H. TREATMENT AND RESEARCH

The GAO Report on "Gulf War Illnesses" responded to the mandate of the Fiscal Year 1997 Defense Authorization Act. GAO examined three issues and made findings and recommendations based on results of the study. The GAO conducted a 6-month study on the Government's clinical care and medical research programs relating to illnesses that members of the armed forces might have contracted as a result of their service in the Persian Gulf War.⁽¹⁹⁵⁾
Issue 1: The efforts of DOD and VA to assess the quality of treatment and diagnostic services provided to Gulf War veterans and their provisions for follow-up of initial examinations.
Finding: Neither DOD nor VA has systematically attempted to determine whether ill Gulf War veterans are any better or worse today than when they were first examined.
Issue 2: The Government's research strategy to study the Gulf War veterans' illnesses and the methodological problems posed in its studies.
Finding: The majority of the research has focused on the epidemiological study of the prevalence and cause of the illnesses rather than diagnosis, treatment, and prevention of them.
Issue 3: The consistency of key official conclusions with available data on the causes of the veterans' illnesses.
Finding: Support for some official conclusions regarding stress, leishmaniasis (a parasitic infection), and exposure to chemical agents was weak or subject to alternative interpretations.
Dr. Donna Heivilin, Director of Planning and Reporting for GAO's National Security and International Affairs Division, appeared before the Human Resources Subcommittee on June 24, 1997, to review results of the GAO study. Concerning the quality of medical treatment and diagnostic services, Dr. Heivilin stated: "Over 100,000 of the approximately 700,000 Gulf War veterans have participated in DOD and VA health examination programs [DOD's Comprehensive Clinical Evaluation Program or CCEP, and VA's Persian Gulf Health Registry]. Of those veterans examined, nearly 90 percent have reported a wide array of health complaints and disabling conditions. Officials of both DOD and VA have claimed that regardless of the cause of veterans' illnesses, veterans are receiving appropriate and effective symptomatic treatment. Both agencies have tried to measure or ensure the quality of veterans' initial examinations through such mechanisms as training and standards for physician qualification. However, these mechanisms do not ensure a given level of effectiveness for the care provided or permit identification of the most effective treatments."
"We found that neither DOD nor VA has mechanisms for monitoring the quality, appropriateness, or effectiveness of these veterans care or clinical progress after their initial examination and has no plans to establish such mechanisms. VA officials involved in administering the Health Registry program told us they regarded monitoring the clinical progress of registry participants as a separate research project, and DOD's [CCEP] program made similar comments."
Dr. Heivilin said that such monitoring is important because: 1) undiagnosed conditions are not uncommon among ill veterans; 2) treatment for veterans with undiagnosed conditions is based on their symptoms; and 3) veterans with undiagnosed conditions or multiple diagnoses may see multiple providers.
"Without follow-up of their treatment, DOD and VA cannot say whether these ill veterans are any better or worse today than when they were first examined." ⁽¹⁹⁶⁾
Concerning the Government's research strategy, Dr. Heivilin stated: "Federal research on Gulf War veterans' illnesses and factors that might have caused their problems has not been pursued proactively. Although these veterans' health problems began surfacing in the early 1990's, the vast majority of research was not initiated until 1994 or later. This 3-year delay has complicated the task facing researchers and has limited the amount of completed research currently available. Although at least 91 studies have received Federal funding, over 70 or four-fifths of the studies are not yet complete, and the results of some studies will not be available until after the year 2000." ⁽¹⁹⁷⁾
"We found that some hypotheses [about causes of the illnesses] received early emphasis, while some hypotheses were not initially pursued. While research of exposure to stress received early emphasis, research on low level chemical exposure was not pursued until legislated in 1996. The failure to fund such research cannot be traced to an absence of investigator-initiated submissions. According to DOD officials, three recently funded proposals on low level chemical exposure had previously been denied funds. We found that additional hypotheses were pursued in the private sector. A substantial body of research suggests that low level exposure to chemical warfare agents or chemically related compounds, such as certain pesticides, is associated with delayed or long-term health effects." ⁽¹⁹⁸⁾
Dr. Heivilin said there is evidence from animal experiments, studies of accidental human exposures, and epidemiological studies of humans that low level exposures to certain organophosphorus compounds, including Sarin nerve agents to which some of our troops may have been exposed, can cause delayed, chronic neurotoxic effects. The ill-defined symptoms may be associated with objective brain and nerve damage, and due in part to organo-phosphate-induced delayed neurotoxicity [OPIDN], according to Dr. Heivilin.⁽¹⁹⁹⁾
Studies "further linked the veterans' illnesses to exposure to combinations of chemicals [emphasis added]," Dr. Heivilin stated, "including nerve agents, pesticides, insect repellants, and pyridostigmine bromide tablets. Exposure to combinations of organophosphates and related chemicals ... has been shown in animal studies to be far more likely to cause morbidity and mortality than any of the chemicals acting alone."⁽²⁰⁰⁾
The GAO study found the ongoing epidemiological Federal research suffered from two methodological problems: a lack of case definition, and absence of accurate exposure data. Without valid and reliable data on exposures and the multiplicity of [chemical] agents to which the veterans were exposed, researchers will likely continue to find it difficult to detect relatively subtle effects and to eliminate alternative explanations for Gulf War veterans' illnesses. The study found that while multiple federally funded studies of the role of stress in the illnesses have been done, basic toxicological questions regarding the substance to which they were exposed remain unanswered.⁽²⁰¹⁾
Dr. Heivilin stated: "We found that Federal researchers have faced several methodological challenges and encountered significant problems in linking exposures or potential causes to observed illnesses or symptoms. For example:

• Researchers have found it extremely difficult to gather information about exposures to such things as oil well fire smoke and insects carrying infection.
• DOD has acknowledged that records of the use of pyridostigmine bromide and vaccinations to protect against chemical/biological warfare exposures were inadequate.
• Gulf veterans were typically exposed to a wide array of agents, making it difficult to isolate and characterize the effects of individual agents or to study their combined effects.
• Most epidemiological studies on Gulf illnesses have relied only on self-reports for measuring most of the agents to which veterans may have been exposed.
• Information gathered from Gulf veterans gathered years after the war may be inaccurate or biased. There is often no straightforward way to test the validity of self-reported exposure information. As a result, findings from these studies may be spurious or equivocal.
• Classifying the symptoms and identifying illnesses of Gulf veterans have been difficult. From the outset, symptoms reported by veterans have been varied and difficult to classify into one or more distinct illnesses. It has thus been difficult to develop a case definition (that is, a reliable way to identify individuals with a specific disease), which is a criterion for doing effective epidemiological research.

"In summary," Dr. Heivilin stated, "the ongoing [Federal] epidemiological research will not be able to provide precise, accurate, and conclusive answers regarding the causes of veterans' illnesses because of these formidable methodological problems." ⁽²⁰²⁾

I. OTHER EXECUTIVE AGENCY ACTIONS ON GULF VETERANS' ILLNESSES

DOD and CIA Gulf War Illnesses Investigation Teams
In November 1996, Deputy Secretary John White appointed Bernard Rostker, Ph.D. economist and Assistant Secretary of Navy Manpower, to the position of Special Assistant for Gulf War Illnesses. Under Dr. Rostker, DOD expanded its Gulf illness investigative team from 10 to more than 100 people. It was up to an estimated 150 people as of October 1997. To date, the DOD team has focused its investigation mainly on troop chemical exposures from fallout resulting from the Iraqi bunker detonations at Khamisiyah, and on case narratives to disprove specific chemical detection incidents reported by military specialists such as Human Resources Subcommittee witnesses Major Johnson and Gy/Sgt. Grass.
On March 3, 1997, Deputy Secretary John White directed the DOD Inspector General to take over the investigation of what happened to the missing nuclear, biological, chemical [NBC] logs maintained at U.S. Central Command during the Gulf War. As mentioned, in March 1997 Dr. Stephen Joseph resigned. In April 1997, Secretary Cohen named former Senator Warren Rudman as his special advisor on Gulf War illnesses. In July 1997, Deputy Secretary White resigned. DOD's former Deputy Assistant Secretary for Health Affairs, Dr. Sue Bailey, is expected to be nominated by the President to replace Dr. Joseph.
In March 1997, CIA Director George Tenet formed a Task Force on Gulf War Illnesses headed by Robert Walpole. The team's assignment is to declassify and make public as many CIA documents as possible concerning the controversy about events at Khamisiyah. To date, 41 documents have been released, ⁽²⁰³⁾ 1 of which indicates the CIA had received warnings in the 1980's that chemical weapons were stored in Khamisiyah munitions bunkers.
According to the Congressional Research Service [CRS], "On April 9 [1997], amid growing tension and charges of a cover-up, the CIA released a report showing that the agency had solid intelligence in 1986 that thousands of chemical weapons had been stored at Khamisiyah. However, the CIA failed to include the depot on a list of suspected CW sites provided to the Pentagon before the war. The CIA warned the Army of the possible presence of chemical weapons at Khamisiyah just days before the depot was blown up, but the information was not relayed to the engineers who carried out the detonations."⁽²⁰⁴⁾

