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Bellagio Group - Ethics and Pandemics
Exploring ethical issues that arise in influenza pandemic planning and response, focusing on issues of social justice
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Re: Bellagio Group - Ethics and Pandemics
Preamble
Socially and economically disadvantaged groups and individuals are almost always the worst affected by epidemics. Too often, they have little voice in making and implementing policy responses to health emergencies ? responses which, in turn, commonly neglect the needs and rights of the disadvantaged.
Consideration for the interests of the disadvantaged is important for practical as well as ethical reasons: public health efforts are more likely to succeed in an atmosphere of social solidarity and public trust, including the trust of disadvantaged people. Avian and human pandemic influenza planning and response should therefore not only be based on sound science and public health principles, but should also respect and give particular attention to the needs and rights of the disadvantaged, and include processes through which their preferences and interests can be articulated and incorporated.
The following principles aim to help governments and intergovernmental and nongovernmental organizations take account of the interests of the disadvantaged in avian and pandemic influenza planning and response. "Checklists" (PDF) of the type attached to this statement provide a ready means of ensuring that this occurs. These principles do not exhaust all relevant technical and moral considerations but focus rather on those with the most salience for the needs and rights of disadvantaged peoples.
Principles
I. All people should have ready access to accurate, up-to-date and easily understood information about avian and human pandemic influenza, public policy responses, and appropriate local and individual actions. Communications should be tailored to overcome obstacles that disadvantaged groups face in accessing such information..
II. Veterinary and public health strategies should foster wide engagement in planning for and responding to the avian and pandemic influenza threat. Civil society, religious groups and the private sector should be involved in helping to overcome barriers to effective engagement by disadvantaged groups.
III. Planning and response should facilitate public involvement in surveillance and reporting of possible cases without fear of discrimination, reprisal or uncompensated loss of livelihood. Recognizing their vulnerability, special efforts are needed to foster reporting by disadvantaged groups, as well as to protect them from negative impacts which could worsen their situation.
IV. The impact and effectiveness of interventions and policies need to be evaluated and monitored, especially with respect to prospects for providing fair benefits to, and avoiding undue burdens on, disadvantaged groups, so that corrective adjustments can be made in a timely manner.
V. Developing as well as developed countries should have access to the best available scientific and socio-economic data and analyses to inform avian and pandemic influenza planning and response, including information on the particular burdens and secondary harms that a pandemic and pandemic responses may inflict on disadvantaged groups.
VI. National and international efforts are needed to promote equitable access to vaccines, antivirals and other appropriate public health and social interventions, both between and within countries, so as to provide fair and non-discriminatory treatment for traditionally disadvantaged groups as well as those who are specially disadvantaged in the context of avian and human influenza.
About the Bellagio Group
With support from the Rockefeller Foundation, an international group of experts in public health, animal health, virology, medicine, public policy, economics, bioethics, law and human rights met in Bellagio, Italy from 24 July to 28 July 2006 to consider questions of social justice and the threat of avian and human pandemic influenza, with a particular remit to focus on the needs and interests of the world?s disadvantaged. The Bellagio Statement of Principles, above, captures the major conclusions of the group?s deliberations.
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Re: Bellagio Group - Ethics and Pandemics
This is a very interesting commentary about the distribution priority for vaccines (if there are any at the time of a pandemic) and anti-virals.
October 26, 2006
Rationing and Priority Setting
A colleague recently had an article published in PLoS Medicine, entitled Priority Setting for Pandemic Influneza: An Analysis of National Preparedness Plans (open access article). This is an interesting comparative analysis of how countries are planning to distribute resources (specifically, vaccines and antivirals) in the event of a pandemic. One striking finding is the variation in how countries approach prioritization of scarce resrouces (indeed, whether they set out criteria for prioritization at all: 38% of the 45 plans analyzed did not prioritize vaccine, and 51% did not prioritize antiviral drugs).
There seems to be a reasonable degree of consensus around the prioritization of health care workers and those who provide other essential services (although what consitutes "essential" may vary from country to country). Less agreement exists around the prioritization of children for receipt of vaccines. Several countries do prioritize children (never at the top, but they appear somewhere in the prioritization scheme). Others explicitly exclude or de-priortize children (e.g., Canada and the United States). ..............
http://bellagio.typepad.com/main/
Who should be first in line? Apparently it will be a local decision. If you are on the panel who decides, who receives life saving medications and devices first?
