[House Hearing, 106 Congress] [From the U.S. Government Publishing Office] GULF WAR VETERANS: LINKING EXPOSURES TO ILLNESSES ======================================================================= HEARING before the SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS, AND INTERNATIONAL RELATIONS of the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED SIXTH CONGRESS SECOND SESSION __________ SEPTEMBER 27, 2000 __________ Serial No. 106-270 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform __________ U.S. GOVERNMENT PRINTING OFFICE 74-864 WASHINGTON : 2001 _______________________________________________________________________ For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001 COMMITTEE ON GOVERNMENT REFORM DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California CONSTANCE A. MORELLA, Maryland TOM LANTOS, California CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania JOHN L. MICA, Florida PATSY T. MINK, Hawaii THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington, MARK E. SOUDER, Indiana DC JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio Carolina ROD R. BLAGOJEVICH, Illinois BOB BARR, Georgia DANNY K. DAVIS, Illinois DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts ASA HUTCHINSON, Arkansas JIM TURNER, Texas LEE TERRY, Nebraska THOMAS H. ALLEN, Maine JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois DOUG OSE, California ------ PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont HELEN CHENOWETH-HAGE, Idaho (Independent) DAVID VITTER, Louisiana Kevin Binger, Staff Director Daniel R. Moll, Deputy Staff Director James C. Wilson, Chief Counsel Robert A. Briggs, Clerk Phil Schiliro, Minority Staff Director ------ Subcommittee on National Security, Veterans Affairs, and International Relations CHRISTOPHER SHAYS, Connecticut, Chairman MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois ILEANA ROS-LEHTINEN, Florida TOM LANTOS, California JOHN M. McHUGH, New York ROBERT E. WISE, Jr., West Virginia JOHN L. MICA, Florida JOHN F. TIERNEY, Massachusetts DAVID M. McINTOSH, Indiana THOMAS H. ALLEN, Maine MARSHALL ``MARK'' SANFORD, South EDOLPHUS TOWNS, New York Carolina BERNARD SANDERS, Vermont LEE TERRY, Nebraska (Independent) JUDY BIGGERT, Illinois JANICE D. SCHAKOWSKY, Illinois HELEN CHENOWETH-HAGE, Idaho Ex Officio DAN BURTON, Indiana HENRY A. WAXMAN, California Lawrence J. Halloran, Staff Director and Counsel Robert Newman, Professional Staff Member Jason Chung, Clerk David Rapallo, Minority Counsel C O N T E N T S ---------- Page Hearing held on September 27, 2000............................... 1 Statement of: Feussner, Dr. John, Chief Research and Development Officer, Department of Veterans Affairs, accompanied by Mark Brown, Ph.D., Director, Environmental Agents Service, Department of Veterans Affairs........................................ 49 Sox, Harold, M.D., professor and chair, Department of Medicine, Dartmouth-Hitchcock Medical Center, accompanied by Samuel Potolicchio, M.D., professor, Department of Neurology, the George Washington University Medical Center. 27 Letters, statements, etc., submitted for the record by: Feussner, Dr. John, Chief Research and Development Officer, Department of Veterans Affairs: Followup questions and answers........................... 75 Prepared statement of.................................... 52 Metcalf, Hon. Jack, a Representative in Congress from the State of Washington, prepared statement of................. 4 Sanders, Hon. Bernard, a Representative in Congress from the State of Vermont, prepared statement of.................... 24 Sox, Harold, M.D., professor and chair, Department of Medicine, Dartmouth-Hitchcock Medical Center, prepared statement of............................................... 31 GULF WAR VETERANS: LINKING EXPOSURES TO ILLNESSES ---------- WEDNESDAY, SEPTEMBER 27, 2000 House of Representatives, Subcommittee on National Security, Veterans Affairs, and International Relations, Committee on Government Reform, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m., in room 2247, Rayburn House Office Building, Hon. Christopher Shays (chairman of the subcommittee) presiding. Present: Representatives Shays, Sanders, and Schakowsky. Also present: Representative Metcalf. Staff present: Lawrence J. Halloran, staff director and counsel; J. Vincent Chase, chief investigator; R. Nicholas Palarino, senior policy advisor; Robert Newman and Kristine McElroy, professional staff members; Alex Moore, fellow; Jason M. Chung, clerk; David Rapallo, minority counsel; and Earley Green, minority assistant clerk. Mr. Shays. I'd like to call this hearing to order, this hearing of the Subcommittee on National Security, Veterans Affairs, and International Relations of the Government Reform Committee, which is conducting a hearing entitled, ``Gulf War Veterans Linking Exposures to Illnesses.'' Doubts remain, and may always remain, about the role of battlefield toxins and medicines in causing Gulf war veterans' illnesses. Today, we continue our oversight of the statutory process established to resolve those doubts in favor of sick veterans seeking proper diagnosis, effective treatment and fair compensation for their war-related injuries. Embodying a recommendation made by this subcommittee, the Gulf War Veterans Act of 1998 directs the Department of Veterans Affairs [VA], not to wait for scientific certainty, but to look for any plausible association between presumed exposures and subsequent ill health. If credible evidence for the association is equal to or outweighs the credible evidence against, the VA Secretary is authorized to presume the illness is service related for purposes of health care eligibility and compensation determinations. The National Academy of Sciences' Institute of Medicine [IOM], recently completed a study of peer-reviewed research on four of the agents of concern to Gulf war veterans: Sarin, pyridostigmine bromide [PB], depleted uranium [DU], and vaccines against anthrax and botulinum toxin. The IOM report now under review by the VA suggests the difficulty and the urgency of linking presumed toxic exposures with chronic health effects. Not surprisingly, medical literature to date contains little evidence to support any association between low doses of the agents in question and long term illnesses. Those findings say far more about the stunted scope of scientific inquiry over the past decade than about the likely weight of scientific evidence. The significance of the report lies in the fact the IOM found virtually no evidence that would rebut a presumption of a causal association between these agents and many of the maladies suffered by Gulf war veterans. As the IOM panel noted, the task of establishing plausible dose-response relationships was made more difficult by the lack of hard data on wartime exposures and by the lack of adequate military medical records. Based primarily on studies following the Tokyo subway attack, the committee did conclude sarin exposures inducing immediate, if moderate, symptoms could also cause longer term health effects similar to those observed in many Gulf war veterans. But veterans' illnesses could not be more firmly associated with sarin because battlefield medical surveillance did not distinguish between the acute symptoms of mild sarin toxicity and the myriad of other environmental and stress- related health effects suffered by U.S. service personnel. The IOM committee was also hampered by lack of access to classified information held by the Department of Defense [DOD], on toxic agents in the war theater. In the course of our oversight, many have called for full access to DOD records on chemical and biological detections. Given the statutory mandate that VA search broadly for information on toxic exposures, the VA should join us in pressing for declassification of all records relevant to the health of Gulf war veterans. Doubts remain. But our obligation to act now on behalf of those willing to make a certain and timeless sacrifice can be subject to no doubt, no delay. They earned the benefit of any doubt about the extent of our debt to them. They should not be asked to wait for certainty that might come too late, if at all. Mr. Metcalf is joining us from the great State of Washington, and I'd welcome any comment you'd like to make. Mr. Metcalf. Thank you very much. I do have a statement. Mr. Chairman, I want to thank you for the opportunity to once again be a small part of your courageous effort to answer questions regarding Gulf war illnesses and the vaccines used by our military personnel. Your determination to move forward and find answers has provided vital leadership for Congress on this critically important issue. Indeed, we have an obligation to pursue the truth, wherever it may lead us. To do less would be to act dishonorably toward the dedicated men and women who stand between us and a still dangerous world. For that reason, I have issued a report I would like to present to you and to the IOM committee culminating a 3-year investigation into the conduct of the Department of Defense with regard to the possibility that squalene, a substance in vaccine adjuvant formulations not approved by the FDA, was used in inoculations given to Gulf war era service personnel. According to the GAO, General Accounting Office, scientists have expressed safety concerns regarding the use of novel adjuvant formulations in vaccines, including squalene. The report reveals that the FDA has found trace amounts of squalene in the anthrax vaccine. The amounts recorded are enough to boost immune response, according to immunology professor, Dr. Dorothy Lewis of Baylor University. Therefore, my report concludes that, Mr. Chairman, you are absolutely correct in demanding an immediate halt to the current Anthrax Vaccination Immunization Program. My report further states that an aggressive investigation must be undertaken to determine the source of the squalene and the potential health consequences to those who have been vaccinated, both during and after the Gulf war. The report also documents at length DOD, Department of Defense, stonewalling attempts to resolve the squalene issue, which GAO investigators characterized as a pattern of deception. I think that's very significant. The GAO stated that the Department of Defense denied, denied conducting extensive squalene testing before the Gulf war, then admitted it after being confronted with the public record. The DOD denied conducting extensive squalene testing before the Gulf war and then admitted to it after being confronted with the public record. I think that's significant. The GAO revealed that Department of Defense officials deliberating deployment of the anthrax vaccine expressed a ``willingness to jump out and use everything,'' that's a quote, in discussing the experimental vaccines containing adjuvants not approved by the FDA. GAO also found Peter Collis, Department of Defense official, who headed vaccine efforts, refused to cooperate with them. The report states that the Department of Defense has refused to act in good faith upon the GAO recommendations to replicate the findings of a test developed by renowned virologist, Dr. Robert Garry of Tulane University, although Department of Defense admitted that they could easily do so. The work of the Tulane researchers has been peer reviewed in a scientific publication of high standing. Finally, my report states that Congress should take immediate action to review the findings of the GAO and the Armed Services Epidemiological Board and provide independent oversight for the immediate implementation of their recommendations. The board called upon the DOD to engage in close cooperation with the Tulane researchers. Congress must get to the bottom of the labyrinth that has become known as Gulf war illnesses. Mr. Chairman, you have been in the forefront of this effort. As I am about to leave the Congress, I just want to once again commend you for your courage in this leadership role. Please stay the course. Veterans, active service members and their families deployed around the world are counting on you. Thank you very much. [The prepared statement of Hon. Jack Metcalf follows:] [GRAPHIC] [TIFF OMITTED] T4864.001 [GRAPHIC] [TIFF OMITTED] T4864.002 [GRAPHIC] [TIFF OMITTED] T4864.003 [GRAPHIC] [TIFF OMITTED] T4864.004 [GRAPHIC] [TIFF OMITTED] T4864.005 [GRAPHIC] [TIFF OMITTED] T4864.006 [GRAPHIC] [TIFF OMITTED] T4864.007 [GRAPHIC] [TIFF OMITTED] T4864.008 [GRAPHIC] [TIFF OMITTED] T4864.009 [GRAPHIC] [TIFF OMITTED] T4864.010 [GRAPHIC] [TIFF OMITTED] T4864.011 [GRAPHIC] [TIFF OMITTED] T4864.012 [GRAPHIC] [TIFF OMITTED] T4864.013 [GRAPHIC] [TIFF OMITTED] T4864.014 [GRAPHIC] [TIFF OMITTED] T4864.015 [GRAPHIC] [TIFF OMITTED] T4864.016 [GRAPHIC] [TIFF OMITTED] T4864.017 Mr. Shays. Thank you, Mr. Metcalf, and I was just going to comment that you will be very missed. We have appreciated your interest not only in this issue but in so many others, and I was sorry when you announced you weren't running again and I just know whoever gets to return next year, they will certainly miss you, and I will just say whatever this committee has done on this issue, and they have done, has been shared equally with Mr. Sanders on this issue. He has been truly at the forefront, and I welcome him here and I welcome any statement he'd like to make. Mr. Sanders. Thank you very much. And as Jack Metcalf just said, you have played an outstanding role in keeping this issue alive on