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Human Resourses Subcommittee Chairman October 3, 1996 The Honorable Jesse Brown
Dear Mr. Secretary:
1. Why did the VA diagnostic screening protocol for Gulf War veterans fail to identify even one veteran exposed to chemical weapons agent(s) or other toxins?
2. Please identify each specific element of the VA diagnostic screening protocol for Gulf War veterans designed to capture evidence of chemical exposure.
3. What immediate changes will VA make to diagnosis, treatment and compensation policies in light of recent disclosures by DOD regarding exposure of U.S. troops to chemical agents?
4. On what data does the VA rely to conclude that low-level chemical exposures cause no chronic health effects in the absence of acute symptoms at the time of exposure?
5. Why does the VA assume there were no acute symptoms of chemical exposure?
Sincerely, Christopher Shays
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Secretary Brown's response follows: THE SECRETARY OF VETERANS AFFAIRS
The Honorable Christopher Shays
Dear Mr. Chairman:
Sincerely yours, Jesse Brown Enclosure
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POST-HEARING QUESTIONS
FOR THE DEPARTMENT OF VETERANS AFFAIRS FROM THE HONORABLE CHRISTOPHER SHAYS
Question 1: Why did the VA diagnostic screening protocol for Gulf War veterans fail to identify even one veteran exposed to chemical weapons agent(s) or other toxins? The DoD now estimates more than 15,000 troops were in the path of the toxic plume generated by the detonation of Iraqi chemical weapons in the pit area at Khamisiyah. We can only expect that number to increase. From an initial estimate of 400, Pentagon estimates of U.S. troops probably exposed to toxic nerve or blister agents have steadily increased, first to 1,100, then 5,000, now 15,000. A recent news report indicates the number could be as high as 130,000. VA adherence to the DoD "no exposures" doctrine, often in the face of compelling clinical evidence to the contrary, could be viewed as Department-wide medical malpractice. Many of those exposed have been examined by the Gulf War Health Registry program. Others have sought treatment at VA facilities. How is it that VA doctors appear to have misdiagnosed all of them? Answer: The question assumes that there is some diagnostic test to detect temporally remote neurotoxic exposure. Unfortunately, there is no such test. The challenge we face with neurotoxic chemical warfare agents is that there is no pathognomonic set of signs or symptoms, diagnostic test or biomarker for chronic toxicity. Likewise, there is no specific treatment for any chronic effects from these exposures once they occur in an individual. Causal inference in most cases is not scientifically possible, unless exposure has been quantified by specific measurement and accurately documented. There are many similar examples where medical science cannot link a specific outcome to a specific toxic exposure in an individual patient Conversely, similar clinical effects can be the end result of a variety of different toxic or nontoxic causes. Inability to assign a definitive cause for an individual veteran's diagnosis hardly equates to misdiagnosis. VA's Registry physicians are aware of the environmental exposures and toxins relevant to Persian Gulf War service and have been instructed to ask questions in the veteran's medical history concerning this wide range of exposures. These exposures include, but are not limited to: chemical warfare agents; smoke from oil well fires, tent heaters, and burning trash; CARC paint; fuels and solvents; pyridostigmine bromide; vaccinations; and depleted uranium. Many veterans report exposure to one or more of these agents during their Gulf service. In some cases, a diagnosed medical condition has been causally linked to one of the reported exposures, e.g., CARC paint and asthma. However, in many cases medical science is simply unable to determine the cause for individual symptoms or diagnoses. This does not mean such individuals were "misdiagnosed." We strongly disagree that VA has either adhered to a "no exposures" belief or ignored compelling clinical evidence. Our policy makers, researchers, and clinicians have been open to all possibilities, and we are deeply disappointed that you would intimate that the Department committed medical malpractice. VA has diligently pursued scientifically supportable medical diagnoses in Persian Gulf War veterans. Our care is consistent with medical community standards. There is simply no factual support for your statement that there was "compelling clinical evidence" for chemical warfare agent exposure. Question 2: Please identify each specific element of the VA diagnostic screening protocol for Gulf War veterans designed to capture evidence of chemical exposure. Recently, both Dr. Kenneth W. Kizer, Under Secretary for Health and Dr. Frances M. Murphy testified the "VA has always remained open to the possibility that [Persian Gulf War] PGW veterans were potentially exposed to a wide variety of hazardous agents while serving in the Southwest Asia theater of operations, including chemical warfare agents." Yet veterans consistently tell the Subcommittee that VA officials ignore or discount their recollections of battlefield exposures. As a result, the variable range of veterans' illnesses, characterized by rashes, headaches, muscle and joint pain, gastrointestinal dysfunction and impaired cognition, are diagnosed as Post Traumatic Stress Disorder (PTSD), somatoform disorder or other psychological conditions. Could these same symptoms be associated with exposure to low levels of toxic agents? Has VA ignored logical, even obvious, theories of toxicological causation for Gulf War veterans illnesses for five years simply because DoD had already concluded, erroneously, that U.S. troops had not been exposed? Answer: The Registry examination requires a careful medical history including