Presidential Advisory Committee on Gulf War Veterans' Illnesses
President Clinton established the Presidential Advisory Committee on Gulf War Veterans' Illnesses [PAC] in May 1995 to examine the health concerns related to Gulf War service. The Committee, a 12-member panel made up of veterans, scientists, health care professionals, and policy experts, held 18 meetings between August 1995 and November 1996 to hear witness testimony and take public comment. A Final Report of findings and recommendations was issued December 31, 1996. However, the President extended the panel's investigation until September 30, 1997. The PAC held additional meetings this year, with plans to present its updated Special Report to the President by late October 1997.
While the PAC's December 1996 report found that "many veterans have illnesses likely to be connected to their service in the Gulf," it did not support a causal link between the illnesses and exposures to environmental risk factors.⁽²⁰⁵⁾ In the face of overwhelming evidence that Gulf War veterans were exposed to multiple toxic agents, the PAC instead placed emphasis on stress as a cause of these health problems. The PAC report stated: "Stress is likely to be an important contributing factor to the broad range of illnesses currently being reported by Gulf War veterans." ⁽²⁰⁶⁾
The PAC also discounted most environmental risk factors as causes of veterans illnesses. The December report stated: "Current scientific evidence does not support a causal link between the symptoms and illnesses reported by Gulf War veterans and exposures while in the Gulf region to the following environmental risk factors assessed by the Committee: pesticides, chemical warfare agents, biological warfare agents, vaccines, pyridostigmine bromide, infectious agents, depleted uranium, oil well fires and smoke, and petroleum products." ⁽²⁰⁷⁾
The PAC report did identify DOD and VA "problems related to missing medical records, the absence of baseline health data, inaccurate records of troop locations, and incomplete data on the health effects of what should have been viewed as reasonably anticipated risks."⁽²⁰⁸⁾
As numbers of troops presumed exposed to chemical weapons continued to rise following the events at Khamisiyah, DOD's handling of the investigation into the Gulf veterans' illnesses came under criticism from PAC members and staff. In September 1996, the PAC's chief investigator, James Turner, stated in a committee hearing that since the Gulf War, DOD's position has remained essentially unchanged "and inflexible ... in the face of growing evidence that there were possible low level exposures." Turner said DOD's position "can be summarized in three no's ... there was no use, no exposures, and no presence of chemical warfare agents in-theater."
Turner stated, "The slow, reluctant on-again, off-again release of information to the public by the ... [DOD's] senior level oversight panel, has also served to undermine credibility and confidence in the DOD's efforts. To fulfill the government's obligation to tell the truth about chemical warfare agent exposures to veterans and the American public, DOD's investigations must be timely, thorough, independent, credible and public. On each of these counts ... DOD's efforts have fallen short of the mark."
Turner's statement found the evidence of chemical agent release at Khamisiyah overwhelming, other site-specific exposures must be presumed, and DOD has conducted a superficial investigation of possible chemical and biological exposures "which is unlikely to provide credible answers to veterans' questions."⁽²⁰⁹⁾
In the PAC's final public hearing September 5, 1997, monitored by Human Resources Subcommittee staff and covered by national news media, the PAC did not amend its conclusions about the importance of stress as a cause of Gulf War illnesses, nor its rejection of most environmental risk factors as possible causes. Some panel members suggested that the updated Final Report include a statement acknowledging the possibility of low level chemical warfare exposures, but no vote on the proposal was taken.
Members did agree in the final meeting, however, to recommend that the Pentagon's investigation of Gulf War illnesses be transferred to another agency in view of DOD's loss of credibility in the handling of chemical weapons exposures.
"The Pentagon is failing in a multimillion dollar effort to salvage its credibility among ailing Persian Gulf War veterans for its investigations into the possible sources of their illnesses, according to the draft of a final report by a White House advisory committee," the Washington Post reported.
"The report," according to the Post, "scheduled to be presented to President Clinton next month, concludes, `Public mistrust about the government's handling of Gulf War illnesses not only has endured, but has expanded' in the 10 months since the Defense Department, at the panel's urging, agreed to intensify its research efforts. It blames the office of the Pentagon's special assistant for Gulf War illnesses [Dr. Bernard Rostker] for failing to examine reported incidents thoroughly and suggests the DOD may be institutionally incapable of acknowledging that chemical exposures could have occurred." <sup>(210)</sup>
