The committee recognizes that Department of State (DOS) employees serve a vital role to the country and are vulnerable to a wide range of potential threats. Their health and well-being is a national imperative. The committee believes that DOS has a tripartite ethical obligation to safeguard the well-being of deployed personnel. This entails the prompt identification of threats, expeditious diagnosis and treatment, and the provision of rehabilitation and long-term care for service-related injuries. The committee believes that this is an enduring fiduciary responsibility of DOS much like that afforded to military service members and others who have sustained injuries or disabilities in the performance of their government duties.
Clarity about the nature of the illnesses that first began to affect DOS employees in Cuba in 2016 and subsequently in China, and the causative mechanism(s), remains elusive. What is clear is that a distinct set of unusual clinical manifestations occurred abruptly in some individuals at the onset of their illness, and that the illness became chronic and debilitating for some, but not for all individuals. It is also clear that there is significant heterogeneity among a larger population of affected employees; some did not experience the distinct set of manifestations at onset, and some have had only nonspecific common manifestations. This heterogeneity may reflect evolution of the illness over time, multiple mechanisms at play within and between individuals, and the varying methods used to investigate these individuals at different clinical study sites.
Among the plausible mechanisms that the committee considered, directed radio frequency (RF) energy, especially in those with the distinct early manifestations, appears most germane, along with persistent postural perceptual dizziness (PPPD) as a secondary reinforcing mechanism, as well as the additive effects of psychological conditions. The committee cannot rule out other possible mechanisms (see Section 4), and again, considers it likely that a multiplicity of factors explains some cases and the differences between others. Commencement of appropriate neurological rehabilitation methods early in these illnesses, even without a diagnosis, would have been helpful.
The committee recognizes the impossibility of going back in time to examine the affected individuals early in their illness, gather evidence for or against any of the possible mechanisms, and begin treatment. The committee and others are limited today in what can be pieced together about these cases. However, the committee believes that it would be useful, and even imperative, for actions to be taken now in anticipation of future cases. Although these future cases may resemble in some fashion those that began in Cuba and China in 2016-2018, they need not be similar. Early in a future “event,” cases may not be identifiable as such, and the existence of an event worthy of attention may not be initially obvious. Planning should accommodate all of these possibilities.
The committee’s purpose is both to respond to the needs of U.S. government employees in the wake of the experience in Cuba and China as well as to anticipate future threats to their well-being. While the committee clearly needs to understand these events in order to be able to respond to a recurrence, the larger issue is preparedness for new and unknown threats that might compromise the health and safety of U.S. diplomats serving abroad. It is not enough to design a plan that prepares DOS for the past. The emergence of the novel pathogen SARS-CoV-2 is a
stark reminder that DOS must be thoughtful and creative in its anticipation of future threats, both natural and human-made, and agile in its response. To that end, the committee proposes a number of recommendations in order to enhance future responses.
Recommendation 1. The Department of State should expand its collection of baseline and longitudinal data and biological specimens from all personnel prior to and during overseas assignments.
A major limitation to establishing associative or causal health effects among DOS personnel assigned to Cuba or China was the lack of pre-exposure or baseline health status. It is critical to identify changes in the health of embassy personnel from their baseline if a threat occurs. To make these determinations, medical staff who collect necessary information at the time of the incident must have access to baseline information on the affected individuals. Therefore, for surveillance, the committee believes that there should be routine data collection for all DOS employees on foreign assignments, including collection of whole blood, plasma, and urine, as well as general medical and neurological examinations. Given the nature of the symptoms of the Havana personnel, baseline visual and auditory examinations would be useful, at least for personnel assigned to locations where similar kinds of events might take place. Baselines should be updated regularly, and whenever a significant medical or environmental event occurs. For the affected cohort of DOS employees, DOS should establish ongoing registries to identify any late-onset symptomatology or illness attributable to exposures at post.
The Acquired Brain Injury Tool (ABIT) is a clinical assessment tool that is currently used by DOS pre- and post-deployment to inventory the same neurological, vestibular, and auditory symptoms that were identified in DOS personnel in Cuba and China. However, given that the committee does not know the nature of future events, it would be wise to revise it and include symptoms beyond those encountered in Cuba and China. Establishing a pre-deployment baseline is key.
