Flu: Some ethical questions.

An essay I wrote in 2006 when avian flu was all the rage. A lot of it seems relevant to the problems we’re faced with now. Just think pigs instead of chickens.

Several times a day the BBC RSS news feed adds headline stories about newly discovered cases of the deadly H5N1 strain of avian flu to my Internet browser, so that in order to keep my essay up to date I continually monitor the latest statistics about the numbers of countries and individuals affected. Weekly the numbers increase by a handful. Meanwhile a program on Radio 4 informs me that every day on Britain’s roads there are 9 fatalities, and a newsletter arrives from a medical charity asking for donations to help save some of the one million lives a year lost due to malaria. I check the RSS news feed, there is nothing about malaria even though by my crude reckoning, another 114 people must have died in the hour since I last checked. According to the World Health Organisation (WHO) on Feb 20th 2006 there have been 170 confirmed cases and 92 deaths from the H5N1 strain of avian flu since February 2003. (1)

When governments claim there is no need for panic, they are stimulating panic, bringing up comparisons with the 1918-1919 Spanish flu pandemic.  Research in October 2005 concluded that the strain of flu at that time was ‘entirely avian and bore some similarities with the H5N1 virus’ (WHO). This resulted in up to a third of the world’s human population becoming infected and of these, 20-100 million died. The reason for the very wide range of estimates of deaths was due to a paucity of data from the African and Asian subcontinents. Mortality data for the USA and Western Europe was extrapolated to estimate the effect in other continents. At that time the infection spread rapidly around the world, helped in part by the mobilisation of troops for war. Its spread was truly global; 5% of the population of Ghana died in just 2 months and nearly 20% of the population of western Samoa died. Entire Inuit villages in very remote areas of Alaska were wiped out. As is often pointed out, more people were killed by the flu epidemic than by the fighting in the first world war. Unlike most strains of flu, in which people die from secondary bacterial infections, the Spanish flu caused death directly and affected the young in particular, especially pregnant women, in whom mortality was more than 70%.

Since H5N1 was first discovered in Hong Kong in 1997 it has undergone various mutations, each increasingly virulent and capable of killing a wider range of species and becoming resistant to one of the two classes of anti-flu drugs; amantadines. The effectiveness of the other class of antiviral drugs, neuraminidase inhibitors which includes oseltamivir (tamiflu) is in doubt. Nevertheless, vitally,  there is still no evidence of a mutation resulting in a form of the virus that can be spread between humans and so the current WHO phase of pandemic alert is 3, a ‘pandemic phase’, where there is ‘no, or very limited human to human transmission’. In contrast, phase 6, a ‘pandemic’, refers to the stage where there is ‘efficient and sustained human to human transmission’. Far more frequently, epidemics of avian flu like this, affect poultry without effecting humans such as in 1983 when an H5N2 virus infection in the United States caused 13 million poultry deaths either as a result of infection or because of the poultry cull instituted to control it. (3)

An unfair global burden.

As with all infectious diseases, including tuberculosis, HIV/AIDS and malaria, poor people in underdeveloped countries are bearing the burden of avian flu. Since the disease affects only those people who are in close contact with infected birds, almost all the deaths so far have been in peasant poultry farmers in Vietnam, Indonesia, Thailand, China and Turkey. It is farmers in these countries who bare not only the risks of succumbing from the disease themselves, but also of having their chickens killed by infection or by culling. The H5N1 virus is particularly virulent, killing up to 100% of young chickens (DEFRA) More than 150 million birds have been culled so far in an attempt to prevent the spread of the disease and tens of thousands more are being culled daily. In poor countries such as these, compensation for loss of animals and loss of business is either none or negligible.

