Tuesday, April 2, 1996 - 2:45 p.m.
[This is a special DOD News Briefing to announce the release of the DOD Reporton the Comprehensive Clinical Evaluation Program for Persian Gulf WarVeterans]
Dr. Joseph: Following Admiral Smith is like teaching a course on Fridayafternoon at three o'clock. But, what I'm here to do and if we can put theslides up, Colonel Gackstetter is to give you what will, in all likelihood, bethe definitive report in the series of reports that we have made to you on theComprehensive Clinical Evaluation Program looking at Persian Gulf illnesses.
Some of you will remember we made a report on our first thousand and our first2,000 and our first 10,000 patients and now we're almost at 19,000 patients,fully worked-up in a very sophisticated clinical round of physical andlaboratory and sub-specialist examinations. These are almost all the peoplewho have registered for this program and asked for an examination. So, interms of where we are with the population that has come forward and asked to beworked up medically, in terms of what we think we can speak firmly about as towhat we have found and in terms of the relationships between all the elementsin the exam, we think we're about ready to give you not a final answer, butrather a definitive statement.
I do want to make clear: I'm choosing that word, not a "final" answer verycarefully, because part of our commitment here is to not close the door, to notclose the books. We will continue to follow this issue with the clinicalprogram and with our ongoing research, declassification, and investigationalefforts as long as there are any more stones or pebbles to turn over. So, Iwould hope that you would not report this as a "final" or as a "close-out"statement. It's far from that. But, we do believe, and you'll see when youpick up the report that we're issuing today -- there are copies here for you --that we feel that from what you can learn from this sort of clinicalexamination, we have pretty well mined it.
You remember that we initiated the program in the middle of 1994. Is mylavaliere on? Can you hear me if I step back? Will that be all right? And wewent through this series of reports. We have, as you'll see in the report,about 27,000 people who came in primarily through the hot line that we set upin California. About 21,000 of those asked for the clinical exam that we haddeveloped and coordinated with the VA. And this report that you're getting nowis the information on almost 19,000 of those patients.
May I have the next? You might as well stay up there, Gary. I'm going to gofairly quickly through this so that everybody can get to file.
In the report, these are the key findings of that report. As I said on theother times that I've been up here talking about it, this population, it'scharacterized by quite a broad range of diagnosis that go all across themedical spectrum. All organ systems, all kinds of diagnoses and most importantfor where we came from in this issue, there's no indication that we can find ofclustering. There is not a single organ system kind of illness, a kind ofillness that we would associate with a specific cause that clusters in thisvery large group. It's probably the largest group of people ever studied inthis kind of an endeavor.
Of the patients who came into the C-C-E-P -- Comprehensive Clinical EvaluationProgram -- severe disability is not a common feature. Now, here I also want toadd a note of caution. Of course, we are dealing with patients in thisinvestigation who are still on active duty or who are dependents of those onactive duty. And it is not impossible that those who have greater disabilitymay well have left the military in the time since the desert. But of those whoare in the system, disability -- measured by loss of work days -- is not amajor factor.
This is a commercial. I think our doctors and nurses who've done this thingout in our med centers have done an extraordinary job and our patients agree.
Most important, we have found no indication -- as others before us have foundno indication -- and, certainly, in this very large, in this very largeinvestigation, no indication of a unique illness or a "Persian Gulf syndrome,"or a single entity that would account for illness in any large or significantfraction of these 20,000 people.
Let's do the next one. My lavaliere is dead. Well, they promised me it wasgoing to be on and I noticed Admiral Smith had trouble with it when he left.So, I'll try to stay here. Shout if I get out of range. These are the mostprevalent symptoms among about the first 18,000 of those 19,000 patients.These are upside down, the way I view the world, so read from the bottom up.The four most common symptoms: joint pain; fatigue; headache; and memory loss;again, are the very ones that were the complaints that first came to attentionas it became a public concern three years or so ago. Next one.