In a the New York Times article, Defense Secretary William Cohen took issue with the PAC's recommendation. "I think that the Pentagon is fully capable of conducting an investigation. So I would disagree with that recommendation."<sup>(211)</sup>
Others also disagree with the PAC. In a letter to PAC Chairman Dr. Joyce Lashof, Congressman Bernard Sanders (I-VT), a subcommittee member, called for a reassessment of the PAC's conclusions relating to stress and environmental factors in its Final Report to the President in view of the growing numbers of troops that were exposed to chemical weapons and other toxic agents. The letter, signed by more than 80 Members of Congress including Subcommittee Chairman Christopher Shays, stated:
"We are writing to ask you to reassess your conclusion that current scientific evidence does not support a causal link between the symptoms and illnesses reported by Gulf War veterans and their exposure to a variety of chemicals during their service in the Persian Gulf War. In fact, it is our belief that more and more scientific evidence suggests that a major cause of Persian Gulf illness is the synergistic effect of a wide variety of chemicals to which our soldiers were exposed. Our hope is that by reassessing your conclusion, you will recommend increasing research into and treatment for the health effects of chemical exposures experienced in the Persian Gulf."<sup>(212)</sup>
In response, Dr. Lashof informed Congressman Sanders that "... peer-reviewed literature published since the Final Report does not, to date, indicate a causal link between the commonly cited risk factors and the broad range of illnesses currently being reported by Gulf War veterans." <sup>(213)</sup>
Concerning the PAC's official conclusions about the causes of Gulf veterans' illnesses, GAO's Dr. Heivilin in her June 24, 1997 statement to the Human Resources Subcommittee hearing said: "Six years after the war, little is known about the causes of Gulf War veterans' illnesses. In the absence of official conclusions from DOD and VA, we examined conclusions drawn in December 1996 by the Presidential Advisory Committee on Gulf War Veterans' Illnesses [PAC]."
"First, the Committee [PAC] concluded that `stress is likely to be an important contributing factor to the broad range of illnesses currently being reported by Gulf veterans.' While stress can induce physical illness, the link between stress and these veterans' physical symptoms has not been firmly established. For example, a large-scale federally funded study [by Walter Reed Army Institute of Military Medicine, see footnote 8] concluded that for those veterans deployed to the Gulf War `neither stress nor exposure to combat or its aftermath bear much relationship to their distress.' The Committee stated that `epidemiological studies to assess the effects of stress have found higher rates of PTSD than among individuals in nondeployed units.' Our review indicated that the prevalence of PTSD among Gulf veterans may be overestimated due to problems in the methods used to identify it. Specifically, the studies on PTSD to which the Committee refers have not excluded other conditions, such as neurological disorders that produce symptoms similar to PTSD [emphasis added] and can also elevate scores on key measures of PTSD."
"Second, the Committee concluded that `it is unlikely that infectious diseases endemic to the Gulf region are responsible for long term health effects in Gulf veterans, except in a small known number of individuals.' Similarly, the Persian Gulf Veterans Coordinating Board [comprised of representatives of DOD, VA, and HHS] concluded that because of the small number of reported cases `the likelihood of leishmania tropica as an important risk factor for widely reported illness has diminished.' While this is true for observed symptomatic infection with the parasite, the prevalence of asymptomatic infection is unknown, and such infection may reemerge in cases in which the patient's immune system becomes deficient."
"As the Committee noted, the infection may remain dormant up to 20 years. Because of this long latency, the infected population is hidden, and because even classic forms of leishmaniasis are difficult to recognize, we believe that leishmania should be retained as a potential risk factor for individuals who suffer from immune deficiency."
"Third, the Committee also concluded that it is unlikely that the health effects reported by many Gulf veterans were the result of: 1) biological or chemical warfare agents; 2) depleted uranium; 3) oil well fire smoke; 4) pesticides; 5) petroleum products; and 6) pyridostigmine bromide or vaccines. However, our review of the Committee's conclusions indicated:

• While the Government found no evidence that biological weapons were deployed during the war, the United States lacked the capability to promptly detect biological agents, and the effects on one agent, aflatoxin, would not be observed for many years.
• Evidence from various sources indicates that chemical agents were present at Khamisiyah,** Iraq and elsewhere on the battlefield. The magnitude of the exposure to chemical agents has not been fully resolved. As we recently reported, 16 of 21 sites categorized by Gulf War planners as nuclear, biological and chemical [NBC] facilities were destroyed. However, the United Nations Special Commission found after the war that not all of the possible NBC targets had been identified by U.S. planners. The Commission has investigated a large number of the facilities suspected by U.S. authorities as being NBC related. Regarding those the Commission has not yet inspected, we determined that each was attacked by Coalition aircraft during the Gulf War. One site is located close to the border, where Coalition ground forces were located.
• Exposure to certain pesticides can induce a delayed neurological condition without causing immediate symptoms.
• Available research indicates that exposure to pyridostig-mine bromide can alter the metabolism of organophosphates (the chemical family of some pesticides used in the war, as well as certain chemical warfare agents) in ways that enhance chronic effects on the brain.⁽²¹⁴⁾

Dr. Heivilin concluded her statement with the following: "In our report, we recommended that the Secretary of Defense, with the Secretary of Veterans Affairs:

1. - set up a plan for monitoring the clinnical progress of Gulf War veterans to help promote effective treatment and better direct the research agenda;
2. - give greater priority to research on effective treatment for ill veterans and on low level exposures to chemicals and their interactive effects, and less priority to further epidemiological studies; and,
3. - refine the current approaches for diagnosing post-traumatic-stress-disorder consistent with suggestions recently made by the Institute of Medicine. The Institute noted the need for improved documentation of screening procedures and patient histories, and the importance of ruling out alternative causes of impairment.⁽²¹⁵⁾

III. FINDINGS

[NOTES]

195. See supra note 48, p. 1.
196. Statement of Donna Heivilin, Human Resources Subcommittee hearing, No. 3, pp. 47-48.
197. Ibid., pp. 48-49.
198. Ibid., p. 49.
199. Ibid., p. 50.
200. Ibid., p. 51.
201. Ibid., pp. 52-53.
202. Ibid., pp. 53-54.
203. See supra note 77.
204. See supra note 4.
205. PAC Final Report, Executive Summary, p. 2.
206. Ibid., p. 125.
207. Ibid.
208. Ibid., p. 4.
209. Statement of James Turner, Chief Investigator, Presidential Advisory Committee on Gulf War Veterans' Illnesses [PAC], September 4-5, 1996, p. 5.
210. McAllister, Bill, "Mistrust of Pentagon on Illness in Gulf Grows, Report Concludes," Washington Post, September 24, 1997, p. 2.
211. Krauss, Clifford, "Pentagon Should Retain Role In Illness Inquiry, Cohen Says," New York Times, September 26, 1997, p. A24.
212. Letter from Representative Bernard Sanders (IVT) to Joyce Lashof, June 20, 1997 (copy in subcommittee files).
213. Letter of response from Dr. Joyce Lashof to Representative Sanders, July 25, 1997 (copy in subcommittee files).
214. See supra note 196, pp. 55-58.
215. Ibid., pp. 58-59.