Recommendation 5: The VA should add toxicological and environmental medicine expertise to the staff resources dedicated to Gulf War illnesses.

In the December 11, 1996 subcommittee hearing, Chairman Shays asked Dr. Frances Murphy of the VA how many toxicologists and environmental medicine specialists were among the estimated 14,000 VA physicians (approximately 8,000 full-time and 6,000 part-time).
Dr. Murphy could not answer the question, other than to name two physicians, but did say such experts usually work in health care organizations, research laboratories, or agencies like the EPA. Dr. Murphy promised to provide an answer for the record.⁽³⁸⁹⁾
One of the reasons VA doctors have been unable to diagnose and treat the illnesses of some Gulf veterans is the lack of expertise in the specialties of toxicology and environmental medicine. Dr. Robert Haley, University of Texas Medical Center researcher, stated in testimony before the subcommittee in January 1997, that "few regular physicians are familiar with OPIDPN [organophosphate-induced-delayed-polyneuropathy] ... this probably explains why no one [in the VA] explored this diagnosis earlier."⁽³⁹⁰⁾
In response to Representative Shays' question, the following letter was received from Dr. Kenneth Kizer⁽³⁹¹⁾ on June 6, 1997:

The Honorable Christopher Shays
Chairman
Subcommittee on Human Resources
Committee on Government Reform and Oversight
House of Representatives
Washington, D.C. 20515


Dear Mr. Chairman:

I want to briefly follow-up on our meeting of January 29,1997, as well as the preceding hearing you held on January 21,1997, regarding Persian Gulf War Veterans. I specifically want to apprise you about four things.

First, one of the areas that seemingly has been in dispute between your Subcommittee and VA has been the extent to which VA examiners listened to Persian Gulf War (PGW) veterans about their possible exposure to chemical warfare agents, especially in the years immediately after the Gulf conflict. Not being a part of the Department of Veterans Affairs during this time, I have no independent knowledge of what actually transpired. Given the different perspectives, and in an effort to better inform myself, on January 24,1997, I asked the Office of Medical Inspector (OMI) to conduct an independent review of PGW veteran medical records at a number of facilities to see what was actually recorded in the charts regarding environmental exposures. In asking for this review, I recognized that what is recorded in a patient's medical record often understates the extent of history taking, especially with regard to negative responses. Nonetheless, I felt that this would provide an independent, verifiable assessment of at least the minimum level of information obtained in this regard. In brief, the OMI concluded that VA Registry Staffs have been listening to PGW veterans about possible exposure to environmental contaminants, although that seems to be better in the last two years. A copy of the OMI's final report on this matter is enclosed (enclosure 1). Second, your exchange with Dr. Frances Murphy during the January 21,1997, hearing prompted me to query our personnel office regarding the information they obtain and track about the specialty certifications of VA physicians. My conclusion from this discussion was that VA has not maintained a complete data base regarding the areas of expertise of VA physicians. This is being corrected. In March 1997, we began efforts to detail the complete specialty and subspecialty status of all VA physicians. We do not yet have all this information for VA's approximately 15,000 physicians, but I expect we will within a few months, if not sooner. Third, as you may recall from our discussion on January 29,1997, I agree with you that VA has not historically had a sufficient reservoir of medical toxicology and occupational medicine expertise. In an effort to improve our toxicology and occupational medicine assets, I directed the Office of Academic Affiliations to initiate efforts to fund 12 medical toxicology fellowship positions and 25 occupational medicine residency positions for the 1997-1998 academic year. All relevant postgraduate training programs were contacted (enclosures 2-4). The response from medical toxicology programs so far has been disappointing, but not altogether unexpected given the short time between the solicitation and the beginning of the 1997-98 academic year. We have identified and consummated arrangements for 3 additional medical toxicology fellowships beginning in July 1997. Efforts to increase this number continue. A total of 5 new occupational medicine residency positions have been identified so far, and more are expected. This brings to 9.25 the number of occupational medicine residents VA will support in the 1997-98 academic year. Both efforts will continue in the future. Based on feedback from several medical toxicology programs, I expect we will have a substantially greater response next year when the training programs have had more time to gear up for additional trainees. Of note, a major reservation expressed by the toxicology programs has been whether there will be a market for their trainees after fellowship.

Finally, I also want to let you know that I am establishing occupational and environmental health as a VHA strategic healthcare group (SHG). This will be VHA's fifteenth SHG. (Enclosure 5 lists all 15 SHGs.) As you probably know, the strategic healthcare group is a new concept being implemented in VA as part of our larger transformation. The SHG is a multidisciplinary group organized to support the delivery of a continuum of care to a defined population or care in a particular setting. The SHG functions by integrating data, skills and best practices into systemwide policy, planning and service delivery through the development of clinical care strategies (e.g., practice guidelines or critical pathways) and decision support mechanisms. I expect the Occupational and Environmental Health SHG to encompass the many occupational health issues attendant to the military worksite (including such things as pre and post deployment surveillance), as well as the healthcare worksite.