And of the diagnosis of these patients, this is a cut-out of those. I wantto.... If you take the top three: muscular skeletal conditions; psychologicalconditions; and this area here, called, signs and symptoms and ill-definedconditions; they represent well over half of all the diagnosis among thosepatients. I want to say a word about "signs and symptoms and ill-definedconditions;" sometimes that label is misinterpreted and read as "we don't knowwhat's going on with those people." That's not at all the case. In the formalsystem of disease classification that the medical profession uses, this is sortof a large grab-bag of things that may be an abnormal laboratory test; thatcan't be tied to a specific diagnosis or a common symptom that isn't backed upby a detailed diagnosis.
You may know -- those of you who have kids -- that very common in pediatricpractice is abdominal pain without any other diagnosis attached to it.Abdominal pain of unknown etiology after all the expected diagnosis that wouldbe associated or ruled out. Well, that would fall in this kind of group.Again, I put it up to show you the variety of diagnosis categories and the bigthree.
We had right from the start, we asked the Institute of Medicine, which is themedical arm of the National Academy of Sciences, to put together a committeethat would act as a sounding board for us; as an expert group that could lookand measure the quality of our work and give us constructive criticism aboutthe directions that we are going in. And they put out a final report of theireffort several months ago. I just want to give you four quotes from thatreport to back up against the thing that I have said.
First, they felt that we had done our work well. Second, "The IOM committeeencourages the DOD to emphasize in its future reports that psycho-socialstressors can produce physical and psychological effects that are as real andpotentially devastating as physical, chemical, or biological stressors. Endquote. I put that up here because each time I've come up, I've tried toemphasize to you that because we are saying there is no syndrome; because weare saying there is no unique illness; because our data show that the largestsingle category of diagnosis are psychological ones, it is terribly importantfor us to understand and to stress that this is not saying that these symptoms,and that these diagnosis, are not real or that all this is in our vets' headsor some such. This is as real as relevant and as important to the health ofour people, and our responsibilities for that, as a bad hip from falling offthe back of a "HUMVEE". Next one.
The IOM committee agreed, as I have said, that we don't find any clinicalevidence in this really exhaustive clinical study for an unknown seriousillness among Persian Gulf veterans. But they make the point -- and I'd liketo leave that point with you -- that there well may be small groups, smallnumbers of patients, with illnesses that we have not precisely targeted yet ortargeted at all yet. We don't find them and we do know that they don'trepresent any large proportion, any significant proportion, of Persian Gulfillnesses among DESERT [STORM] veterans. But, we can say, at this moment, thatthere might not be "two-sies" and "three-sies" and small numbers of clusters ofpeople who were exposed to some particular issue.
The best example here, of course, is the parasitic disease Leishmanaisis,which had great favor in the Press as quote, "The cause of Persian Gulfillness," some three and half years ago. We know we've diagnosed -- I believeit's 32, isn't it Colonel Patterson? Thirty-two cases of Leishmanaisis amongthe 697,000 returned veterans. There may be other small numbers of thingsburied in these 19,000 examinations that we have not yet found and that is animportant point. That's another reason to keep looking.
Q: That's not 18 percent? That's within -- that's less than 18 percent?
A: Eighteen. We're now talking -- I think what the IOM had in mind, and whatI'm certainly trying to say, we're talking way down in fractions of a fractionof a percent. Were there 15 members of a motor pool, for example, who on agiven day were exposed to a spill from some chemical or fuel that they wereworking with and who became ill, we might not see? That is what the IOM issaying, because the numbers are so small. But, that's a counterpoint to theissue that there is no single unique large majority illness or syndrome inhere. Next.
Well, where do we go from here? We will continue to take care of our peoplein this clinical effort as it progresses and we will use this model, by theway, for future deployments and return from future deployments. But we haveother initiatives that will be ongoing as well. We have $12 million dollars inPersian Gulf illness research both for FY 95 and for FY 96. And really, that'swhere we need to move now. The clinical examination effort is a rather crudetool. There are a lot of things that will help you learn, the directional signpost it will give you as I've just mentioned. But, you can't be precise aboutetiology, or a lot of other things, and it's now in the area of research orepidemiologic research, biochemical research, etcetera, that we need to pressforward in.