This leads to a serious disincentive to report suspicious illnesses among their flocks. Though a poor farmer’s family may face starvation and financial ruin because of the uncompensated loss of livelihood, wealthier farmers may also be tempted to sell birds or hide suspicious deaths to avoid the financial consequences. The moral obligation is based on the public good, the assumption being that the measure of culling and quarantine are intended to reduce the spread of avian flu locally, nationally and internationally in both bird and human populations. This calls for the farmers to act altruistically, sacrificing their livelihoods for the public good. They have to face a choice that farmers in wealthier countries do not. In July 2005 the U.S. poultry and egg industries drew up a plan authorizing the U.S. Department of Agriculture to “pay for 100 percent of the cost of purchase, destruction, [and] disposal of poultry infected with or exposed to H5/H7” viruses (PoultryUSA, July 2005). Compensation measures are very costly, how should they be funded, -to what extent should farmers, insurance companies, governments -tax payers- or international organisations be responsible? Should there be a global fund for compensating farmers for culled birds, birds that die as a direct result of the virus, or loss of business? Although the government of a poor country may be morally obliged to reduce the risk of avian flu to its citizens, lacking the funds for compensation, it may have to rely on a combination of authoritarian coercion and peasant altruism to do so.

Compensating the farmers may help prevent the spread of avian flu, but there are other problems of compensation common to both poor and wealthy countries. After the discovery of H5N1 in Italy, the Italian Farmers Confederation said eight out of ten consumers had stopped buying chicken. The Federation said since October the poultry sector has lost some 600m euros (£410m) and 30,000 workers have been temporarily laid off. (4) Paying farmers compensation for their culled stock may be sufficient incentive to prevent the spread of avian flu, but it doesn’t compensate associated businesses. Even if some compensation should be forthcoming, the networks of people employed and affected by the industry are too wide-ranging to be adequately or fully compensated. Hence the question of whether obligations are relative to means. The ethical delineation of how much compensation can be afforded would be limited minimally according to the minimal cost of restricting the spread of avian flu in the human population, partially in fully compensating all those affected by measures imposed on the poultry industry and fully in making sure the costs of poultry farming additionally encompass the costs necessary for revolutionising the poultry industry to ensure that the conditions that contribute to the development and spread of infection are eliminated.

Those who are not in the poultry business share responsibility for its methods because they expect cheap poultry. The price of tax increases required to compensate those affected, even in the maximal case described above, if any, are likely to be negligible. The main costs would be reflected in the price of poultry, yet there is no intrinsic right to cheap chicken. The measures imposed are in anticipation of a more infectious strain of avian flu, yet farmers who are expected to bear the costs of draconian measures designed to protect the urban consumers who face the risk of a pandemic that may never happen.

An appetite for flesh.

The global scale of intensive farming is mind-boggling. China produces 13 billion chickens annually, 60 percent of them on small farms. In the US more than 9 billion chickens are raised every year in factory farms. As people become wealthier and food is produced more cheaply, the appetite for meat increases and so the market in the world’s largest nations, China and India, can be expected to rise massively to meet the demand. Basic market forces and economies of scale force the production costs down as low as possible to satisfy consumer demand. Animal welfare takes second place to economic concerns so that the vast majority of chickens no longer roam the yard, but are manufactured in factories. The rise in demand for organic meat, whilst an encouraging reflection of concern for animal welfare, is insignificant in scale by comparison. That animals are capable of suffering, and that they do so particularly in conditions of intensive farming is self evident and does not need expansion here, except in relation to avian flu. At the time of writing, evidence points away from wild birds and towards domestic birds as the cause of the H5N1 variety of avian flu.

