Mr. SHAYS. Well, we can't get into the issue of the studies, but I have a feeling that you are aware that the studies go into more than whether they fit properly.

Ms. WINEGAR. Yes, that is correct.

Mr. SHAYS. And the question I am asking is should someone like Dr. Feussner and Dr. Barrett and Dr. Newton and Dr. Gerrity, shouldn't they be aware of these studies? Do you all have a security clearance?

Ms. BARRETT. No.

Dr. FEUSSNER. No, sir.

Mr. GERRITY. No, sir.

Mr. SHAYS. You don't have security clearances?

Dr. FEUSSNER. No, sir.

Mr. SHAYS. You see, my problem is there are studies out there that I think people should get and see and evaluate, and you are not even allowed to see them. I find that incomprehensible.

Let me take one more line of questioning and then we will get to you again, Mr. Sanders.

There is a question on whether our studies have not been focused too much on trying to find the smoking gun, even if it is chemical, and that it should be more focused on treatment and treatment outcomes. Dr. Feussner, why don't you respond to that.

Dr. FEUSSNER. Well, I've indicated before that we have program announcements that are open-ended to solicit research for treatment trials. We have convened a planning group to plan a trial in the area of chronic fatigue syndrome and fibromyalgia. We are quite receptive to trying to plan an antibiotic trial, and Mr. Sanders has volunteered to help me with that. And we have treatment trials under way, at least one treatment trial under way for posttraumatic stress disorder that we began in, I believe, June or September 1996. The reason we released the program announcement was to make it clear that there is essentially an open-ended solicitation for treatment trials. We made the criteria for those trials, I think explicit.

The way that VA would typically go about planning these trials is we would convene a planning committee that would bring in whatever expertise is required to plan the study; we would assign it to one of our coordinating centers. We have four such centers around the country who would facilitate the methodological, statistical, and data management issues. The completed proposals then are submitted for peer review by our Cooperative Studies Evaluation Committee. If they are approved, then we would initiate them. So that is the process that exists. The program announcement opens the door, in my view, to trials, at least on subsets of patients who can be defined. As I said earlier, they require that the patients be definable, that the treatment protocols be replicable and explicit, and that the outcome measures be credible. Other than that, I think it is an open opportunity.

Mr. SHAYS. But do you think that most of our research is more toward trying to find the cause and less-or more on trying to find treatment and focusing on treatment outcomes?

Dr. FEUSSNER. I think that we have not had research efforts to systematically appr eatment issues.

Mr. SHAYS. Sc

more on that?

Dr. FEUSSNER. Yes, sir.

Mr. SHAYS. Let me just one last point. I am sorry, but I want to get on the record-the VA officials, and I should have gotten the name of the individual in the report-Dr. Murphy, described, characterized the registry as "a very crude health surveillance tool," and a primary source of primary hypotheses for subsequent research.

I want to know what role the registry plays, the Gulf War Health Registry plays in our research?

Dr. FEUSSNER. Specifically regarding treatment?

Mr. SHAYS. Just in terms of guiding any research.

Dr. FEUSSNER. Well, I think that it is-it collects information on patients, it identifies symptoms; issues of fatigue, issues of myalgias and muscle problems, issues relating to cognitive impairment have been detected on the registry. I think that those problems are potential treatment targets. As I say, my impression is that patients have been getting treatments that are symptombased, but there have not been systematic clinical research treatment protocols that we have embarked on as yet.

Mr. SHAYS. I will just conclude by making a statement. I had Dr. Rosker who told me he was not aware of the two studies I made reference to in regards to the viability of the masks. He told me that he would work hard to have them released and put on the Internet, and it still hasn't been done. And when people like yourself don't have access to those studies, I find it beyond my patience. I am going to personally write the President of the United States to ask him to intervene. I am going to ask you, Dr. Winegar, because you are aware of those studies, to make sure that we find a way that people in the VA get to see these studies, and I am going to pursue this. This is classified information that I can't disclose publicly, other than to say it exists, which I am allowed to do. And I am determined, after 5 or 6 years, that these reports be made public, unless someone can tell me why there is a national interest reason why it can't be, and why someone like Dr. Feussner can't get access to that report. Reports, two. Excuse me, two.