We have, as many of you know, an incident investigation team, which hasanother hot line [1-800-472-6719], and which responds for follow-upinvestigation calls or assertions or questions about possible events or causesof illness. I must tell you that the most important findings of theinvestigation team to date -- and they have run down everything that they'vebeen given -- ought to be published in the journal of negative results. Themost important result of the investigation team so far is that there is nopattern. There are not events that have checked out. Again, no reason to stoplooking and close the book, but the evidence begins to be very strong.
And, finally, we're proceeding -- as the Department committed to last year --with an effort to declassify documents, put many of them on the internet, andmake all the relevant information out of the desert available to the generalpublic. I should also add that one of the things that we are going to do withthe clinical information, all the data base that lies behind this is anenormous clinical data base and we will -- I believe, in June of this year --make that data base public to non-federal investigators who wish to use it fortheir own research purposes, looking at possible correlations, etectera.
We're also heavily engaged, now, in cluster analysis, computer runs looking tosee if anything is related to anything else in terms of statisticalprobabilities. I believe the computer has looked at, is it 100,000 or 47?Some very large number of thousand possible correlations of anything withanything else. All of them have turned up negative so far. I believe thepossible number of correlations that anyone can get out of here is around 16million. So the computer has a ways to spend, but again, the weight of theevidence is beginning to push very, very heavily in the direction that I havedescribed.
I think there may be one more. Two more. We're going to quickly.... This isjust some more on future direction. It starts, again, with where we startedthis.... We started figuring that the way you begin with a clinical problem isyou look at the patients you're responsible for and, I think, that has provedvery valuable for us. And we will go on.
One of the useful things that has come out of this has been a major change inthe way we prepare for deployments and preventive medicine, since the thingsthat we do during deployment both looking for potential causes of problems andthe things that we will be doing after deployment for health assessments as thetroops come back. And one more, Gary.
Well, these basically just outline what I have said. Let me make one commentabout this last one. You... some of you heard me say before that a mostvaluable tool, which is just about now on-line has been a computer modelingtechnique put together by the Army, which makes it possible to locate any unit[on] any given day, as to their geographic position in the Gulf. And we cannow take all this clinical data and we can say, Well, is there any correlationof people with red hair in terms of where they were on a particular date in theGulf and the symptoms that they may have described to the C-C-E-P?
Again, that's work that will be ongoing and may yield us some increasedinsight into the problem. I'll stop with that.
Q: Doctor, do you know of any epidemiological study involving examinations ofpeople in a systematic way that is this large anywhere?
A: Not of this kind. I have to say this is the biggest, you know, becausethere's always somebody that's going to say they have one that's largest. Ithink in this context of trying to look retrospectively at an issue that's beenraised of a mystery illness or a new syndrome or a emergent disease or thatcategory. I'm not aware of any and I would imagine that there is not. I mean,the nature of this I think is what has made it both necessary and possible toexamine a very large number of people.
Q: Largest at the time by the DOD?
A: I'm certain that's true.
Q: And lastly, you mentioned am I correct that it's $12 million dollars wasthe budget in two successive years so that the total cost of this study was $24million?
A: That's only -- no, that's our research area. We did a -- this clinicalprogram, our people did out of hide. I mean, the doctors and nurses at WalterReed or at Wilford Hall or any of our med centers, they saw those patientsaccording to protocol and that just came out of the regular health budget. Thebest quick-and-dirty that we have done on total cost of this for `95-'96 --including the declassification, the investigation team, the research effort andthe clinical comprehensive program -- is somewhere in the $80 million dollarrange. I use to say $100 million dollars -- I guess I was a little high. But,that's the cost. But much of it is absorbed by ongoing budget efforts.
Q: Except for the evidence of no Gulf War disease syndrome, does anything jumpout? Is it unique for us to have so many joint pains, headaches -- the fourcommon ones that you described. Is there anything unique about this Gulf Wargroup?
