Thursday, March 9, 1995 - 1:30 p.m.
[Introducing Dr. Joseph is Colonel Douglas J. Kennett, USAF, Director for Defense Information]
Col. Kennett: Good afternoon.
As you're all aware, the President announced on Monday the formation of an advisory committee to look into the concerns raised by illnesses appearing among some Persian Gulf War veterans. Today we thought it would be appropriate for Assistant Secretary of Defense for Health Affairs, Dr. Stephen Joseph, to bring you up to date regarding the comprehensive clinical evaluation program and medical research efforts regarding Persian Gulf illnesses. We did this last December, and I'm pleased to introduce him to you again today. A single-subject briefing.
Dr. Joseph: Thank you, and good afternoon.
As you've just heard, with the President's initiatives announced earlier this week and because we are at another one of these nodal points in the clinical evaluation program that we've been undertaking, we thought this was an appropriate time to come down and present some of that information and try to respond to your questions.
I can give you some more information about the advisory committee that the President announced in his speech, but many of the details there will be forthcoming from the White House.
With regard to our clinical evaluation program, or CCEP, some of you will remember that I was down here in December and we talked about the preliminary findings from the first 1,000 patients who had been all the way through this intensive medical screening process. Let me give you the current numbers now and tell you a little bit about where the findings are.
You remember that we have a national Hot Line set up. We have now had over 15,000 people register for the CCEP. Of that 15,000, approximately 12,000 actually are symptomatic and want to come into the clinical program. About 3,000 only wanted to register. Of the 12,000 who are symptomatic, somewhere between 8,000 and 9,000 are currently in the medical exam process. Of that 8,000 to 9,000 we have completed, as I say, a rather extensive medical evaluation on over 4,000. Of the 4,000, we have scrubbed the data, validated all the laboratory results, etc., on over 2,000. So our bottom line number compared to the 1,000 of last December is now double that -- 2,000 patients.
We've done the same analyses on the 2,000 patients as we ran in December on the first thousand, and we will be updating you periodically as we get through the entire group. I think there are two "most important" things to say about the 2,000 -- which actually is really beginning to be a number of some power.
First of all, there is no significant change in the diagnostic groupings and the diagnostic findings of the first 2,000 patients from the initial 1,000. You have those specifics in the press release and I'll be happy to go into the details with you if you wish.
Second, that is even stronger, I think, evidence that what we are dealing with here is not a single or unique agent, but rather a wide variety of illnesses caused by a wide variety of medical causation, and that we have not identified, to-date, a sort of silver bullet -- single cause -- for even a large fraction of the patients who are symptomatic.
We have about the same percentage -- again, I think it's gone to 16 percent instead of 14 percent -- where we still do not have clear diagnosis or diagnoses. And we still have that roughly 15 percent of patients who are coming through the system who we need to work further with: both in terms of symptomatic treatment for their complaints, and also in trying to pin down what the specific diagnoses and etiologies are.
Our intention is to get through certainly about 10,000 patients by the late spring, and we think we're on track to do that. I would just say once again, we're anxious to have all our people who feel that they're ill -- who are symptomatic -- to come into this program, to get into the evaluation process both for what we can offer them -- that's our responsibility in terms of individual treatment -- but also to help us look for a clustering of problems and a better sense of what might be going on here.
I think at the last briefing I talked about us setting up specialized care centers particularly for that group of patients where we don't have a clear diagnosis or who may not have responded well to treatment. Those are now coming on line. There is one here in the national capital region, using the resources of Bethesda and Walter Reed, it's focused at Walter Reed; and there's one in San Antonio at Wilford Hall, using resources from Brooke [Army Medical Center] and Wilford Hall Air Force Medical Center.
In those specialized care centers we will attempt both to focus increased awareness on the symptoms that people have, try to group them into some understanding diagnoses; but perhaps even more important, offer a range of integrated therapy and symptomatic treatment for the individuals who come into those specialized care centers.
I think I would stop with that. I'd be happy to respond to any questions you have across the range of the issues.
Q: You said that of the 2,000 you've completed, you still have a "wide variety of illnesses" with different causes. The largest group of those have what and caused by what apparently?
A: The largest groups within that category would be the same as we had back in December. Those are the groups that are musculoskeletal complaints, illnesses of psychological or psychiatric etiology, and then this 15 percent group that I mentioned with ill-defined and not yet clear diagnoses. We actually have a sheet
-- I guess it's not on the Blue Top -- but we have a sheet that goes down those of you who remember that preliminary report that we put out in December -- we have a sheet that goes down all those categories, the diagnoses. We can make that available to you this afternoon for anyone who is interested. We will be producing another report similar to the last one on paper within the next couple of weeks.
I guess the other thing I would say is once again, infectious disease accounts for a very small proportion of these diagnoses. This time instead of four percent, it's three percent. Of course there are no statistical differences in that order of difference. But once again, we are not seeing infectious or parasitic disease as a major cause of illness in people on the registry.
