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Confronting an Influenza Pandemic: Ethical and Scientific Issues

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  • Confronting an Influenza Pandemic: Ethical and Scientific Issues

    <nobr>Confronting an Influenza Pandemic: Ethical and Scientific Issues </nobr>
    <nobr>Udo Schuklenk</nobr>
    <nobr>, Kevan MA Gartland</nobr>
    <nobr>* </nobr>
    <nobr>Centre for Ethics in Public Policy and Corporate Governance, Glasgow Caledonian</nobr>
    <nobr>University, Glasgow G4 0BA, Scotland </nobr>
    <nobr>School of Life Sciences, Glasgow Caledonian University, Glasgow G4 0BA,</nobr>
    <nobr>Scotland </nobr>
    <nobr>*Corresponding Author</nobr>
    <nobr>Keywords: resource allocation, liberty, governance, global cooperation, health policy,</nobr>
    <nobr>planning </nobr>
    <nobr>The prolonged concern over the potential for a global influenza pandemic, to sweep </nobr>
    <nobr>across the world causing perhaps many millions of fatalities is a chilling one. After </nobr>
    <nobr>the severe acute respiratory syndrome (SARS) scares [1], attention has turned </nobr>
    <nobr>towards the possibility of an avian influenza virus hybridising with a human influenza</nobr>
    <nobr>virus to create a highly virulent, as yet unknown killer, on a scale unseen since the</nobr>
    <nobr>Spanish flu outbreak of 1918, producing more fatalities than the Great War. In</nobr>
    <nobr>deciding how countries should react to this potential pandemic, individually and</nobr>
    <nobr>collectively, a reasonable and practical balance must be struck between the rights </nobr>
    <nobr>and obligations of individual citizens and protection of the wider community and </nobr>
    <nobr>indeed society as a whole. In this communication, ethical issues are discussed in the</nobr>
    <nobr>context of some of the scientific questions relating to a potential influenza pandemic.</nobr>
    <nobr>Amongst these issues are the rights and obligations of healthcare professionals, </nobr>
    <nobr>difficulties surrounding resource allocation, policies impacting upon liberty and trade, </nobr>
    <nobr>when and how to introduce any vaccine or other form of mass treatment, global </nobr>
    <nobr>governance questions and the role of health policies in contemporary society. By </nobr>
    <nobr>considering these issues and questions in advance of an influenza, or indeed other </nobr>
    <nobr>form of pandemic commencing, countries can be better prepared to deal with the</nobr>
    <nobr>inevitably difficult decisions required during such events, rather than dusting down </nobr>
    <nobr>out-dated previous plans, or making and implementing policy in an ad hoc manner </nobr>
    <nobr>with a resultant higher risk of adverse consequences. </nobr>
    <hr><table border="0" width="100%"><tbody><tr><td align="right" bgcolor="#eeeeee">Page 2</td></tr></tbody></table>
    <nobr>Health Care Professionals’ Obligations </nobr>
    <nobr>Pandemic planning must include consideration of the risks that health care </nobr>
    <nobr>professionals, including medical practitioners, nurses, dentists, optometrists and </nobr>
    <nobr>ancillary workers in health facilities can reasonably and justifiably be expected to</nobr>
    <nobr>expose themselves to [2]. An acceptance of serious risks of infection or bodily harm</nobr>
    <nobr>was historically integral to being a health professional since time immemorial. </nobr>
    <nobr>Acceptance of this is less obvious in the era of readily available antibiotic treatment,</nobr>
    <nobr>vaccination against blood borne infectious agents such as Hepatitis B and drug</nobr>
    <nobr>cocktails to control the consequences of human immunodeficiency virus (HIV) </nobr>
    <nobr>infection [3]. Modern medical students no longer consider their profession as </nobr>
    <nobr>particularly hazardous.</nobr>
    <nobr>Instead, health professionals’ responses relate to the</nobr>
    <nobr>potential transmissibility and consequences of exposure. This is exemplified by the </nobr>
    <nobr>duty to treat felt by healthcare workers dealing with HIV infected patients, where the</nobr>
    <nobr>infection risk is considered negligible if universal precautions are being followed, in</nobr>
    <nobr>contrast to those dealing with SARS patients [4]. Little or no debate took place</nobr>