A: I think what I would say the lesson in this is, when you send a largenumber of healthy young people often to an extremely dangerous and stressfulenvironment, surprise, surprise, some proportion of them come home with avariety of illnesses. Some of those illnesses are the direct result ofphysical events that have occurred. Again, the person who falls off the"HUMVEE" and has a chronically bad knee. Some of them are results of all thestressors, all the psychological and individual stressors that took place topeople in this austere environment with the threats hanging over them and allthe rest of that. Some of them are diseases that would have developed anyway-- whether they had gone to the Gulf or whether they had stayed in San Diego --and what you get is a complex mosaic. I mean, the bottom line here is, acomplex mosaic of diseases and conditions that are in part a reflection of thispopulation -- and you'll see in the report, we make some good comparisons withother population-based studies that have been done. There aren't many of them.And some of them are a result of the particular environment that people foundthemselves in. What is not apparent in this study -- after some very carefullooking -- is some, again, unique, mysterious, over-riding cause that wouldexplain a large volume or any significant fraction of these symptoms andillnesses.
Q: Doctor, the 18 percent, put that in perspective: Is that a large number ofgeneral population of people that would show these ill-defined symptoms? Or isthat on average? How would you put that in perspective?
A: In the other population based studies that have been done and I have to beclear that you can't draw exact comparison. There are no other apples tocompare with these apples because various national health surveys and primarycare studies have been done. The population being a different age or a gendermix or why they came in for the study or who they are, etectera. But, giventhat we're comparing apples and oranges and pears but all the same kind of --the same kind of thing. This is not at all unusual and in some studies likethis up to 75 percent of conditions would not be directly pinned down to aspecific diagnosis. And probably, the physician's intuitive response to thatquestion would be somewhere around a quarter of your patients you neverestablish a firm diagnosis on. Think to yourselves of the last ten timesyou've gone to see the physician or your family has gone to a physician and howmany times in that ten times you come home saying oh yes, this is micoplasmapneumonia or even oh yes, this is pneumonia. Medicine doesn't really work thatway. This is not a surprising figure.
Q: Dr. Joseph, how frustrating is it to be at this point to have come so farto have spent so much time and money and still not have an indication of whatkind of illness it involves?
A: Well, I think you missed the point. It's not frustrating at all. I thinknumber one, our people have done an extraordinary job taking care of ourpatients. Number two, what we have shown is the very important finding thatthere is no focus specific unique illness. That's not frustrating. What'sfrustrating is the difficulty of communicating that sometimes as your questionindicates.
I think we have a very important answer here. It may not be the answer thatsomeone who wants to kind of whip up the mystery disease would like to hear,but it is the answer you get when you look with very high scientific quality at20,000 patients. Not at all frustrating.
Q: Given the chemical soup environmentally both in the atmosphere that thetroops were exposed to in the Gulf, basically two questions. Medically, isthis a kind of a new sort of unique thing that one, prevent you from everfinding a specific cause because of so many things involved and is it the kindof thing that we need to start looking at from now on in combat? Industrialchemicals, biological --
A: I suspect -- well first of all, I think data clearly show and I would -- Iwould personally feel very secure in saying that this environmental or chemicalsoup you described is responsible for only a minuscule sub-percentage fractionof the symptoms and diagnoses we see and we've got some data that show that.The Army Smoke Plume study, etcetera.
But, I guess I would say that another important thing about this. I think ifthis had been done before, if circumstances had called for it to be done beforeor after former conflicts, my guess is somebody would have been up here in the1940's or early 1970's and describing about the same thing. I think if youlook at a population of healthy young people who go off to war in a veryhostile environment which it always is, you would see something like this.Perhaps, that's one of the most important findings. So, rather than kind ofanticipating that after each successive deployment or contingency we will see amystery Bosnian illness or a mystery Antarctica illness or something, I thinkthe lesson we'll take out of it and this is the lesson that we're implementingin JOINT ENDEAVOR is that it pays good dividends both in terms of the medicalcare that you give your patients and also in understanding what's happeningduring and after deployment to really look ahead preventively. To do -- wehave in Bosnia a very heavy emphasis on preventive medicine teams on theground, combat stress teams on the ground, environmental and epidemiologicallaboratories for good accurate disease surveillance on the ground.Pre-deployment health assessment of people going over and a plan forpost-deployment health assessment of people coming back.
So, if and as questions develop on the current deployment or futuredeployments, we'll be in a better position to get data quickly. Both to eitherunderstand a general pattern such as this or under the possibility, certainlythere is a possibility that you might be in a situation where there is aspecific trigger or a unique illness. We'll be in a better position to findit. Yes?
