For this interim report, the Committee focused on three medical treatment issues that surfaced during the deployment and demobilization of troops: the adequacy of medical screening and evaluation; the use of unapproved drugs and vaccines; and the quality of medical recordkeeping in theater. In 1994, the DSB Task Force concluded that DOD needs substantial improvements in pre- and postdeployment medical assessments and data handling ( 3 ). We agree, and make specific findings and recommendations in these areas in this chapter.
The Senate Veterans' Affairs Committee examined the decision to use investigational products (i.e., drugs or vaccines not yet approved for the purpose used) as protective measures against chemical and biological warfare in the Gulf War in a 1994 hearing that explored broad issues related to military research ( 9 ). The findings and recommendations for future government actions that we discuss in this chapter are more limited in scope.
DOD has established medical and fitness standards to ensure all forces can perform their military duties. Identical standards apply to active and reserve personnel.
Establishing Fitness for Deployment. Active duty forces undergo continual medical and fitness surveillance and have access to military health care. The Ready Reserve relies on other mechanisms, including periodic physical examinations and regular self-reports on health status, to ensure readiness for activation. The Assistant Secretary of Defense (Health Affairs) sets DOD medical fitness policy, and the services are responsible for implementation. The policy identifies the diseases and medical conditions that may render active service members unfit for military duty and also applies to reserve personnel while in an active status. According to testimony before the Committee, personnel were considered medically unfit for deployment due to one of the specified medical conditions, e.g., asthma, diabetes, pregnancy.
At the time of Operations Desert Shield/Desert Storm, DOD-wide policies called for medical examinations at four-year intervals and annual certificates of physical condition for Ready Reserve members of all services. Each military service could require more frequent examinations if considered necessary for mission-specific reasons. These policies, however, were not uniformly enforced across the services, particularly with regard to annual certifications. For example, the Navy and Marine Corps Ready Reserves required their members to submit annual statements indicating any changes in health status since their previous statements. The Army had no formal documented requirement, although some unit commanders required documentation of health status. The Air Force monitored physical condition through monthly unit procedures, but did not require members to submit an annual certification.
Each service implemented its own predeployment screening program for reservists, but three components were common to all:
Only Air Force regulations required a physical examination in addition to the record screening and health questionnaires of the other services. This requirement was waived for members whose periodic physical examinations had occurred within the past year.
Despite readiness requirements, DOD found significant numbers of reservists were nondeployable at the time of Operations Desert Shield/Desert Storm. DOD was unable to provide the Committee with comprehensive data about reservists found to be nondeployable, asserting that its emphasis was on expediting deployment rather than maintaining databases on the nondeployed. Some service-specific information, however, is available:
Health Screening of Demobilized Gulf War Veterans. At the time of demobilization, DOD policy required each member of the Ready Reserve released from active duty to receive a separation physical examination established in accordance with individual service directives. The Army extended this requirement to both regular duty and reserve members and published specific guidance detailing the components of the postdeployment physical examination. The Air Force authorized a separation physical examination at an individual's request; if the member's previous physical examination was less than five years old, the scope of the examination consisted of a detailed medical history with a physical examination focused only on problem(s) identified. The medical records of Navy and Marine Corps reservists being returned to a drill status were reviewed, and reservists were asked about changes in health status; members without changes to report signed statements to that effect and were released. The Committee has received testimony that these demobilization medical screenings did not uniformly occur in the rush to return reservists to their civilian lives.
Policy Changes Post-Gulf War. The General Accounting Office (GAO) identified a number of problems in DOD's policies and procedures and made recommendations to correct them ( 7 ). DOD concurred with most of GAO's findings and agreed to take the necessary actions to correct the problems.
The Assistant Secretary of Defense (Health Affairs) has mandated the use of a standard Report of Medical Assessment Form for all service members separating or retiring. The memorandum, dated May 10, 1995, also directs that any separating or retiring service member who desires a complete physical examination is entitled to receive such an examination.
A draft DOD Instruction, called Joint Preventive Medicine Support of Military Operations (now in review), states it is DOD policy:
. . . that the military departments shall conduct joint preventive medicine support of military operations to include comprehensive medical surveillance. Surveillance shall be in effect continuously for each individual service member throughout their entire period of military service in a manner consistent across the military services. The surveillance process shall be specifically configured to assess the effects of deployment on the health of the service member.
Finally, DOD has informed the Committee that it is completing a revision of its accession and retention physical standards. New policies and separation review procedures for members who do not meet physical standards are under review. Moreover, the frequency of routine physical examinations is now five (rather than four) years, with increased emphasis on the annual certificate of physical fitness.
During Operations Desert Shield/Desert Storm, DOD anticipated the threat of exposure of U.S. military personnel to chemical and biological warfare. DOD used two investigational products in the Gulf War as prophylactic measures against chemical and biological warfare agents: pyridostigmine bromide (PB), a drug that is classified as an anticholinesterase that binds reversibly with acetylcholinesterase, and botulinum toxoid (BT) vaccine. Anthrax vaccine, an approved (licensed) product, also was used as a prophylactic measure during the Gulf War.