behalf of tens and tens of thousands of men and women who are suffering from Gulf war illness, and it has been a pleasure to work with you and I applaud you for your leadership. Over the past 5 years you have worked diligently to hold members of the military establishment accountable for their actions and, most importantly, their inaction. You and I and others have worked closely to try to get the Congress and the administration to fund serious research into potential causes and cures for the diseases known as Gulf war illness and to push for compensation for those veterans who have contracted these diseases. I am sad to say that despite our efforts we have up to this date only had limited success. The findings of the IOM study that we are examining today only serves to remind us how far we have yet to go on this issue. Some good news is that Chairman Shays and I worked very hard this year to secure 1.6 million in the defense appropriations bill for research into whether Gulf war illnesses is the result of low level multiple toxin exposures which manifests itself as a condition known as multiple chemical sensitivity. We will be playing an active role in making sure that this money goes for serious research into this area. I notice that Dr. John Feussner is here and he'll be speaking later, and I look forward to his discussion, the clinical study done with doxycycline and what the status is of that report, which is also an area we've worked on. Let me begin by stating how I approach the issue of Gulf war illness, and that is when this country asks men and women to serve in the Armed Forces and those men and women are injured, whether in body or in mind or in spirit, the Federal Government has an absolute, unquestionable obligation to make those people whole to the maximum medical and scientific extent possible. In addition, the Federal Government has an obligation to compensate those veterans fairly, not to argue with them every single day, but to give them the benefit of the doubt, and when it is clear that veterans have been injured during their service, we should not deny them compensation just because we cannot say which particular exposure or combination of exposures caused that injury. In my view, on all counts the Federal Government has failed and failed miserably with respect to Gulf war illness. You know, one of the unanswered questions of our time, and I certainly don't have the answer, Mr. Chairman, is that this turning one's back on veterans has gone on in this country for so very long. It started at the very least in World War II when for years we ignored the impact of radiation illness. It went to Vietnam, where veterans organizations had to struggle for years and years to get the VA to acknowledge the horrendous impact that Agent Orange had, and we're still struggling with that fight today, and look what we have to do with Gulf war illness. I don't understand it. I really do not understand why when we ask men and women to put their lives on the line, when they come home we fight them. We become the enemy that they-- similar to the enemy they fought in battle. Over 100,000 veterans have reported suffering from some combination of symptoms associated with the syndrome we call Gulf war illness. Certainly it is important that we exhaust every possible research avenue to find the cause and the cure but we should not hold up compensation of Persian Gulf war veterans who have very real illnesses, because we have failed either through incompetence, insufficient resources or lack of dedication, or just lack of scientific knowledge, to identify the specific toxic compound or compounds that are responsible. This is particularly true because the Pentagon's negligence in keeping adequate records of exposures in the Gulf theater may prevent us from ever finding a definitive answer. As for the IOM study that we are reviewing today, I say with all due respect to the IOM that this study only confirms what most of us already knew. There is a dearth of research in peer-reviewed scientific literature on the long-term health effects of exposure to various toxins that our soldiers encountered in the Gulf war theater. Let me just add something to that. When I used to hear the word ``peer-reviewed'' I thought that was the right thing. But since I have been involved in this issue, you know when I hear ``peer-reviewed'' what it often connotes to me is the people who do not know much about an issue who cannot come up with an answer in an issue will always tell us what other people are doing, cutting edge research, that it's not peer reviewed and the peer-reviewed research that we hear tells us we don't know anything, that's the good research, we don't know anything when people are doing breakthroughs, who are doing cutting edge stuff, is not peer reviewed, and that's a problem I have seen for many years in this issue, in this area. As the IOM reported, the peer-reviewed literature contains inadequate or insufficient information to determine whether there is an association between Gulf war illness and exposure to depleted uranium, between Gulf war illness and pyridostigmine bromide, between Gulf war illness and low level exposure to sarin gas, between Gulf war illness and anthrax vaccine or other vaccines or combinations of vaccines. These findings do not come as a shock to me or anyone else who has followed this issue. The reason we do not have this research is that the Federal Government and, in particular, the Pentagon has failed to keep faith with the men and women who served in the Gulf. They have dragged their feet and, were it not for the efforts of people like Chairman Shays and the Gulf war veterans themselves, the military long ago would have forgotten about this issue. There would not have been--there would not be a Gulf war problem today. I do want to commend the IOM on their research recommendations. These track the approach Chairman Shays and I have been advocating. Instead of looking for one single toxin as the cause of Gulf war illness, we need to investigate the impact of the multiple, often low level exposures that Gulf war veterans experienced. As the IOM report states, this, ``may provide a more realistic approach toward understanding veterans' health issues and may provide insights for preventing illnesses in future deployments.'' Finally, Mr. Chairman, I want to express my concern that there is still not the will within the military to get to the bottom of this very real health emergency. In my view, it is time for the military to make available to properly cleared independent researchers--you know, if you go back to somebody who year after year tells you, gee, I don't understand the problem, gee, I don't have a cure for the problem, what do you do? You go to a doctor that says, well, I'm not 100 percent sure that I have it, but this is a breakthrough, we're working on this. And the good news is you and I know, because you have brought every serious researcher in the United States to this committee, there are some good people out there doing some breakthrough research. Let's put more emphasis on some of those people. So I want to just applaud you, Mr. Chairman, and commend the veterans organizations for their persistence, and you and I will continue to work on this issue, I'm sure. Jack, thank you very much for your work over the years. [The prepared statement of Hon. Bernard Sanders follows:] [GRAPHIC] [TIFF OMITTED] T4864.018 [GRAPHIC] [TIFF OMITTED] T4864.019 [GRAPHIC] [TIFF OMITTED] T4864.020 Mr. Shays. Thank you, Mr. Sanders. Just before going on with our panel, I ask unanimous consent that all members in the subcommittee be permitted to place an opening statement in the record and the record remain open for that purpose. Without objection so ordered. I ask further unanimous consent that all witnesses be permitted to include their written statements in the record and, without objection, so ordered. And I also without objection ask that the gentleman's statement, Mr. Metcalf's statement, and report be included in the hearing record, and I will move to include it in the full committee hearing on anthrax next Thursday. You have been patient. Thank you very much. We will call on Mr. Harold Sox--Dr. Harold Sox, excuse me--professor and chair, Department of Medicine, Dartmouth-HitchCock Medical Center, accompanied by Samuel Potolicchio, who is professor, Department of Neurology, the George Washington University Medical Center. As you know, gentlemen, we swear you in and then we will take your testimony. If you would please stand. [Witnesses sworn.] Please be seated. I thank our other two staff for standing up in case you're required to make a statement. Thank you for anticipating that. It's very thoughtful. Dr. Sox. STATEMENT OF HAROLD SOX, M.D., PROFESSOR AND CHAIR, DEPARTMENT OF MEDICINE, DARTMOUTH-HITCHCOCK MEDICAL CENTER, ACCOMPANIED BY SAMUEL POTOLICCHIO, M.D., PROFESSOR, DEPARTMENT OF NEUROLOGY, THE GEORGE WASHINGTON UNIVERSITY MEDICAL CENTER Dr. Sox. Good morning, Mr. Chairman and members of the committee. My name is Harold Sox. I chair the Institute of Medicine Committee on Health Effects Associated with Exposures During the Gulf War, which released its report about 3\1/2\ weeks ago. I appreciate the opportunity to provide testimony to you today based on the findings of our report. And I am accompanied by Dr. Samuel Potolicchio, also a member of the IOM committee. The genesis of our report was a request from the Department of Veterans Affairs asking the Institute of Medicine to study the available scientific evidence on potentially harmful agents to which Gulf war veterans may have been exposed. Congress subsequently mandated a similar study specifying 33 specific agents. Before going further, I want to clarify the scope of the committee's work lest there be any misunderstanding. The committee, IOM committee, was charged with assessing the scientific literature about potential health effects of chemical and biological agents present in the Gulf war theater. The Department of Veterans Affairs will use the findings of the report as it sees fit as a scientific basis for developing a compensation program for Gulf war veterans. Our committee was not asked to examine whether a unique Gulf war syndrome exists or to evaluate the literature on Gulf war syndrome or illnesses. The committee was not asked to make judgments about individual veterans' level of exposure to the putative agents, as there is a presumption of exposure for everyone who served in the Persian Gulf theater. For the first study of the series, the Institute of Medicine chose to study the agents of most concern to the veterans who advised us: Sarin, pyridostigmine bromide [PB], depleted uranium, and the vaccines to prevent anthrax and botulism. Because there had been very few published studies of Gulf war veterans, most of the studies that we examined were about exposures in occupational, clinical and healthy volunteer settings. The committee members carefully assessed each study's quality, limitations and applicability, but it relied upon the peer review system that precedes publication in scientific journals as well. Let me begin with the nerve agent sarin. Relatively high doses of sarin can cause overstimulation of nerves and muscles within seconds or hours, creating symptoms such as severe cramping, difficulty breathing, twitching and heavy sweating. All of these short-term effects are well-documented and our committee ranked the evidence as sufficient to establish causality, the highest level of evidence. The long-term effects of sarin are a very different story. The evidence is far more limited in quantity and is weaker. Studies describing three different populations exposed to sarin, two involving victims of terrorist attacks in Japan and one involving industrial accidents in the United States, establish possible links to neurological and psychological symptoms that persisted for 6 months or longer after exposure. In one of these studies some symptoms were still present up to 3 years after exposure. In all three studied populations, however, the patients all had an immediate, intense, widespread acute reaction, typical of high levels of exposure to sarin. Among the symptoms that persisted over the long term in these individuals were fatigue, headache, blurred vision and symptoms of post-traumatic stress disorder. It's important to remember that people who had long-term symptoms had all experienced intense symptoms immediately. Because we are dealing with only three studies and because we could not rule out explanations, other explanations for the effects, the committee categorized these findings as limited or suggestive of an association well shy of the evidence needed to establish a strong link, but clearly warranting further investigation. We recommend long-term research to track the health of victims of the sarin attacks in Japan, since controlled studies of them offer the best opportunity to see if sarin has long-term health effects. Few, if any, veterans reported symptoms of acute exposure to sarin in the Persian Gulf theater. Therefore we concerned ourselves with possible effects of sarin in doses too low to cause the acute reaction. Based on available evidence, we could not form a conclusion about an association between the long-term health effects and exposure to doses of sarin that are low enough so that immediate signs and symptoms did not occur. Yet research with nonhuman primates gives us a hint