Q: Were you saying that a small number of troops were or may have been exposedto chemical or biological weapons?
A: I was most definitively not saying that. We really have no persuasiveevidence from any of the vectors that have looked at this starting with theDefense Science Board, or own work, the investigative team, the clinicalpattern among this 20,000 people that we've looked at. There is absolutely nopersuasive evidence that chemical or biological weapons are associated withthis. I also keep saying we're not closing the book. We're going to continueto look. When somebody calls up and says, "I know I was in Al-Jubayl on x andx-y date, and I now I was gassed," etcetera, we're going to continue to runthat issue down. We're continuing to declassify the documents and we'recontinuing to match that data with the clinical data. So far, we come up withnothing that would give any credence to those suppositions.
Q: On the future. We're wondering -- one of things that has been an issue isa few people talk about vaccines, cocktails, and medicines that they suspecthave given them problems. Is the FDA planning to make permanent a ruling towaive informed consent for experimental drugs for the future. Is that a goodway do you think to encourage confidence in the system?
A: Well, I think your statement is a little overdrawn about the FDA planningto waive informed consent. I mean, the FDA is looking at the interim rulestatus that deals with military contingencies and that's a complicated issue.I would be very surprised if the FDA would take off all, I can't speak for theFDA, but if the FDA would take off all the protective things that we put around-- that we put around vaccines and other medicines, etcetera, that are given totroops on deployment. I think that whether this is confidence building or notdepends on the objectivity with which people look at the issue. You know, ifyou look at the data and you look at how it all fits together whether it's onthe chem bio warfare agents issue or whether it's on the Smoke Plume issue orwhatever, the data while not absolutely airtight. This is not a carefullydesigned postspective experiment. But all the data we have moves in onedirection. There really is not a single thing in any of these patterns,whether it's in research side, whether it's on declassified "op-document" sidecertainly, whether it's in our clinical experience side, that is an outlierthat moves in the other direction.
So at some point, I mean, that's really the way medicine works. At somepoint, you say there's enough information all moving in the same directionwithout conspicuous outlying off-shoots that go in an opposite direction thatit becomes reasonable to stand pretty firm on your conclusions. One more.Yes?
Q: Is any data available from other coalition forces for the medical issuethey faced?
A: Well, as you may know, there has been considerable controversy as there wasand is here in the United States, in Britain. That and they have begun to dosome research and done some clinical investigations, but nothing really on thisscale. With that exception, there really is very little in the way of eitherreports from the Armed Forces, reports from Veterans Groups, etcetera -- eitherfrom the North Atlantic Coalition partners or from the Middle Eastern coalitionpartners -- that would indicate any issues of, you know, this type andspecifically anything related to a unique syndrome.
Q: Regardless of whether or not there is a unique overriding cause, I mean,you realize that most of these veterans have gotten sick because of theirservice in the Gulf?
A: Well, in my business the word "because" is a very important word. Youknow, if... let's take my example way over here that I use about the guy thatfell off the "HUMVEE" and now has a bad joint. Is that because of this?Absolutely. If we go over here in the middle and we talk about the person whohas a chronic duodenal ulcer, because of either the microorganism that causesulcers we learned of in the last couple of years, or -- in all my years ofeducation in medicine -- the psychic stresses that were on that person, is thatbecause of the service in the Gulf? As we look at the person out here whodevelops rheumatoid arthritis -- or you pick it -- ten years after or fiveyears after they were in the Gulf, do we really know whether they would havedeveloped it anyway? Or whether it came on earlier? Or is more severe? Ordeveloped it because of whatever it is that causes rheumatoid arthritis? Wedon't know that either.
So, if you're asking me the question, "Are these symptoms and illnessesrelated in important ways to what happened to people, because they deployed tothe Gulf?" I would say, "Yes." But if you're asking me the question, "Wasthere a specific epidemiological agent" -- whether it was biological weaponryor "moondust" or a new infectious organism that was there that got 19,000people sick who wouldn't have gotten sick if they weren't there -- I think thedata show you emphatically not.