I hope you are supportive of these efforts, and I would welcome any comments that you might have in this regard.

Sincerely,

Kenneth W. Kizer, M.D., M.P.H.⁽³⁹²⁾

Enclosures

The subcommittee supports the VA's belated effort on this matter and encourages an aggressive program to bring such expertise into the Department as quickly as possible. Such an effort, accompanied by a sincere communications effort on the part of VA headquarters to physicians in the field, would help restore confidence in the VA's medical protocols among Gulf veterans and the Congress.

Recommendation 6: DOD and VA should make every effort to find, and where necessary re-create through veterans' testimony, individual Gulf War medical records to reflect vaccines administered, PB use, and exposure to DU, pesticides and other hazardous materials.

According to the GAO, ongoing epidemiological research sponsored by the VA and DOD is being hampered by the inability of researchers "to gather information about toxic exposures. DOD has acknowledged that the records of the use of PB and vaccinations to protect against chemical and biological warfare exposures were inadequate. There is research going on right now to try to find the majority of the records, which seem to be missing. Classifying the symptoms and identifying illnesses of Gulf War veterans has been difficult. As a result, the findings from these studies may be spurious or equivocal. In summary, the ongoing epidemiological research will not be able to provide precise, accurate, and conclusive answers regarding the causes of the illnesses because of these formidable methological problems."⁽³⁹³⁾
An IOM report stated: "The committee has concluded that the information on veterans' health that exists in the [DOD and VA health] registries cannot serve alone as a basis for scientific study of the health effects of the Persian Gulf War. Lack of uniform and retrievable medical information concerning reserve, National Guard, active, and separated forces has greatly inhibited systematic analysis of the health effects of mobilization. Neither the DOD nor VA has automated outpatient recordkeeping. Current systems are fragmented, disorganized, incomplete, and therefore poorly suited to support epidemiologic and health outcome studies."⁽³⁹⁴⁾
According to the PAC Final Report, "We found DOD's inability to produce records of who received PB or BT [botulinum toxoid] indicative of much need for wholesale improvement in the government's performance on medical recordkeeping during military engagements. DOD should assign a high priority to dealing with the problem of lost or missing medical records. A computerized data base is important. Attention should be directed toward developing a mechanism for computerizing medical data in the field. DOD and VA should adopt standardized recordkeeping to ensure continuity." ⁽³⁹⁵⁾ Missing or inadequate personal medical records, along with missing or destroyed NBC logs, and unreleased CIA intelligence logs, comprise the complete medical history of each Gulf War veteran. In the absence of this critical information, sick veterans have a difficult - if not impossible - task of receiving proper medical treatment and fair compensation. DOD and VA should make every effort to find these records,⁽³⁹⁶⁾ and where necessary recreate them through listening carefully to veterans' testimony. Under these present conditions, the burden of proving a service-connected disability should not fall on the sick veteran but upon the government. In other words, the sick Gulf War veteran should be given benefit of the doubt.

Recommendation 7: The President should order an intensified effort to declassify Gulf War documents in any way related to Gulf War veterans' illnesses and should personally certify to the appropriate committees of Congress when he deems declassification of such documents to be against the national interest.

After 6 years, it should be clear by now that ordinary processes of Government inquiry and disclosure will not yield solutions to the mysteries of Gulf War veterans illnesses. Extraordinary steps must now be taken to declassify and disseminate all information in any way pertinent to the health of those who served.
The disclosure of Central Intelligence Agency [CIA] reports regarding chemical weapons at the Khamisiyah munitions depot, and the apparent loss or destruction of more than three quarters of the chemical weapons logs produced during the Gulf War, appear to confirm what many have long suspected about a systematic, and to date largely successful, effort to minimize, discredit or suppress intelligence data on alleged chemical exposures.
To a sick veteran, the missing unit logs, chemical detection reports and intelligence analyses are not just military records. They are medical records essential to the proper diagnosis and treatment of Gulf War-related illnesses. The current DOD system of random, unannounced posting of newly discovered documents on the Internet simply does not meet demands by veterans and Congress for timely, full disclosure.
The so-called "firewall" erected to protect intelligence sources and methods must yield in this instance to the president's own promise that "no stone remain unturned" in the search for answers to Gulf War veterans' illnesses. Moreover, if the intelligence sources and methods sought to be protected also formed the basis of the long-held, but now discredited, Pentagon and CIA conclusion that stories of chemical weapons at Khamisiyah were an Iraqi ruse, then those sources and methods were unreliable, unworthy of continued protection, and far less valuable to the national interest than the health of United States veterans.
Therefore, the President should direct an immediate and expanded declassification review of all CIA and Defense Department intelligence dealing in any way with chemical or biological exposures in the Gulf War, and that all such information be made available to Congress unless the President personally determines disclosure would be harmful to the national security.