Because intensively farmed animals are in such close proximity to each other the risks of diseases spreading rapidly between them are very high. As a result, prophylactic antibiotics are routinely used in animal feeds. Antibiotics are also added to animal feeds to promote growth, independently of their use to prevent disease. Disease resistance to antibiotics increases with the amount and range of antibiotics used and is higher in more intensively bred livestock (DEFRA) so that industrial farming presents new and significant opportunities for emerging diseases. Unlike antibiotics, which are relatively cheap to produce and are varied in type, there are only two groups of antiviral drugs that may be of use in avian flu. The first strains of H5N1 found in China were sensitive to the antiviral amantadine, representing one of the antiviral groups, but since then resistance has developed, prompting speculation that resistance developed as a result of widespread and innapropriate use of prophylactic amantadine in poultry in China (WHO). The result is that now only the remaining, significantly more expensive drug, oseltamivir (Tamiflu) is effective in humans, and as I discuss below, only partially. WHO has called for the use of antiviral agents to be banned in poultry because of the risk of resistant organisms developing which could then effect humans. If there is an acceptable level of risk of developing new infectious diseases as a result of antimicrobials, then how should it be measured, and when do we decide that it has been exceeded? Animals suffer from the effects of antimicrobial treatment when they grow unnaturally fast and suffer from disease and humans are susceptible to the same diseases and rely on the same antibiotics.

The SARS outbreak in 2002-2003 led to 8,437 cases and 813 deaths. Eventually the virus was traced to a small mammal called a palm civet and the spread initially occurred through markets where wild mammals were traded in China’s Guandong region. In H5N1 avian flu was detected in 2 mountain hawk-eagles that were smuggled from Thailand into Belgium in hand luggage. The annual trade in wild animals is estimated to be 4 million birds, 640 000 reptiles, and 40, 000 primates. In May 2003 a prairie-dog trader in Wisconsin let his animals mix with other mammals imported from Ghana and within a month, 71 cases of monkey-pox in humans had been reported in 6 states. (5) In the UK, mad cow disease (BSE) led to new variant CJD in humans with tragic consequences for those effected. The disease only spread into cattle because farmers started feeding infected sheep byproducts to their cows. In all these cases human treatment of animals lead not only to the development and or spread of new diseases, but to animal suffering. The Kantian principle, that humans ought never to be used merely as means, but should be ends in themselves, ought to apply to animals, that are capable of suffering, as well.

In the UK, the measures for control set out by DEFRA are for the “culling of all susceptible birds on affected premises together with dangerous contacts on other premises.” Globally more than 150 million birds have been culled and the numbers are increasing by tens of thousands daily. The methods for culling birds are significantly less humane that those supposedly humane methods used for slaughter in developed countries and in less developed countries there have been reports of birds buried and burned alive (6). How many millions of healthy birds can be killed in order prevent the spread of a disease or to save a single human life? Can the destruction of wild birds and natural habitats be justified in order to control the spread of avian flu, and if so, what level of evidence is required? Can endangered species be culled if they are thought to be carriers? The traditional precautionary principle would accept the destruction of all these on the basis of flimsy and uncertain evidence. An alternative precautionary principle that values animals and the natural environment more highly would aim to tackle the problem with far less destruction.

A global response.

Pandemics do not respect national borders and the international spread of the disease and the international response headed by the WHO demonstrate the global scale of the problem. Since the response needs to be international, a number of dilemmas arise, such as the extent to which a global organisation should be able to dictate measures to control avian flu in different countries and to what extent should those countries be able to make their own contingency plans. A joint FAO/OIE/WHO joint statement released in November 2005 urged member states not to use antiviral drugs in animals in order to preserve their effectiveness for humans. Guidelines have also been drawn up for countries to prepare for a human pandemic. In January 2006, $1.8bn from World Bank, EU, US, and other countries was pledged to stop the spread of avian influenza from bird to human populations in affected countries (7). A pandemic involving human to human spread would put everyone at almost all nations at a similar level of risk. Trans-national, internationally funded bodies such as the WHO have reciprocal duties to their member states as well as shared duties and duties which extend beyond those states. In one respect their duties extend beyond their member states because a pandemic virus is not confined to any association of states, and so in order for their duties to their members to be fulfilled they need to act outside their borders. As members of a global community, by virtue of their shared humanity, as well as their privileged position of wealth, power and expertise, they also have duties to act in order to protect people in other countries irrespective of their duties to their own members. Likewise, governments have to decide whether their duty is to protect their citizens only within the jurisdiction of their own borders such as by the use of vaccinations and antiviral treatments, or whether they are able to dictate measures outside their borders to other countries in an attempt to protect their own citizens, such as import and immigration restrictions; whether they can dictate measures to prevent the global spread of disease, such as compulsory quarantine, culls and restrictions on trade in other countries, or whether they can reduce, by positive measures such as scientific, economic and logistical support, the spread and impact of avian flu. If a country refuses to impose measures agreed by international bodies, the degree to which its autonomy is respected has to be balanced with the risk it poses to other countries.