that low doses of sarin over a period of several days may create delayed neurological reactions. More research is needed to substantiate this single finding. The second agent that we considered was the drug pyridostigmine bromide [PB]. There have been many studies of the short-term effects of PB. The committee judged this evidence to be sufficiently strong to demonstrate an association between exposure and the immediate onset of mild transient symptoms, a link seen consistently in many studies. Long-term side effects of PB are another story. There simply was not enough evidence to draw any conclusion about PB's long- term effects. In other words, we don't know if they occur and we can't be certain that they don't occur. The author of one series of studies has suggested that PB, either alone or in combination with other chemicals, may be related to some chronic changes in nerve function reported by Gulf war veterans. However, weaknesses in the design of these studies, which include uncertainty about whether exposures occurred and a small number of affected subjects, made it impossible for us to decide if exposure to PB is associated with long-term nerve damage. We recommend further investigation of this issue using an improved study design. The third agent was depleted uranium. Health effects of natural uranium have been widely investigated, mostly in occupational settings, principally workers in uranium processing mills. While these studies have shown that uranium either has no effect or only a small effect, our committee found weaknesses in many of these studies. We could not draw conclusions about exposure to uranium and death from a number of diseases, including lymphatic or bone cancer, nonmalignant respiratory disease and diseases of the liver and gastrointestinal tract. We were able to arrive at more certain conclusions regarding two diseases, kidney disease and lung cancer. We concluded that there is limited evidence of no association between kidney disease and exposure to uranium. We based this conclusion on adequate consistent studies that showed good kidney function despite continuous exposure to uranium as it dissolved from uranium fragments embedded in body tissues. Similarly, at low levels of exposure to uranium, we found limited evidence of no association between--with death from lung cancer. At higher levels of exposure, though, the evidence did not permit any conclusion about a relationship between uranium and lung cancer. We recommend followup research on veterans with embedded fragments of depleted uranium and other long-term studies. Finally, our committee considered the vaccines given to prevent anthrax and botulism. Based on our review of the scientific literature, we concluded that the evidence is sufficient to demonstrate an association between these vaccines and subsequent short-term local and systemic effects similar to those associated with any vaccination. But when we sought evidence for more lasting effects, we didn't find any published, peer-reviewed studies that systematically followed subjects over the long term. This situation is not unusual as vaccines are seldom monitored for adverse effects over long periods of time. Since troops usually receive several vaccines, often within a short span of time, some have questioned whether several vaccines in combination may have created a cumulative effect that would not occur with any single injection. Although we did find some research on cumulative effects of combinations of vaccines, the shortcomings in these studies made it impossible for us to form a strong conclusion. We did decide that this evidence was inadequate to determine whether an association with long-term effects exist. I have provided a brief overview of our report's findings. The IOM is beginning the second phase of the study, in which it will examine the literature on health effects of pesticides and solvents. This study is scheduled to be completed in 2002, as the committee must review a vast body of literature on these compounds. Plans for future IOM studies include completion of the studies of the remaining agents listed in the legislation. In addition, the IOM will update its studies and reports as new studies become available in the published literature. Thank you. Dr. Potolicchio and I will be happy to respond to your questions. [The prepared statement of Dr. Sox follows:] [GRAPHIC] [TIFF OMITTED] T4864.021 [GRAPHIC] [TIFF OMITTED] T4864.022 [GRAPHIC] [TIFF OMITTED] T4864.023 [GRAPHIC] [TIFF OMITTED] T4864.024 [GRAPHIC] [TIFF OMITTED] T4864.025 Mr. Shays. You needed a cheat sheet like I had, Potolicchio, correct? Dr. Potolicchio. It's an Italian name. Just follow all the vowels. Dr. Sox. Sorry, Sam. Mr. Shays. Just trying to get back at all those tough medical names that you guys have. What we're going to do is we're going to start out with Mr. Sanders, I'm going to ask some questions, and then we've been joined--Ms. Schakowsky is here. I will recognize her third and then we'll go to Mr. Metcalf, who's not an official member of this committee, though he has all the rights to ask the same questions we will, but just then at the end. Mr. Sanders. And we're going to go 10 minutes. We'll do 5 and 5, roll over 5. Mr. Sanders. Thank you very much, Mr. Chairman. Let me start off by asking you the question. You say in your statement, Dr. Sox, that for the first study of the series the Institute of Medicine chose to study the agents of most concern to the veterans, sarin, pyridostigmine bromide, depleted uranium and the vaccines to prevent anthrax and botulism. Now isn't one of the problems that we have is that we're sitting in a lovely room here in Washington, DC, but the reality of life, when you're at war, is that it may not be just one--there may not be just one agent that impacts on you. For example, 23, you're sitting there, you're scared to death, sitting in the heat, that the next day there may be a nerve gas attack on you. Psychologically what does that do to you? Meanwhile, at some point during the theater you may have been exposed to sarin, you may have been given a pyridostigmine vaccine, you may have had anthrax, you may have been exposed to burning oil wells, you may have a genetic disposition, you may have come from a place in your whole life you didn't absorb a lot of chemicals, so you're more susceptible to multiple chemical sensitivity. So my life history going into that battle is very different say than Mr. Shays. And so you add all of those things together, isn't there a problem that we're not looking at the totality and the synergistic impact rather than sarin here, depleted uranium here? Isn't there more to it than just one possible agent, and isn't that lacking in the way we're approaching this problem? Dr. Sox. Well, our--the answer to your question is yes. We need to be aware of the potential for interactions between different agents as well as potentially a person's past history of exposure and, in an ideal study, to try to look at the links between agents and combinations of agents. We would have a clear understanding of an individual's personal exposure history, both before and after service in a theater of war and then reliable information about subsequent health experiences, and then we would try to link those together and see if we can detect effects that would not be seen looking at a single agent. Most of the research on the health effects of the agents that we studied were on single agents. In fact, we found only one study in our search which suggested a possible link between two agents, one in which mice that were injected with PB were subjected to the stress of having to swim. Mr. Sanders. All that I am saying, and I have got a number of other questions, in the real world it is not just sarin, she's in the military, she's suffering trauma being there, and so forth and so on, that's the reality. It's not just we're sitting in a laboratory and we give somebody some sarin. No. 2, I want to make sure I understand exactly what your report says. Am I correct that you have not ruled out, not ruled out depleted uranium, pyridostigmine bromide, sarin gas, anthrax vaccine or multiple vaccines or some combination of these as the cause of Gulf war illness, you have not ruled them out? Dr. Sox. Our study was to look at the linkage between these four exposures and health effects, both diseases that are in textbooks as well as diseases that are not in textbooks because they're not well understood, such as Gulf war illnesses, and while we didn't find any compelling evidence that these exposures do cause health effects, neither was the evidence strong enough to conclusively rule out that they were not present. The closest we came was kidney disease and lung cancer with depleted uranium. Mr. Sanders. OK. I know that your mandate was only to review the peer-reviewed scientific literature on links between certain toxins and the symptoms that many Gulf war veterans are experiencing. Clearly, though, you had to undertake some background research into the types of symptoms these veterans are experiencing and the extent of those symptoms in order to do this analysis, is that correct? Dr. Sox. Yes, sir. Mr. Sanders. OK. Based on that background review, is it your medical opinion that in general Gulf war veterans are suffering from a physical illness or illnesses as opposed to what might be termed a psychological condition? Dr. Sox. Again, our committee charge was not to establish existence of a Gulf war syndrome. We read the published literature on this subject in order to provide background for our study of these compounds and their possible health effects, both on unexplained Gulf war illnesses as well as other illnesses. So if you want my personal opinion as a physician, I would say that ever since the Civil War, veterans of combat have experienced unexplained symptoms, and there's a great deal of overlap as you look at the symptoms that they experience in war after war coming right down to the present. So there's no question in my mind but what veterans do suffer unexplained illnesses, but this is a personal opinion. It was not a judgment of our committee. We didn't look at that question. Mr. Sanders. In your medical opinion, based on the background research you did, in your own experience does the fact that over 100,000 Gulf war veterans out of a total of less than 700,000 soldiers who served in the Gulf war have some combination of these symptoms suggest to you that these conditions we refer to as Gulf war illness have a connection to service in the Gulf war? In other words, if you have 100,000 or more folks out of 700,000 who have come down with a variety of illnesses now, it could be absolutely coincidental? Dr. Sox. Well, again you're asking me to express a personal opinion, which is somewhat more informed than the average physician, but I am not expressing an opinion based on the findings of our committee, and based on my personal reading of those articles, I think that there's a relationship between service in the Gulf war and these unexplained illnesses, but that was not a subject of the study. Mr. Sanders. Based on your own personal experience. Dr. Sox. My own personal reading of those articles. Mr. Sanders. I appreciate that. In your view, is it possible that we will never establish the precise cause of Gulf war illness other than to conclude that it has some connection to service in the Gulf war. Dr. Sox. I don't know how to answer that, sir. We have a number of exposures still to study and I would not want to form a judgment about what those studies might find. I don't have an opinion on that. Mr. Sanders. My last question is: Would you please explain what steps you took, if any, to obtain data from the DOD? Were they cooperative; were they not cooperative? You apparently did not get to review the classified materials. Did you request to and do you have staff who have security clearances? Dr. Sox. Well, we did not actively seek DOD documents. Our charge was to study the published peer-reviewed literature, and there's a history of several hundred years that states that reliance upon scientific reports that have undergone peer review forms a credible basis for forming scientific judgments. And DOD documents, they are not scientific reports and so--but to answer your question briefly, we did not seek them. We were not interested in the level of exposure of individual veterans because that's something that because of presumption of exposure exists. So it wasn't part of our charge to study DOD documents, and we did not request them. Mr. Sanders. Mr. Chairman, thank you very much. Mr. Shays. Let me, if you don't mind, not on anybody's time, but just ask Mr. Potolicchio if he would want to respond to any of those questions that you asked. Is that all right? Mr. Sanders. Sure. Mr. Shays. And then you can followup. Dr. Potolicchio. I think Dr. Sox has answered the questions appropriately. Dr. Sox. If you think I am not doing a good job, you will interrupt. Mr. Shays. Let me say because you're both partners here, you had one statement, but I don't mind if a question is directed to one of you to have the other jump in either with a qualifier or with whatever. I'd like either one of you to respond to--first, I'd like to just make a point. I wrestle with the fact that in terms of criminal law you're presumed innocent until guilt is proven and not, at least in the United States, presumed guilty until proven innocent. But I have the