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Avian Flu Control in Vietnam
"....Vietnam's is one of the few plans--possibly the only one--that takes the needs of the poor seriously. Even if this is primarily rhetoric, it's rhetoric that most countries don't bother to engage in. ...
..But I think there are important principles that do carry over, not only to controlling HPAI, but also to responding to a pandemic if/when it occurs. First, if top-level policies are going to have a chance of being successful, they need to be implemented locally and consistently, and people need have a sense that the policies are going to be effective, that it matters that they comply (or else why bother?). Second, people need to be able to trust that policymakers are acting with their interests at heart, that even if measures prove inconvenient or burdensome, the government acknowledges this and will take measures to fix things. ....."
http://bellagio.typepad.com/main/Comment
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Re: Bellagio Group - Ethics and Pandemics
December 01, 2006
Triage Protocol
The November 21 issue of the Canadian Medical Association Journal featured a pair of articles on developing a triage protocol for critical care (ventilators etc.) during a pandemic. An article by Christian & colleagues describes the protocol and how it was developed (it was commissioned specifically for the province of Ontario, but one would expect it might be adopted, in whole or in part, by other Canadian provinces, and perhaps outside Canada). In brief, the protocol has 4 components:- Inclusion criteria: dictate the presence of one or more conditions indicating a patient might benefit from ICU care
- Exclusion criteria: exclude patients who have an especially poor prognosis, those with medical needs that couldn't be provided during a pandemic, and those with underlying illnesses with a high likelihood of death (e.g., metastatic cancer, severe organ failure).
- Minimum qualifications for survival: call for reassessment at 48 and 120 hours to identify and exclude those who aren't improving significantly (i.e., even if a patient initially qualifies for critical care placement, he/she may not stay indefinitely) ......
http://bellagio.typepad.com/Comment
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Re: Bellagio Group - Ethics and Pandemics
Poverty & Mortality
Christopher Murray & colleagues published an interesting paper in the Lancet (article | abstract) that uses data on excess mortality from 1918 pandemic to produce an estimate of global mortality if a similar pandemic were to occur to day. Particularly interesting is that they correlated excess mortality statistics to per capita income in different countries in 1918.
Basic findings:Excess mortality data show that, even in 1918?20, population mortality varied over 30-fold across countries. Per-head income explained a large fraction of this variation in mortality. Extrapolation of 1918?20 mortality rates to the worldwide population of 2004 indicates that an estimated 62 million people (10th?90th percentile range 51 million?81 million) would be killed by a similar influenza pandemic; 96% (95% CI 95?98) of these deaths would occur in the developing world. If this mortality were concentrated in a single year, it would increase global mortality by 114%.In their discussion, they grant that advances since 1918 would probably be of some benefit. Basic medical management, treatment with antivirals, the possibility of producing a pandemic vaccine, and availability of antibiotics (to treat secondary bacterial pneumonia) could all help to reduce the impact of a severe pandemic, at least in developed settings. The authors conclude with some excellent insights:
Our results indicate that, irrespective of the lethality of the virus, the burden of the next influenza pandemic will be overwhelmingly focused in the developing world, as has been suggested for the 1918?20 pandemic. Symptomatic treatment, antivirals, vaccination, and antibiotics for secondary bacterial pneumonia, combined with the underlying relation between per-head income and mortality, perhaps mediated through nutritional status, will reduce the effect of the pandemic in OECD [i.e., more developed] countries. By contrast, the countries and regions that can least afford to prepare for a pandemic will be affected the most. The potential risk to populations of sub-Saharan Africa, south Asia, and other developing regions presents a policy dilemma. When resources to tackle the health problems already present in the community?including HIV, tuberculosis, malaria, cardiovascular diseases, and road traffic accidents?are already scarce, how much can these populations afford to spend on preparing for a potentially very harmful but also very uncertain threat?The only lingering question, I suppose, is .....
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[F]ocusing on practical and affordable strategies for low-income countries where the pandemic will have the biggest effect, is clearly prudent.
http://bellagio.typepad.com/Comment
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HPAI and Biosecurity Measures
January 12, 2007
HPAI and Biosecurity Measures
As part of a larger strategy to control avian influenza, policymakers are contemplating ways of "resturcturing" the poultry sector in developing countries to improve biosecurity. Since the majority of infections of poultry flocks occur in small ("backyard") farms--the thinking goes--efforts are needed to control the spread of AI in these environments. Proposed measures include mandating the housing or confinement of poultry and placing restrictions on the markets where poultry are bought and sold.
