Can we create a democratic genomics?
A valuable report from the World Health Organisation outlines in measured tones the many potential contributions of genomics to the health of developing nations. But significant economic, social and political hurdles remain to be overcome.
Few technologies have entered the world with the frenzied excitement that greeted the birth of genomics. The ability to read the detailed genetic make-up of any living organism — particularly the human being — by listing the sequence of the chemical components of its DNA fuelled a spiral of anticipation in the scientific community and stock markets alike. In late 2000, shortly after the first full sequence of a human chromosome had been published, shares of many small genomics companies, which promised investors a stake in a new gold-rush, increased in value by up to ten times within a few weeks.
Today, these dreams have burst and reality has set in. The companies that saw their stocks hit dizzy heights have watched their value collapse equally rapidly, leaving investors who swallowed the hype angry and frustrated. Some companies have gone bankrupt. Others are facing mixed fortunes in their efforts to find effective medical applications for the sequencing data that originally bought or generated with such high hopes. The general situation is epitomised by the fate of Celera Genomics (now known as Applera Celera), whose shares currently trade at US$14 — a far cry from the US$245 they were worth in March 2001, shortly after the company had announced joint victory with a public programme in sequencing the complete human genome.
The plight of such companies may not attract much sympathy from those who have long lamented the excessive commercialisation of genomics research, in particular the use of the patent system to limit access to and control over gene sequences. But it holds important lessons for those who might otherwise be tempted to get carried away by overly optimistic projections of the speed with which genomics may revolutionise modern medicine. Equally importantly, it underlines the fact that the rate at which genomics enters the medical mainstream will be driven not only by the science behind it, but also by the preparedness of the economic and social environment in which this science takes place.
Dampening the hype
Similar lessons emerge from the report released last week by the World Health Organisation (WHO) on the potential contribution of genomics to the health of developing countries (see WHO seeks genomics boost for poor countries). Genomics and World Health, prepared by an expert panel set up by the WHO's Advisory Committee on Health Research, sketches a vivid picture of the many ways in which knowledge of the genomic sequences of living organisms — including viruses and other pathogens — is likely to become an invaluable weapon in the fight again disease.
At the same time, the report is refreshingly realistic about the timescale on which this is likely to occur. Indeed, it warns about over-expectations, and underlines the need for those who administer health services to be able "to distinguish between hyperbole and reality in a new rapidly-expanding field". The scientific uncertainties alone, the report argues, suggest a need for caution. While calling for a substantial investment in the genomics research that could make a major contribution to the alleviation of disease in developing countries, it also says that it is "vital" that such research "is not pursued to the detriment of the well-established methods of clinical practice, and clinical and epidemiological research".
Not only is the science uncertain. So, too, are some of the impacts that the science of genomics is likely to have on our lives. Here the need for caution is expressed primarily in terms of the requirement for ethical oversight. The report argues that the WHO is well-placed "to adopt a leadership role in bioethics, particularly as it relates to genomics and world health", and suggests that the agency "should ensure that countries develop the capacity to evaluate the ethical implications of genomics, and also engage in public education at all levels".
The biggest hurdles, however, lie not in the scientific or ethical area, but in economics and politics. The reality of the genomics revolution is that it has been supported by industry and governments alike not as a disinterested scientific endeavour, but as a route towards new therapies and diagnostic techniques. Much of this support, particularly for the substantial proportion of genomics work being carried out in the private sector, has been seen as an investment, with an expectation of high returns. As a result, most of the research so far has been directed at diseases prevalent in the world's richer nations.
Shifting the focus of genomics research to diseases of poorer nations will be a daunting task. Companies already uncertain of their ability to turn genomic information into profitable new drugs are likely to be even more reluctant to invest significant efforts in products aimed at developing country markets that will probably not be able to pay a high price for them. Yet giving in to market forces will be both a medical and a political failure. As the report says: "all member states must ensure that genome technology is used to reduce rather than exacerbate global inequalities in health status".
Components of a solution
There are no easy ways of doing this. However, three components are likely to be essential to any lasting solution.
The first is essentially economic. Genomics research is expensive, and large funds will be required if it is to reach its full potential. The WHO appears to have set its sights on promoting genomics under the umbrella of a broader project, proposed in the recent report of its Commission on Macroeconomics and Health, to create a so-called Global Health Research Fund (see WHO wants $66 billion investment in health).
The logic for creating this fund is attractive. It would, for example, help redress the current widely-criticised imbalance in research funding, under which 90 per cent of the world's medical research is spend on the needs of 10 per cent of its population. And as the WHO commission makes clear, investment in science-based research is a cost-effective approach to achieve broader development objectives.
So far, however, there has been no indication of where the money is likely to come from. Vague suggestions that the private sector should be required to cover most of the costs have, perhaps unsurprisingly, found little resonance within the pharmaceutical or biotechnology industries. Perhaps, as individuals such as John Sulston, the former director of the UK Sanger Center and head of the British team engaged in sequencing the human genome, are suggesting, the answer lies in some form of global taxation on profits from their activities in the genomics field, analogous to the carbon tax proposed to combat global warming.
The second component needs to be a more imaginative approach to the question of creating trust in genomics research. Society has many legitimate — and some not so legitimate — reasons to be wary of genetics. The spectre of eugenics may be fading, but it is being gradually replaced by fears of various forms of genetic discrimination. In addition, the increasing use of forensic DNA techniques by police forces, however effective it has been in combating crime, has raised wariness about the way that genomic data might be used.
Ethics committees are part of the answer. But they are not the only part. Nor does the solution lie purely in combining greater transparency in decision-making involving genomic information (although this is a key component) with enhanced public understanding of genomics (as a means of ensuring that transparency can be used responsibly). The biggest cause for distrust lies, as it does with genetically modified crops, in fears of exploitation by the private sector through its control of the data that emerges from the research it has funded.
The political challenge
This raises the third component of any solution, namely the need to address the political issues that lie at the heart of so many dimensions of the knowledge society. No-one pretends that the rules of world trade — which, through the patent system, determine who can use this knowledge and how — can be changed overnight. Equally no-one can dispute that the way these rules currently operate exacerbate the problem at the heart of the WHO report, namely that, as one observer puts it, "developing nations are in danger of being left out of the benefits of genomics research".
The real challenge here is to modify world trade rules, including those that govern intellectual property, around a single, powerful concept: social equity. The WHO has the moral authority to place this task on the agenda. But addressing it will mean not only persuading governments to take the message of the recent genomics report on board, but also confronting those who argue that the only form of equity that counts is that of the market-place. For those unable to buy the goods on show, this form of equity is meaningless. Somehow a democratic genomics is required that helps to place social equity back at the heart of healthcare.
© SciDev.Net 2002