Since PB and the BT vaccine were investigational product as used in the Gulf War, DOD could not have administered them under normal circumstances without the informed consent of the military personnel who received them. The Food and Drug Administration (FDA), however, issued a new regulation in December 1990 that permitted use of these products without informed consent under specific military circumstances. Controversy exists about whether creation of a waiver of informed consent mechanism for these circumstances and use of these particular products with the waiver was appropriate from an ethical, regulatory, and military perspective.
Issuance of the New Rule. An October 30, 1990, letter from the DOD Assistant Secretary of Defense (Health Affairs) to the Department of Health and Human Services (DHHS) Assistant Secretary for Health, requested an amendment to FDA's informed consent regulations to include a combat exigency as a circumstance in which medical professionals could deem it "not feasible" to obtain the informed consent of a person receiving an investigational drug or vaccine. In response FDA formed a task force of government employees that concluded it would be possible to develop a rule that would meet DOD's needs and be protective of the health and welfare of military personnel. FDA published an interim final rule on December 21, 1990, that took effect immediately because of the urgency presented in the military situation ( 10 ); the rule was upheld by the courts.
Under the interim rule, DOD initiates the process of obtaining the waiver of informed consent for a combat exigency by filing a written request with FDA along with an investigational new drug application (IND), a treatment protocol, and evidence that an institutional review board (IRB) has reviewed and approved the use of the investigational drug or vaccine without informed consent in the specific circumstances. Subsequently, the Commissioner of Food and Drugs may find that informed consent is not feasible (and thus may be waived) only when withholding treatment would be contrary to the best interests of military personnel and there is no available satisfactory alternative therapy. The rule stipulates four additional, nonexclusive criteria the Commissioner must consider: 1) the strength of the evidence of the safety and efficacy of the drug (or vaccine) for the intended use; 2) the context in which the drug will be administered (e.g., battlefield or hospital); 3) the nature of the disease or condition for which the preventive or therapeutic treatment is intended; and 4) the information to be provided to the recipients of the drug concerning its potential risks and benefits.
Implementation of the New Rule. One week after the interim final rule was issued, DOD requested waivers of informed consent for PB (30 mg tablets) and BT vaccine. The request followed months of deliberations-encompassing political, diplomatic, resource, logistical, and ethical considerations-within DOD. Ultimately, the decisionmaking involved the Secretary of Defense, the Joint Chiefs of Staff, and Central Command (CentCom) in what has been characterized as an intense timeframe extending from August through December 1990. After extensive consultation and scientific analysis, the Commissioner of Food and Drugs approved DOD's waiver requests for BT vaccine and PB on December 31, 1990, and January 8, 1991, respectively.
Decisions about who would actually receive BT vaccine or take PB were made by CentCom based on perceived threat and unit locations. Although FDA issued a waiver of informed consent for PB and BT vaccine, CentCom determined that service personnel designated to receive the BT vaccine should be given a choice as to whether they received the vaccine. CentCom's decision was based on concerns about the ethics of giving investigational vaccines to service personnel and on the insufficiency of vaccine supplies. The perception about PB appeared to differ-i.e., even though this drug was investigational for use in theater, it had been widely used as an approved drug in other populations and, therefore, absence of informed consent was not a cause for concern.
DOD estimates 150,000 service members received at least one dose of anthrax vaccine (an approved biologic) between January 23 and February 28, 1991. About 8,000 troops received BT vaccine in the same period. Approximately 250,000 military personnel took at least one dose of PB, according to DOD estimates.
DOD currently is pursuing approval of BT vaccine and PB. DOD also has asked FDA to make the interim regulation permanent.
During the deployment period for the Gulf War, both active and reserve personnel who developed medical problems were evaluated, treated and returned to duty, hospitalized and returned to duty, or evacuated from the theater of operations. Interactions between deployed forces and medical care providers were recorded in a paper-based system, and much of this information was not incorporated in service members' permanent health records. This breakdown was particularly common for the recording of immunizations given in the theater of operations.
DOD guidelines required field units to maintain rosters of personnel receiving vaccines that included name, Social Security number, rank, and unit. In addition, vaccinations could be recorded on PHS-731 (Yellow shot record) or on SF-601 (Immunization Record).
The secrecy of the vaccination program complicated recordkeeping and created some confusion and fear among service members. Medical personnel in the field received instructions that receiving the shots was classified "Secret" and that the shots were not to be discussed with anyone. DOD asserts the secrecy protected troops since it limited Iraq's knowledge of U.S. defensive capabilities.
When the vaccinations were recorded in medical records retained by individual service members, they were encoded to eliminate document classification problems. Some medical officers have suggested, however, that field personnel were unprepared to deal with what appeared to be classified entries in centrally-maintained medical records, presenting a serious obstacle to proper records management.
According to testimony presented to the Committee, in the flurry of personnel anxious to come home at the end of the Gulf War, much of the documentation about vaccinations was lost or destroyed. DOD maintains rosters of a fraction of the service members who received anthrax and BT vaccines; most are missing. DOD also has reported to the Committee that it is not possible to determine with certainty who actually ingested PB, or in what doses, because service members were supplied PB for self-administration.