This policy brief from the UN Food & Agriculture Organization's Pro-Poor Livestock Policy Inititative (PPLPI) points out the problems inherent in such an approach. The apparent threat posed backyard farms is due to sheer numbers: there are a lot more small farms than there are large, commercial poultry operations. In Thailand, for example, small farms account for 20% of the poultry population, but represent about 75% of the total number of flocks. By contrast, commerical operations (with thousands of birds), account for about 60% of poultry production, but represent only 2% of the number of flocks. Looking at data from surveillance in Thailand in 2004, the brief points out that, statistically speaking, backyard flocks had the lowest risk of detected HPAI infection (0.05 percent). The likelihood of detecting HPAI in commerical flocks was 4 times higher.
This not to say that backyard poultry farming is "safe" and commerical production isn't. The point is, rather, that policies need take the evidence into account. Advanced biosecurity measures, like those used in commerical operations (whether in Thailand or the United States), provide no guarantee of safety. Pathogens can still move into and out of these facilities (e.g., through ventilation systems and disposal of poultry waste). The prospect of imposing costly biosecurity measures on backyard farmers (who are often poor), then, needs to be viewed with some skepticism.
And this is the tie in to ethics & social justice that we're trying to focus on here. One of the principles in the Bellagio Statement was that:The impact and effectiveness of interventions and policies [to prevent and contain avian and human influenza] need to be evaluated and monitored, especially with respect to prospects for providing fair benefits to, and avoiding undue burdens on, disadvantaged groups, so that corrective adjustments can be made in a timely manner.Clearly that's important in this instance. As the PPLPI policy brief clearly argues that proposed biosecurity measures (1) may not work and (2) may be costly for farmers who cannot affort to implement them.
Given the much stronger political influence of commercial interests vis-?-vis smallholder producers there is a clear danger that regulators will opt for ?easy? solutions, such as imposing measures to make subsistence poultry production ?safer?, eg forced housing or confinement of poultry. This will impose very high costs, particularly upon a marginal group of entrepreneurs and household producers and may lead to an overall reduction of HPAI outbreaks, but more as a result of the loss of household production flocks than as a result of enhanced bio-security.
The imposition of measures which do not significantly reduce the risk of pathogen introduction and spread but place severe economic burdens on society or groups thereof may be politically opportune but is socially unjustifiable. Appropriate social investments to reduce health risk locally and nationally, which draw on the current global momentum for rapid and intensive measures to control HPAI, can have the very significant dividend of improving smallholder commercial viability, a pro-poor benefit that stands in sharp contrast to the displacement effects many of the proposed control strategies threaten to cause.Disclosure: Two of the authors on the PPLPI policy brief, Joachim Otte (FAO) and Ellen Silbergeld (Johns Hopkins) are members of the Bellagio Group.
http://bellagio.typepad.com/
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Re: Bellagio Group - Ethics and Pandemics
This is a low economic impact alternative to help protect individuals from avian influenza. It is a "must read".
http://www.flutrackers.com/forum/showthread.php?t=14088Comment
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Re: Bellagio Group - Ethics and Pandemics
"The imposition of measures which do not significantly reduce the risk of pathogen introduction and spread but place severe economic burdens on society or groups thereof may be politically opportune but is socially unjustifiable. Appropriate social investments to reduce health risk locally and nationally, which draw on the current global momentum for rapid and intensive measures to control HPAI, can have the very significant dividend of improving smallholder commercial viability, a pro-poor benefit that stands in sharp contrast to the displacement effects many of the proposed control strategies threaten to cause."
True. A leading poultry expert recommends an aggressive poultry reimbursement problem to compensate "small holders".
"One of the most important factors for a successful program for H5N1 containment is the reimbursement program for citizens to turn in their poultry" says Dr. Butcher. "You have to have an incentive program built-in so people are actually encouraged."Comment
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Re: Bellagio Group - Ethics and Pandemics
February 12, 2007
World Bank Web Seminar on Compensation
Tomorrow (February 13), the World Bank is live webcasting a seminar on Compensation Policies: Issues and Good Practice. It's scheduled for 2:00-5:00 am EST (Note: AM, not PM). It promises to be an intersting seminar, with remarks and presenations from David Nabarro (UN), Anni McLeod (FAO), and Alain Dehove (OIE), as well as brief presenations on successes and challenges of managing compensation by representatives in Nigeria, Romania, Vietnam, Indonesia, and Kenya. To access the seminar via the web, visit: http://vcg01.worldbank.org/vc/. I'm hoping to post a recap of the seminar here in the next few days.