feeling that veterans are basically sentenced guilty because they're ill and they're guilty with no help in sight, and I have this general view that's come about through so many hearings that because there isn't a proven study or something that documents, therefore they're not going to have the presumption of an illness caused by their experience in the Gulf and therefore they are not going to get the help, not because there isn't that connection but because we can't illustrate that in fact there is that connection. And I understand where you come from as doctors and I think you understand where we come from as people who actually sent them off to war. And so I'm troubled by the fact that we still have a system that is not going to help our veterans and that maybe 20 years from now they will prove there was this connection but by then it will be too late. So I don't have the same kind of patience that I think some people have. My understanding is that you have looked at sarin, you've looked at pyridostigmine bromide, you've looked at depleted uranium, and you're looking at vaccines that were intended to prevent, deal with anthrax and botulism, and it's my understanding that the committee--let me say this to you before I ask the specific question. It's also my sense that the bill we passed makes the presumption of exposure to 33 agents; in other words, that at least we're not going to debate about it and then allow--that is the keyword, ``allow''--the VA to establish a presumption that the exposures are related to illness and they're going to look at what you all have done and they are going to come to some conclusion. It allows but does not require. Now when you tried to establish the categories of association from previous IOM studies, you would first agree that in some cases you were hampered by the fact there weren't enough studies, is that correct? Dr. Sox. Enough studies. Mr. Shays. I'll start with you, Dr. Sox. Dr. Sox. Well, there were not enough studies of a quality that allowed you to make a scientific conclusion, yes, sir. Mr. Shays. But not necessarily related to war experience? Dr. Sox. Well, there were very few studies related to war experience. Most of them are in other settings, yes, sir. Mr. Shays. And none of these studies would enable you to deal with the isolated--all things being equal, you look at a particular agent and then you've come up with some conclusions, is that correct? In other words, everything else is frozen? Dr. Sox. Most of them are isolated studies in which you looked at one exposure in isolation of others. Mr. Shays. And so you would certainly acknowledge, as I think Mr. Sanders has pointed out, that all things aren't equal, all things aren't held constant, there's exposure potentially to something but there's also exposure to others? Dr. Sox. Yes, sir. Mr. Shays. Would you make any comment, Dr. Potolicchio? Dr. Potolicchio. Maybe just one brief comment and that is, for instance, if you take two of the agents that we're considering here, pyridostigmine and sarin, actually one of them is given in order to protect the individual from exposure to the other. So they are given, they're sort of given simultaneously, but one hopefully is going to be protective and there's scientific evidence to prove that's the case. Mr. Shays. Did you look at any studies that tried to determine what would happen if someone took more than the required allotment of PB? For instance, I have this tendency if I am putting fertilizer on my lawn, at least I did, that if one bag was good, two bags was better and three bags would be really terrific and I ended up with a lawn that was totally dead, and I know for a fact from our witnesses that we had some who took the pill far in excess of what was recommended, far in excess. They went through that same logic. Did you look at any study that would have helped you determine that? Dr. Potolicchio. There were, we know from--and there's clinical evidence that if you take a whole bunch of pyridostigmine, let's say hundreds of pills, that you're going to really get sick, vomit and know that you have taken it, and I think that clinical response at least, tells you that we better not take anymore. Mr. Shays. You know that from just observation, but did you look at any studies? In your peer review that dealt with taking too many pills, not your intuitive sense. But did you, was that part of your reviews and what reviews did you do? I'd like to know specifically. Dr. Potolicchio. Well, there are case reports of people being overexposed to certain agents, particularly pyridostigmine, and they will have clinical signs. But were studies taken in a double blind fashion that, you know, we were going to see how much can a person take of the drug, just to see what the side effects are going to be? No. Mr. Shays. No. The view--we have had extensive testimony from MDs that have said that once you've taken so many you open yourself up to exposures that you wouldn't have been opened up to before, and the question I'm asking you is have you looked at anything in that regard? Dr. Potolicchio. The only studies that look at large doses of pyridostigmine are those confined to myasthenics; in other words, myasthenics have taken relatively large doses of pyridostigmine over a long period of time and there really haven't been any long-term health consequences of that. But as far as acute exposure to very large doses, will pyridostigmine kill you basically? We know well that sarin in little drops will kill you, but pyridostigmine will not kill you. Mr. Shays. That's not what I'm asking. See, if you had been on this side you would have been, you would have been exposed to what we were, and that was that we had--we'd start our hearings from sick veterans who would explain to us that they were given really no instructions on what to do with these pills and that they didn't take them for days and then they took a lot of them, and then we had researchers come in and say that the impact on your brain and what it does in terms of it opens up the potential for other illnesses, so--do you want to just jump in? Mr. Sanders. Mr. Chairman, perhaps you have a better memory than I do, but I recall that we had the pharmacologist from Maryland, Dr. Teet, I believe his name was, who if I remember correctly said that that there is evidence if you are--it's one thing to take PB before exposure to sarin, which is the goal of presumably what that benefit was, but that if you take PB after the exposure to sarin it has an extremely negative impact. That's my memory, and I was wondering if they had looked at that. Dr. Potolicchio. There is, there is evidence that that's true because, you know, sarin, remember sarin is an agent that irreversibly blocks your cholinesterase. So in other words, once you're exposed to it and that cholinesterase is basically crippled, therefore if you take another anticholinesterase on top of it after having that acute exposure, obviously you're going to amplify that. That's true. I don't disagree with that. Mr. Shays. The question I'm asking is was that part of your peer review? Dr. Potolicchio. The study that you're referring to is done only in animals. There is no evidence in humans that that kind of after exposure is going to lead to further compromise. Mr. Shays. I still want an answer, though. It wasn't part of your peer review because there were no studies? Dr. Potolicchio. In animals. Mr. Shays. But there were no studies in humans? Dr. Potolicchio. There are no studies in humans. Mr. Shays. So it's not part of your peer review? Dr. Potolicchio. Correct. Mr. Shays. So what am I supposed to conclude in that? And what I conclude, I think, is that it kind of relates to your observation about peer review, there's no peer review there, but I'll tell you what happened when your report came out. The press said there's no linkage, you've discounted and--but it's like not having all the facts, and this is what--you know, I know you're doing your best but the bottom line is what are we supposed to conclude. Dr. Sox. Well, no evidence isn't the same as evidence of no effect. Mr. Shays. Say that again. Dr. Sox. No evidence is not the same as evidence of no effect. So clearly the press, if they concluded there was no effect, made a mistake. Mr. Shays. I understand, but that's the reality. Dr. Sox. Yeah. Mr. Shays. Would you walk me through, and then I will go to my colleague, on the concept of sufficient evidence of a causal relationship, sufficient evidence of an association, limited suggested evidence of an association, inadequate, insufficient evidence to determine whether an association does or does not exist, and then limited suggested evidence of no association, so there are five categories. If you would walk me through those. Dr. Sox. It will just take me a minute to find them. Mr. Shays. Yeah, take your time. Dr. Sox. First of all, the causal relationship. The evidence fulfills the criteria for sufficient evidence of an association; that is to say, all of the other levels of evidence, and satisfies several of the criteria that have been used to assess causality. Mr. Shays. So that would be the most certain, you would have very little doubt there's evidence of a relationship? Dr. Sox. Yeah, it is very hard to---- Mr. Shays. The causal relationship. Dr. Sox. Yes, sir. Mr. Shays. The cause and effect. The second one is sufficient evidence of an association. Dr. Sox. And that states that there's been a positive association between an exposure and a health outcome in studies where other factors that might confuse the interpretation of that relationship can be ruled out with reasonable confidence, so that you think you can focus just on the exposure and not on other factors that might lead to the same result. Mr. Shays. The next one is limited suggestive evidence of an association. Dr. Sox. Here there's, there is evidence of an association between an agent and health outcomes, but the strength of the conclusion that you can draw is limited because you can't be sure that other factors that might explain the results aren't present. So you might have four or five things that could account for the result, one of which is the exposure. You can't be sure that the other ones aren't there and accounting for at least part of the effect. Mr. Shays. We have two more. Inadequate, insufficient evidence to determine whether an association does or does not exist, and I would assume that's neutral, you can't go either direction? Dr. Sox. It doesn't change your thinking one way or the other. It's like there isn't any information. Mr. Shays. But the first three lead you toward---- Dr. Sox. Uh-huh. Mr. Shays. The last one is limited suggested evidence of no association. So we have those five. If you would just quickly tell me, sarin fit which category again? Dr. Sox. Well, the acute effects of sarin were a causal relationship. Mr. Shays. So that's the strongest you could have. Dr. Sox. Yes, sir. And then there were long-term effects in people who experienced the acute effects and that came in the limited suggestive category. Mr. Shays. OK. That was just one higher than neutral? Dr. Sox. Inadequate, yes, sir, and then---- Mr. Shays. PB. Dr. Sox. Just to finish on sarin, evidence for long-term effects in people who did not experience any short-term effects of sarin, there was just no information except the one study in primates, which obviously requires a lot of followup. Mr. Shays. OK. And PB. Dr. Sox. In PB, the evidence was sufficient of an association between PB and acute effects lasting pretty much during the day that you took it. Mr. Shays. No long-term harm? Dr. Sox. But in terms of long-term effects the evidence was inadequate to determine whether there was or was not an association. Mr. Shays. But you didn't look at whether PB then opened the door for other illnesses with other agents? I mean, that's on the record, correct? Dr. Sox. There wasn't, there weren't any studies that showed us that PB opens the door to other exposures causing, leading to illness, yes, sir. Mr. Shays. Thank you, and depleted uranium. Dr. Sox. Depleted uranium, with two exceptions, the evidence was inadequate to determine whether an association does or does not exist. The two exceptions were lung cancer and kidney disease and in those cases there was limited or suggestive evidence of no association. Mr. Shays. OK. And then finally, vaccines to prevent anthrax and botulism? Dr. Sox. There was sufficient evidence of an association between immunization or vaccination and acute effects lasting a day or two, the sort of thing that many of us in this room have experienced. But the evidence was insufficient, similarly, just wasn't there. The studies weren't there---- Mr. Shays. You couldn't determine one way or the other? Dr. Sox [continuing]. To determine any long-term effects. Mr. Shays. So that's a neutral issue? Dr. Sox. Yes, sir. Mr. Shays. Thank you very much, and, Ms. Schakowsky, I do appreciate your patience. Thank you. Ms. Schakowsky. Thank you very much, Mr. Chairman. I haven't been here as long as the chairman or Mr. Sanders, but I have to tell you that in the hearings we have had regarding issues where we put our people in the Armed Services in harm's way and the kind of information we had, it has been very, very frustrating. It seems in some ways that the policy of our government is no news is good news or no findings are good findings or no studies are good studies. And I'm looking through your