an exposure history. The exposure history asks the veteran to report whether he or she believes that they were exposed to a nerve agent or mustard gas. A complete physical examination is required, which includes mental status and neurologic examinations. The Phase II protocol, a set of clinical guidelines for Persian Gulf veterans with difficult-to-diagnose medical conditions, contains symptom-specific diagnostic guidelines for numbness, muscle complaints, and memory loss which could potentially result from a toxic exposure to chemical warfare nerve agents. A copy of the manual and code sheet are attached (Attachment 1), and the relevant sections are tagged and highlighted. As outlined in our testimony, the issue of chemical warfare agents is given specific attention and focus in the protocol. Many of the signs, symptoms, and medical diagnoses of individual Persian Gulf veterans who have undergone VA registry examinations are not conventionally considered to be causally linked to chemical warfare agent exposures. You have stated "Both DoD and VA continue to insist that low-level exposures cause no long-term, chronic health effects unless acute symptoms appeared at the time of exposure." In VA's view, the published literature, while limited, does not demonstrate the development of readily identifiable, long-term adverse health effects due to nerve agent exposures in human subjects who have not shown signs of acute toxicity or poisoning. There are no scientifically endorsed, published studies showing clinically important adverse health effects after low dose exposures. Several prestigious medical advisory groups, including The National Academy of Science's Institute of Medicine and the Armed Forces Epidemiology Board, have also concluded that the available published scientific literature does not contain clear evidence that long-term, chronic adverse health effects result from exposures that do not produce acute clinical signs and symptoms. However, as we stated in our testimony before a joint hearing of the Senate Veterans' Affairs Committee and the Senate Select Intelligence Committee, "[I]n VA's judgment this should not be construed to mean that clinically important adverse health effects cannot or definitely do not occur in the setting of low-level neurotoxin exposures, especially if combined with other components or environmental stressors." Because there are so few studies on this question, we believe that additional research is needed to determine whether exposure to low-levels (non-poisoning, subtoxic) of chemical warfare nerve agents cause long-term health effects, including chronic or delayed onset of a characteristic set of symptoms, signs or medical conditions. VA is fully committed to pursuing answers to this question. VA will work with DoD on a call for proposals to fund research in this area. VA is also sponsoring an international symposium on low-level chemical warfare and nerve agent exposure to stimulate scientific thinking and benefit from the scientific experts published and unpublished knowledge of the topic. Question 3: What immediate changes will VA make to diagnosis, treatment and compensation policies in light of recent disclosures by DoD regarding exposure of U. S. troops to chemical agents? In testimony before a joint hearing of the Senate Select Intelligence and the Senate Veterans' Affairs Committees, Dr. Kizer said, "The diagnosis of conditions related to nerve toxins, whether they be chemical warfare agents, pesticides or hazardous industrial chemicals, is based on two things: first, known or presumed [emphasis added] exposure to the chemical agent, and second, symptoms or physical signs consistent with the known biological effects of the chemical. Absent definite exposure data and/or typical symptoms and signs, it is essentially impossible to make a definitive diagnosis of chemical-related neurotoxicity." Do you believe you now have "definitive exposure data?" Prior to the recent revelations, the VA neither acknowledged nor presumed exposures in diagnosis, treatment or compensation of Gulf War veterans. Now that exposures may, indeed must, be presumed, will VA policies change? In what way? Answer: In light of the recent DoD announcements concerning the destruction of the Khamisiyah Ammunition Storage Area in March 1991, we believe there is evidence of release of nerve agents to the atmosphere and exposure of U.S. troops in the vicinity to unknown levels of these agents. No verifiable determination of the amount of nerve agents released or measurements of sarin or cyclosarin concentrations in the air at the time of release is available to us. Therefore, despite use of modeling techniques, the identification of troops exposed and level of the exposure will never be exact or absolute. VHA has also requested that our advisory groups review the protocols in light of this new information. We have begun a thorough review of the evidence utilizing internal, interagency, and external advisory groups. We have reviewed our clinical protocols and compensation policies. Based on currently available scientific information and evidence and the fact that we have always accepted the possibility of exposures, no changes in diagnosis, treatment or compensation policies will be undertaken, until the review is completed. As discussed in Response 2, current clinical protocols were designed to identify the sequelae of neurotoxic exposures. In the absence of a definitive diagnostic test and lack of specific treatment clinical care for Persian Gulf veterans will not immediately change. Treatment, appropriate to symptoms and/or diagnosis, will continue to be provided. We have initiated several continuing medical education activities to ensure that VA health care providers have the latest information regarding chemical warfare agent exposure of Persian Gulf veterans. These activities reinforce appropriate use of the Phase I and II protocols. While we will continue to