Resource allocation and the genetic revolution

I want to address two questions about resource allocation and the genetic revolution. They are:

1. Is a new discourse needed specifically to discuss resource allocation in the age of the human genome?
2. If the answer is ‘no’, as I shall argue, what will be the new vectors in that discourse? I believe there are three:

• commercialisation;
• global impact; and
• community ignorance or indifference.

I want first to sketch our experience with ethical resource distribution for health, then establish the context created by knowledge of the human genome. I will then touch briefly on the essence of the ethics of resource allocation and conclude with several looming questions.

Experience with resource allocation

Our experience with rapid expansion of effective technology in medicine has presented us with a much more weighty set of applied ethical challenges. When the cost of medical care was much lower and what we could do to help relieve pain and extend life was much less, deciding how to allocate resources for medical care was less complex. The advent of noninvasive and highly informative diagnostic procedures such as CT and PET brought with it concerns about where the technology should be provided and to whom, and questions about who should pay. These in turn provoked ethical debate at a higher level than we had been used to over resource allocation.

The context of the human genome

The powerful symbolic event that has galvanised debate about the medical and public health consequences of confronting and seeking to manage through technology genetic variation is the exploration of the structure of the human genome. This has many of the mythic qualities of Neil Armstrong’s first step onto the moon. It is breathtaking in its audaciousness, frightening in its adventurousness, worrying in its significance.

Elucidating the structure of the human genome adds substantially to our understanding of the way in which diseases are transmitted by heredity from one generation to the next. But more than that, it opens up new vistas for the prevention and early treatment of many diseases. Prevention could be achieved by genetic manipulation, selective environmental hazard avoidance according to genetic susceptibility (not working anywhere near a specific chemical) or a eugenic manoeuvre.

Stephen Russell from the UK sees future possible developments in gene therapy including ‘improved manipulation of human cells and tissues outside the body to facilitate implantation of genetically engineered products, innovative approaches to gene therapy applied to common diseases of the cardiovascular, respiratory, gastrointestinal and nervous systems, future vectors to deliver genes more accurately and efficiently and considerable resources … concentrated in regional gene therapy centres’ (1997, pg 1289).

The mapping of the human genome augurs for a rapid advance in both our knowledge and application of genetic science. While much concern is given to the management of genetic information for individuals, their families and society, the Galbraithian technological imperative, which presses us to do things because they are technically feasible, may well over-ride some or even much of the debate about disclosure. New notions of privacy and confidentiality, constructed from durable principles but with due acknowledgement of context, are within reach.

In a recent presentation to the UNESCO Asian Bioethics Congress, Glenn McGee, Editor-in-Chief of the American Journal of Bioethics and Assistant Professor of the Center for Bioethics, University of Pennsylvania, said:

There is more than enough ethical mud in genetics of 1998 to keep physicians, lawyers, scientists and bioethicists on guard. A majority are unaware of the progress made in routine and exotic genetics, and most are caught off guard by each new technology. At the same time, in the United States most scientists receive no more than a few hours’ training in ethics, most physicians take no training in genetics, and it was revealed in 1997 that less than 16% of those who received a prominent genetic test for susceptibility to cancer were counseled about the choice. The first time most families in the West learn about the practical issues in genetic testing is when a friend or relative needs a test urgently during pregnancy. To make matters worse, apart from bioethics conferences there is still virtually no common public or scientific international conversation about gene therapy, reproductive rights, or genetic patenting.

Costs of genetic services will fall precipitously just as evidence accumulates about the costs associated with having particular genes. Virtually every culture will have to cope with an unparalleled pressure to conserve social resources by applying pressure to individuals in an attempt to modify their reproductive behavior and other life choices.

Bioethics and resource allocation

Bioethics is only 40 years old! Much has been discussed and written about the ethics of equity especially Utilitarianism and Consequentialist derivatives of it. Rawls’ concepts of distributive justice have been important here as well, interpreted by Norman Daniels, as have the economics of efficiency and their respective applications to how best to match limited resources to demand. These ethical and economic notions – of equity and efficiency - in turn stimulated health services research and technology assessment as research methods. The intention was to provide better quality data relating to effectiveness, side effects, and cost of treatment. This was one of the drivers behind the evidence-based medicine movement of the past decade.