testimony, Dr. Sox, and I see words like ``limited studies.'' Because of the limited studies in Gulf war veterans, when it comes to long-term health effects of these substances, the bottom line is we simply don't know enough on PB. There simply was not enough evidence to draw any conclusion about PB. In other words, we don't know long-term effects, if they occur, and we can't be certain if they don't occur. Weaknesses in the design of these studies made it impossible for us to decide. When it came to anthrax and botulism, we've had lots of hearings on anthrax. When it came to evaluating more lasting effects, we didn't find any published peer review study. I'm saying pretty much what everybody has said already. This is not unusual. As few vaccines have been monitored for adverse effects over long periods of time. When it comes to combinations, you say the shortcomings in these studies made it impossible for us to form a strong conclusion, and I am wondering if we're going to go on for another 10 years, and I realize this isn't your fault. I'm just trying to ask you what we can do about this. We come and say, well, someone studied your study and what they found was there wasn't enough information. We keep doing studies of studies that have been done that say there hasn't been enough study. So I'm wondering when we get down to doing some real study and what your recommendations would be so that next time we have a study we can come back with some real reports. Dr. Sox. Well, the wheels of research grind slowly. Ms. Schakowsky. Are they in process? Dr. Sox. Pardon me. Ms. Schakowsky. Are they in process? Dr. Sox. Basically physicians have known about postwar syndromes, as I said, since the Civil War and, from my understanding, serious research into the cause of those syndromes really has only begun after the Persian Gulf war. So we're, in my opinion, at the beginning of serious, careful study of an important group of illnesses that have existed for 100, nearly 140 years and it's going to take a while to accumulate good evidence. LBJ declared war on cancer in 1968 and we have made a lot of progress in understanding the biology of cancer, but actually we're only now beginning to see some results or promise of some results from that research 30, 35 years later. I'm optimistic that we're starting on a process that's going to lead us to answers, but I don't expect the answers to come quickly. Ms. Schakowsky. Well, inconclusive results of real clinical studies that happen, that's one thing, and research that's being done, but I'm just wondering what the protocols are, for example, if we had--we made a decision about how many anthrax vaccines, how many dosages we should give and etc., and then when we come back and say well, based on what, what is your knowledge of this, how do we know about its effectiveness and its side effects, short and, well, mostly long term, so at what point should we be doing these studies and I would say that, that with agent orange, I mean, we have known about these symptoms that result from exposures during wartime, but are we engaged directly in the kind of research right now, and if that's the case, I haven't really heard about it. I mean, we heard when it came to anthrax all kinds of these voluntary reporting systems and no real answer as to how are we going to determine the effects. Dr. Sox. Well I am not an expert on the current state of research on Persian Gulf-related illnesses. Dr. Feussner, who will be speaking to you shortly, I am sure can tell you what studies are being done. Ms. Schakowsky. Thank you. Mr. Shays. Thank you. Mr. Metcalf does not have any questions. Mr. Sanders. Mr. Sanders. Thank you very much Mr. Chairman. As I indicated earlier because of the diligence of the chairman and his staff, we have had the opportunity on this committee to hear from, seems to me, some extraordinary researchers all over this country who have been doing breakthrough work, and there are a number of them, and I don't recall all of them, but I just was kind of curious, two names come to my mind, and I wonder if you can give me your views having reviewed their works. Dr. Robert Hayley is with the University of Texas, and as I recall, not having his work in front of me, he is not ambiguous about his belief that exposures in the Gulf have resulted in brain damage, which are causing severe physical problems for Gulf war veterans, no ifs, ands, buts and maybes, that is his belief. What's your view on that? Dr. Sox. Well, the committee carefully examined Dr. Hayley's work and had the opportunity to talk with Dr. Hayley about his work at one of our open sessions, and the committee ultimately concluded that there were difficulties with the design of Dr. Hayley's work that made it impossible to draw any conclusions at this point. I think our bottom line would be that in a small population of veterans, Dr. Hayley has done some studies that generate interesting ideas and hypotheses about the biological basis for some of the symptoms that people are experiencing, but until those studies are replicated by other investigators and larger more representative populations, the evidence that Dr. Hayley has produced is too weak for us to draw any conclusions upon which to base in our report. Mr. Sanders. Too weak in the sense that the number of veterans, the sampling was too small. Dr. Sox. Well, the sampling was too small. He studied basically a group of symptomatic veterans, and he, using some statistical techniques, put them in the subgroups which seemed to have different combinations of symptoms, and then he looked at different measures of brain function comparing one group of sick veterans to another group of sick veterans. It's a pretty basic principle of epidemiologic research to include an unexposed control, somebody who never went into the Persian Gulf theater, and with the exception of a couple of more recent studies, he has not had unexposed controls, but even putting that aside, the history of science is that you don't rely on one study. You, somebody does a study, and then several people try to replicate it. Sometimes they succeed and then it becomes part of the body of scientific understanding, and sometimes they don't and it falls by the wayside and right now, I think Dr. Hayley's work is in the category of remains to be repeated by other investigators. Mr. Sanders. Are other people, to your knowledge, trying to replicate that? Dr. Sox. I will have to ask Dr. Feussner to respond to that, I don't know. Mr. Sanders. What about Dr. Urnovitz. Dr. Sox. Doctor who? Mr. Sanders. Urnovitz. Dr. Sox. I don't know about his work. Sam, do you remember anything. Dr. Potolicchio. By name, I don't. Mr. Sanders. Don't know his name, no? Dr. Sox. None of us. Mr. Sanders. Dr. Claudia Miller, peer review. Dr. Potolicchio. Claudia Miller I think--we know we've had exposure to Claudia Miller. Dr. Sox. If I remember. Mr. Sanders. She's involved in multiple chemical sensitivity. Dr. Sox. She gave us a presentation. We did not review the literature on multiple clinical sensitivities and really don't have a basis upon which to judge her work. Mr. Sanders. See Mr. Chairman, may I repeat a point I made earlier, what seems to happen, and I think Ms. Schakowsky was making this point, we review people who say I don't know the cause of Gulf war illness, I don't have a cure to Gulf war illness, that's peer review. The people like Hayley or Urnovitz or Miller who say, you know, I think we're on to something, I think there's something real here, those are rejected because apparently not enough people have peer-reviewed that, we push them aside. It would seem to me, and correct me if I'm wrong, given the fact that after--and I don't mean to be critical of you. I know you're just one part. We've had 100 people up here who keep telling us the same thing. So we get a little bit frustrated, but when people come up here and they say I think we're on to something, it would seem to me that the logical reaction for Hayley's work or Urnovitz's work or Miller's work would be for people to jump up and down and say, thank God, we may have a breakthrough, why are we--are you recommending for example that resources now be devoted to replicate Hayley's work so that 5 years from now, we don't have people coming before us saying Hayley's work was interesting, but nobody's replicated it, so why don't we replicate it? Tell us that Hayley is wrong or he is right, or Urnovitz is wrong or is right. Dr. Sox. You know the history of scientific enterprise is somebody comes up with a finding and then somebody funds studies to try to replicate that study. So the answer to your question is yes, if somebody comes in here and makes a claim of an important result, the answer should be to fund other investigators to replicate the result. Mr. Sanders. I agree with you but based on that I mean all that you told me about Hayley, Urnovitz, you've never heard of Hayley. You said there is nobody, you know, he's out there, we don't have enough evidence to suggest that he is right or wrong, but you should be coming in here and saying this guy is saying something that's significant, it's different to other people, he's claiming some results, either he's crazy or he's not, let's find out; true? Dr. Sox. Well, yes and in our research recommendations, we called for work to replicate Dr. Hayley's findings. Mr. Sanders. One of the things that we can use--we have gone through this for 10 years, so what we would like people to say is look, there are some breakthroughs here, we cannot tell you at this moment whether these people are right or wrong, maybe they're wrong, let's find out and say that they're wrong, or if they are right, let's devote a whole lot of money to moving forward so we can use their research to develop a cure for Gulf war illness. I didn't hear you say that. Dr. Sox. Did you hear me say it? Mr. Sanders. No, I didn't hear you say it. Dr. Sox. Well---- Mr. Sanders. For example, tell me now, based on all of your research, if you were the President of the United States, or better yet, if you were going to recommend to the President of the United States, Mr. President, we have got a problem and I, based on all of my research, advocate to you that you spend X dollars in the following areas because we have some promising breakthroughs, but we just don't know about it. What would you recommend to the President? Dr. Sox. Well, I would recommend to the President a program of research to try to replicate some of the interesting results of investigators like Dr. Hayley, but I probably also call upon the President to establish a committee, to establish research priorities so we don't just focus on the areas where some scientists are working, but also going out and looking at areas where nobody has looked yet, perhaps for lack of funding, so in other words, we need a comprehensive approach to the study of postwar illnesses, and part of that approach is to followup on promising results of investigators like Dr. Hayley. Mr. Sanders. But that's where we were 10 years ago. You've studied all of the literature. So I am asking you, all right, give me, at this point, if you can, who are the people out there that you see are doing breakthrough work that, in fact, need help right now for additional funding so that we can determine whether they're right or whether they are wrong. Is Hayley one of them? Dr. Sox. I don't know anything about Dr. Hayley's funding, but clearly, Dr. Hayley is studying veterans and coming up with some interesting results, but I'm not sure it's Dr.