You are on.

Mr. SANDERS. I will be very brief, because I look forward to hearing the next panel.

No. 1, I look forward to working with you, Dr. Feussner. We can maybe just chat for a few minutes and then decide how we will proceed.

My question, my brief question to Dr. Winegar, maybe you answered that in terms of what Mr. Kucinich was asking, but I am still not quite clear. I hope very much for a dozen different reasons that there is not a war in the Gulf, but what is the position of the DOD regarding pyridostigmine bromide and the administration of that drug to the men and women who are over there right now? Are you asking a waiver from FDA? What is going on with that? Ms. WINEGAR. No. We have no plans at this time to use pyridostigmine, nor have we made any request to the FDA for any waivers.

Mr. SANDERS. OK. So you are pretty definitive on that. At this point there are no plans?

MS. WINEGAR. That is correct.

Mr. SANDERS. What about your response to the FDA filing in September? Does that mean anything to you?

Ms. WINEGAR. Our response to the interim rule, or our re

sponse

Mr. SANDERS. Yes.

Ms. WINEGAR. Yes. I indicated that we would make that available to you.

Mr. SANDERS. You would make that available to us?

Ms. WINEGAR. Yes.

Mr. SANDERS. But what I am hearing you saying is that in terms of the present military situation, you have no-you are not intending to go to the FDA for the waiver of the use of pyridostigmine bromide?

Ms. WINEGAR. That is correct.

Mr. SANDERS. Thank you. That's all I have,

Mr. Chairman.

Mr. SHAYS. I do want to say to you that I know that there is enough blame to go around on this issue. Congress was asleep, I was asleep, we all were asleep on this issue. My big concern is the eagerness in which we try to undo the past and move forward. With that, I thank all of you for your participation.

We will now call on our second panel. We appreciate the patience of our second panel, as well as the patience of our first panel. Dr. FEUSSNER. Thank you, sir.

Mr. SHAYS. Our panel consists of testimony from five people and six will sit on the panel. Excuse me, four testimonies: Dr. Heivilin, Director of Planning and Reporting, General Accounting Office, accompanied by Kwai Chan, Director of Special Studies Evaluation, General Accounting Office, and Sushil Sharma, Assistant Director of Special Studies and Evaluation, General Accounting Office; Dr. Robert Haley, director, Epidemiology and Scientific Graphics Laboratory, University of Texas Southwestern Medical Center; Dr. Daniel Clauw, chief of rheumatology, Georgetown University School of Medicine; and Dr. William Reeves, Branch Chief, Viral Exanthems, Center for Disease Control and Prevention.

[Witnesses sworn.]

Mr. SHAYS. For the record, all witnesses have responded in the affirmative.

We will start, I think, by the way I called you. Do you remember how we started? We will start with Dr. Heivilin.

STATEMENTS OF DONNA HEIVILIN, PH.D., DIRECTOR, PLANNING AND REPORTING, GENERAL ACCOUNTING OFFICE, ACCOMPANIED BY KWAI-CHEUNG CHAN, DIRECTOR, SPECIAL STUDIES AND EVALUATION, GENERAL ACCOUNTING OF. FICE, AND SUSHIL SHARMA, PH.D., ASSISTANT DIRECTOR, SPECIAL STUDIES AND EVALUATION, GENERAL ACCOUNTING OFFICE; ROBERT HALEY, M.D., DIRECTOR, EPIDEMIOLOGY AND SCIENTIFIC GRAPHICS LABORATORY, UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER; DANIEL CLAUW, M.D., CHIEF OF RHEUMATOLOGY, GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE; AND WILLIAM REEVES, M.D., BRANCH CHIEF, VIRAL EXANTHEMS, CENTER FOR DISEASE CONTROL AND PREVENTION

Ms. HEIVILIN. Mr. Chairman, members of the subcommittee, I am pleased to be here to discuss GAO's evaluation of the Federal strategy to research Gulf war illnesses. We reported our findings on this strategy in June 1997 as part of our response to a congressional mandate. However, before I discuss our findings, I would like to provide a little background information.