assess our compensation policies on an ongoing basis, no immediate changes appear to be indicated. Current VBA policies already allow compensation for conditions which began during or were exacerbated by military service, including exposure to chemical warfare agents resulting in medically recognized disabling sequelae. In addition, VA can compensate Persian Gulf veterans for chronic disabilities resulting from undiagnosed conditions which develop within two years of military service in the Persian Gulf. Question 4: On what data does VA rely to conclude that low-level chemical exposures cause no chronic health effects in the absence of chronic symptoms at the time of exposure? Both DoD and VA continue to insist that low-level exposures cause no long-term, chronic health effects unless acute symptoms appeared at the time of exposure. However, given the status of research in this area, that conclusion seems premature. Dr. Kizer told the joint Senate hearing "the research in this area is sparse and in VA's judgment it should not be construed to mean that clinically important adverse health effects cannot or definitely do not occur in the setting of low-level neurotoxin exposures." Shouldn't sick veterans be given the benefit of any doubts in this regard? While VA research in this area is underway, what role will VA health screening and health care play in gathering data to support, rather than disprove, the hypothesis that low-level exposures can cause chronic health effects, even in the absence of evidence of acute symptoms at the time of exposure? The Subcommittee has been troubled by the VA's selective, even disingenuous, use of Gulf War Health Registry information to support epidemiological hypotheses favorable to the "no exposure" conclusion, while the VA aggressively disputes any contrary implications drawn from Registry data due to the self-selected nature of the cohort. Answer: VA's assessment, based on current published scientific literature, is that low-level asymptomatic exposures to chemical warfare nerve agents have not been shown to cause delayed or long-term health effects. However, VA also recognizes that the existing scientific data is incomplete and contains gaps which need to be addressed by further scientific investigations. We have based these conclusions regarding the potential health effects of exposure on our review of the available medical literature on the subject. Several bibliographies of relevant literature are attached (Attachment 2). In addition, VA has given due consideration to the expert opinions of external scientific advisory committees. The Armed Forces Epidemiology Board and the National Academy of Science's Institute of Medicine Committee on the Health Consequences of Persian Gulf War Service have recently released reports which support this conclusion (Attachment 3). Despite the lack of scientific evidence that long-term adverse health outcomes result from subtoxic exposures to organophosphate nerve agents, VA has provided Registry examinations and ambulatory and inpatient medical care under special medical care eligibility. In 1993, legislation that we supported gave special eligibility for VA health care to any Persian Gulf veteran whose health concerns or problems cannot be attributed to a cause other than an environmental or toxic exposure which occurred during their Gulf War service. Thus, our health care policies resolve benefit of the doubt in favor of the Persian Gulf veteran. We strongly disagree with your statement that VA has been "disingenuous" in its use of the Persian Gulf Registry data. We would also like to emphasize that the clinical information contained in the Persian Gulf Registry and patient treatment file (PTF) databases has not been used as a method to support a conclusion of "no exposure" on any Persian Gulf health issue. VA has repeatedly stated that all exposures are still under active consideration. The VA Persian Gulf Registry Health Examination program was established in 1992 as a health surveillance program and a mechanism for Persian Gulf veterans to gain entry to the VA health care system. The Persian Gulf Health Registry and the VA patient treatment file databases are not epidemiologic tools and, therefore, cannot be used to determine that low-level chemical warfare nerve agent exposures cause chronic health effects in the absence of acute symptoms at the time of exposure, as you suggest in your letter. However, these clinical databases can be utilized as a health surveillance and hypothesis-generating tool for future research studies. To date, VA has not found evidence from the Registry to support a hypothesis that neurotoxic exposures are responsible for the illnesses of the majority of Persian Gulf veterans. If there were a neurotoxic exposure that could cause serious neurologic disease in a high proportion of Persian Gulf veterans, it would probably have been identified in the 60,000 Registry exams completed to date. However, if the illness was mild or affected a very small number of veterans, it may not be recognized in the larger clinical case series. This negative data did not change VA's resolve to continue to look for evidence to support the hypothesis that Persian Gulf veterans' illnesses could be caused by low-level chemical warfare exposure but did cause that particular hypothesis to be given a lower priority by both the internal and external scientific reviewers prior to DoD's June 1996 announcement. In contrast, if a high frequency of certain peripheral or central nervous system conditions had been identified which suggested the possibility that neurotoxic exposures occurred, research is this area would have been aggressively pursued at an earlier date. These conclusions were supported by numerous internal and external scientists who have reviewed the information contained in this database. Our use of the Registry and other clinical databases has been appropriate and scientifically accurate. In