--that Dr. Hayley needs more money. It may be that other people need more money to followup on his studies and to take it to the next step. Mr. Sanders. That's fine I am not here defending Dr. Hayley. All I am saying is you've done a lot of research; you're a scientist we are not. You have studied the literature. Can you just tell us who are the people out there you are thinking that you think are doing breakthrough work that we should try to give more support to? Dr. Sox. Well, the only name that comes to mind is Dr. Hayley. I do believe that the Baltimore group has been studying the veterans with depleted uranium fragments needs continued support but if--but I really don't think that I should be the person to tell you who ought to be funded. I think that's something for more deliberation. Mr. Sanders. In all due respect, I disagree with that. We need guidance. We are not scientists, you are, and what we need help on is for somebody to come before us and say look these guys have been doing this stuff for 10 years. It's going nowhere in a hurry, this is possible, this is potential we do need that kind of help Mr. Chairman. Mr. Shays. The other place we need help is when you're looking at what studies are available and you realize there just aren't any peer review studies in certain areas. I'd like to--in general, I'd like to read one paragraph, then we're going to get on to the next panel, unless Ms. Schakowsky has any questions. But this is the paragraph on page 3. It's a fairly long one, but I am going to read it all to you. It starts out--it's kind of in the middle of the page. All these short term effects are well documented, and we rank the evidence as sufficient to establish causation, the highest level of evidence. In part, this means--and we're talking about nerve agent sarin--in part, this means many studies have strongly repeatedly and consistently linked these acute health effects and exposures to sarin, and that the greater the exposure, the greater the effect, but the long-term effects of sarin are a very different story. The evidence is far more limited and much weaker. Studies describing three different populations, two involving victims of terrorist attacks in Japan and one involving industrial accidents in the United States, link neurological and psychological symptoms that persisted for 6 months or longer. In one of these studies, some symptoms persisted for up to 3 years, the longest that any of the subjects were followed. In all three studied populations, however, the doses of sarin were high enough to trigger an immediate, intense widespread and acute reaction. Among the conditions that persisted over the long term were fatigue, headaches, blurred vision and symptoms of post traumatic stress disorder. I might just say parenthetically, that's a very common symptom for our veterans who have come before our committee. In other words, people who had long-term symptoms were the ones who had experienced intense symptoms immediately. Now, I want--the keyword here is ``intense.'' How did you define ``intense?'' Was it walking intense or drop dead intense? I mean, fall down intense? What defines ``intense?'' Dr. Potolicchio. The level of exposure was based only on clinical findings, and maybe one laboratory test when it was available. You know, there is no real exposure data on sarin in any of the Japanese populations. We don't know how much any individual got at any time. If you look at the reports and the way they were written up, there was a man that was 100 feet from the release of the gas in Matsumoto, Japan, and he opened the window of his room and that man eventually died in convulsions and respiratory arrest, and he was just a few hundred feet away, but he probably had a maximum exposure but nobody knows exactly how much. Mr. Shays. I am just trying to understand. Dr. Potolicchio. The thing is that when you get to the clinical findings, you say, well, there has to be an intense-- in other words, someone's had an exposure, he, at least, had some symptoms of exposure that we recognize and that would be the acute cholinergic syndrome. Mr. Shays. I understand that. Dr. Potolicchio. Or the enzyme that you measure in the blood is depressed to such a degree---- Mr. Shays. Let me not get to that. Let me just get to your concept of ``intense,'' and I want to relate ``intense'' into war. I mean, I can remember when I was being chased by some older kids who wanted to beat me up, I've never run so fast. I didn't even know that I was exhausted. I was so damn afraid. I ran across a highway without looking either direction, and as far as I was concerned, I was pretty healthy, but later I realized I was just, I was just totally--I was sore, I was always these things and I was sore when I was running, but I didn't know that. I didn't have people shooting at me. So I guess what I'm trying to determine is are you making an assumption that there was not an intense exposure in the Gulf because people didn't fall down or something? Dr. Potolicchio. We're not making an assumption about anything that happened in the Gulf war theater. We're saying if you have an exposure to sarin, you will have acute symptoms. Now whether or not you can identify those---- Mr. Shays. Describe those acute symptoms, please. Dr. Potolicchio. Well, your acute symptoms would be---- Mr. Shays. Would be fatigue, headaches, blurred vision, what? Dr. Potolicchio. No. Mr. Shays. What would they be? Dr. Potolicchio. Your acute symptoms would be difficulty breathing, watery eyes, probably GI upset, in other words, gastrointestinal upset, your muscles might start to twitch, and you can actually go into a convulsion if the exposure is intense enough. Mr. Shays. But not necessarily. All those symptoms I would wager our veterans have experienced in the Gulf, not all of them but a good number, blurred vision. Dr. Potolicchio. You wager they have been exposed to that? Mr. Shays. We had testimony of people describing those very symptoms, not after but during. OK. So the symptoms you have described, just for the record I will state, was statements to us by veterans that they experienced in the theater, clearly. I think we're all set unless you have any, Ms. Schakowsky, any questions. Thank you all very much. Our next witnesses are John Feussner, Dr. John Feussner sorry, chief research and development officer Department of Veterans Affairs accompanied by mark brown Ph.D. director environmental agents study, department of Veterans Affairs. Do you all have anybody else that would help you in any testimony? If so I would ask them to stand up. Thank you and if you're asked to then respond, we would check out the names. I ask you to raise your right hands please. [Witnesses sworn.] Mr. Shays. Note for the record that our witnesses have responded in the affirmative and Dr. Feussner, you will be making the statement, and Dr. Brown you would also be responding to questions. Thank you very much. Appreciate your patience. STATEMENTS OF DR. JOHN FEUSSNER, CHIEF RESEARCH AND DEVELOPMENT OFFICER, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED BY MARK BROWN, Ph.D., DIRECTOR, ENVIRONMENTAL AGENTS SERVICE, DEPARTMENT OF VETERANS AFFAIRS Dr. Feussner. Mr. Chairman and members of the subcommittee, thank you for this opportunity to discuss the status of the current Federal research program on Gulf war veterans illnesses. Accompanying me today is Dr. Mark Brown, who is the director of the VA's Environmental Agents Service. In your invitation letter, you indicated that the purpose of the hearing was to review the findings and recommendations of the recent Institute of Medicine report. You also requested a discussion of the plans for additional research by the IOM and a status report on other research on Gulf war veterans illnesses. To date, the Federal Government is projecting cumulative expenditures of $151 million of Gulf war research from fiscal year 1994 through fiscal year 2000. There are over 192 projects at various stages of completion in the research portfolio on these veterans illnesses. For the sake of brevity, Mr. Chairman, I will only summarize the research recommendation of the Institute of Medicine report and the response of the research working group. With regards to sarin specifically, the IOM has recommended long-term followup of populations exposed to sarin in the Matsumoto and Tokyo terrorist attacks. The research working group concurs with the IOM recommendation. The IOM recommends studies in experimental animals to investigate the long-term effects of acute, short-term exposures to sarin at doses that do not cause overt cholinergic effects. Since 1996, the DOD has funded nine toxicology studies focusing on the effects of sarin, alone or in combination. In addition to the IOM recommendations on animal studies on sarin, the research working group is coordinating three epidemiological studies that are focusing on the health of veterans potentially exposed to low level sarin due to the Khamisiyah demolitions, one at the Navy Health Research Center, a second at the Oregon Health Sciences University, and a third by the Medical Followup Agency of the Institute of Medicine. In addition to the IOM recommendation on animal studies on sarin, the research working group also is coordinating a contract to the medical followup agency to perform an epidemiologic study of the long-term effects of short-term exposure to nerve agents in human volunteers in experiments conducted at the Aberdeen Proving Ground in the 1950's to 1970's. With regard to pyridostigmine bromide, the IOM recommends research on chemical interactions between PB and other agents, such as stressful stimuli and certain insecticides. Since 1994, VA and DOD have funded 30 projects related to PB alone or in combination with other chemicals or stressful stimuli. One important and consistent result of recent studies is that stressful stimuli such as swimming, heat or restraint stress do not cause an increase in the permeability of the blood brain barrier or cause pyridostigmine bromide to cross the blood brain barrier into the brain. The IOM recommends research on differences in genetic susceptibility that may contribute to increased risk of disease. VA and DOD have funded eight projects on genetic factors that may alter the susceptibility to the effects of PB or sarin. Concerning vaccines, the IOM has recommended long-term systematic research to examine potential adverse effects of anthrax and botulinum toxoid vaccination in multiple species and strains of animals. The research working group concurs that long-term research is needed to examine potential adverse effects. Such research is underway in DOD laboratories. Also, the CDC, the Centers for Disease Control and Prevention, plans to fund nonhuman primate studies of the health effects and efficacy of the anthrax vaccine later this year. The IOM has recommended identification of cohorts of Gulf war veterans and Gulf war era veterans for whom vaccination records exist. The CDC published a study of Air Force Gulf war veterans in 1998 which included measuring antibodies to anthrax and botulinum to determine which individuals had received the vaccines. The CDC found no relationship between the vaccinations and development of multisymptom illnesses. Similarly, researchers in the United Kingdom have also published a study this year on a cohort of nearly 1,000 Gulf war veterans for whom vaccination records exist. There was no association between having received the anthrax vaccine and the development of multisystem illness. The IOM has also recommended long-term longitudinal studies of the participants in the anthrax vaccine immunization program. In 1999, DOD funded a long-term longitudinal study of participants in the anthrax vaccine immunization program study located at the Naval Health Research Center. Finally with regard to depleted uranium, the IOM recommended continued followup of the Baltimore cohort of Gulf war veterans with DU exposure. The research working group concurs with the recommendation. While the Baltimore clinicians have seen no definitive evidence of adverse clinical outcomes associated with uranium exposure to date, the veterans who were involved in the friendly fire incidents will remain under continuing medical surveillance. The IOM has recommended continued followup of the cohorts of uranium processing workers. The research working group concurs with this recommendation. The IOM has recommended additional studies of the effects of depleted uranium in animals. DOD has funded five toxicology projects that are investigating the health effects of DU in experimental animals. For example, there was no detectable kidney toxicity in rats embedded with DU pellets, even at very high concentrations of urinary uranium. Mr. Chairman, we know that combat casualties do not always result in obvious wounds and that some veterans from all conflicts return with debilitating health problems. VA recognizes its responsibility for developing effective treatments and prevention strategies for such illnesses. Studies clearly show that some Gulf war veterans report chronic and ill-defined symptoms including fatigue, neurocognitive problems and musculoskeletal symptoms at rates that are significantly greater than nondeployed veterans. Mr. Chairman, thank you again for permitting me this opportunity to summarize our work. You have my assurance that we will continue this effort to resolve, or at least ameliorate health problems in our patients to the greatest extent possible. Mr. Chairman, I will conclude my testimony here and ask that you enter the entire written testimony into the record. I actually think you did that. [The prepared statement of Dr. Feussner follows:] [GRAPHIC] [TIFF OMITTED] T4864.026 [GRAPHIC] [TIFF OMITTED] T4864.027 [GRAPHIC] [TIFF OMITTED] T4864.028 [GRAPHIC] [TIFF OMITTED] T4864.029 [GRAPHIC] [TIFF OMITTED] T4864.030 [GRAPHIC] [TIFF OMITTED] T4864.031 [GRAPHIC] [TIFF OMITTED] T4864.032 [GRAPHIC] [TIFF OMITTED] T4864.033 [GRAPHIC] [TIFF OMITTED] T4864.034 [GRAPHIC] [TIFF OMITTED] T4864.035 [GRAPHIC] [TIFF OMITTED] T4864.036 [GRAPHIC] [TIFF OMITTED] T4864.037 [GRAPHIC] [TIFF OMITTED] T4864.038 [GRAPHIC] [TIFF OMITTED] T4864.039 [GRAPHIC] [TIFF OMITTED] T4864.040 [GRAPHIC] [TIFF OMITTED] T4864.041 Mr. Shays. Already covered, but it doesn't hurt to ask. Let me just, before recognizing Mr. Sanders, say they wish a lot of these studies had begun 10 years ago. I think that many of them are very important and valuable. I think that it's good they're happening. I wish they could have happened sooner, but I guess we call that progress, and Mr. Sanders. Mr. Sanders. Thank you very much, Mr. Chairman. As you know, I have been very critical of the DOD and the VA for many years in this area, but I do want to single out Jack Feussner as somebody who I think for many, many years has been trying to do the right thing, Jack and I appreciate the work you have done. Let me just ask you, you remember, Dr. Feussner, a couple of years ago at a hearing, I had indicated to you that I was distressed that there was some apparently breakthrough work being done around the country, and I asked you if the VA had begun the process of trying to replicate some of that work, tell us whether it was right or wrong, and I think out of that discussion with Chairman Shays' help and so forth, you began a clinical trial based on I think