    <nobr>regarding the obligations expected of SARS care professionals even though some</nobr>
    <nobr>staff became infected and died as a result of such exposure [5]. In some cases, </nobr>
    <nobr>however, at the height of the SARS scare, some Canadian healthcare staff refused to</nobr>
    <nobr>treat SARS victims [6]. </nobr>
    <nobr>The altruistic behaviour expected of professionally </nobr>
    <nobr>autonomous care workers previously may no longer hold in contemporary society </nobr>
    <nobr>with greater knowledge of risks and hazards. Altruistic behaviour is no longer</nobr>
    <nobr>expected to the same degree as has been the case historically [7], although some</nobr>
    <nobr>element of risk could be considered a contractual obligation since, for example,</nobr>
    <nobr>National Health Service workers do not routinely choose which patients they attend</nobr>
    <nobr>to [8]. Whilst healthcare professionals have a special obligation of beneficence to </nobr>
    <hr><table border="0" width="100%"><tbody><tr><td align="right" bgcolor="#eeeeee">Page 3</td></tr></tbody></table>
    <nobr>patients, this is not an infinite obligation, since doctors are not routinely asked to, for </nobr>
    <nobr>instance benefit their patients by donating their kidneys to those of their patients who </nobr>
    <nobr>would clinically benefit from such a donation. There does not seem to be a clear </nobr>
    <nobr>boundary to assist in determining what is a moral obligation and what would</nobr>
    <nobr>constitute a supererogatory action. The role of contractual obligations in determining </nobr>
    <nobr>acceptable levels of risk are also pertinent here, as risks tend to be determined as </nobr>
    <nobr>either usual or extraordinary for a particular occupation. At times of pandemic, what </nobr>
    <nobr>is accepted as usual may however change, requiring infectious disease specialists</nobr>
    <nobr>for example, to accept higher risks than other healthcare workers [9]. These risks </nobr>
    <nobr>would include potential transmission to family and friends. Toronto doctors and </nobr>
    <nobr>nurses refusing to treat SARS patients suffered no disciplinary sanction as a result of</nobr>
    <nobr>their withdrawal of treatment, in an eerie reflection of Roman plague doctors</nobr>
    <nobr>remaining in their homes and refusing to attend the sick to protect themselves and</nobr>
    <nobr>their families [1]. Thankfully however, such instances are rare. Managers of </nobr>
    <nobr>healthcare systems have a duty of care towards their staff to minimise such risks and</nobr>
    <nobr>hazards, but also have a responsibility to determine, justify and make clear in </nobr>
    <nobr>advance of a pandemic their understanding of health professionals roles and the</nobr>
    <nobr>reasonable limits of their exposure. In developing such an understanding, consensus</nobr>
    <nobr>should be encouraged, including the involvement of professional associations such </nobr>
    <nobr>as the British Medical Association (or equivalent) and statutory bodies should be fully </nobr>
    <nobr>engaged and encouraged to issue their own guidelines. </nobr>
    <nobr>Resource Allocation </nobr>
    <nobr>As recently noted by Sir Liam Donaldson, England’s Chief Medical Officer healthcare </nobr>
    <nobr>facilities and staff will be placed under enormous pressure during an influenza</nobr>
    <nobr>pandemic and access to facilities will need to be targeted at those most in need [10 ]. </nobr>
    <nobr>Primary care staff themselves will also fall ill until any vaccination campaign becomes </nobr>
    <nobr>effective, and local hospital trusts and strategic health authorities must consider, plan </nobr>
    <hr><table border="0" width="100%"><tbody><tr><td align="right" bgcolor="#eeeeee">Page 4</td></tr></tbody></table>
    <nobr>and regularly test how they would respond to the difficult ethical issues likely to arise.</nobr>
    <nobr>Who will be given priority access to primary care facilities? Will healthcare staff, local </nobr>
    <nobr>planners, politicians, police or armed forces personnel receive priority, to the</nobr>
    <nobr>disadvantage of more severely ill others, including family members? The importance </nobr>
    <nobr>of a home-based care strategy and communicating the benefits of frequent hand-</nobr>
    <nobr>washing are considered crucial, as is the establishment of a national group to</nobr>