Q: Do you consider that you're making progress on this? You have 2,000 people now, but no substantial difference in terms of figuring out what the causes are or...
A: That's the most important sign of progress, of course.
Q: Are people getting cured of this?
A: Let me answer that in three parts. I think we're making tremendous progress on the clinical side. In this issue, substantiating a negative finding is as important as substantiating a positive finding. The most important finding that I think is being progressively locked in so far: is no single or unique cause, and a wide range of diagnoses. As we go further through these thousands of patients and lock that in tighter and tighter, that is a very important finding indeed. So while it's, as you say, no closer to finding an answer, the answer may well be -- and I think it becomes progressively likely -- the answer is that there is a variety of answers and no one answer. That's a very important finding.
Second, I didn't say in my opening statement anything about the research activities, both in '94 and '95. Here I think we're on the lip of having some important findings released. By "on the lip," I guess I mean within this calendar year. Some of the research on the possible combination effects of pyridostigmine and other chemicals, some of the research on reproductive health and birth outcomes, some of the research on comparing hospitalizations between people who served in the Gulf and active duty soldiers at the same time who were not in the Gulf. All these important issues, many of them we'll be able to talk about the data and the research results in '95, and certainly early in '96. So it's a little bit like boiling water on that one, while there's really nothing to see at the moment, the temperature is way up and I think there will be a variety of very important findings. Many of them will also, I think, be negative, in the sense that you raised the question, during this year and early in the next year.
I can't give you a percentage number, but a very large proportion of the people who go through the CCEP process are getting significant relief and cure.
Let me say two things about that. First of all, I think one of the things we're learning through that process is that the level of disability and the level of -- the intensity of -- symptoms in most cases is more moderate than severe. I don't want to at all give the impression that there aren't many people in the program who are severely ill or severely disabled, but the mean, so to speak, is more moderate than severe. Particularly those people, and again, across a whole range of diagnoses, whether they be musculoskeletal or psychological diagnoses, I think are getting significant therapeutic benefits from the program.
Q: In the course of this are you finding any evidence to support any of the widely held theories about possible causes such as exposure to chemical or biological agents or parasites or reaction to the vaccines or any of those theories that have been widely advanced? Have you gotten any evidence to support any of those?
A: I think there is a difference between widely held theories and widely advanced theories. On both scores, I think to date it's quite clear that none of them are leaping off the page and very impressive. There really is not significant evidence coming out of the clinical studies that would relate symptoms or groups of patients to any of those widely held or widely advanced studies.
That gives me an opportunity to make another point, if I may. One of the most important factors in trying to figure out this puzzle is going to come on line probably in early '96. It is the geographic locator study that the Army is doing. The Army has been involved for some time now in a very complex effort to, in essence, draw a space/time map at the small unit level for every day and every place in the theater. When that effort is finished, and indications now are that's early in '96, it will be possible to take anything, any group of patients in the CCEP, anything that is known or alleged about a specific -- a possible -- cause or incident, any demographic group of people, and overlay them onto that space/time grid. That, I think, will be a way to really look at some of these theories and allegations in the most persuasive kind of way. But we're still some distance off from that.
The other thing that we're some distance off from, just because it takes that kind of time to do it... Up until now, most of the research that's been done are focused issue-specific studies. The concern about birth defects in the Mississippi group was one example; or research on the possible effects of depleted uranium is another. But the really important and likely to be productive research in this area involves taking large groups of people, taking comparison groups of people, looking at some issue -- for example, rates of hospitalization in the years since the Gulf War among people who were there and people who weren't there. Those kinds of larger epidemiologic distribution of disease in population type studies will start coming off in late '95 and into '96. That's the other very important and potentially very rewarding group of research.
Q: You were talking about the comparison, but is there any indication that there was something about the Gulf War theater and the environment that led to these illnesses? Or is this something that could have happened had we not even had a deployment to the Persian Gulf in that area? Are these symptoms that are so vague and widespread that they could have happened regardless?
A: That's one of those "yes on both" answered questions. First, I think what you said was very important, very correct. We're talking about illnesses and not illness. When somebody asks me is there a Gulf War Syndrome, I say absolutely "yes," because the collection of symptoms or a collection of illnesses tied to some event or process can be a syndrome. But I think we're quite clear now we are not talking about a single illness accounting for a large fraction of symptoms and illnesses among our personnel. That's one.
Number two, I think we can give examples of things that are specific to the Gulf that have affected a small group of people. For example, out of the 697,000 people who served in the Gulf, we have I believe it's 32 cases of leishmaniasis, a tropical parasitic disease. Well, those troops would not have gotten leishmaniasis in Philadelphia, but it's not the same as saying leishmaniasis is "the cause" as was said in the more simplistic days of this "The Cause" of Gulf War illness.