the past, VA has resisted inappropriate use or interpretation of this clinical data. VA will continue to utilize these databases in a scientifically sound manner. Question 5: Why does VA assume there were no acute symptoms of chemical warfare exposure? What does VA consider an "acute" symptom? What evidence does VA require to support a veteran's claim that acute symptoms were the direct result of an exposure? Does VA believe only incapacitating symptoms are acute? Sick veterans consistently reported flu-like symptoms, rashes, headaches and other maladies during their service in the Gulf. Others simply went about their duties as best they could, and did not report the ill-effects variably attributed to pills, vaccines, pesticides, engine fumes, rocket fuel, oil fires, indigenous infectious agents... and chemical warfare agents. Even when illnesses were reported, DOD medical records are not complete. Some were "lost" or destroyed. Unit chemical detection logs are also missing. DoD troop locator data is unreliable. Given this lack of consistent or reliable DoD information on chemical exposures and their effects, as opposed to consistent and persistent reports of illnesses by veterans, why does VA choose to listen to DoD rather than the veterans? How can VA conclude that Gulf War exposures caused no immediate health effects? At our most recent hearing, medical witnesses discussed the possibility that pyridostigmine bromide (PB) could mute or mask the onset of acute symptoms resulting from chemical exposure. Could this account for any lack of acute symptoms noted by DoD? Finally, I am personally skeptical of the Pentagon's call for another review of its handling of this matter by the Institute of Medicine (IOM) and the National Academy of Sciences (NAS). Those are both prestigious institutions, but the IOM has already made detailed recommendations about the quality and quantity of government research into Gulf War illnesses. Another review of the current investigation could involve the IOM in a critique of their own earlier work. If only to avoid the perception that DoD is seeking a friendly forum for its a priori conclusions, shouldn't another review of these issues be truly independent of all that went before? Moreover, many of the disease conditions of which Gulf War veterans often complain chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity- are poorly understood and only recently characterized by standardized diagnostic criteria. Shouldn't an independent review of the issues surrounding Gulf War veteran's illnesses be broad enough to include researchers and practitioners involved in the study and treatment of these disease states? Answer: In medical terminology, acute symptoms are not synonymous with incapacitating symptoms. Acute in this context is defined as occurring "immediately" or "in a short period of time" after exposure to the chemical warfare nerve agents. Exposures to high concentrations of organophosphate nerve agents, such as sarin or cyclosarin, cause loss of muscle control, generalized twitching, paralysis, unconsciousness, convulsions, and coma or even death. The most common cause of death is acute respiratory failure due to diaphragmatic paresis/paralysis. Exposure to moderate or even small amounts of these agents may result in sudden onset of impaired vision, drooling, coryza, severe flu-like symptoms, chest discomfort, and hyperhidrosis. These symptoms would have occurred either immediately or a short time after exposure. Since both pyridostigmine bromide (PB) and organophosphate nerve agents increase the amount of synaptic acetylcholine of cholinergic nerves, even if PB pretreatment had been used, one would not expect PB to blunt these acute symptoms. Troops located in the same geographic area would be expected to experience and report this characteristic constellation of symptoms simultaneously. Such outcomes were very evident after the unexpected terrorist attacks in Matsumoto and Tokyo, Japan, in 1994 and 1995, respectively. The release of sarin during these incidents resulted in large numbers of emergency room visits and hospital admissions. Neither DoD nor veterans responding to their telephone survey have reported that this occurred at Khamisiyah. Furthermore, DoD reports that no such characteristic set of signs or symptoms were reported or identified by specially-trained military physicians in the vicinity of Khamisiyah. A characteristic pattern of toxicity was not identified on DoD's review of the medical information for units in the vicinity of Khamisiyah. Veterans likewise have not reported to VA that they noted sudden onset of this symptom complex in their units near Khamisiyah in Southern Iraq during early March 1991. In order to confirm DoD's conclusions regarding the health of troops in the vicinity of Khamisiyah in early March 1991, VA has asked to review the data upon which their conclusio s were based. The data would include data from medical logs, surveys, and questionnaires. We would also welcome the review and opinions of other external scientific advisory committees on these matters. Finally, you asked whether VA supported an independent review of these issues. VA feels that the reviews of the National Academy of Sciences Institute of Medicine, the VA Persian Gulf Expert Scientific Advisory Committees and the Presidential Advisory Committee will provide such independent, objective reviews. You also ask whether these reviews shouldn't be broad enough to include researchers and practitioners from the multiple chemical sensitivity, chronic fatigue syndrome and fibromyalgia community. I can assure you that these groups have been represented on the previous and current external, independent advisory committees, and we would welcome continuing input from credible experts in these areas. We look forward to the recommendations of these advisory groups on this important issue. |
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