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Re: Bellagio Group - Ethics and Pandemics
February 16, 2007
Progress on Sharing Viral Samples
I was going to post on a New York Times editorial that appeared this morning on Indonesia's recently announced decision to stop sharing virus samples with the World Health Organization, but then I saw this announcement on the WHO's website following a meeting between Minister of Health of Indonesia Siti Fadillah Supari, and Dr David Heymann, Acting Assistant Director-General for Communicable Diseases. At the risk of being optimistic, it looks like some real progress has been made this week....Sharing of avian influenza viruses and pandemic vaccine productionThere's been near unanimous agreement that bilateral agreements between individual countries and vaccine manufacturers isn't a particularly good approach to developing a pandemic vaccine. Even after signing the memorandum of understanding with Baxter last week, Indonesia expressed a willingness to work with other companies. And Baxter quickly reassured the world that it would continue to collaborate with WHO on vaccine development efforts.
Indonesia?s leadership alerted the international community to the needs of developing countries to benefit from sharing virus samples, including access to quality pandemic vaccines at affordable prices. The Minister of Health recognizes that both short-term and long-term solutions are needed for countries such as Indonesia to strengthen their capacity to protect themselves against threats such as pandemic influenza. In the short term, Indonesia will pursue discussions with vaccine production companies to meet its vaccine needs. WHO fully supports this. In the long term, Indonesia is working with WHO to develop its local vaccine production capacity through technology transfer. Both WHO and the Ministry of Health of Indonesia agree that local capacity to produce vaccines is the long term solution to ensuring availability and access to influenza pandemic vaccine.
The Minister expressed her appreciation that WHO will continue to work with the Ministry of Health to strengthen its laboratory capacity for emerging infections such as H5N1.
The Minister agrees that the responsible, free and rapid sharing of influenza viruses with WHO, including H5N1, is necessary for global public health security and will resume sharing viruses for this purpose. WHO will continue discussions and work with the Ministry of Health and other countries to assess and develop potential mechanisms, including Material Transfer Agreements, that could promote equitable distribution and availability of pandemic influenza vaccines developed and produced from these viruses.
To this end, WHO and the Ministry of Health have jointly decided to convene a meeting of selected countries in the Asia and Pacific region to identify mechanisms for equitable access to influenza vaccine and production.
But there's also been consistent agreement, even at the WHO, that the status quo--wherein countries share their viral samples without any assurance that they might benefit from the existing vaccine development, production, and distribution system--simply may not survive for long.
Given the limited global vaccine production capacity, and the likelihood that many countries will nationalize the manufacturing plants within their own borders (i.e., "what gets made here stays here"), it seems the solution is not simply to share the vaccine that will be produced. Better yet would be to share the technology for producing vaccines. This approach ....
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Lecture: Ethical Issues
Prof. Alexander Capron (a Bellagio Group member) delivered the 2007 Johnson & Johnson Health Care lecture at the University of South Carolina School of Law, entitled Ethical Challenges in Preparing for a Pandemic (has links to audio & video). Prof. Capron, now at USC, was the WHO's first Director of Ethics, Trade, Human Right, & Health Law. He structures the talk around the broad theme of individual versus group interests. I'd highly recommend listening to the entire thing (it even made FluWiki's "Tip of the Week"), but here are some of the points I found particularly salient:
He pointed out how ethical considerations are often "buried" within other planning activities. For example, national pandemic plans that set a goal of "saving the most lives" or minimizing mortality have thereby made an implicit ethical commitment to give preference for treating certain people, i.e., those whose lives are easiest to save by means of whatever interventions are on hand (not the sickest, who will almost certainly die, and not the healthiest, who might likely recover without treatment). Given the significance of these questions, how can we bring them to the fore?
He described a case study, developed by Harvard ethicist Dan Brock, that highlights the importance of public engagement in prioritization decisions. The hypothetical case involves four community hospitals that adopt four different policies for allocating antivirals: (A) concentrate on prophylaxis of health care workers; (B) focus on treating patients who are sickest; (C) attempt to maximise survival rates by treating those mose likely to benefit; (D) adopt all 3 strategies, resulting in quicker depletion of drug supplies. The point of the case study, as I understand it, is to help generate discussion about what sort of allocation strategy to adopt, since these sorts of hard decisions may well be left to local authorities (hospitals, municipalities, etc.). By outlining different allocation strategies in pretty stark terms, it may be easier for people to voice an opinion about what policy or policies they would recommend. ....
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