Law Center Scholarship @ GEORGETOWN LAW

2014

The Epidemic: A Public Health Emergency of International Concern

Lawrence O. Gostin Georgetown University Law Center, [email protected]

Daniel Lucey Georgetown University, [email protected]

Alexandra Phelan Georgetown University Law Center, [email protected]

This paper can be downloaded free of charge from: https://scholarship.law.georgetown.edu/facpub/1376 http://ssrn.com/abstract=2497542

312 JAMA 1095-1096 (2014)

This open-access article is brought to you by the Georgetown Law Library. Posted with permission of the author. Follow this and additional works at: https://scholarship.law.georgetown.edu/facpub Part of the Health Law and Policy Commons, Health Policy Commons, International Public Health Commons, Public Policy Commons, and the Virus Diseases Commons Opinion

VIEWPOINT The Ebola Epidemic A Global Health Emergency

Lawrence O. Gostin, JD On August 8, the World Health Organization (WHO) Fuelingdisquietaboutglobaljustice,2USaidworkers O’Neill Institute for Director-GeneralMargaretChandeclaredtheWestAfrica infected in were treated with an experimental National and Global Ebola crisis a “public health emergency of international anti-EbolaantibodypriortobeingtransportedtoAtlanta.4 Health Law, concern,”1 triggering powers under the 2005 Interna- This serum had been previously used only in nonhuman Georgetown University 5 Law Center, tional Health Regulations (IHR). The IHR requires coun- primates. Eventhoughtheserum’ssafetyandefficacyre- Washington, DC. tries to develop national preparedness capacities, in- main unknown, it sparked an international controversy. cluding the duty to report internationally significant ShouldUSworkersreceiveadruginextremelyscarcesup- Daniel Lucey, MD, MPH events, conduct surveillance, and exercise public health ply when Africans are affected in far greater numbers? Department of powers, while balancing human rights and interna- Balanced against this sense of injustice is the ethical con- Microbiology and Immunology, tional trade. Until last year, the director-general had cern of administering an experimental drug to African pa- Georgetown University declared only one such emergency—influenza AH1N1 (in tientsthathasnotundergoneanysafetytestinginhumans. Medical Center, 2009). Earlier this year, she declared poliomyelitis a On August 11, WHO convened an expert committee Washington, DC. public health emergency of international concern and toassessthebioethicalimplicationsofwithholdingorpro- 6 Alexandra Phelan, now again for Ebola, signaling perhaps a new era of po- vidingearlyaccesstoexperimentaltreatments. Ifascarce LLM, BBiomedSc/LLB tential WHO leadership in global health security. treatmentoffersbenefitstopatients,theethicalquestion O’Neill Institute for is who should have priority access? Society,for example, National and Global The West African Ebola Epidemic owes a duty to health workers who place themselves at Health Law, Georgetown University Ebola virus disease (EVD) has 3 species of human sig- heightened risk. Other ethical considerations could grant Law Center, nificance: Zaire, Sudan, and Bundibugyo. The West Africa prioritytopatientsmostlikelytobenefit,aswellastarget- Washington, DC. outbreak is from a new strain of the Zaire species,2 with ingthedrugtopreventspreadinhospitalsorthecommu- a reported case-fatality rate of 55%. can cause nity.Moreover,whoshoulddecidewhetheranexperimen- fever, vomiting, diarrhea, and generalized bleeding as tal treatment should be administered? Liberian officials well as death. apparently did not approve the use of an investigational Author Reading at FruitbatslikelycarryEbolavirus,withhumansinfected drugadministeredintheirterritory.7 Nationalleadersalso jama.com byclosecontactwithinfectedbodyfluidsand“bushmeat” wouldneedtobepartoffuturedecisionmakingprocesses of primates, forest antelope, wild pigs, and bats. Human- for allocating scarce vaccines and medications. to-human transmission occurs only by close contact with infectedbodyfluids.Importantly,noairbornetransmission Public Health Countermeasures betweenhumanshasbeendemonstrated.EarlyEVDsymp- Sierra Leone’s president captured the state of crisis: “The toms are similar to those of malaria and typhoid fever— very essence of our nation is at stake.”8 Without effec- as well as endemic hemorrhagic fevers such as Lassa— tive vaccines or treatments, West African governments rendering symptomatic differential diagnosis difficult. have declared public health emergencies, invoking ex- Before the current outbreak began in December traordinary powers—a divisive trade-off between popu- 2013, West Africa had no recorded Ebola deaths. Yet this lationhealthandhumanrights.Thefollowingclassicpub- outbreak is the largest, with the crisis worsening. As of lic health measures are standard responses to EVD but August 8, WHO reported 1779 Ebola cases, with 961 are supported by variable levels of evidence. deaths.3 Cases were first reported in Guinea on March Isolation and Quarantine. Affected states have invoked 23, followed by Liberia, Sierra Leone, and Nigeria (due multiple forms of quarantine, ranging from stay-at-home to an infected airline passenger from Liberia). Of great- days for “reflection, education, and prayers” to guarded est concern is the potential urban spread, including capi- home confinement. The military has been deployed for tal cities. Previously Ebola was concentrated in rural house-to-house searches, traveler checkpoints, and cor- areas, where the public health response was suffi- don sanitaire (a guarded line preventing anyone from ciently rapid to prevent spread to populated cities. leaving)—sometimesseparatingpeopleandregionsofthe country.Yet states have exhibited lax enforcement, with Vaccines and Treatment: Ethical Dilemmas Corresponding the inability to police an evolving crisis. Given EVD’s in- Author: Lawrence O. Since 1976 more than 15 Ebola outbreaks have erupted cubationperiod,quarantinemustlastupto21days—atask Gostin, JD, in sub-Saharan Africa, yet therapeutic options remain un- Georgetown University requiring intensive monitoring, enforcement, and deliv- developed. There are no licensed vaccines or specific an- Law Center, O’Neill ery of essential services such as food and health care. Institute for National tiviral or immune-mediated treatments for ill patients or and Global Health Law, for postexposure prophylaxis. The US National Insti- Social Distancing. Governments have invoked social dis- 600 New Jersey Ave tutes of Health is supporting the first phase 1 clinical trial tancing, such as school closures and bans on public gath- NW, Washington, DC 20001 (gostin@law of a new prototype experimental vaccine expected to erings, including sporting, shopping, and entertain- .georgetown.edu). begin in September 2014. ment. In some areas, fear has produced an eerie quiet jama.com JAMA September 17, 2014 Volume 312, Number 11 1095

