The PAC Special Report contained twelve recommendations directed at several executive branch departments to enhance established programs dealing with Gulf War illnesses and certain Gulf War deployment issues.

The Board�s charter calls for an "overall evaluation of the DoD's plan for and progress toward the implementation of the Presidential Advisory Committee's recommendations contained in its Special Report submitted to the President on October 31, 1997." The Board has used the monthly meeting "process" to receive updates from DoD and other executive branch agencies about the progress that has been made in implementing the twelve PAC recommendations (below in italics).

The Board finds that the Department of Defense appropriately implemented ten of the twelve recommendations contained in the PAC Special Report and was not required to act on the remaining two.

The Board considered the following recommendations in the Interim Report:

• DoD and the Joint Chiefs of Staff, especially, should place a higher priority on addressing pre- and post-deployment surveillance. In particular, these entities should focus on ensuring field commanders are familiar with and implement thoroughly the medical surveillance directive. There is no way to compensate fully for our lack of good health assessment data of U.S. troops prior to and immediately after the Gulf War, but service members participating in future deployments and health care providers should not have to face the same inadequacies.

Representatives from the Joint Staff and the ASD-HA briefed the Board on February 10, 1999, about DoD�s progress in implementing the Deployment Health Surveillance and Readiness Program (DHSRP) specified in the Chairman, Joint Chiefs of Staff Memorandum MCM-251-98 of December 4, 1998. At a June 9, 1999, White House interagency working group meeting, the Assistant Secretary of Defense for Health Affairs noted that a recent spot inspection of some forward-deployed forces in the European theater suggested overall compliance with this program was running at about 60 percent.

The Board believes that the DHSRP addresses the PAC recommendation. However, the Board expressed concerns about two aspects of this program:

1. the program definition of "deployment," and
2. the use of Human Immunodeficiency Virus (HIV)/serum sample collections as the method for post-deployment serum sampling.

The DHSRP�s definition of deployment fails to include any personnel deploying for less than thirty days, and it generally does not include personnel deployed aboard vessels. Reserve component personnel from all branches of service currently deploy overseas routinely in support of ongoing operations. Since many of these deployments last for less than thirty days, these personnel cannot benefit from the protections and health screening/information gathering efforts that this program stipulates.

Additionally, the program relies on the HIV screening program to be the primary source for sera used in the DHSRP. Under existing rules, HIV samples taken one year prior to and one year following a deployment would satisfy DHSRP requirements. The Board invited the Department to comment on this aspect of the DHSRP and invited recommendations on how the HIV sera sample component of the DHSRP can be improved to obtain sera samples in a more timely manner (e.g., draw sera just prior to and just after deployments).

The Board met with representatives from the Joint Staff on January 12, 2000, to obtain additional information on the DHSRP and the implementing Joint Staff memorandum, MCM-251-98. Based on this meeting and staff research, we feel that our previous concerns are being addressed appropriately.

The Joint Chiefs of Staff (JCS) representatives explained that virtually all active and reserve component personnel who deploy overseas for less than thirty days serve at locations that have permanent military medical treatment facilities (MTF). Areas with MTFs typically do not experience the environmental risk factors that can be encountered in areas where no such permanent facilities exist, and the MTFs can identify and treat personnel who do experience a wide range of adverse health outcomes. Similarly, shipboard deployments provide a somewhat controlled environment that differs little whether operating off the U.S. coast or that of a foreign nation. Moreover, deployments that include field operations ashore routinely occur in areas with permanent MTFs or established local health infrastructures.

The JCS representatives also explained the serum sampling protocol. DoD uses periodic HIV testing to provide the pre- and post-deployment samples on which retrospective investigations can be based. The military services do not take samples immediately after deployments because the bacteria and other antigens responsible for chronic problems will be present when the next HIV test is conducted. Additional samples would create additional costs without providing any corresponding value for force health protection or for potential research.

• All research on Gulf War veterans� illnesses that is funded by the government should be subjected to external competition and independent peer review. Circumventing peer review of research proposals undercuts credibility. Respect for the peer review process is necessary to ensure that the highest quality science is funded; in this era of limited fiscal resources, it is even more critical that monies are marshaled wisely to fund the most meritorious proposals. If and when new funds can be identified as available for redirection to scientific and clinical research on Gulf War veterans� illnesses, such monies should be used to fund those projects identified as having been meritorious but that initially did not receive funding due to insufficient funds, or to fund projects via a new competition and peer review.