Recommendation 8: DOD failure to adhere to recordkeeping
requirements or clinical protocols under an informed consent waiver should result in the presumption of service-connection for any subsequent illness(es) suffered by service personnel to whom the drug or protocol was administered.

FDA's Deputy Commissioner Mary Pendergast told the subcommittee at a May 8, 1997 hearing on informed consent that "Under this regulation, waivers were granted for two products during Operation Desert Storm/Shield - pyridostigmine bromide and botulinum toxoid vaccine. Although FDA had concluded that informed consent was not feasible, FDA did obtain DOD's agreement to provide accurate, fair and balanced information to those who would receive the investigational products. To do this, DOD developed information leaflets on both products with FDA's input and these leaflets received final FDA approval."⁽³⁹⁷⁾
FDA has acknowledged that the information sheets were not provided to many Gulf personnel who were ordered to take the unapproved drug and vaccine. In testimony before the subcommittee, Deputy Commissioner Pendergast testified "were we [FDA] even to consider another waiver request, the specific standards would have to be much higher and more rigorous because of the [DOD] failures."⁽³⁹⁸⁾
It is unfair to require the veteran to prove he or she was exposed to either the PB or the vaccine in light of DOD's blatant failure to adhere to the notification requirements of the FDA waiver.

TREATMENT

Recommendation 9: VA and DOD should systematically and
effectively monitor the clinical progress of Gulf War veterans to determine the most effective treatments.

The June 24, 1997 GAO report found that the VA has no program, plans or systematic way of following the clinical progress of sick Gulf War veterans. As a result, VA physicians treating these veterans have no way of knowing whether the veterans who continue to be ill are better off today than when they were first examined and treated. Scientific analysis requires the ability to draw conclusions based on objective and accurate scientific data. The GAO study found that the VA and DOD have made no effort to track veterans' progress and treatment on a methodical, data-based system. ⁽³⁹⁹⁾
Dr. Murphy responded there is no protocol because therapy and the follow-up need to be tailored to the individual veteran. However, evidence shows that veterans are not receiving consistent follow-up care. If progress is only recorded individually, then those treatments deemed successful will have little or no impact on medical research efforts and have limited significance for other veterans. ⁽⁴⁰⁰⁾
The subcommittee recommends that the VA and DOD immediately develop and implement a plan to systematically monitor the diagnosis and treatment of all Gulf veterans with reported symptoms as well as those who may become ill in the future. This action on the part of the VA and DOD would provide a much-needed medical benchmark against which treatment progress, or lack of progress, can be measured for sick Gulf War veterans.

Recommendation 10: VA and DOD clinicians should be encouraged to pursue, and should be trained in, new treatment approaches to suspected neurotoxic exposure effects.

Private physicians have reported some success in treating Gulf veterans - treatment approaches which have been ignored or rejected by the VA and DOD medical hierarchies since the illnesses were first reported more than 5 years ago. Dr. Howard Urnovitz testified: "Recent studies have found that prolonged and aggressive antibiotic therapy appears to abate many of the symptoms associated with Gulf War Syndrome."⁽⁴⁰¹⁾
Dr. Garth Nicolson testified that among the Gulf veterans he has examined, he found "... a slow-growing mycoplasma located deep inside blood leukocytes of slightly under one-half of Gulf War patients studied. Mycoplasmal infections, such as Mycoplasma fermentans, can be successfully treated with multiple courses of specific antibiotics, such as doxycycline." ⁽⁴⁰²⁾
Dr. William Baumzweiger has reported successful treatments of Gulf veterans with calcium channel blockers. Dr. Katherine Leisure-Murray also reported improvement in some of her Gulf patients with alternative treatments. Both physicians were formerly with the VA but terminated, they allege, because of their professional opinions as to the cause and treatment of Gulf veterans' illnesses, opinions in opposition to VA headquarters policy.⁽⁴⁰³⁾
The subcommittee has received reports from VA doctors in addition to Drs. Baumzweiger and Leisure of harassment, threats, and denial of certain tests and treatments by their supervisors. Such restrictions could be considered a violation of medical ethics, if not medical malpractice.
The subcommittee recommends that the VA and DOD encourage their physicians to train in, and actively pursue, new treatment approaches to suspected neurotoxic exposure effects. This encouragement would also include allowing Government doctors to consult with private physicians who have reported some successful treatments with Gulf War patients. Such an effort by the departments, accompanied by a sincere and ongoing communications effort to VA supervisors in the field, would help alter a perception by veterans and the subcommittee that the VA, in complicity with field supervisors, has conspired to stifle VA physicians from fully and freely practicing medicine on behalf of their Gulf patients.