In addition, to be of maximal value, the committee suggests that the ABIT—and other assessment tools—be modified to obtain relevant epidemiological data such as physical location and local environmental parameters at the time of symptom onset to identify potential sources of threat. In order to ensure the sensitivity and specificity of the evaluation of personnel overseas, the committee recommends that the ABIT be reviewed on a periodic basis by an expert panel of physicians and scientists who can keep the assessment tool forward-facing with respect to present and future threats. The committee suggests that this panel include specialists in general internal medicine, neurology, infectious disease, physiatry, tropical medicine, pharmacology, toxicology, biostatistics, epidemiology, environmental health, bioterrorism, and psychiatry, so as to gather information on natural and human-made threats that might affect embassy personnel. The committee recommends that revisions be based on evolving epidemiological patterns or knowledge of potential malign threats. In addition to the data currently collected, the committee strongly recommends collecting data on prior brain injury and additional assessment of prior and ongoing psychiatric symptoms that might be primary or secondary sequelae from a novel threat.
Recommendation 2. The Department of State, with support from the U.S. government, should establish plans and protocols now to enable
comprehensive, expeditious public health and research investigations in the future, should a cluster of new cases warrant investigation.
In considering needs for a response to future DOS cases, it is important to differentiate between personal medical care (which must remain private), research (which must remain voluntary), and the public health necessity for evaluating information on individuals in a way that may impinge on their privacy in order to protect the health of other embassy personnel or their future well-being should there be a public health threat. It appears that the Centers for Disease Control and Prevention (CDC) assumed this public health role with respect to the cases from Havana, but only did so beginning 1 year after discovery of the first case, when there was much less to be gained from their actions. The committee recommends that a similar response be prepared and authorized in advance of the next potential set of cases, so that the necessary collection of information for a proper public health investigation of U.S. Embassy employees can be undertaken in a timely fashion and made available immediately. It is critical that these protocols be developed in an open and transparent manner with the Foreign Service Officer (FSO) community in order to build and maintain trust. To assist with the aforementioned surveillance, DOS should receive increased resources for MED HART (DOS Bureau of Medical Services Health Alert Response Threat) in order to allow for more timely and agile responses to unexpected and novel threats to personnel. The committee notes that while MED HART was intended to provide operational medical support, it was not necessarily designed to perform epidemiological surveillance and analysis in an effort to identify new case clusters in real-time. An occupational health surveillance system that allows DOS to identify high-risk populations and worksites, emerging work-associated problems, hazardous conditions and exposures, and that can target and evaluate interventions, as outlined in the 2018 National Academies report on occupational safety and health, would benefit overseas DOS locations (NASEM, 2018). DOS should also be provided resources to create such an occupational health surveillance system that could provide ready access to information should an investigation need to be launched. The committee suggests that DOS utilize an expert panel to provide advice on the collection of routine medical data.
In addition to the information that may be necessary to counter a public health emergency involving Embassy personnel, a research investigation may be needed. Participation by Embassy personnel in this type of investigation should be subject to the same human subjects protection rules that apply to all human subjects research. In considering the lessons learned regarding the ethical conduct of environmental research following the Deepwater Horizon oil spill by the Gulf Long-term Follow-up Study (GuLF STUDY) (Resnik et al., 2015), the committee urges DOS to prepare in advance for the conduct of human subjects research that might pertain to an unexpected health hazard. The GuLF STUDY investigators recommended that investigators identify an Institutional Review Board (IRB) and be ready to engage in research when and if it became necessary. To that end, the expert panel described here could also inform the training of research teams that could be deployed and it could facilitate the engagement of the broader DOS community, whose trust will be necessary for the conduct of research. Protocols and consent forms could be developed in advance, and revised and modified to account for the specific populations, threats, and urgencies involved in a particular emergency. Such an approach would facilitate a rapid response in an emergency and the collection of data that might be unavailable if usual research approvals had to be initiated coincident with the emergence of a threat. Protocols should stipulate a longitudinal design so that subjects can be followed over time and clinical outcomes captured. The GuLF STUDY investigators strongly recommended this proactive
approach to “ensure adequate review by IRBs and other groups of complex ethical issues without jeopardizing rapid response to a public health emergency” (Resnik et al., 2015, p. A230). The committee believes such attention to anticipatory governance will enable the expeditious and systematic collection of data necessary to elucidate novel threats while ensuring human subjects protections.