    <nobr>consider ethical questions such as whether it is appropriate to prioritise younger over</nobr>
    <nobr>older patients and family carers over single citizens in any primary care rationing</nobr>
    <nobr>strategy [2, 10]. Identifying the likely total resource demands during a pandemic,</nobr>
    <nobr>considering different clinical attack and mortality rates is essential if reasonable </nobr>
    <nobr>attempts at allocation justice are to be made [2, 11]. Clinical attack rates of 5-25% </nobr>
    <nobr>and mortality rates of 0.5-5% appear possible. Better still to have sufficient </nobr>
    <nobr>resources in place before a pandemic strikes, as is being contemplated for anti-virals </nobr>
    <nobr>such as Tamiflu, in the absence of an effective vaccine. Balancing the need to</nobr>
    <nobr>maximise quality additional life years (QUALYS), or disability adjusted life years</nobr>
    <nobr>(DALYS) with the economic value of particular occupations and skills to society is </nobr>
    <nobr>likely to be a difficult task, resting on a utilitarian problem solving strategy [12]. In </nobr>
    <nobr>practice, however, implementing such an approach may be highly demanding on</nobr>
    <nobr>arbitrage staff and health decision-makers. Consideration must be given not just to</nobr>
    <nobr>which types of people should receive care or vaccine access but also to prioritising </nobr>
    <nobr>the types of other illnesses receiving primary care treatment. Many Torontonian</nobr>
    <nobr>cancer and heart disease patients for example, endured surgery postponements </nobr>
    <nobr>during the 2003 SARS outbreak. The level of collateral and consequential damage</nobr>
    <nobr>extended to several patients dying before receiving what would in other </nobr>
    <nobr>circumstances have been priority hospital treatment [1]. </nobr>
    <nobr>Policy Impacts on Liberty</nobr>
    <hr><table border="0" width="100%"><tbody><tr><td align="right" bgcolor="#eeeeee">Page 5</td></tr></tbody></table>
    <nobr>Historical experience suggests that restrictions on individual liberty are likely to be</nobr>
    <nobr>invoked during a pandemic. In deciding upon the nature and extent of such </nobr>
    <nobr>restrictions, there is a need to weigh individual liberty versus public health related</nobr>
    <nobr>concerns. The proportionality of any restrictive response and the desirability of</nobr>
    <nobr>avoiding undue stigmatisation must also be considered. Two types of autonomy </nobr>
    <nobr>restriction are likely, with different aims. Quarantine is intended to separate exposed </nobr>
    <nobr>or potentially exposed individuals who are not yet symptomatic for long enough to</nobr>
    <nobr>determine whether they will develop symptoms, from the general population. This </nobr>
    <nobr>allows for surveillance and the identification of appropriate care strategies prior to the</nobr>
    <nobr>development of symptoms. Isolation, on the other hand, is intended to confine and</nobr>
    <nobr>physically separate symptomatic individuals from distributing infectious agents to the</nobr>
    <nobr>populace [13]. Ethical questions relating to the limiting of autonomy include whether </nobr>
    <nobr>the restrictions are justifiable and likely to be effective [14]. In determining whether </nobr>
    <nobr>restrictions are justifiable, the need for transparent communication with the public </nobr>
    <nobr>cannot be underestimated if goodwill and solidarity are to be maintained [1]. The</nobr>
    <nobr>scale of restrictions must be shown to be the minimum to be effective and applied</nobr>
    <nobr>equitably to all sections of the community. The nature, scale, enforcability and</nobr>
    <nobr>effectiveness of autonomy restrictions are likely to vary during a pandemic between</nobr>
    <nobr>different societies. Both Toronto and Beijing, for example, quarantined or isolated</nobr>
    <nobr>around 30,000 citizens during SARS outbreaks. Ontario authorities needed to issue </nobr>
    <nobr>only 22 compulsory quarantine orders within this, in contrast to the sealing of</nobr>
    <nobr>buildings, electronic surveillance and potential use of execution orders as</nobr>
    <nobr>enforcement devices in Beijing [6]. Potential UK measures restricting liberty may </nobr>
    <nobr>include the closure of sports stadiaums?, theatres, universities, schools and</nobr>