The United States troops were reportedly exposed before, during, and after the Gulf war to a variety of risk factors. The Federal Government, primarily through DOD and VA, has sponsored a variety of research on the Gulf war veterans' illnesses.

Most of the research sponsored by the Federal Government is characterized as epidemiological. The objectives of epidemiologic research are to determine the extent of the disease and illnesses in the populations and subpopulations, the causes of the disease and its modes of transmission, the natural history of the disease, and the basis for developing preventive strategies or interventions.

I would like to point out that epidemiological research is a useful tool for determining the cause of illness and effective treatment. However, to conduct such research, investigators must follow three principles: first, they must specify diagnostic criteria which can be used to reliably determine who has the disease or condition being studied and who does not, and select appropriate controls; that is, people who do not have the disease or condition, for comparative

purposes.

Second, the investigators must have valid and reliable methods of collecting data on the past exposures of those in the study, and possible factors that may have caused the symptoms. It is particularly critical when studying low-level or intermittent exposure to drugs or chemicals to be able to obtain dose-specific exposure information as well as data on the intensity and duration of the exposure, and it is difficult to detect any effects of the exposure when the type, amount, and extent of the exposure of individuals is reported incorrectly.

Third, it is important that a sufficient number of persons be studied to have a reasonable likelihood of detecting any relationship between exposures and disease.

I would like to turn to our findings at this point, and I have five that I want to report. First, the Government was not proactive in researching Gulf war illnesses. Although the veterans' health problems began to surface in the early 1990's, the vast majority of the research was not initiated until 1994 or later, and much of it re

sponded to legislative requirements. For example, the three studies on low-level chemical exposure which were funded by the coordinating board were funded in direct response to congressional mandate.

By the time the research was accelerated and broadened, opportunities had been missed to collect critical data that cannot be accurately reconstructed.

Second, the Government's early research emphasized stress as a cause and gave other hypotheses such as multiple chemical sensitivity short shrift. Although veterans raised concerns about potential chemical exposure soon after the war, the Federal research plan was not modified to include these concerns until 1996, when DOD acknowledged that potential exposures to chemical agents at Khamisiyah Iraq.

Third, in contrast, the private sector pursued research on lowlevel exposures to certain chemical warfare agents or industrial chemical compounds. Although the government argued that there was no evidence that low-level exposure can have adverse health effects, we found a substantial body of research which suggests otherwise.

For example, abundant evidence from animal experiments, studies of accidental human exposures, and epidemiological studies of humans shows that low-level exposures to low-level exposures to certain organophosphorous compounds, including sarin nerve agents to which our troops were exposed, can caused delayed chronic neurotoxic effects. In addition, research that we reviewed also indicates that agents like pyridostigmine bromide, also called PB, which the Gulf war veterans took to protect themselves against the immediate lifethreatening effects of nerve agents, may alter the metabolism of organophosphates in ways that activate their delayed chronic effects on the brain.

Fourth, the Government funded little research on treatment.

Finally, while the Federal Government research strategy heavily emphasized epidemiological research, we believe that the ongoing epidemiological research cannot provide precise, accurate, and conclusive answers regarding the causes of the veterans' illnesses because of methodological problems. To date, most of the studies completed are epidemiologic studies and at this point there has been no light shed on causes or possible treatments.

There are a number of reasons for this. First, researchers have found it extremely difficult to gather information about many key exposures. For example, medical records on the use of PB tablets and vaccinations to protect against chemical-biological warfare exposures are inadequate. Second, Gulf war veterans were typically exposed to a wide array of agents, making it difficult to isolate and characterize the effects of individual agents or to study their combined effects. Third, most of the epidemiological studies on Gulf war veterans' illnesses have relied only on self reports for measuring most of the agents to which veterans might have been exposed. Fourth, the information gathered from Gulf war veterans years after the war may be inaccurate or biased. There is often no straightforward way to test the validity of self-reported exposure information, making it impossible to separate bias and recalled in