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Genomics for health

WHO foresees advances in the struggle against morbid and genetic diseases

If correctly handled, genomic research may change the health systems all over the world and open the way for the prevention and treatment of diseases that are decimating millions of people, particularly in the developing countries. But the risk has to be avoided of the knowledge generated widening the gap in the quality of medical care amongst the countries. This was one of the main conclusions of the report by the World Health Organization (WHO), Genomics and World Health, published on April 30th. The report gathers information on genomic research from all over the world, assesses prospects, and draws up scenarios for the future use of genetics.

The WHO started to investigate the possible impacts of the genome revolution in health and its implications for the developing countries, as soon as the sequencing of the human genome was announced, at the beginning of 2001.The objective was to define the strategies for its activities regarding this new field of research. Over 13 months, a group of 14 doctors, researchers and specialists in ethics, coordinated by Tikki Pang, the WHO’s director for Research and Cooperation Policy, carried out a detailed survey, containing 241 pages, on the current stage and the prospects for the development of research in the several countries.

They found that the information generated by genomics may be used to produce, in the next few years, a spectacular advance in the fight against morbid diseases like malaria, tuberculosis and Aids, which have high morbidity in the developing countries. They will also offer important clues for the prevention, diagnosis and treatment of diseases that are of a genetic origin or chronic, like cardiovascular diseases, cancer and diabetes, amongst others. “Investigation into the genomes of pathogenic agents will help us to understand better the transmission of diseases and the mechanisms for their virulence, as well as the way the infectious agents destroy the defenses of the carrier. This information should make it possible to develop new classes of diagnosis, vaccines and therapeutical agents”, the report points out.

The WHO found, however, that most research into genomics and biotechnology is being carried out in the industrialized world and is always aimed at the market. The report points to a few exceptions, and mentions the cases of China, India, Cuba and Brazil, which are using the possibilities opened up by genetics to carry out research into local diseases. “The danger exists that these advances may intensify the disparity in health care within each country and between countries”, the report warns.

The situation worsens when one takes into account the lack of incentives for the pharmaceutical industry to carry out investigations with the objective of fighting non-assisted diseases that decimate the population ofthe poorer countries. “The potential of genomics for fighting these illnesses will not be realized, and the inequalities in health will worsen, unless these countries increase their biotechnological capacity or encourage investments on the part of public or private institutions, both in developed countries and in the developing ones”, the WHO recommends.

To avoid this risk, the report “strongly” endorses the recommendation of the WHO’s Macroeconomic and Health Commission, to create a Global Fund for Health Research, with initial capital of US$ 1.5 billion, for financing R&D in developing countries. And it advocates making an identical amount available for countries and institutions that are working on new vaccines and on the development of drugs against Aids, tuberculosis and malaria.

Ethics and genetics
The report also examines the role of ethics in research and in genetic medicine. The usual ethical practices, like informed consent and confidentiality, have to be reviewed, due to the nature of genetic information. Each country should establish its own ethical benchmark and create legislation based on internationally defined principles, the report indicates.The WHO also calls attention to the fact the some characteristics of recombinant DNA, particularly when used in the manipulation of human and animal genomes, call for regulation in terms of public security, the health of the investigator, the risks for the environment, and against the possibility of improper social and political uses.

Countries need to be ready to adopt radically new points of view, with regard to research and to the practice of medicine, recommends the WHO, and to assess their current abilities in biotechnology and bioinformatics, in order to establish strategic priorities. The WHO is willing to support nations that wish to expand this field for investigation, through the supply of technical assistance and support for the creation of professional training programs between the north and the south and the development of regional research networks.

Genomic technology may help in the fight against contagious diseases, common in developing countries. This area of research, the report explains, ought to bring together universities, public research institutions and companies to carry out R&D programs that make it possible to obtain new healthcare products. But this strategy will call for the setting up of agreements between the partners, besides tax benefits and a broad research network.

The WHO also recommends that countries should invest in building up a critical mass of specialized knowledge, to be able to take part in the investigations and to have access to the genome databases, a part of which are offered free of charge to the public. The WHO is willing to offer technical assistance to States, for them, for example, to implement courses of a short duration. It is also willing to take on a “crucial role in the vanguard of bioethics”, in particular as far as genomics and world health are concerned, and to counsel governments on the best way of setting up systems of regulations for the wide range of technologies that are being generated by research.