A representative from the Persian Gulf Veterans Coordinating Board (PGVCB) briefed the Board on April 14, 1999, about progress made by the PGVCB in implementing this recommendation. He informed the Board that 99 percent of the extramural funded research had been awarded on a competitive, peer reviewed process.

The Board agrees with the PAC about the need for Gulf War illness research projects to be funded through a peer reviewed, competitive process. The Board believes that the PGVCB, working in conjunction with DoD, VA, and the Department of Health and Human Services (DHHS), has satisfied this recommendation.

• The Secretary of Defense and the Joint Chiefs of Staff should move swiftly and conscientiously to address the past and current technological limitations of U.S. CW agent detectors, so that new products can afford U.S. troops an appropriate degree of protection. To specifically address the development of detectors for low-level, sub-clinical exposures to CW agents, DoD should establish a panel that includes experts from the private sector and other agencies, including the Environmental Protection Agency and the National Institute of Standards and Technology (NIST).
• DoD should immediately begin developing doctrine that specifically addresses possible low-level, sub-clinical exposure to CW agents. Special consideration should be given to doctrine that establishes requirements for preventing, monitoring, recording, reporting, and assessing possible low-level CW agent exposure incidents.

The Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense briefed the Board on April 14, 1999, about progress made by the DoD in implementing these recommendations. The speaker described DoD efforts to address potential hazards from exposure to low levels of chemical warfare agents and chemical defense countermeasures. However, he did not brief the Board about the portion of the PAC recommendation advocating the establishment of a public/private panel of experts to develop detectors for low-level, sub-clinical exposures to CW agents. In its December 1997 response to the recommendation, DoD claimed that, because its current efforts include industry and government agency partnering, "� an additional panel � is not needed at this time."

The Board believes that progress is being made by DoD in developing equipment to detect CW agents at low levels. Significant strides have been made since the Gulf War, both in the command emphasis devoted to the Chemical and Biological Defense Program (CBDP) and in the improvement of aspects of nuclear, biological, and chemical (NBC) detection equipment that were of debatable efficiency during the Gulf War. Multiple chemical alarms were noted during the Gulf War, yet the accuracy of those alarms remains the subject of debate to the present day. The CBDP can be credited with both developmental and research progress as well as progress in fielding equipment that received improvements after examination of its performance during the Gulf War.

The Board considered the remaining PAC recommendations for this Final Report:

• DoD, DVA, and DHHS should complete the comprehensive risk communication program for Gulf War veterans, as well as for forces deployed in the future; community-based outreach should receive particular focus. In view of the delay from the originally projected completion date, this effort should receive heightened priority and be completed by January 1998.

A representative from the PGVCB briefed the Board on October 29, 1999, about the risk communication plan that the Departments of Defense, Veterans Affairs, and Health and Human Services had developed and implemented for Gulf War veterans and for forces deployed in the future. The PGVCB representative described the comprehensive outreach activities that each department has been conducting since 1998.

The Board believes that the departments have created a viable and effective program that has not been uniformly implemented among all services; active, reserve, and National Guard components; veterans; families; veterans service organizations; and other constituencies. Community outreach efforts have contributed greatly to the effectiveness of the risk communication program. However, the tempo of ongoing efforts, particularly town hall meetings, should be consistent with actual needs and not conducted simply for their own sake.

The Board believes that DoD�s risk communication program should increasingly focus on ongoing and future deployments. VA should assume the lead for continued risk communication efforts directed at Gulf War veterans, with DoD assuming a supporting role. The MVHCB should facilitate the transfer of Gulf War responsibilities between the two departments.

• DVA and DoD should move promptly toward full implementation of the Committee�s previous recommendations on medical and clinical issues � especially those focused on follow-up care and staffing matters at DVA facilities. DVA should incorporate Gulf War veterans into its case management system as rapidly as possible.