Recommendation 3. Following the identification of a possible new case cluster, the Department of State should ensure collection of data critical for an effective investigation.
In addition to the collection of data pertaining to individual diplomats, it is critical that additional public health and epidemiological surveillance data be obtained to provide the temporal and geographic context for the health presentation of individuals. In this manner, patterns may emerge that will lead to the identification of clusters of individuals who have become ill, and inform possible causes. This will facilitate the early identification of threats, and also give credence to individuals who present with curious symptoms. When several patients present concurrently and these associations can be made quickly, it lends credibility to each patient’s presentation whereas previously they might have been met with skepticism. This is a critical aspect of early threat identification and recognition of disease clusters. DOS might consider a mechanism for real-time, self-reporting by employees of concerning signs and symptoms. Continuous monitoring of these reports by a multi-disciplinary panel of medical and scientific experts might complement other approaches for health information gathering.
Medical surveillance provides a strategy for illuminating one (i.e., the medical) dimension of a potential health threat. The other critical and complementary strategies include surveillance of potential environmental factors. Routine environmental surveillance comes with the added potential advantage of detecting a threat early and before adverse effects have occurred. Tremendous advances are being made in sensor technology that provide the means for stationary, personal, or wearable devices that capture signal or material or both for evaluating the presence of chemical, biological, or physical agents. Such sensors could be randomly and routinely deployed or be available for response under circumstances when there is concern. One way that medical and environmental surveillance can be effectively integrated is with the collection and archiving of baseline biological and environmental specimens that are available for comparison to samples collected after event onset. It may be that the etiologic agent (metabolite or marker of its biological effect) is present within one or more biological materials (blood, serum, urine, hair, nails) or environmental samples. For example, in addressing the hypothesis put forth by the Canadians about possible etiologic agents in Havana, organophosphate insecticides or their clear biological effect (cholinesterase inhibition) would be apparent in appropriate biospecimens collected within a suitable timeframe of symptom onset and/or suspected exposure. Using appropriate chain-of-custody procedures, levels could be compared to those in baseline samples (preferable) and/or to normative population distribution values such as are available from CDC’s National Health and Nutrition Examination Survey (NHANES).
Recommendation 3-A. If research or assessments support the possibility of radio frequency (RF) energy as a cause of illness experienced by some of its employees, the Department of State should train and equip employees with
the capability to measure and characterize their exposure to RF energy in real time should the need arise in the future.
Capturing a suspected exposure event in real time is critical to establishing cause and effect given the transient nature of the suspected exposure mechanism. It is within the state of the art of RF electronics engineering to measure incident RF energy power levels, frequency bands, pulse width, pulse repetition rate, and angle of arrival. A system could also record secondary effects on other electronics in the vicinity of the employees as well as their own notes on their actions to characterize the situation. Modern electronic measurement devices that are compact and user-friendly require only modest investment for development and deployment. Operationally, a systematic series of RF energy characterization measurements could be made by an embassy employee to map out the spatial energy incident at a particular location. The set of measurements would indicate the direction of incident RF energy, as well as the impact of physical barriers (e.g., walls, doors, etc.) on the transmission of the RF energy and the correlation with the perceived effect by the employee.
In addition to potential trigger and/or monitoring sensors that characterize the exposure characteristics, further experiments are required to demonstrate causal links between an RF exposure regime and biological dysfunction observed or experienced by DOS employees. This would enable an RF exposure diagnostic kit for simultaneously measuring exposure characteristics and estimating potential dosage levels for individuals. Capturing both sets of data (exposure characteristics and biological damage) would allow direct cause and effect to be established and help researchers develop mitigation techniques to counter future exposure events and provide immediate, appropriate medical care based on the exposure.
Recommendation 3-B. The Department of State should develop a systematic approach for toxicological diagnoses, and a protocol that supports this approach.