If international travel contributes to the spread of avian flu, should passengers there be quarantine periods to ensure symptoms did not develop before travel? Should passengers only be able to travel if they had proof of effective vaccination or immunity? If one country in particular has a very high incidence of avian flu, should the international community be able to impose conditions of quarantine and compulsory vaccination on all its citizens in order to try to prevent spread of the virus? In the event of a global pandemic should all international travel be stopped?

A vaccine cannot be manufactured until the virus for which it is being developed has been identified. Since the present H5N1 avian influenza does not have the potential for human to human transmission, a vaccine cannot yet be developed until a mutation occurs that has this potential. Once this variant with human to human transmission is identified it would take at least 6 months to develop a vaccine. All drugs are subject to clinical trials to determine their effectiveness and safety. In the event of a pandemic there would be enormous pressure to reduce this time to the minimum possible. A vaccine produced now, in anticipation of a pandemic strain, to cover part, say the H5 part of the virus, would be unlikely to be specific enough to be effective and so it would be exceedingly risky for companies to produce vast quantities of a vaccine that may never be used; there may not be a pandemic even if the virus mutates into a more infectious form, and there may not be a market for the drugs. Should governments / taxpayers subsidise the costs of research, development and testing of drugs manufactured by private companies for private profit? Should a company be forced to forfeit their patent for a drug that is needed to vaccinate the worlds population? Bitter experience regarding antiretroviral drugs for HIV/AIDS demonstrates that even in cases of diseases that threaten millions, drug companies and governments do not give up patents, rather they seek to tighten property rights (8) No single company has the resources to produce the quantities required in a short time, so should all technologically capable companies be given license to produce the vaccine? If there are limited quantities of the vaccine, it will have to be rationed. If it is to be distributed according to need there would be different ways of assessing need. One approach would to be to prioritise the most vulnerable, the very young and old, pregnant women and the immuno-compromised, healthcare workers and their administrative staff. Poultry workers, veterinarians, and others allied to the poultry industry would be at increased risk. Politicians and other important public sector workers would claim their stake as well. Underdeveloped countries, particularly those with rural populations in close contact with poultry and high incidences of malnutrition and HIV/AIDS would be able to claim that their populations ought to be prioritised according to clinical need because their citizens were particularly vulnerable. It these countries are unable to afford the vaccines, and if supply is limited, then ought they to be protected and funded by organisations such as the WHO?  If a vaccine is developed in sufficient quantities to vaccinate a large proportion of the worlds population many people would nevertheless refuse vaccination. Should they be forced to accept the vaccination in order to prevent them catching and spreading the infection to others or should their autonomy be respected? If there are adverse reactions and side effects to a vaccine produced in massive quantities in a short time, should the manufacturers be expected to bear the costs of litigation? In 1976, fearing a potential swine-flu epidemic, US Congress agreed to cover the liability costs when 40 million people were vaccinated. They paid over $90 million in damages and said they would never again assume the liability of pharmaceutical companies during a potential epidemic (9). If governments expect pharmaceutical companies to take these kind of enormous risks, can they also expect them to assume liability and forfeit their profits by resigning their patent rights?