Copyright 2014 American Medical Association. All rights reserved. Opinion Viewpoint

in usually bustling neighborhoods, while in other areas social life has triggered temporary recommendations directed to affected states, continued unabated. bordering states, and the international community. Risk Communication and Burial. Public education has been incom- Affected States. The WHO director-general asked states with ac- plete, with governments occasionally impeding news coverage and tive Ebola transmission to declare a national emergency,activate di- 9 accurate risk communication. Ministries of health have ordered saster management plans, and establish emergency operation cen- mandatory reporting and required cremation of bodies. Yet tradi- ters. Emergency funding should build core capacities including tional burial services often continue, with loved ones in close con- infection prevention and control. The director-general urged mo- tact with the deceased, posing transmission risks. bilization of health workers, with full remuneration, personal pro- Travel Restrictions. Porous borders place West Africa in jeopardy,but tective equipment, and worker safety assurances. Traditional lead- airline travel could propel Ebola’s international spread, as occurred ers and healers should be fully engaged in risk communication. in Nigeria. Nigeria is screening all arriving air passengers, while sev- All confirmed cases should be isolated and treated, while exposed eral air carriers temporarily suspended flights to the region. The US individuals should be monitored daily, with restricted travel within Centers for Disease Control and Prevention (CDC) issued a level 3 the 21-day incubation period. However, to protect freedom of move- travel warning to the region, reserved for the most serious threats. ment, the director-general did not recommend travel bans but ad- Health Care Settings. Without trained staff, isolation units, per- vised exit screening at international airports, seaports, and land- sonal protective equipment, and strict infection control, hospitals crossings. Individuals with EVD-like illness should not be allowed to have become “amplification points” for spread of EVD, placing health travel except for medical evacuation. workers at significant risk; approximately 140 African health care Land-Border States. Land-border states should conduct rigorous sur- 10 workers have been infected, with 80 deaths. The high risk in- veillance to quickly identify clusters of unexplained fevers or deaths, curred by workers, often with inadequate salaries, has com- with qualified laboratories, rapid-response teams for contact inves- pounded a severe human resource shortage. There are numerous tigations, and case management. ethical dilemmas, such as whether health professionals have a duty to report to work without adequate personal protective equip- The International Community. The director-general cautioned against ment. The is considering medical evacuation of in- international travel or trade restrictions, except for EVD cases and fected aid workers, while the CDC will send additional workers to the contacts. All states should implement risk communication and labo- region. Beyond health workers, patients fearing EVD have shunned ratory diagnostics and prepare for medical evacuations. Interna- hospitals, remaining in the community without adequate treat- tional capacity building for low-income states was conspicuously ab- ment. Affected states rank lowest in global development, with frag- sent in the recommendations, even though it is arguably the most ile health systems and lacking the capacity and expertise to contain effective and humane way to contain the outbreak. the epidemic and treat those infected. Years of civil unrest and weak development have left West Africa Global Governance with fragile health systems as it faces a crisis. Although the director- The West African Ebola crisis is unique given the virulence, inten- general urged international solidarity,global governance once again sive community and health facility transmission patterns, and weak was weakened from a lack of capacity in developing countries. A sus- health systems. The WHO director-general’s declaration of a public tainable solution to EVD, and other emerging threats, requires bind- health emergency of international concern underscores the ur- ing commitments for funding and technical assistance to build na- gency of a coordinated international response and the imperative tional preparedness capabilities, including surveillance, laboratories, of raising the capacity of low-income states. The WHO declaration health systems, and rapid response.