I think we will undoubtedly find clusters of specific events and activities that are indigenous to that activity -- that conflict in the Gulf but I think it's becoming increasingly apparent that we will not find one,or,probably even a couple of things that account for the large bulk of illness and symptoms.
Q: Are you aware of any data from the other countries -- of troops -- that served in the coalition that would tend to either corroborate or dispute your findings?
A: We've had extensive discussions over the last few years, missions that have gone both to the coalition partners actually in the Gulf and relationships with some of our other European partners. In most cases, and most specifically with regard to the nations of the Gulf itself, we have really no corroborative findings or descriptions. That one really has come up empty. When you talk to the Saudis or the Kuwaitis, they don't have anything that they say this equates in either their experience during the Gulf War or in that environment previously. We've gotten similar kinds of responses talking to the industrial groups that have been in the Gulf for many years.
Probably many of you know the one exception to that -- at least that I know of -- is a group of servicemen in the UK who are symptomatic and who are concerned that they have illnesses related to the Gulf. That really has not sharpened in any kind of specificity in terms of comparison with our own situation. But that's the only one I know of both in terms of the European partners and the Gulf nations.
Q: It just occurred to me that we had some of our folks in Kuwait last year, and that would have been an interesting test. How better prepared were you, the medical services, for protecting those people? And how would you be prepared now if we had to deploy a large troop force again in that area?
A: One of the things that has come out of this experience -- the Persian Gulf Illness issue -- has been a review, and working changes now, in our policies, pre-deployment, during deployment, and post-deployment. For example, in the deployment to the Gulf last September/October, we had much more detailed information for the troops in their medical booklets before they went out, particularly with respect to environmental issues and reproductive health issues. We also had on the ground preventive medicine teams -- as we had in Haiti as well
-- that were there to look for and scan for anything that might seem to be something that would be looked at retrospectively later.
To the best of my knowledge, and I think I would know, we have not had any substantial increase or unusual symptoms or illnesses in the troops either that were in Southwest Asia in '94 or in Haiti.
Q: For four years, Dr. Joseph, when anyone from the Pentagon was asked whether any troops might have been exposed to biological or chemical weapons the answer was always there is no evidence. Today you said there's no significant evidence. Does that represent a change in any way?
A: It was not intended to represent a change. I always use the words, and maybe I said "no significant." I try to use the words "no persuasive," because we could get into a "Who shot John?" about what evidence is evidence and what is not. I feel that we're quite clear and have been consistent in not being able to demonstrate any persuasive evidence that there were chemical or biological weapons used in the Gulf.
I used to say no credible evidence, but I stopped saying that. A Marine colonel pulled me up short and said when you say no credible evidence, you're making some imputation on the character or the credibility of somebody like myself who was there and feels, etc. So I think the best word, at least for me, is "no persuasive evidence." That is the status and we've talked a lot about what kinds of surveys and studies and investigations and declassifications have been done.
Q: This advisory group the President is going to name, how large is it and who will head it? And how does this differ from the numerous commissions, groups, whatever that have been named to study this?
A: The specifics as to size and obviously of competition and chair will be a matter for the White House to announce. I expect it will be in the range of 10 to a dozen people. Highly expert and credible people in medicine and science, with some participation by veterans and a broader perspective that has been the case in the past with some of the groups that have come before.
I think the key difference in this advisory committee is that though it will be reporting through the three Secretaries -- DoD, VA, and HHS -- it will be reporting to the President. And the second key difference is it will have a much broader charter. It will be looking not only at research and scientific questions, not only at the chemical and biological agent question, and not only at the medical activities that the various agencies have undertaken; but it will have purview over the widest area of concerns related to illness following the Gulf War.
Q: Is it going to conduct a separate investigation or simply analyze the studies that you all are doing and use that to advise him on what should be done?
A: I can't give you the answer to that.
Q: You went up and testified on the Hill today, and when you were there you again ran into a bit of skepticism about the sincerity and the thoroughness of the Pentagon dealing with this issue. You've been immersed in this issue for quite awhile now. To what extent are you frustrated by the continuing perception among many that the Pentagon is covering up, not being as thorough, not really looking for the answer? I'm sure you run into this all the time.
A: My personal response would be that I'm not frustrated because I assume that's the way the game is played. I think it's very difficult to overcome skepticism. It's very difficult to prove negatives. The easiest and cheapest shot of all is always that government agencies aren't coordinating -- no matter how well you coordinate -- and we coordinate very well on this one.
So I think rather than frustration, you just have to be realistic about it. My answer to that, and the one I gave up there this morning, is I think anybody who poses that question, I make the offer to come with me and talk to some of the 50 docs that are working full-time taking care of these patients, and trying to help them through their symptoms and illnesses. I think that's the most effective counter to conspiracy theories and issues about foot dragging and the rest. I would make that offer to any of you as well.