the work of Dr. Nicholson in California dealing with doxycycline, and I know that clinical trial is going on in a hospital in White River Junction in Vermont, hospitals all over this country, and the thesis was that large doses of doxycycline over a long period than had previously been given seemed to indicate that there would be some alleviation of symptoms. That was Nicholson's hypothesis. You were testing it. Do you have anything to report to us today about the progress of that study? Dr. Feussner. Yes, sir, I have progress to report. You're quite correct, the study continues. You're also quite correct to assert that the treatment was doxycycline and the duration of the doxycycline was quite long, 1 year. Because this is a-- while tetracycline is not an experimental or novel therapy, the use of tetracycline---- Mr. Sanders. Doxycycline is what we're talking about. Dr. Feussner. Yes, sir. Mr. Sanders. Tetracycline is the same? Dr. Feussner. Doxycycline is a specific brand of tetracycline. I will try to keep it straight. At any rate, this trial, as you recall, was planned as a collaborative effort between VA and DOD, went through a very rigorous scientific review process that actually included a formal request for an FDA IND, an investigational new drug not because the drug is investigational, but because the condition for which the drug is being used is not approved by the FDA. We initiated the trial formally in May 1999. The goal was to study--enroll up to 450 Gulf war veterans at 28 sites throughout the United States. We have achieved that goal. As a matter of fact, as we intended to close enrollment in the trial, we had a number of veterans who wished to participate, despite the fact that we had met our patient sample size quota. Nonetheless, we included an additional 41 veterans into the trial. The total sample size now is 491. The patient recruitment period is done and the patients are currently in the process of going through that 1-year treatment. Mr. Sanders. Does that include, that 491, is that some of those--half of those people are getting placebos? Dr. Feussner. Correct, yes, approximately 50/50. So the patients are all enrolled in the trial and are all now being treated with the active agent doxycycline, or placebo, are in the process of being followed on that treatment over the course of 1 year. I expect the study to be complete, the followup to be complete next summer, approximately June or so, and that we will have the final result some time after that, some time probably within the next 90 days of completion of the trial. So the trial has been a success. Mr. Sanders. In the sense of organizing it? Dr. Feussner. In the sense of organizing, recruiting patients, but I can't tell you what the results are yet. Mr. Sanders. So in June you will be beginning the process-- you'll be completing the study and beginning the process of analyzing the results? Dr. Feussner. That is correct. You may recall, Congressman, we also started another major trial, that one much more difficult. We call it exercise and behavioral therapy, organizationally more complex for treatment groups. Similarly, we have closed the patient recruitment for the EBT trial. There are four treatment groups, usual care, exercise only, cognitive behavioral therapy only or both interventions. We did not quite meet our goal for patient inclusion. We'd hope to have approximately 1,300 patients enrolled. We have succeeded, however, in enrolling 1,100 patients in the trial and the trial, whatever the result, will be statistically robust. So while we had hoped to have a few more patients, we are very gratified that 1,100 Gulf war veterans have volunteered to help us with the trial. That trial, as you recall, is a little later in the process than the ABT. I don't expect the final end point of that trial until the fall of 2001, and probably around September or so with the same issue that at that point, we will begin the analysis and should have the results--pretty good result within a 90-day period. Mr. Sanders. And I presume--is my time up, Mr. Chairman? Mr. Shays. No, no. Mr. Sanders. I presume that if one or both of those studies indicate that approach alleviates symptoms--that approach will become recommended form of treatment throughout the VA system. Dr. Feussner. Yes, I would say the answer to that question would be yes, that the trials, as you know, the trials are large, they're very expensive and they are constructed to be definitive. So that if the result is positive, then the treatment is known to work, and if the result is negative, then the treatment is known not to work. Mr. Sanders. Dr. Feussner, I am, as you know, not a scientist, and the way my mind works, as I mentioned to you before, and I appreciate you moving with that type of approach, is that if somebody is doing interesting work, we test the hypothesis, and frankly, this work was based on what Nicholson had indicated out in California, is that correct? More or less through other people? Dr. Feussner. As you recall, sir, Dr. Nicholson's work was quite controversial. Mr. Sanders. I sure do. Dr. Feussner. There were two observations. While his results were controversial, one of our own physicians Dr. Gordon had anecdotal experience---- Mr. Sanders. That's right. Dr. Feussner [continuing]. On his own in a significant number, not two or three, but perhaps several dozens of patients where he had observed clinically that he had tried the therapy and believed that the therapy worked. Mr. Sanders. Dr. Gordon from Manchester, New Hampshire? Dr. Feussner. Yes, sir. Mr. Sanders. That's right. And it seems to me that a good administrator, such as yourself, listens to those people, who may only have anecdotal evidence of some success. OK. So I am applauding you for this, but let me ask you this, getting back to the question I asked Dr. Sox a moment ago, if there appears to be some breakthroughs, what you're saying is if Dr. Gordon came to you and said listen, I'm applying this treatment, it appears to be working, let's go further with it and you said yeah, let's go further with it, Nicholson did his work, and I think you did exactly the right thing, what about the work that people like Hayley or Urnovitz or Miller are doing out there? There is also anecdotal evidence that there may be some breakthroughs. Are you prepared to say come on in, let's work together, let's see, in fact, to answer the question that Dr. Sox raised with Hayley's work that the sampling was too small, there hasn't been enough replication, are you going to help us--tell us whether or not Hayley is on to something or whether he's not? Dr. Feussner. Well, before we get to Dr. Hayley's work specifically, Congressman Sanders, you will recall that some years ago, I believe in 1998, that VA announced an open-ended what we call RFP, request for proposals, DOD calls BAA, broad area announcement, indicating our receptivity to treatment trials of any novel therapy agent. That RFP is still active, but I will concede that we perhaps should reannounce it just to make sure that those that need to know are reminded that that is still active. Mr. Sanders. What I am asking, Dr. Feussner, you know what I'm asking, are we welcoming in the door people who have controversial ideas who are not quote unquote, peer reviewed by folks who have not given us any information in 10 years? Are you having the courage to go out and say, look, people may--I may be attacked for going to somebody who is controversial, but I'd rather be attacked for going to somebody who is controversial and may contribute something to our knowledge rather than go back to the same old folks who 20 years from now tell us we don't know the cause. Are you prepared to do that, to take the heat? Mr. Shays. You recognize that's a loaded question, don't you? Mr. Sanders. You understand where I am coming from? Dr. Feussner. Sir, I certainly do understand where you're coming from, and what I would say is I think our actions do speak to that issue, and that is, that we have followed up with larger scale research, looking at reasonable testable hypotheses, specifically with regard to Dr. Hayley. Dr. Hayley published preliminary work in the Journal of the American Medical Association exploring possible definition for a number of Gulf war syndromes. You will recall that very early on after that work is published, I had the opportunity to testify before the committee. I think that Dr. Sox's point is well taken. Dr. Hayley studied a small number of study subjects. His response rate in the initial study, even in a highly selected patient population, was only 40 percent. There were no controls. But the observation bore attention, OK. I mean, he put something on the table. Now, the follow-on to that is it's--as you know, because we've talked about this a lot, scientific process. It's not important for the initial investigator to replicate his or her own work but for other scientists to do that. We have supported four follow-on studies looking at those syndromes, three in the United States and one in the United Kingdom. The United Kingdom was published in the Journal Lancet by Dr. Wesley. We have the Naval Health Research Center in San Diego. We have the CDC study of Fukuda and colleagues, and we have the Iowa study just recently published this year in the American Journal of Medicine. None of those studies is able to replicate Dr. Hayley's initial observations in terms of finding the kinds of unique syndromes that Dr. Hayley found in his preliminary hypothesis-generating research. What we are left with in that effort is, one, we have followed on the effort to replicate the work. We have not been able to replicate the work at this point in time. But actually, there is yet another study that we are supporting in collaboration with researchers at GW using the same analytical strategy, etc. Mr. Sanders. What you're saying is you've taken Hayley's work seriously, you're putting money and resources into trying to replicate it, at this point that has not happened. Dr. Feussner. In that particular one we have not been able to replicate the work. With regard to the work on the structural brain disease, we have talked about that at the hearing in February, and we have a number of studies ongoing that are looking also at structural brain disease. The most--and so, an effort is underway to try to explain, replicate, extend that observation. The most recent observation, actually I haven't had an opportunity to go over in detail myself. It is quite recent, within the last week or so, looking at neurotransmitters, chemicals in the brain that tell other parts of the brain what to do, and since the brain tells the rest of the body everything to do, very important, called--dopamine is the chemical. We haven't taken a hard look at that yet, but what I will tell you, the worry here has to do with Parkinson's disease, and independent of this issue with Hayley, VA is currently reviewing, as a result of another RFP VA is currently reviewing, and hopefully later this calendar year will fund up to six major centers, research centers devoted to the study of Parkinson's disease and movement disorders. We call them PADRECC's, Parkinson's Disease, Research Education and Clinical Centers, modelled after the VA-funded geriatric centers. So that we will have the capacity, I believe, within--at least within VA, certainly within the broader scientific community, to follow on those observations. So I think what I'm doing, Congressman, is giving you a long answer to a short question. Mr. Sanders. It's a good answer. Let me ask you this and I'll give the mic back to the chairman. I remember, sometimes there are instances where things occur and you never forget them, but I remember meeting with many Vermont veterans who are suffering from Gulf war illness, and one of the symptoms, many of them relayed to me is when they were exposed to perfume or detergent smells or other chemical presence, gasoline fuels, they would become sick, which suggested to me that we're looking perhaps at what might be called multiple chemical sensitivity, and as you know, I am sympathetic to the work that Dr. Claudia Miller and others are doing. Can you tell us a little bit about some of the research the VA may or may not be doing in following up on the issue of multiple chemical sensitivity in Gulf war illness? Dr. Feussner. I think what I would have to say, Congressman Sanders, is that the last time you asked that question, I don't have much of a different answer to give you this time. We have about half a dozen or so research projects looking at the issue of multiple chemical sensitivity. They're currently active. In a response to a meeting that we had with you in your chambers some time ago, we invested a considerable amount of energy trying to forge a collaboration between Dr. Miller and VA investigators, both in San Antonio and, as I recall, in Tucson with Dr. Iris Bell, who's testified before you in the past. We have also indicated, as you know, the interest in explicitly looking at prospective treatment trials and also, as you know, some of the difficulty in pursuing those ideas aggressively relate to the infrastructure that is required in order to do the research. It's not as---- Mr. Sanders. Let me just jump in and bring this to the point. To the best of my knowledge the U.S. Government, despite the widespread feeling of many physicians, certainly not all, that multiple chemical sensitivity is a serious disease