12th Greek Australian Legal and Medical Conference
Samos, Greece 2009

ARE WE GETTING VALUE FOR OUR INCREASED SPENDING ON THE CONTROL OF INFECTIOUS DISEASES?

Professor Ian Gust

Professorial Fellow
Department of Microbiology and Immunology
The University of Melbourne
Victoria 3010 Australia

idg@unimelb.edu.au

Good morning, being placed on the program between Ian Frazer talking about sex and John Mathews talking about swine flu is a bit lke being Zsa Zsa Gabors 9th husband on their wedding night. I know what is expected of me but wonder if I will be able to retain your interest!

My topic is very broad, so, since most of the new money coming into the field is to expand immunization coverage and develop new vaccines, and this is the field I am most familiar with, I will confine my comments mainly to that area.

Most people would agree that the outstanding public health achievement of the 20th century was the eradication of smallpox – an outcome made possible by the unique properties of the disease, the absence of an animal reservoir, the availability of a cheap, widely available vaccine and the effective leadership of D.A. Henderson and the World Health Organisation.

Buoyed by the success of the program, WHO looked for other diseases which could potentially be controlled by immunization and for which, effective, inexpensive vaccines existed.

In 1974 it launched The Expanded Program for Immunization, which sought to protect every child against tuberculosis, diphtheria, tetanus, whooping cough, poliomyelitis and measles, using BCG, DTP, oral polio and measles vaccines.

Donor funds were sought and vaccines were procured by UNICEF and provided to countries which were unable to produce or purchase their own. UNICEF also assisted countries to develop storage and distribution systems.

The Program has been running for 35 years and has been very successful. Even allowing for local factors which encourage over reporting, between 1974 and 1990, the proportion of children immunized against these 6 diseases rose from less than 5% to around 80% - although the overall figures concealed significantly poorer coverage in South East Asia (especially India) and much of Africa.

By 1990 it became apparent that the EPI program was in trouble – coverage rates in some regions had begun to fall and donors began shifting resources to areas of higher priority – such as the fight against AIDS.

Faced with an unpredictable budget, UNICEF was unable to place standing orders with manufacturers, and when funds became available tended to purchase vaccines on the spot market, at the lowest possible price.

These factors, resulted in an irregular supply – with countries sometimes going without stock for up to a year, and several producers exiting the field because the price UNICEF was able to pay, did not cover their cost of production.

As the 1980s and 90s coincided with the start of a period of unprecedented productivity for vaccine developers, UNICEF and WHO found themselves in the unenviable position of resisting calls to add Hepatitis B vaccine to the EPI, for fear that the additional cost was the straw that would break the camels back.

It took a decade of advocacy by a catalytic group, the International Task Force for Hepatitis B Immunization, before the World Health Assembly finally recommended that WHO make HB its 7th EPI vaccine.

The HB dilemma forced the International Public health Community to rethink the issues involved in delivering new vaccines to the developing world.

Catalysed by an important, if short lived, entity, the Children’s Vaccine Initiative, a Geneva based NGO, powerful arguments were developed on the health and economic benefits of immunization. As a result of this advocacy, and the World Health Report of 1997, immunization became one of the central issues of the Children’s Summit of New York, which put immunisation firmly back on the International Agenda and led to new mechanisms for funding and co-ordination being developed.

This movement came to fruition at a UN convened meeting of Heads of State in September 2000, which signed off on, a series of challenging goals for the first 15 years of the New Millennium – the so called

Millennium Development Goals – which begin with eradication of poverty and hunger and end with establishing global partnerships for development.

The 4th Development Goal set an ambitious target of reducing infant mortality by 2/3 by 2015 and like the other goals it is strong on the what and weak on the how! Which is probably why UNICEF, now speaks of those targets as aspirational!

In practice, setting a set of clear goals and monitoring progress (or failure) in their achievement has been a worthwhile exercise and has lead to billions of dollars of new money flowing into the field.

Where is the new money coming from and is it making a real difference? In addition to huge investments in basic research through the National Institute of Health, European Commission, Wellcome Trust etc there have been massive increases in funding from US AID, Pepfar (The Presidents Emergency Fund for AIDS Relief), the Bill and Melinda Gates Foundation, the Global Fund to fight AIDS,TB and Malaria, OECD, Governments, especially the UK and Scandinavia and the World Bank. US AID is spending over US$20B per annum on overseas development assistance, the Pepfar budget for AIDS relief, is $15B over 5 years, the Gates Foundations investments in public health are upwards of $1B pa while several Billions more have been set aside to address the potential problems of avian and swine influenza. These are big numbers.

Where is it all going? A high proportion of this new money is going to purchase vaccines for the poorest countries in the world, to add new vaccines like Hepatitis B and haemophilus influenzae b to strengthen delivery systems and improve the safety of vaccine delivery.