    <nobr>shopping centres. Serious consideration must be given to severe limitations of</nobr>
    <nobr>national and international air travel. The sensitive use of restriction orders in </nobr>
    <nobr>justifiable circumstances can also include ‘work quarantine’ orders preventing health</nobr>
    <nobr>workers from breaking journeys, donning masks and limiting contact with family or </nobr>
    <hr><table border="0" width="100%"><tbody><tr><td align="right" bgcolor="#eeeeee">Page 6</td></tr></tbody></table>
    <nobr>visitors [6, 15]. Public forebearance in accepting autonomy limitations should be</nobr>
    <nobr>matched by government acceptance of the need to promulgate the benefits of these</nobr>
    <nobr>measures and endeavour to care and compensate affected individuals. The majority </nobr>
    <nobr>of Toronto paramedics voluntarily accepted 10-day home quarantine measures in the</nobr>
    <nobr>knowledge of Ontario legislation preventing loss of employment and providing </nobr>
    <nobr>generous compensation measures [6, 16]. Where justifiable and likely to be </nobr>
    <nobr>effective, autonomy restricting measures can reinforce the individual’s moral </nobr>
    <nobr>obligation of not infecting others [17]. </nobr>
    <nobr>Vaccination Timing </nobr>
    <nobr>Vaccination and the use of anti-viral drugs prior to symptom onset are currently seen</nobr>
    <nobr>as the most effective precautions against an influenza pandemic. Demand for anti-</nobr>
    <nobr>virals currently outstrips supply and can only increase with the arrival of such a</nobr>
    <nobr>pandemic. Scientific issues surrounding a vaccination strategy include the precise </nobr>
    <nobr>nature of the viral agent against which protection is to be gained, the scale, timing </nobr>
    <nobr>and cost of vaccination needed. At this time, whilst the H5N1 avian flu strain has </nobr>
    <nobr>caused fatalities, and has recently shown human-human transmission in Indonesia</nobr>
    <nobr>[18], the real concern comes from a hybrid between H5N1 and a highly virulent</nobr>
    <nobr>human influenza strain, of the type which routinely infects 10-20% of the population </nobr>
    <nobr>annually [10]. Ethical questions include whether it is appropriate to immunize with</nobr>
    <nobr>potentially sub-optimal, early versions of vaccines, and how best to deal with an </nobr>
    <nobr>anticipated surge of risk behaviour once vaccinated. Communicating the need to</nobr>
    <nobr>limit movements for up to two weeks after vaccination is also necessary, before any </nobr>
    <nobr>protection takes effect. A difficult trade-off must be made between protection from</nobr>
    <nobr>early vaccine release and losses due to therapeutic misconception [19]. Recent </nobr>
    <nobr>improvements in adjuvants for influenza vaccines developed by Glaxo Smith Kline </nobr>
    <nobr>may enhance our response. Resource allocation issues will remain, however, no</nobr>
    <nobr>matter how effective novel vaccines may be, whilst Ferguson et al. [20] have recently</nobr>
    <hr><table border="0" width="100%"><tbody><tr><td align="right" bgcolor="#eeeeee">Page 7</td></tr></tbody></table>
    <nobr>suggested that as little as a three-week window will exist to quarantine, identify </nobr>
    <nobr>carriers, and treat symptomatic citizens with anti-virals in an affected country before</nobr>
    <nobr>infection spreads out of control. </nobr>
    <nobr>Global Governance </nobr>
    <nobr>As shown by the ease with which SARS spread across Asia and on to Canada,</nobr>
    <nobr>epidemics do not respect national boundaries. Should a pandemic arise, global </nobr>
    <nobr>governance issues will become as important as local arrangements. The role of the</nobr>
    <nobr>World Health Organisation (WHO) in communicating information on disease status, </nobr>
    <nobr>travel advisory warnings and regional information will be very important. In this</nobr>
    <nobr>regard, recent events in Indonesia including the deaths of seven members of the </nobr>
    <nobr>same family from avian flu in Sumatra, are concerning. Speed of response, sharing </nobr>
    <nobr>of viral sequence information and data sharing have all been shown to be key </nobr>
    <nobr>matters where improvements are desirable. WHO and the governments involved </nobr>