An ASD-HA representative briefed the Board on October 29, 1999, about the progress in implementing previous recommendations concerning medical and clinical issues. He addressed the expanded research programs, improvements in medical deployment surveillance, increased force health protection, and the establishment of DoD Centers for Deployment Health. He also discussed the Department�s efforts to establish Redeployment Clinical Practice Guidelines, a program designed to support service members and their families while enabling DoD to optimize force health protection on a continuing basis. He also described DoD�s efforts to help the Military and Veterans Health Coordinating Board begin its operations.

The VA representative briefed the Board on its responses to the PAC�s previous recommendations. He detailed how the VA has incorporated Gulf War veterans into its case management system and highlighted the July 1997 guidance from the VA Under Secretary for Health regarding that policy and the use of teleconferencing to disseminate techniques on "whole patient" care. He noted the implementation of health care provider training, evaluation, and certification programs that have helped to institutionalize the case management system. In addition, the Department has encouraged more innovative approaches to improving patient care by funding Gulf War Veterans� Illnesses Clinical Demonstration Projects. Five demonstration projects at selected VA medical centers have been funded, and the department will incorporate successful programs at all VA medical centers.

The Board believes that the efforts of the two departments have fulfilled the PAC�s recommendations and, more important, demonstrate their commitment to meeting the health needs of Gulf War veterans.

• DHHS should ensure that FDA places a high priority on resolving the issues raised by the Interim Final Rule on waiver of informed consent for the use of investigational products during military exigencies. Although FDA notes this matter raises several complex issues, the agency routinely handles many sensitive and difficult areas with due diligence and timeliness. FDA should finalize or revoke the Interim Final Rule no later than September 30, 1998.

The DHHS representative briefed the Board on October 29, 1999, on this regulation. He noted that the Food and Drug Administration (FDA) had revoked its Interim Final Rule in response to the President�s approval of Executive Order 13139 on September 30, 1999. The executive order is consistent with congressional legislation and permits only the President to waive informed consent rules. This action effectively resolves the PAC�s concerns.

The FDA has since asked for public comment on a new Interim Final Rule that will enable the agency to establish criteria that the President will use to determine waiver approvals. In addition, the FDA asked for public comment on its Animal Efficacy Rule. This rule will establish guidelines for approving vaccines for human use when human testing would be unethical. The FDA is evaluating the responses to the proposed rules and hopes to finalize them soon.

• DoD should seek an independent evaluation of policies and practices concerning the use of investigational products during deployments, as well as the concepts and practices of obtaining informed consent from U.S. troops and the role of troops as human research subjects, given the nature and structure of military service. Such assessments could be sought from the President�s National Bioethics Advisory Commission.

A DoD representative detailed to the Board the steps that DoD has taken to respond to this PAC recommendation. He noted that the Department has established an interagency group consisting of DoD, FDA, NSC, and the Office of Management and Budget that will evaluate all aspects of investigational product usage and advise the President when such products are needed to ensure force health protection. The interagency group will consult with three non-federal representatives during its evaluation process. In addition, DoD is currently drafting a directive that will clearly enunciate and implement the procedures necessary for the Department to obtain independent assessments of investigational product requirements. Executive Order 13139 satisfies this recommendation.

• Future investigations of possible chemical warfare agent exposures should adopt an objective standard against which all case investigations and all elements within a particular case � e.g., type(s) of detectors, eyewitness reports, secondary reference in an operational log, intelligence � are held to scrutiny. When evidence is indeterminate or ambiguous, the government�s interpretation of, or decision-making related to, the element or investigation should weigh in favor of a presumption that ensures veterans� access to information and/or benefits.

The Board culminated its review of DoD investigation methodologies with a January 12, 2000, meeting with the Office of the Special Assistant for Gulf War Illnesses. We believe that the methodologies currently used in OSAGWI case narratives and environmental exposure reports employ objective standards that must be used in future investigations. The narratives and reports incorporate investigation and validation processes used by the international community and the United Nation�s Special Commission (UNSCOM) that inspected Iraqi facilities.