Much of the remainder is being spent on vertical, disease specific programs, such as rolling out anti retroviral therapy for people with AIDS and attempts to develop vaccines against HIV, Malaria and TB, through public private, product development partnerships.

The public health community has responded to the need for greater co-ordination of immunization activities, and belatedly recognised the critical role played by industry, by creating of a body, known as GAVI.

Not the famous Italian wine but The Global Alliance for Vaccine and Immunization and establishing a Fund to raise money to support immunization services in the poorest countries ie those with a per capita income of less than US$1000pa, until they are able to fend for themselves.

GAVI which is an alliance of manufacturers, donors, Public Health authorities, Research Organizations, Foundations and major institutions serves as a co-ordinating and liaison body and provides a mechanism of establishing production and funding priorities.

The Fund, which is managed separately from GAVI, uses donations from countries and foundations, to purchase vaccines and make investments in infrastructure and vaccine safety. It’s current plan calls on it to spend some 3.5B by 2015, of which 74 % will be used to purchase vaccines. Of the rest, only $780m, or about $50m pa is going to strengthening health services and delivery systems.

These new mechanisms are bearing some fruit.

Coverage rates for the original 6 EPI vaccines are increasing, although not rapidly enough to achieve the MDG’s. Disappointingly there are some areas, like India and much of sub Saharan Africa, where coverage remains extremely low and little is being done to seek novel solutions.

Coverage of newer vaccines, such as HB and HIb, is increasing, albeit slowly: it is chastening that 25 years after its licensure, when HB vaccine is now available for about 20 cents a dose, only 50% of the world’s children are being immunized.

If we are still having trouble with the introduction of HB, its hard to think that the long list of vaccines like Japanese B, HRV or HPV which are lining up behind it and are likely to be significantly more expensive, will be any easier – let alone what will happen if we are able to develop vaccines against HIV, malaria or TB.

The Global Financial Crisis makes it uncertain to whether countries will be able to meet their pledges to the Global Fund – especially where the promises are based on spending a certain proportion of GDP. Of the US$3B pledged to the fund, only 20% has been received to date.

If we are to just maintain the current level of immunization and cope with a global population growing at 80m per annum, at a minimum, we need reliable and increasing funding, a greater focus on improving infrastructure, better means of accessing children in hard to reach areas and a more realistic time frame for introduction of new vaccines.

Perhaps the greatest challenge is to ensure that the Elephant in the Room – the Gates Foundation – which has undoubtedly reenergized the field, doesn’t distort its priorities.

The Foundation, which with the addition of Warren Buffets donation is now the biggest in the world, has an annual Health Budget, approaching that of WHO and has spend more than US$10B over the past decade. It is time to take stock. A series of recent commentaries in The Lancet, suggest that the Emperor, if not naked, has holes in its clothes.

A major criticism is that the Foundation and its Founder are unabashed believers in technical solutions to complex problems. This faith in technology, which seems to be shared by the US military, underestimates the complex, social, economic and political problems to be overcome before it is possible to establish an effective health system, of which immunization services are useful markers. While new technology is a necessary component of attempts to improve immunization services, it is not sufficient alone to achieve the task.

Having a safe and effective vaccine against malaria for example, will be of limited value, even if provided free, if countries using the vaccines lack competent governments and governance, there is no ability to estimate what quantity of vaccine is required, no capacity to store or distribute it, no reliable source of power for refrigerators or capacity to repair broken ones, an inadequate supply or poorly trained, poorly motivated and poorly remunerated health care workers, if mothers live far from vaccination posts and can only access services if the weather is clement , they have someone to care for their children. Very little of the Foundations budget is being spent on addressing these low risk high reward problems and seeking innovative solutions.

A significant proportion of The Foundations funds go to basic research on HIV, malaria and TB, high risk, high reward targets, already well supported by other funders like the NIH and the EU and it has had little interest in harvesting low hanging fruit. Given the Millenium Development Goals, better returns could almost certainly be obtained with greater emphasis on more effective use of existing products and technology.

Finally the Foundations current priorities don’t align with the major causes of disease in the developing world, and seem to be driven by what is fashionable and a sense of what is needed, rather than the priorities of local decision makers.

The biggest killers in the developing world are maternal deaths associated with childbirth, pneumonia and diarrhoea, but provision of antenatal care, clean water, proper sanitation and adequate housing, don’t attract influential lobby groups and are not nearly as attractive to donors.

The rapid increase in funding and top down decision making has created a number of problems and highlighted a lack of absorptive capacity. While there are never enough good people to go around, this is especially so in International Public Health and Vaccine Development and Delivery, where there is a major shortage of people with the relevant skills..most of the latter being found in industry. As a result almost all of the Public Private Product Development Partnerships are currently run by public health workers rather than people with industrial product development experience.