Since resources are limited, if companies concentrate their efforts on drugs to prevent and treat avian flu, a disease that may never occur, it would be at the expense of research and development into diseases such as malaria, HIV/AIDS and tuberculosis which already kill millions every year in developing countries. The Africa Report (10) estimated that $1bn a year, just over half the amount pledged to combat avian flu so far this year, would significantly reduce the more than one million deaths from malaria that occur every year. Global funds for malaria, a disease that is known to kill, and for which cheap, effective preventive methods and treatments are available, are seriously lacking, and yet, for a disease that does not yet exist, billions are being spent on highly expensive, ineffective treatments. Given that there are limited global funds for tackling diseases, those diseases that are known to kill and for which cost-effective treatments are available ought to be prioritised.

The antiviral, oseltamivir (Tamiflu) manufactured by Roche has attracted the most attention in the hope for a treatment for avian flu because it appears that it may reduce the severity and duration of the illness marginally, although it  probably does not reduce mortality. Not surprisingly, given that there have been so few cases of H5N1 infection in humans, there are very few published reports of the use of tamiflu. The New England Journal of Medicine reported in December 2005 that treatment with the recommended dose of oseltamivir, did not completely suppress the virus and, even more worrying, led to oseltamivir resistance during treatment. (11) Antiviral drugs are very rarely used because of their high cost and relative ineffectiveness and yet vast amounts of money are being spent stockpiling tamiflu, including nearly 15 million doses for the UK. (12)

This in itself is alarming despite being in line with WHO guidance. It may also come from democratically elected governments feeling pressure from their electorate to be doing something in preparation. The evidence for the electorate’s demand for tamiflu comes at least in part from the enormous demand for the drug on the black market. On October 31st 2005, Fortune magazine reported that, “Tamiflu is the most sought after drug in the world and that avian flu is “very good news” for investors”

Tamiflu is available to the NHS at a cost of £16.36 for a course of 10 capsules. It is widely available online  for £99 for 10 capsules (13). Since tamiflu is being sold legally from sites such as these, then it is being rationed according to the market and not according to need. It is being stockpiled by individuals to be used in the absence of medical supervision, on low risk situations, as and when they perceive the need. This raises a new concern that, inappropriately administered, it is quite possible that it could lead to the development of other tamiflu-resistant viruses that may present quite unexpected epidemics unrelated to H5N1. Responsibility for the use inappropriate use of these drugs ought to be shared between the manufacturers, distributors and purchasers as well as the government authorities responsible for controlling the pharmaceutical industry.

Despite negligible evidence for its efficacy, tamiflu remains the only drug with any evidence of effectiveness. Yet, as with vaccinations, should infected people be quarantined and/or forced to take tamiflu or other drugs to treat the infection to prevent its spread?

Summary

Pandemic avian flu presents a number of interesting ethical challenges since it does not yet exist, yet if it was to occur it would be devastating. National and individual autonomy is challenged by a disease that could infect us all. The necessary ethical responses are limited by economic factors and highlight inequalities in global wealth. Industrial animal production continues to threaten animals and humans, and the limitations of a capitalist system that profits from healthcare are highlighted.

1.   http://www.who.int/csr/disease/avian_influenza/country/cases_table_2006_02_20/en/index.html

2.   http://www.who.int/csr/disease/avian_influenza/phase/en/index.html

3.   http://bmj.bmjjournals.com/cgi/content/full/331/7524/1066

4.   http://news.bbc.co.uk/1/hi/world/europe/4714574.stm

5.   Cook, Robert A and Karesh, William B, The Human-Animal link. Foreign Affairs, Vol 84, No. 4, p.46

6.   http://www.upc-online.org/slaughter/22805karenflu.htm.

7.   http://news.bbc.co.uk/1/hi/world/asia-pacific/4622982.stm

8.   http://www.accessmed-msf.org

9.   Laurie Garrett, The Next Pandemic? Foreign Affairs, Vol 84, No. 4 p.10

10. http://news.nationalgeographic.com/news/2003/06/0612_030612_malaria_2.html

11. http://content.nejm.org/cgi/content/full/353/25/2667?ijkey=a09c5bdd2d7c7acd1ff6048c550b1fb1fd2a9eec

12. http://www.dh.gov.uk/pandemicflu

13. http://www.ukmedixplus.co.uk.

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