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Summary and Assessment
Pages 1-30

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From page 1...
... . Particular attention has been paid to the potential pandemic threat posed by the H5N1 strain of avian influenza, which is now endemic in many Southeast Asian bird populations.
From page 2...
... To focus attention on these concerns as well as on other profound ethical and legal issues that are inherent in various pandemic disease mitigation approaches being proposed domestically and internationally, the Forum convened a public workshop, Ethical and Legal Considerations in Mitigating Pandemic Disease on September 19–20, 2006. Through invited presentations and discussions, participants explored lessons learned from past pandemics, identified barriers to equitable and effective responses to future pandemics, and examined opportunities to overcome these obstacles through research, policy, legislation, communication, and community engagement.1 ORGANIZATION OF THE WORKSHOP SUMMARY This workshop summary was prepared for the Forum membership in the name of the rapporteurs and includes a collection of individually-authored papers and commentary.
From page 3...
... , David Heymann, Executive Director for Communicable Diseases at the World Health Organization (WHO) , discussed notable outbreaks of emerging and reemerging diseases in the context of several interrelated issues, each of which -- either individually or collectively -- carries profound ethical and legal implications: • The vulnerability of health workers to infectious disease and their duty to provide care • Each country's responsibility to reduce the international spread of infectious diseases while simultaneously preserving trade • Ensuring equitable access to health-care resources • Balancing individual rights and the public good Defined by past epidemics, these issues challenge our highly interconnected world with unprecedented urgency, as we anticipate the next infectious disease pandemic.
From page 4...
... to encompass all infectious diseases of global importance, including emerging microbial threats such as SARS (see below)
From page 5...
... Today, although substantial efforts are under way to develop and stockpile vaccines and antiviral pharmaceuticals in anticipation of a threatened pandemic of H5N1 avian influenza, it is unlikely that enough of these measures will be available at the beginning of such a crisis, and their effectiveness is far from assured. Should influenza -- or any other infectious disease with pandemic potential -- strike, the initial individual and community containment measures employed will almost certainly be similar to the nonpharmaceutical interventions that were used almost a century ago: isolation of ill persons and quarantine of their suspected contacts from the "well"; social distancing; simple sanitary measures such as washing hands and wearing facemasks; and providing the public with information about the disease and its risks (Markel et al., 2006)
From page 6...
... are prominent within this story, which he recounts in detail in Chapter 1. This experience demonstrated the feasibility of containing a pandemic through a coordinated, international effort, but it also highlighted the economic and political costs associated with reporting an outbreak and their potential to undermine efforts to protect the global community from infectious diseases.
From page 7...
... , is attempting to increase acceptance and improve enforcement of the IHR in the global community. An Exceptional Case: Smallpox Eradication In 1980, smallpox became the first -- and, to date, only -- human infectious disease to be eradicated from the planet.
From page 8...
... Influenza Pandemic Planning in the Americas Oscar Mujica, communicable disease epidemiologist for the Pan American Health Organization (PAHO) , described his organization's efforts to plan for pandemic influenza in Latin America and the Caribbean, in collaboration with partners that include the U.S.
From page 9...
... Reflecting on the process of developing a national pandemic strategy, workshop participants applauded efforts to date but voiced concerns regarding the translation of national policies into local actions. Asserting that all responses to pandemic disease are local, Steven Bice, a former CDC infectious disease specialist now at Battelle Science and Technology International, advised planners to consult with the public health officials "who will have the fight on their shoulders" in a pandemic.
From page 10...