Another problem is that much of the funding comes with strings attached. These may be political, such as the previous US administrations failure to support HIV prevention activities if they endorsed the use of condoms, or organizational, such as the requirement to employ nationals or purchase goods originating from the donor country, or to use a foreign set of accounting and reporting standards.

In many developing countries a significant amount of the new money available is absorbed by the bureaucracy and while providing some benefit is often not being applied to its stated purpose – in others huge amounts are lost to corruption. A 2006 World bank report found that less than half the funds donated to countries in Sub Saharan Africa reach their intended target. They leak away in payments to phantom employees, padded prices, siphoning of products to the black market etc. Ghana holds the unenviable record with some 80% of funds diverted from their original purpose. The new global health initiatives have achieved some notable gains, several countries have increased the proportion of GDP spent on health, coverage with EPI vaccines, is increasing and deaths from measles have fallen. The provision of ARVs in Africa has not only had an impact on mortality but has enabled many infected HCWs remain in their posts. The number of people receiving directly observed therapy for TB and the number of families receiving insecticide impregnated bed nets has increased dramatically, but are these achievements sustainable, are they having an impact on the delivery of other services and are they focussed on the right targets?

Most of these programmes are externally planned, managed and funded and seem likely to collapse when donor support is declines as it probably will.

Collectively they are having an inadvertent impact on local manpower, by attracting many of the most competent people in the public sector to work for NGOs to help them negotiate a path through numerous local obstacles.

Typically NGOs offer a range of benefits and incentives that the public sector in developing countries is unable to match. These people get to work on interesting projects, in a stimulating environment, with superior resources and opportunities for additional training and travel. It’s a seductive mix and not surprisingly few return to their previous positions creating a serious brain drain. For example a recent survey in Malawi found that more than half of all health administrations, two thirds of nurses and 85% of doctors trained between 2002-7 had been recruited by foreign NGO’s. Very few donors provide funding or arrange secondments to replace local staff absorbed by their programs.

As Jim mentioned on Monday, the issue is complicated by the emigration of doctors and nurses to fill better paid posts in the developed world. . In Ghana of 800 doctors trained in the last decade, 600 now practice overseas and in Zambia of the last 600 doctors trained only 40 remain in the country.

The creation of disease specific programs, so called “stovepiping”, while satisfying the donors needs, may have unintended consequences.

A good example is seen in Haiti, which since 2002 has focussed on control of HIV, malaria and TB. Most of the AIDS funding has gone to a dedicated program which provides HIV testing and counselling, dedicated hospices and orphanages, AIDS education and ARV distribution sties. Because of the stigma associated with HIV this has created a cadre of Health Care Workers who work largely outside the existing system. Instead of the rising tide lifting all boats, while the use of anti retrovirals has increased steadily, and HIV infection rates have fallen – every other measurable health indictor in Haiti , including life expectancy has declined. But perhaps the most pointed criticism of the current increased spend on global health, as mentioned earlier, is that much of it is aimed at the wrong targets.

Arguably we could use the money more effectively and have a greater impact on Global health and the MDGs if greater emphasis was placed on improved antenatal care, breast feeding, greater availability of antibiotics to treat pneumonia, and oral rehydration fluids to treat diarrhoea, that is harvesting some low hanging fruit.

Huge gains could be obtained by using the tools we have more effectively. For example, the basic architecture of the EPI was designed nearly 40 years ago, long before companies such as Fedex and Walmart had turned logistics into a science. The Public health field has been slow to respond to these lessons and to involve individuals with the relevant skills. A new level of sophistication is needed to find ways of reaching previously inaccessible groups, forecast demand, maintain stock levels and avoid wastage. Pleasingly this has recently been recognized by the GF which is devoting some funds to innovative approaches and pilot studies.

If it was possible to bring greater order to a field, which because of the multiple agendas and sources of funding, is inherently chaotic, what should be done?

I think, as Lawrie Garret has suggested, the first thing to do is to get away from disease specific targets and focus on a limited number of outcomes which reflect the strength of the underlying health systems, like maternal survival and life expectancy which can be readily measured. Within that framework countries should establish their own priorities and tackle problems which are likely to give them the greatest reward for their, or others, investment.

Thirdly it is critical to expand programs to train and retain HCWs and ensure that, in parallel, the developed world had plans to reduce its dependency of foreign personnel.

Finally we need to find ways to continue to fund programs to assist the poorest countries and develop exit strategies for those better able to care for themselves.

While these are important objectives, I can’t help think that they are second order issues and that, without a reduction in the rate of population growth and effective government and governance, our increased investment, is simply providing a bandaid solution and simply preventing the situation from deteriorating.