    <nobr>face several dilemmas, including the ownership of and when to share viral sequence</nobr>
    <nobr>information with others, and the economic and social implications of issuing travel</nobr>
    <nobr>advisories for international air travel, tourism and other forms of commerce.</nobr>
    <nobr>Differences of opinion between WHO and affected governments appear inevitable </nobr>
    <nobr>and the ethical dimension of these differences should not be ignored. As yet, no</nobr>
    <nobr>clearly communicated decision support tool to decide whether the national economic</nobr>
    <nobr>interests, or global concerns should take priority exists. In the recent Indonesian </nobr>
    <nobr>avian flu clusters, the first acknowledgement of likely extended human-human </nobr>
    <nobr>transmission caused stock market panic. The understandable protectiveness of </nobr>
    <nobr>national governments towards their own economy must however be weighed against</nobr>
    <nobr>delaying release of scientific data. A mutation found in Turkish and apparently at</nobr>
    <nobr>least one Indonesian sample substituting glutamic acid with lysine at position 627 in</nobr>
    <nobr>the PB2 domain of the polymerase gene may be associated with an increased viral</nobr>
    <hr><table border="0" width="100%"><tbody><tr><td align="right" bgcolor="#eeeeee">Page 8</td></tr></tbody></table>
    <nobr>ability to survive and be distributed from the cooler regions of the upper respiratory </nobr>
    <nobr>tract, including the throat and nose compared with previous H5N1 strains [18]. Other </nobr>
    <nobr>governments, including China have also been slow to release avian flu viral</nobr>
    <nobr>sequence information and this reticence to share biological data internationally must </nobr>
    <nobr>be overcome if effective and ethical preparations are to be made [21]. </nobr>
    <nobr>Policy Responses, Society and Preparedness </nobr>
    <nobr>Considering important ethical issues prior to setting pandemic policy will help to </nobr>
    <nobr>ensure that appropriate responses are developed [10]. Levels of preparedness will </nobr>
    <nobr>be lower if questions of healthcare workers’ obligations [22], resource allocation</nobr>
    <nobr>prioritisation, restricting autonomy, treatment timing and global governance have not </nobr>
    <nobr>been addressed. Ethical policy responses in a just society should be the product of</nobr>
    <nobr>transparent decision making processes, involving, as far as is reasonable, public</nobr>
    <nobr>participation. Measures for dealing with an influenza pandemic should be published</nobr>
    <nobr>and easily accessible in advance and related to the analytical framework guiding the </nobr>
    <nobr>decision making [23]. It is only by incorporating consideration of ethical issues such </nobr>
    <nobr>as these, alongside scientific, sociological and economic issues, that society can be </nobr>
    <nobr>fully prepared for the pandemic. </nobr>
    <hr><table border="0" width="100%"><tbody><tr><td align="right" bgcolor="#eeeeee">Page 9</td></tr></tbody></table>
    <nobr>References </nobr>
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    <nobr>2 </nobr>
    <nobr>Kotalik, J., (2005) Bioethics 19(4), 422-431 </nobr>
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    <nobr>292, 1474-1479 </nobr>
    <nobr>4 </nobr>
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    <nobr>5 </nobr>
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    <nobr>City of Toronto Department of Public Health (2003) SARS Fact Sheet </nobr>
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    <nobr>State of Ontario (2003) SARS Assistance and Recovery Act</nobr>
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    <nobr>Harris, J., Holm, S., (1995) Br. Medical J. 311, 1215-1217 </nobr>
    <nobr>18 </nobr>
    <nobr>Butler, D. (2006), Nature 441, 554-555 </nobr>
    <nobr>19 </nobr>
    <nobr>Dennis, C. (2006) Nature, 440, 1099</nobr>
    <nobr>20 </nobr>
    <nobr>Ferguson, N.M., Cummings, D.A., Cauchemez, S., Fraser, C., Riley, S., </nobr>
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    <nobr>Schuklenk, </nobr><nobr>U., (2004) Journal of Medical Ethics,</nobr><nobr> 30, 53-60 </nobr>

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    Re: Confronting an Influenza Pandemic: Ethical and Scientific Issues

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