not only facing Gulf war veterans but the American population. Correct me if I'm wrong, Dr. Feussner, but I don't know that the Veterans Administration or DOD owns what is called an environmental chamber where we can do scientific studies regarding treatment of multiple chemical sensitivity. Is that a fair statement? I know we're trying to get funding for it, but it's beyond my comprehension that the U.S. Government doesn't own one of those units quite yet. Dr. Feussner. I think I answered that question the last time and said yes, the U.S. Government does own these facilities. I am searching my hard drive to find those data, sir. What I can tell you is the VA does not. I can't recollect about DOD. I do recollect that EPA has such laboratories in the research triangle in North Carolina, and I do believe that DOD has several of these facilities, but I cannot remember the last time I looked this up. I'll have to---- Mr. Sanders. Short term memory loss, multiple chemical sensitivity, there it is. Thank you very much, Mr. Chairman. Mr. Shays. I'm just going to have a slight advertisement for a committee meeting that we're having next week on Gulf war illnesses. The Royal British legion formed a Gulf veterans group some years ago to provide a focus for Gulf veterans issues. It is made up of Gulf veterans, parliamentarians, representatives of VSOs and service welfare organizations and medical and scientific advisers. A delegation from the Gulf war veterans group visited the United States in July 1995 and similar group intend to visit Washington, DC, from October 2nd to 6th. We will be meeting with a group on Wednesday, October 4th from 10 a.m. in room 2154 with Lord Morris, the distinguished parliamentarian, with a background in trades and union members; Colonel Terry English, director of welfare at the Royal British legion; Kathy Walker, director of welfare, the Soldiers, Sailors and the Airmen Families Association; Dr. Norman Jones, medical adviser, Royal British Legion; Mr. John Nichol, author, Gulf war veteran and ex-POW; Professor Malcolm Hooper, scientific adviser, Gulf Veterans Association. Let me first ask you, Dr. Brown, is there anything that you would want to respond to Mr. Sanders, any comment or observation? Dr. Brown. No. When it comes to research issues, Jack is your man. Mr. Shays. OK. Well, I'll ask either one of you, how many of the 83 research projects--there are 192 research projects in Gulf war veterans illnesses at various stages of completion, 83 have been completed, and I want to know of the 83 projects completed, how many have been published and peer reviewed? Dr. Feussner. I'll have to get that information for you, Congressman Shays. Mr. Shays. Could someone else give us that? Dr. Feussner. We don't have that off the top of our heads. Mr. Shays. How many completed projects involve sarin and have been published and peer reviewed? Dr. Feussner. I will have to get those data for you as well. Mr. Shays. How many involving PB? Dr. Feussner. How many are already finished and published? Mr. Shays. Published and peer reviewed. Dr. Feussner. I think it's approximately six to eight. Mr. Shays. OK. How many as relates to DU, depleted uranium? Dr. Feussner. I would say, again, probably six or seven. Mr. Shays. And how many involving vaccines? Dr. Feussner. I don't know the answer to that question. I'll have to get you those data. Mr. Shays. I know you will do that. I do want to ask the questions though. What yet unpublished studies are underway which would address the long-term effects of exposure to these toxic agents? Dr. Feussner. Well, there are quite a large number of projects that are still ongoing. For example, in PB, the total number of funded projects is about 30. With regard to chemical weapons, there are about 22. The DU focus at the moment in humans is pretty much limited to followup of the friendly fire soldiers in Baltimore, and there are a small number of probably four or five animal studies in DU. Mr. Shays. OK. Dr. Feussner. Did I answer all the parts? Mr. Shays. Well, it's a pretty extensive question. You said there are many. Do you think, in fact, there are many? Dr. Feussner. Yes. Mr. Shays. OK. And by ``many,'' you would give a number of what approximately? Dr. Feussner. For which issue? Mr. Shays. I just asked what yet unpublished studies are underway which address the long-term effects of exposure to these toxic agents which involve those four agents. Dr. Feussner. Yes, I could do the math real quick. Mr. Shays. Some you don't know. You said many. Are we talking 20, are we talking 80? I mean, what are we talking about? Dr. Feussner. In terms of total number of projects I think we're talking about in the ballpark of perhaps 100. Mr. Shays. And you will get back to us and document those? Dr. Feussner. You not only want the number of projects, you want the number of projects, those finished and the publication? Mr. Shays. Right. Dr. Feussner. Yes, sir, I'll have to get you that data. [The information referred to follows:] [GRAPHIC] [TIFF OMITTED] T4864.042 [GRAPHIC] [TIFF OMITTED] T4864.043 [GRAPHIC] [TIFF OMITTED] T4864.044 [GRAPHIC] [TIFF OMITTED] T4864.045 Mr. Shays. I understand. According to a January 2000 General Accounting Office report on Gulf war illnesses, the Department of Veterans Affairs stated that the research working group, which I'll refer to as RWG, would, ``establish a date in fiscal year 1999 or fiscal year 2000 for publishing its assessment of progress toward addressing the 21 research objectives that's identified in 1995.'' When will the research group assessment's of progress toward addressing the 21 research objectives be published? Dr. Feussner. We've actually made a substantial progress in this area, Congressman. We discussed this at our last hearing, and the majority, 11 of the 15 papers that we had commissioned at that time are in draft form. We have worked with a very prestigious medical journal, and the editor of that journal to not only produce these papers for the Congress, but to produce these papers for the larger community. We have a commitment from---- Mr. Shays. Isn't that the key? The larger community is complaining to us that they're not getting access to this research. Dr. Feussner. Yes, I think that is the issue. Mr. Shays. To date, we don't really have any published. Dr. Feussner. The papers have received preliminary review by the editor of the journal already, but the next step for the manuscripts will be to go out to independent experts to get an additional episode of review. I would hope that the manuscripts would be published electronically after the 1st of the year, perhaps the second quarter of fiscal year 2001. We have discussed with the editor the possibility of publishing the manuscripts electronically while we await for the manuscripts to appear in print. It is my hope that we can have the manuscripts in electronic format between January and March and in print as a special supplement, probably between March and May. Mr. Shays. So basically you're in fiscal year---- Dr. Feussner. I am in fiscal year 2001. Mr. Shays. Right. You're really at the end of that fiscal year--well, it starts in September. Dr. Feussner. Yes. Mr. Shays. Not in the end. You're kind of in the middle. What is the research working group's role with the Military and Veterans Health Coordinating Board? Dr. Feussner. Well, the research working group, the Military and Veterans Health Coordinating Board has three subcomponents underneath the executive, the executive leader. The research is one of those three subgroups. Within the research group, there will really be two primary foci. The first will be the Gulf war research activities, since 60 percent of these projects are incomplete. As a matter of fact, I think just in fiscal year 1999 and 2000, we have launched 42 additional studies. The second component of the research activity within the military and veterans coordinating board will deal more specifically with the generic issue of post deployment health and three major, at least three major interests within that area will include an effort to improve the situation with regards to systematically obtaining baseline data so that after subsequent deployments, we will systematically have baseline data; systematically collect data through time on the soldiers which would also require an integration and a merging of the VA and DOD data bases; and then increasingly apply research activities or research results became available that could document exposures. Mr. Shays. To what extent will the absorption of the RWG into the new Military and Veterans' Health Coordinating Board diminish the RWG's focus on Gulf war illnesses, veterans illness research? Dr. Feussner. Well, it is my intent that it not diminish the focus on Gulf war veterans' illness, and given the incomplete status of the formal research and the emerging research that is going to be initiated with regards to post deployment health issues, I would imagine over the next period of time, say the next 3 or 4 years, that the dominant research effort within that larger group will continue to be Gulf war research projects. Mr. Shays. I'm going to try to finish because Mr. Sanders and I need to vote, but to what extent is the new board fully operational? Dr. Feussner. The new board has already engaged in a series of meetings several weeks ago. All leaders of the boards and a larger community of involved participants had a 2-day retreat at Andrews Air Force Base. We are completing the formal strategic planning process for the coordinating board and have identified the three leaders of the three major subgroups. Mr. Shays. So you haven't started being operational yet but you're at that point? Dr. Feussner. I think that's fair. Mr. Shays. According to a General Accounting Office, GAO, January 2000 report on Gulf war illnesses, questions remain regarding, ``how many veterans have unexplained symptoms and whether those who have received care in VA facilities are getting better or worse.'' What progress has been made toward developing a system of tracking clinical efforts and treatment outcomes among sick Gulf war veterans? Dr. Brown. I'll take a stab at that. We have a number of ways in which we track the health of Gulf war veterans. The Institute of Medicine recently released a report that I'm sure you're aware of which made the point that if we really want to study the long-term health consequences of service in the Gulf war, that is, your question whether veterans are getting better or worse are staying the same, that you need to set up appropriate longitudinal studies to follow those populations. We have a couple of studies already underway that are looking at subgroups of veterans. Dr. Feussner mentioned the Iowa study. I also want to make this committee aware, we just published a report just last April on a study that was looking at the health of all Gulf war veterans, called National Veterans Health Survey, looked at the health of all Gulf war veterans across the board. I can provide the committee with a copy of the report. It found similarly to other studies that when you look at a national survey of all Gulf war veterans, that you find greater rates of symptoms, greater rates of illnesses in terms of self-reported symptoms, and a number of other findings. It is unique in that it's the only study that looks across the board at all veterans, and it's our intention--it's my office's intention to follow that study up in a longitudinal sense. Mr. Shays. Basically though what I am hearing you say, we really don't have a system yet to track. Dr. Brown. I think we do have some initial data. Mr. Shays. You have data but you don't have a system, you are not tracking all these. Dr. Brown. The system that would do that for us would be a longitudinal study. Mr. Shays. ``Would be'' is not---- Dr. Brown. We don't have that in place yet. Mr. Shays. This is all. And finally, what is the Department of Veterans Affairs doing about obtaining access to classified information? This really galls me that we don't have information. I mean we had the DOD who said our troops weren't exposed to offensive chemical exposure, and yet they were exposed to defensive chemical exposure. So I want to know what the VA's doing. Are we just lying back or are we trying to get this information? Dr. Feussner. In the research mode, we have not made efforts to get classified information. Two comments. The first is that my understanding is that the IOM will gain access at least to unpublished information about anthrax research in a new study that is being undertaken by them, and that with regard to CW, chemical weapons, issues that both the Presidential Advisory Commission and the Senate Veterans Affairs Investigating Committee had access to that classified information. Mr. Shays. The challenge we do have is the IOM did not have access to certain information. Dr. Feussner. That is correct. Mr. Shays. And I think it galls both me and Congressman Sanders that that's not made available, and it would strike me that anybody who's worked with our veterans would demand the same, so I just plead with you to be a little more aggressive. We will. We'd like you to be as well. I think what we'll do, I usually invite comments, if you have a 30 second comment either one of you, I'd welcome that, but we need to get voting. Any comment? Dr. Feussner. No, sir. Mr. Shays. Thank you both for being here. 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