... , with the caveat that these priorities remain under review and, in the event of a pandemic, would be subject to change based on exactly how the disease spreads in space and time. As is the case for any distribution of scarce resources, the assignment of priorities for influenza vaccination involves, in addition to scientific and admin TABLE SA-1 NVAC/ACIP Recommendations for Prioritization of Pandemic Influenza Vaccine Tier 1A Health-care workers • Health-care workers with direct patient contact and critical health-care support staff • Vaccine and antiviral manufacturing personnel Tier 1B Highest-risk groups • Patients 65 and older with at least one high-risk condition • Patients 6 months to 64 years with at least two high-risk conditions • Patients hospitalized in the past year because of pneumonia, influenza, or other high-risk condition Tier 1C Household contacts and pregnancy • Household contacts of children under 6 months • Household contacts of severely immunocompromised individuals • Pregnant women Tier 1D Pandemic responders • Key government leaders and critical pandemic public health responders Tier 2A Other high-risk groups • Patients 65 and older with no high-risk conditions • Patients 6 months to 64 years with one high-risk condition • Children 6 months to 23 months Tier 2B Critical infrastructure groups • Other public health emergency responders, public safety workers, utility workers, critical transportation workers, and telecommunications workers Tier 3 • Other key government health-care decision makers • Individuals providing mortuary services Tier 4 • Healthy patients 2 to 64 years without any high-risk conditions SOURCE: HHS (2005)
From page 11...
... Unfortunately, Gellin pointed out, it would be imprudent to wait for better vaccines before accumulating stockpiles because of the immediacy of the threat posed by the various infectious agents. Gellin also noted that as this country's experience with the 1976 "swine flu" scare demonstrated, correctly timing the switch from producing a seasonal flu vaccine to producing a strain-specific pandemic influenza vaccine is an inherently difficult task.
From page 12...
... Henderson, who criticized government planners for focusing on what he believed to be "fringe things," such as stockpiling and delivering countermeasures of questionable efficacy, rather than concentrating its efforts on "a problem which we know we are going to have." He attributed the lack of progress toward addressing this critical and predictable need to poor communication between public health officials and hospital administrators, as well as between HHS and CDC. Although individual hospitals are attempting to prepare themselves for pandemic influenza by conducting surge capacity trials, Henderson observed that few facilities are prepared to handle a worst-case scenario in which patients could exceed capacity by 30 to 40 percent.
From page 13...
... FROM PANDEMIC PLANNING TO PUBLIC HEALTH PREPAREDNESS While workshop discussions focused on the imminent threat of pandemic influenza, many of the issues raised apply equally to preparations for public health emergencies of all kinds, from emerging infectious diseases to bioterrorism
From page 14...
... Strategies for Disease Containment Workshop discussion on the topic of pandemic preparedness focused on medical interventions but, as many participants noted, given the present supplies of vaccines, antiviral drugs, and ventilators, nonpharmaceutical interventions are likely to dominate the public health response to an H5N1 avian influenza pandemic. Behavioral strategies for disease containment and mitigation are thus critical to pandemic planning, but they are also fraught with legal and ethical concerns.
From page 15...
... Modeling the Effects of Social Distancing There is limited empirical evidence supporting the effectiveness of social distancing in fighting the spread of infectious disease. As illustrated in Figure SA-1, there are several ways that social distancing -- in combination with additional infection control measures -- could be expected to alter the course of an outbreak: it could can delay the peak of the outbreak (#1)
From page 16...
... and are currently developing such a model for pandemic influenza. Epstein's team is also working on a global model to demonstrate the effects of international travel restrictions and other nonpharmaceutical interventions in a variety of circumstances.
From page 17...
... These include the potential for infectious disease surveillance to violate individuals' rights to privacy, the economic costs of controlling zoonoses, trade limitations imposed by international travel restrictions, and the loss of personal freedom associated with community hygiene measures, such as compulsory temperature monitoring, and the spectrum of contact-reducing interventions, ranging from voluntary sheltering in place ("snow days") to mandatory isolation of the ill (see Gostin and Berkman, page 78)
From page 18...
... As cruelly demonstrated in the aftermath of Hurricane Katrina, disaster response can be slowed and sometimes even brought to a halt by confusion among national, state, and local jurisdictions about who has authority and responsibility for various decisions and actions. In addition, IOM president Harvey Fineberg expressed concern that a "horizontal dimension of ambiguity" of federal public health authority has been created as a consequence of the organization of the Department of Homeland Security (DHS)
From page 19...