ARTICLE INFORMATION 2. Baize S, Pannetier D, Oestereich L, et al. 6. WHO to convene ethical review of experimental Published Online: August 11, 2014. Emergence of Zaire Ebola virus disease in Guinea: treatment for Ebola. http://www.who.int/en/. doi:10.1001/jama.2014.11176. preliminary report. N Engl J Med. doi:10.1056 August 6, 2014. Accessed August 9, 2014. /NEJMoa1404505. Conflict of Interest Disclosures: The authors have 7. McWhirter C, Loftus P, Hinshaw D. Giving completed and submitted the ICMJE Form for 3. Ebola virus disease, West Africa: update 8 Americans drug for Ebola virus prompts flak. http: Disclosure of Potential Conflicts of Interest and August 2014. http://www.afro.who.int/en/clusters //m.us.wsj.com/articles/second-ebola-patient none were reported. -a-programmes/dpc/epidemic-a-pandemic-alert -lands-in-u-s-1407256243. August 5, 2014. -and-response/outbreak-news/4241-ebola-virus Accessed August 10, 2014. Disclosure: Mr Gostin directs the WHO -disease-west-africa-8-august-2014.html. Accessed 8. Nossiter A. Lax quarantine undercuts Ebola fight Collaborating Center on Public Health Law and August 11, 2014. Human Rights. in Africa. New York Times. August 5, 2014: A1. 4. Blinder A. Atlanta hospital admits second 9. Williams WCL. In the grip of Ebola. New York Additional Contributions: We acknowledge the American with Ebola. http://www.nytimes.com contributions of John D. Kraemer, JD, MPH. Times. http://www.nytimes.com/2014/08/08 /2014/08/06/us/nancy-writebol-kent-brantly /opinion/in-the-grip-of-ebola.html?_r=0. August 7, -ebola-atlanta.html?_r=0. August 5, 2014. Accessed 2014. Accessed August 10, 2014. REFERENCES August 10, 2014. 10. Hinshaw D, Akingbule G. Ebola virus inflicts 1. WHO Statement on the Meeting of the 5. World Health Organization. Ebola virus disease International Health Regulations Emergency deadly toll on African health workers. http://online in Guinea. http://www.afro.who.int/en/clusters-a .wsj.com/articles/nigerian-health Committee Regarding the 2014 Ebola Outbreak in -programmes/dpc/epidemic-a-pandemic-alert-and West Africa. http://www.who.int/mediacentre -minister-says-nurse-died-of-ebola-1407325187. -response/outbreak-news/4063-ebola Updated August 7, 2014. Accessed August 10, 2014. /news/statements/2014/ebola-20140808/en/. -hemorrhagic-fever-in-guinea.html. March 23, August 8, 2014. Accessed August 10, 2014. 2014. Accessed August 9, 2014.

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