Recommendation 11: The diagnoses for somatoform disorders and
Post Traumatic Stress Disorder [PTSD] should be refined to insure that physiological causes are not overlooked.

In the absence of definitive medical evidence to explain the mysterious illnesses of Gulf veterans, DOD and VA physicians assumed the causes of many of these illnesses were stress-related or PTSD. Through subcommittee testimony, letters and phone calls, sick veterans have universally rejected psychiatric problems as an accurate diagnosis of their physical illnesses. ⁽⁴⁰⁴⁾ Many private physicians and research experts have also rejected stress as an important factor in these illnesses. ⁽⁴⁰⁵⁾
The GAO report recommended: "The Secretaries of Defense and Veterans Affairs refine the current approaches of the clinical and research programs for diagnosing PTSD consistent with suggestions recently made by the Institute of Medicine."⁽⁴⁰⁶⁾ The DOD partially concurs with this recommendation;⁽⁴⁰⁷⁾ the VA does not concur. ⁽⁴⁰⁸⁾ The Persian Gulf Veterans Coordinating Board, which includes DOD and VA representatives, stated: "Published findings suggest an increased prevalence of PTSD and other psychiatric diagnoses, such as depression ... [and that] stressors during the Persian Gulf conflict were sufficient to cause significant psychiatric morbidity." ⁽⁴⁰⁹⁾ The PAC Final Report also states that "stress is an important contributing factor" in the veterans' illnesses.⁽⁴¹⁰⁾
The GAO report stated: "The link between stress and those veterans' physical symptoms has not been firmly established [by DOD, VA and the PAC]."⁽⁴¹¹⁾ The subcommittee, in view of the fact that there is no credible evidence that stress or PTSD is the principal cause of the veterans' illnesses, recommends that the DOD and VA re-evaluate and refine the definition of stress as it applies to Gulf veterans' diagnoses. Such a re-definition would create a new and much-needed diagnostic and treatment attitude among VA field physicians which could translate into improved medical care for sick Gulf veterans.

COMPENSATION

[NOTES]

389. See supra note 174.
390. See supra note 325.
391. Letter in subcommittee files.
392. Letter in subcommittee files.
Footnote 392 appears as a copy of 391 on the electronic version of this document only.
393. Statement of Donna Hevilin, Human Resources Subcommittee hearings, No. 3, p. 38.
394. See supra note 125, pp. 6-7.
395. See supra note 138, pp. 18-19.
396. See text to accompany note 181. See also, Background section entitled "Other Executive Agency Actions on Gulf Veterans' Illnesses."[On October 21, 1997, the Department of Defense Inspector General informed the subcommittee that the investigation into missing nuclear, biological and chemical logs had been completed. Only 37 of an estimated 200 pages of log entries are retrievable, all in hard copy form. Print-outs of the complete logs, and the computer disks and drives on which they were stored, cannot be found. The investigation discovered a 20-page document containing 165 missing entries, or approximately 15 new log pages. The IG found that regulations and guidelines on the preservation and archiving of Gulf War documents were not followed by CENTCOM. Although the officer found in possession of the mission log extracts is under criminal investigation, the IG did not receive any evidence that individuals or organizations conducted a concerted effort or conspiracy to destroy or conceal the logs.]
397. Hearing on Oversight of NIH and FDA: Bio-Ethics and the Adequacy of Informed Consent, [hereinafter "Human Resources Subcommittee hearing of May 8, 1997"] (Statement of Mary Pendergast, FDA Deputy Commissioner) (prepared statement p. 37, in subcommittee files).
398. Testimony of Mary Pendergast, Human Resources Subcommittee hearing of May 8, 1997, original transcript, p. 59 (in subcommittee files).
399. See supra text to accompanying note 196.
400. See supra text to accompanying note 336.
401. See supra text to accompanying note 90.
402. See supra text accompanying note 92.
403. See supra text accompanying note 189.
404. See supra text accompanying notes 11-39.
405. See supra text accompanying notes 185-194.
406. See supra note 48, p. 70.
407. Ibid.
408. Ibid., p. 85.
409. Ibid., p. 57.
410. Ibid., p. 56.
411. Ibid., p. 8.