The debate has broadened well beyond professional and political boundaries. Through the connectivity of information technology (not just the web and associated nets), it has engaged broad community interest in the relation of breakthroughs to rationing. Public opinion in Australia remains firmly wedded to universal health insurance as the dominant method of payment for health care. This derives in part from an appreciation that illness and injury remain largely capricious and that there is a need to distribute the high costs of effective health care across a wide community base.

In a sense, therefore, we have been primed to contemplate the impact of the human genome project, post-genome technology roll-out and all the attendant and derivative technologies within an ethical and economic context. Featuring in the discourse with stronger valence than previously are the interests of commerce.

Questions that loom large

The questions that might be asked in our discussion about resource allocation for the future have more to do with the relation of therapeutic commercial and industrial development and the style of society in which we live than about genetics itself. Many of these questions are pre-figured in our current concern with multinational commercial hegemony. Multinationals exert great pressure on countries, especially those in the Anglophone democratic world where governments have downsized and rolled over in near surrender and abandoned the welfare state (Cass, 1999). Eschewing dependence and powerlessness among their people, they have set out to become dependent and powerless themselves by abdication to the market. And the market is precisely where gene technology is to be found. ‘The human genome project will provide enormous commercial opportunities for the pharmaceutical and biotechnology industries, which have been quick to realise the potential for new treatments…there is growing excitement in pharmaceutical circles that the genome project may identify new genes and proteins that have a role in disease’ (Savill 1997, pg 44). However, with this will come huge risks. If biotechnology is the commercial rage of the next age of therapeutics, and genetically modified food producers are to call the shots in world agripolicy, we have worries in store that are only hinted at in our current ethical debates.

Let us assume that genetic interventions with preventive or therapeutic value do emerge and that gene therapy (at which there have already been many thousands of attempts) becomes an effective addition to the therapeutic armamentarium. The likelihood is that this will be commercially led. The commerce of these developments is foreshadowed in aphorisms such as ‘biotech is as big as the IT revolution’. It will be driven by commercial values. Products will follow that are either desperately expensive for the few (if the market is small) or focussed on disease of high frequency only among those communities that could afford to pay for them (hypertension rather than malaria). Where, pray tell, in all of this is poor old ‘equity’? The time is now to begin the complex but essential health economic/health ethical discussion lest the north-south divide is further widened, all in the name of genomic science and its boisterous progeny, genetic-based prevention and therapy.

Jeffrey Sachs, director of the Centre for International Development and professor of international trade at Harvard University, wrote last year of the north-south divide in The Economist. 'Just as knowledge is becoming the undisputed centrepiece of global prosperity (and lack of it, the core of human impoverishment), the global regime on intellectual property rights requires a new look...now transnational corporations and rich-country institutions are patenting everything from the human genome to rainforest biodiversity. The poor will be ripped off unless some sense and equity are introduced into this runaway process' (1999, pg 20).

To summarise, the mapping of the human genome will release intense commercial energy. This will pose huge problems about access to new therapies, which will inevitably be expensive. Only the new slaves, the normal, ever-more-working workers, will be able to pay.

Gene technology applied to food crop development has been heavily entrepreneurial, in many instances disrespectful if not arrogant, in relation to long-term human and environmental consequences. It does not bode well for future cut-throat commericalisation of gene-based technologies directed toward disease prevention and cure. The public-commercial interactions may not evolve favourably for those who value equity.

What can be done? The power of individuals and specific nations to resist global commercial depredation varies. The nature of the problem of global multinational hegemony is not uniformly well understood. But it is within the power of the people to elect governments in democracies to do their bidding. It is a matter of the greatest urgency that public health professionals perceive what is at risk and begin its advocacy in favour of local action, after thinking carefully about global issues.

In his presentation to the UNESCO Congress, McGee concluded:

It is clear that the maldistribution of public resources in health care cannot continue in the U.S. or other countries. The U.S. spends billions on genetic research and biotechnology, yet still is unable to spend pennies on public health prenatal services for all pregnant women. Americans spend millions on genetic research concerning intelligence, but find their institutions unable to spend pennies to educate the world's children to the point where comprehensive understanding of, and informed consent for, genetic services is possible. This is dangerous because it suggests that we hope for a future in which nutrition, education and environmental issues are sublimated to genetics or genomics or gene therapy.

A rediscovery of the notion of altruism appears to be critical, for both its actual and symbolic impact. Thus the contribution of $100M by the Bill and Melinda Gates Foundation toward the development of a malaria vaccine (which depends upon an understanding of the malaria genome) may point the way forward. But we have a long way to travel.