Standard procedures now consist of substantiating the incident followed by reviewing available data and documents, interviewing witnesses, and coordinating with external organizations and authorities, especially those with subject matter expertise. Because information from various sources may be contradictory, internal and external reviews seek to assess the evidence using the reasonable man concept, one of the judicial cornerstones of the U.S. legal system. In essence, analysts and reviewers must balance eyewitness accounts, hard sampling data, medical diagnoses, laboratory results, and subject matter expertise against one another and then select one of five conclusions based on the preponderance of evidence. The conclusions are: definitely, likely, indeterminate, unlikely, and definitely not.

• The White House and DVA should work with Congress to establish a permanent, statutory program for Gulf War veterans� illnesses. The Committee envisions legislation that directs DVA to contract with an organization with the appropriate scientific expertise�e.g., the National Academy of Sciences�for a periodic review, for benefits and future research purposes, of the available scientific evidence regarding associations between illnesses and Gulf War service. The object of such an analysis would be to determine statistical associations between service in the Gulf War and morbidity and mortality, while also considering whether a plausible biological mechanism exists, whether research results are capable of replication and of clinical significance, and whether the data withstand peer review. Based on the external evaluation, the Secretary of Veterans Affairs would make a presumption of service connection for positive associations or publish reasons for not doing so. We believe specific details of such a program�e.g., risk factors exposure; the timing, length, and location of an individual�s service; frequency of the scientific review�are best left to the department and legislators.

Legislation enacted on November 11, 1998, meets the spirit of this PAC recommendation. Section 101 of Public Law 105-368, the Veterans Programs Enhancement Act of 1998, requested that the VA contract with the National Academy of Sciences (NAS) "as an independent nonprofit scientific organization with appropriate expertise that is not a part of the Federal Government, to review and evaluate the available scientific evidence regarding associations between illness and service in the Persian Gulf War." The law stipulated that NAS conduct "a comprehensive review and evaluation of the available scientific and medical information regarding the health status of Gulf War veterans and the health consequences of exposures to risk factors during service in the Persian Gulf War" and specified that thirty agents, hazards, and medicines be evaluated.

Prior to the passage of this legislation, on October 31, 1997, the VA had officially requested that NAS, and its component Institute of Medicine (IOM), conduct such a review, and the two parties signed the contract on June 24, 1998. The IOM completed its review of the peer-reviewed literature for these initial four Gulf War health concerns�depleted uranium, sarin, pyridostigmine bromide, and vaccines�in August 2000, and the report was issued September 7, 2000. The Acting Secretary of Veterans Affairs has since determined that no service connection exists between these four factors and adverse health effects. The IOM will continue to examine other health concerns listed in the law in comparable peer-reviewed literature reviews.

The model for these reviews and evaluations is the ongoing IOM examination of Agent Orange. This model has proven to be effective in forming the basis for presumptive service connection for Vietnam veterans.

The Board determined that briefings were not required for the following PAC recommendations:

• The White House should develop a plan to ensure Gulf War veterans and the public have access to and can be represented in the future deliberations about possible CBW agent exposures. To ensure full public accountability and reinforce the commitment to an independent review, an entity other than DoD should perform any oversight.

The White House�s response to this recommendation was to establish the Special Oversight Board. The Board is governed by the FACA, which requires public access to unclassified meetings and records.

• DoD should identify all individuals within a 300-mile radius from the Khamisiyah pit and conduct an additional, complementary notification. In addition to the current effort, individuals who were in the Khamisiyah vicinity, but not under the plume, also deserve to hear from the government.

DoD reviewed the recommendation and determined that expanding notification was not necessary. The Board agrees with DoD. DoD has notified over 100,000 veterans who may have been exposed to low levels of nerve agent as the result of the Khamisiyah demolition. This notification was based on a modeling process that took a conservative approach and included the appropriate military personnel.

At the Board�s October 2000 hearing, the Special Assistant announced that DoD had revised its previous potential exposure assessment based on modeling refinements, better unit locations, and a more precise understanding of the effects of cyclosarin and the total amount of nerve agent present. More than 30,000 veterans were found not to be potentially exposed, while more than 30,000 additional veterans could have been potentially exposed. DoD sent notification letters to all concerned veterans on December 5, 2000, in conjunction with a formal press release. The Board is satisfied that DoD has complied, and continues to comply, with the spirit of this recommendation.