. JOSEPH: Absolutely, and I feel the department on Khamissiyah, and I think your own staff report indicates that we've been very forward stepping on the Khamissiyah incident. And as I said in my statement, if there are other areas or generic issues where we can do better across the board, we're happy to sit down and talk about those. That's our intention. Quite the opposite of deception.
MAJOR CROSS: Dr. Joseph, just to follow up on what Elaine said, I think also the perception in the veteran's mind is, in light of the Khamissiyah, where there's one there's going to be more. So I think we need to not rest our laurels on the Khamissiyah incident, but with vigor pursue some of these other potential incidents and get them out in the open.
DR. JOSEPH: Have you heard me resting on any laurels this afternoon, Mr. Cross?
DR. LASHOF: Further questions? Let me change the subject for a minute, which I'm sure will be a relief to Dr. Joseph and ask both Dr. Kizer and Dr. Joseph about the national survey. My understanding of that one, a 15,000 questionnaire survey, has three phases, it's a VA one, but it needs to be done in cooperation with DOD in some aspects. Phase one has been completed and the response rate wasn't enough that one would want to go ahead and say much about what information you have at that point. It's my understanding phase two is going back, trying to increase that, and get telephone interviews and so on. I don't know how long that will take.
Phase three, however, includes doing actual physical examinations on 1,000 families of deployed and nondeployed, and is in a sense independent of phase one and two. My understanding is that there needs to be cooperation and there has been and things are set and that that could proceed. I wonder if either of you have a sense of a time table on which phase three might proceed.
DR. KIZER: Let me ask Dr. Fran Murphy to comment specifically about that.
DR. MURPHY: In fact, those phases are not independent. We had close to 55 percent response rate for the mail survey, which is actually a very good response for a mail survey. We will go out and do a telephone survey of some of the non-respondents and choose individuals for phase three from both the responses that we got from phase one and two. So we can't proceed with the examinations until both are completed.
In addition, we've gone back and tried to reassess the protocol for the examinations based on some of the newer information that's come out of current research in the Khamissiyah incident, et cetera. So we are proceeding, but we expect that the phase two of the survey will take until early spring of 1997 and then we will proceed thereafter with the remainder of the phase three examinations.
DR. LASHOF: I'm sorry, clarify for me the reason phase three must follow phase two. I thought they were separable, but I'm wrong.
DR. MURPHY: We have 15,000 Persian Gulf veterans and 15,000 era(?) veterans, people who were not deployed but were in the military who are included in the study. We will then do a random selection of the participants in the survey for the exams in both groups.
DR. LASHOF: Okay, so in other words, you've got to get their answers in phase one or two before you're willing -- so you're not trying to take a separate group of that 15,000 and go after them regardless of whether they respond or not.
DR. MURPHY: We're trying to get the best random selected population from the entire group that we can.
DR. LASHOF: Thank you. Are there other questions? We are running a little late.
DR. NISHIMI: I just have one question for Dr. Lee. We've run into some difficulties the past year in trying to get FDA to respond to our requests regarding the interim final rule on the waiver of informed consent on how things were decided in the past and how that process is currently moving forward. As you know, that was initially issued over five and a half years ago. My sense, frankly, is that without the committee's prodding over the last year, there would be zero forward motion on resolving the issue of moving to an MPRM. And so, I was wondering if you could give us some sense about whether you would in fact move forward with rulemaking prior to the committee's sunset.
DR. LEE: I doubt that we will complete that prior to the committee's sunset. Mary, would you want to make a comment on that also, whether we can finish it?
DR. MURPHY: When is the sunset?
DR. LEE: When is it, December?
DR. NISHIMI: The end of this year.
DR. MURPHY: I agree with your assessment.
DR. LEE: Yes.
DR. NISHIMI: Would you anticipate at least moving forward with the publication?
DR. LEE: Of the interim proposed rule?
DR. NISHIMI: So that there would be a public comment process during the committee's tenure?
DR. LEE: Within the next couple of months, I would say that's possible, but would not necessarily happen in that time period.
DR. NISHIMI: Okay then, perhaps you can help me understand a little bit better why five a half years has elapsed and another year even within this committee's within that five and a half years, what is so complex that it's taking that long to move forward?
DR. LEE: Well, obviously there are lots of other issues on the FDA's agenda. I think this committee's prodding has been very important in terms of moving it forward. The issues that we have raised with respect to terrorism and the issues with respect to the standards for approval of a drug for either prevention or treatment further complicate the problem. So it's not a simple process.
Now, why has it taken five years, it's really hard to justify that in fact, but the fact is we're where we are now. We are moving forward. There are serious issues. There are clear differences that we have currently with DOD that we want to resolve before we move this forward. Those are active discussions.
DR. LASHOF: Thank you very much. Are there any -- I know we're running late and we're going to lose the committee and some of us are going to miss our flights if we don't wrap up. So we thank you all very much for coming and appreciate your testimony and we will continue our labors and be in contact.
I urge you all that are left to look at your tentative schedule for the rest of our period.
DR. NISHIMI: Perhaps I could just for the committee members that are left --
DR. LASHOF: Could I ask the audience as you're leaving to be a little quiet. We still have some committee business we have to wrap up and we're trying to talk to each other as we wrap it up. So you continue your conversations in the hallway and we will try ours here.
All of you have in your book a tentative schedule by which we intend to get through the other issues that we have to do with our full committee meeting. Is it October 8 and 9?
DR. NISHIMI: The next full committee meeting is October 9. It's a one-day meeting now in Tampa, Florida. At that time, I would anticipate that we would review the outstanding issues, some of which we discussed today, and the major focus again would be staff briefings and committee discussions. It would be on the research agenda, some of the forward looking recommendations based on the entire analysis, and then whatever mop up occurred there.
Following that, the committee would proceed, and staff would proceed, to prepare the draft as we did with the interim report, go through several iterations and rounds of review, again along the same time table as we did for the interim report, which I think worked quite well. Then move to publish the report, issue it to the secretaries before the committee sends it at the end of the year.
DR. LASHOF: I think it's a tight schedule if you will all look at it. It's going to require some quick turnaround. We did it on the interim report. I think today and yesterday has been an excellent meeting. If we succeed as well in our October meeting, I think we should be in good shape to have a pretty reasonable draft in our hand for our November meeting and be able to meet this time table.
If there are any questions, I will take them. If not, the few of us who are left --
MR. JOHNSON: The November meeting is contemplated to be in Washington?
DR. NISHIMI: That meeting will be in Washington, right.
DR. LASHOF: Yes. If Cliff will adjourn this meeting for me.
DR. GABRIEL: We're adjourned.
DR. LASHOF: Thank you.
[Whereupon at 4:31 p.m., the meeting was adjourned.]
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