Research out of step

Countries that finance genome research find themselves in a privileged position for understanding and debating the clinical, ethical and legal implications resulting from the advances achieved in this area of knowledge. This is the opinion of Tikki Pang, the director of the World Health Organization (WHO) for Research and Cooperation Policy, who coordinated the works for the report on Genomics and World Health. “We do not agree with the idea that only the rich nations should carry out genome research, which, for its very nature, is expensive”, says Pang, in an interview with Pesquisa FAPESP.

He does not regard the national investments in biotechnology and genomics as a luxury. “Developing countries also must do this”. For the WHO’s director, societies that have a better understanding of the profound impacts of genomics will be able to benefit more effectively from the discoveries and technologies created by this branch of science. “The nations that understand more clearly the impact of genomics and invest in this sector will be able to maximize their gains”, explains Pang.

In the greater part of the developing world, there is almost no genome research. This picture of diminished investments in science in the poorer regions of the planet worries the WHO, since many corners of the globe run the risk of being left out of the novelties produced by this line of research. Four peripheral nations, however, feature as exceptions to this rule: China, India, Cuba and Brazil, which have invested in the sector. Amongst these four countries, Brazil has a prominent position. “In terms of genome research applied to the agricultural area, Brazil is second to none, not even rich countries.

Then China seems to have concentrated its efforts in the health area”, is Pang’s comment. To reduce the distance between the levels of the research carried out in the rich countries and the poor ones, the WHO advocates setting up alternative forms of finance for genome research in undeveloped countries. According to Pang, the creation of the Global Fund for Health Research – a mechanism for financing scientific studies (and genome studies as well) in developing countries, which would be able to count on an initial budget of US$ 1.5 billion – will depend on raising funds from two sources: the developed countries and the pharmaceutical industry. “It isn’t easy to convince the taxpayers in these countries, and it is they who pay the bill in the end, to give this money”, comments Pang. “It is even more difficult to sway the pharmaceutical industry, which is more interested in having profits and in producing for the major markets”.

According to the WHO’s director, Brazil, for its position of leadership in Latin American science, is one of the nations that may come to receive part of the resources of the fund. “Brazil has centers of excellence in research, the government has invested in science, and the country has all the conditions for being a center for the irradiation of knowledge to its neighbors in the region”, says Pang.

Despite a greater or lesser degree of investment in genome research, all and every country suffers from a universal problem, in the view of the WHO’s director: the latest advances in research are out of step with the legislation that governs the practice of science. “The changes generated by the new discoveries are very fast, and societies move slowly to create regulatory mechanisms”, says Pang. For him, this problem affects indiscriminately both the rich and industrialized countries and the developing nations.

Brazil sets a good example

The Genomics and World Health report dedicates page 95 and part of 96 to giving an account of the strategies for the development of genome research in Brazil, which, over the last five years, has joined the first echelon amongst the countries that are carrying out research in genomics, using a model of research in a network that is an example for other nations. It recalls that, in 1997, FAPESP took the “strategic decision” to start a major research program that began with the sequencing of the genome of the Xylella fastidiosa bacterium. Instead of building a center for the work to be carried out there, FAPESP started a “virtual genomics institute”- the network called Onsa (Organization for Nucleotide Sequencing and Analysis)-, with roughly 200 researchers based on 30 laboratories in the state of São Paulo, maintained with initial funds in the order of US$ 13 million.

In less than one year, the report stresses, the network sequenced 90% of the 3 million genomes of Xylella, and published the complete sequence in the July 2000 issue of Nature. This achievement attracted considerable attention from the media, both in Brazil and all over the world, the report states.

The second major program of the Onsa network, the report reckons, was the Cancer Genome project, which was able to count on US$ 10 million from FAPESP and the Ludwig Research Institute, using Orestes, a pioneering technique for sequencing. “The project was a phenomenal success: one week after the sequencing of Xylella was announced, the Cancer Project announced that it had mapped 500 million ESTs”, as the report puts it. In October 2001, the group published, in the Proceedings of the National Academy of Science, of the United States, the identification of 700,000 active fragments in 24 normal and cancerous tissues.

“This work suggests that the initial estimates of the total number of human genes may be an underestimate”, the report comments. Brazil now has, alongside the United States and the United Kingdom, the status of world leader in cancer genome research. Also mentioned are the sequencing projects for the genomes of Schistosoma manzoni and sugarcane, the latter now concluded.

Furthermore, the report mentions that the Ministry of Science and Technology has launched a national program for genome research, in partnership with the National Council for Scientific and Technological Development (CNPq), which has brought together a network of 25 laboratories from all over the country. The network has already sequenced the genome of Chromobacterium violaceum. And it concludes that there is no doubt that other countries have a lot to learn from the Brazilian ability for constructing successful research strategies.