... A number of state and local public health officials who attended the workshop commented that such federal guidance on pandemic mitigation is very much needed. ETHICAL ISSUES IN PANDEMIC PLANNING AND RESPONSE The various efforts at planning for an H5N1 avian influenza pandemic have created an awareness of the challenges involved in addressing infectious diseases in a highly interconnected and interdependent world.
From page 20...
... "The key to an ethically responsible and appropriate response is advance planning, including communication," Capron said. "Part of communication is recognizing scarcity and the resulting need for collective allocation and personal responsibility." Capron then revisited the four primary ethical considerations raised by pandemic disease that had been discussed previously in connection with SARS and other infectious diseases (see previous section, "Learning from Pandemics Past," and Heymann, page 33)
From page 21...
... Capron also described how WHO has incorporated certain ethical principles, as outlined in Table SA-3, into technical recommendations for pandemic influenza planning and response. The CDC has taken a similar route in formulating ethical guidelines for pandemic preparation and response, according to James LeDuc (see LeDuc et al., page 90)
From page 22...
... For instance, trust in public health policies -- particularly among the typically poor inhabitants of regions where an influenza pandemic is expected to begin -- will invite compliance, without which infectious disease will not be able to be controlled (Bellagio Group, 2006)
From page 23...
... According to Capron, if such expectations for health-care workers are going to be mandated -- possibly along with specific consequences for dereliction of duty -- the expectations must be agreed upon as part of pandemic planning and should be done through a transparent process that involves local and national professional associations. Ethical Guidelines for Clinicians An influenza pandemic is likely to produce extraordinary shortages in medical care.
From page 24...
... . As previously described, public participation has been incorporated in pandemic planning efforts undertaken by both PAHO and CDC (see Mujica et al., page 66, and Cetron and Landwirth, page 99)
From page 25...
... She expressed the hope that such reforms could be structured to engage that public in emergency planning and response, and, as a result, transform a future pandemic into a "controlled chaos event that gives us a better chance of saving more lives and having a public that trusts its government." Ethics in the Midst of Uncertainty While recognizing the ideal of public participation in pandemic planning, workshop participants nonetheless agreed that public health professionals must expect most people to be entirely unprepared when the next pandemic strikes. In order to mount an effective response, public health authorities will need to act rapidly and authoritatively on the basis of incomplete knowledge.
From page 26...
... 1. A Comprehensive, Global Plan for Addressing Infectious Disease Given the globalization of commerce, travel, and economics, and the worldwide migration of people, goods, and ideas, there needs to be a coordinated, international approach to pandemic disease mitigation which includes the following features: • Universal implementation of core disease surveillance and control capacities • International cooperation and coordination in disease surveillance
From page 27...
... • Public communication prior to -- as well as during -- a pandemic that explains the rationale for disease control measures, establishes realistic expectations, and allows for the "emotional rehearsal" of pandemic scenarios • Measurable endpoints for NPIs and other disease control measures • Research protocols to gather evidence for the efficacy of NPIs • Capacity building to address a range of potential public health emergencies 3. Improved Coordination of Federal, State, and Local Pandemic Planning Activities Workshop participants noted several critical weaknesses in current structures and strategies for pandemic planning.
From page 28...
... Presentation at the Institute of Medicine's Forum on Microbial Threats workshop entitled "Ethical and Legal Considerations in Mitigating Pandemic Disease," Wash ington, DC. Clark CC.
From page 29...
... Keynote address at the Institute of Medicine's Forum on Microbial Threats workshop entitled "Ethical and Legal Considerations in Mitigating Pandemic Disease," Washington, DC. HHS (Department of Health and Human Services)
From page 30...
... 2005b. WHO Checklist for Influenza Pandemic Preparedness Planning.


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