The absence of such an approach hampered the committee’s assessment of toxicants as possible contributors to the illnesses in DOS employees from Havana. With respect to missing data for these employees, such a protocol might include more detailed records of pesticide and other potential chemical use (e.g., more extensive environmental sampling for OPs and pyrethroids, particularly proximal in time and space to the occurrence of symptoms in affected individuals), and the archiving of biological samples collected from affected individuals at the time of initial symptoms for subsequent targeted testing of environmental chemicals suspected of contributing to these illnesses. A valuable model for a coordinated system-wide research response to public health emergencies is provided by the National Institutes of Health (NIH) Disaster Research Response (DR2) Program.5 This program was motivated by many of the same goals and has successfully addressed many of the same needs as the system the committee envisions for DOS in the future.
Recommendation 4. The Department of State, with support from the U.S. government, should provide for appropriate personnel to identify public health emergencies and activate the necessary response.
To facilitate early identification of health threats to Embassy personnel, the committee suggests an expanded role for health attachés. Health attachés are diplomats with specialized knowledge in health-related issues who engage in global health diplomacy to promote U.S. national interests, serve as liaisons with in-country counterparts, and provide technical assistance to Embassy personnel and local stakeholders. Health attachés are cross-trained in foreign affairs, international law, and other domains, as well as the public health disciplines. They are not present in every Embassy and in fact are posted sparingly around the globe. Most are on loan from the Department of Health and Human Services, CDC, the Food and Drug Administration, NIH, or from the Office of Global Affairs (OGA) in the Office of the Secretary of Health and Human Services. Others have hailed from the Department of Defense and the U.S. Agency for International Development. As of 2014, their work was coordinated with DOS’s Office of Global Health Diplomacy (Brown et al., 2014). The committee believes that health attachés can serve as a critical nexus of timely information from in-country and cross-agency sources. As such, they would be well positioned to identify and respond to threats quickly, provide advice, and collect relevant data needed for informed responses. The committee urges increased budgetary support for health attachés posted in U.S. embassies. It suggests prioritization for their deployment based on perceived need and/or threat in order to utilize their interdisciplinary skills in an optimal fashion.
To remain responsive to the threat environment, DOS should engage in regular action reviews, or root cause analysis of sentinel events, to borrow a process from the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission on Accreditation of Healthcare Organizations, 1998), in order to minimize delays in the identification of novel threats or in their communication from posts to Washington, DC. DOS should establish a system such that the intensity of an investigation into a new health threat rapidly escalates in real time, as needed. An established team with institutional knowledge that can quickly incorporate specific medical and environmental specialty expertise depending on the nature of the condition is best suited for such investigations. An associated advisory board might add expertise on relevant political, environmental, and other matters, in order to provide context for interpretation of unusual medical findings. As the committee already noted, DOS should consider a change in policy that enables structured medical investigations of affected individuals in a manner that does not preclude, but is separate from private medical care. Such medical investigations may be reserved for pre-specified circumstances in which there is concern that multiple DOS employees are the subject of a health attack. The committee urges additional specificity of response to the findings of the July 2018 Government Accountability Office Report in order to ensure that the proper information flow occurs between posts and Washington (GAO, 2018).
Brown, M. D., T. K. Mackey, C. N. Shapiro, J. Kolker, E. Thomas, and T. E. Novotny. 2014. Bridging public health and foreign affairs: The tradecraft of global health diplomacy and the role of health attachés. Science & Diplomacy 3(3). http://www.sciencediplomacy.org/article/2014/bridging-public-health-and-foreign-affairs (accessed July 19, 2020).
GAO (U.S. Government Accountability Office). 2018. Reported injuries to U.S. personnel in Cuba: State should revise policies to ensure appropriate internal communication of relevant incidents. https://www.gao.gov/assets/700/693516.pdf (accessed July 27,2020).
NASEM (National Academies of Sciences, Engineering, and Medicine). 2018. A smarter national surveillance system for occupational safety and health in the 21st century. Washington, DC: The National Academies Press.
Resnik, D. B., A. K. Miller, R. K. Kwok, L. S. Engle, and D. P. Sandler. 2015. Ethical issues in environmental research related to public health contingencies: Reflections on the GuLF STUDY. Environmental Health Perspectives 123(9):A227-A231.
Joint Commission on Accreditation of Healthcare Organizations. 1998. Sentinel events: Approaches to error reduction and prevention. Joint Commission Journal on Quality Improvement 24(4):175-186.