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image European Research News Centre > Medicine and Health > Aids, malaria, tuberculosis: an urgent clinical counter-attack in Africa
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image image image Date published: 07/11/02
  image Aids, malaria, tuberculosis: an urgent clinical counter-attack in Africa
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  Sub-Saharan Africa is plunging ever deeper into a deadly spiral. Poverty engenders disease which in turn generates more poverty. In partnership with scientists and health officials in the countries affected, the European Union is launching a major clinical research project to halt the progress of the three transmissible diseases which are draining this sub-continent of its lifeblood.
   
     
   

Health threats to the world’s poorest countries, which lock them into a vicious circle of underdevelopment, are reaching the limits of endurance. The international community officially recognised the seriousness of the situation three years ago. Meeting in Okinawa in July 2000, the G8 countries agreed on the need ‘to step up the fight against poverty in the developing countries’ and to implement ‘urgent measures to combat infectious and parasitic diseases’.

Field trials

In September of the same year, the European Commission proposed a new political framework to ‘accelerate the fight against the principal transmissible diseases in the context of poverty reduction’ and, in partnership with the WHO and the UNAIDS programme, organised broader consultation with many of the countries concerned, international development agencies, the world of research and the pharmaceutical industry. In April 2001, the first HAD (Health, Aids, Demography) action took practical shape, aimed in particular at strengthening pharmaceutical policies, stepping up the research effort and boosting international partnerships.

Last April, this new commitment gave rise to the launch in Barcelona of the European and Developing Countries Clinical Trials Programme on Poverty-related diseases (EDCTP). This aims to develop clinical trials for new treatments and vaccines against Aids, tuberculosis and malaria in sub-Saharan Africa.

‘Increased and more effectively coordinated clinical research is a prerequisite for pushing back the tide of destruction caused by these diseases,’ stresses Antoni Trilla of Barcelona University’s Hospital Clinic, coordinator of the project’s start-up phase. ‘Each of them takes a different form and poses its own problems of diagnosis, treatment and prevention which are also linked to specific local conditions, both geographic and social.’

A la carte research

One example is Plasmodium falciparum, which is wreaking havoc across whole swathes of sub-Saharan Africa. This agent is at the origin of a very severe form of malaria made all the more serious as populations are showing an increased resistance to known anti-malaria drugs, resulting in an increasingly high mortality among new-borns and pregnant women. New treatment combinations and possible vaccines must therefore be tested, while at the same time developing new preventive measures based on insecticides.

In the case of Aids, the genetic diversity of the HIV virus found in Africa poses a major problem. The use of complex forms of preventive or therapeutic vaccines which are the subject of intense research in developed countries is not a realistic prospect in the African context. There must be research and clinical trials on forms of prevention/treatment/vaccination adapted to the capacities for the supply and consumption of health care in the poor countries.

Finally, new medicines – and the research to develop them – are needed to combat the resurgence of tuberculosis, now present in a particularly acute and resistant form.

Public aid

Vital clinical research is most certainly the heaviest initial item of investment in developing new vaccines and treatments adapted to the socio-economic context of the Southern Hemisphere. ‘It is essential for the public authorities to initiate this process as at this stage the pharmaceutical industry is clearly reluctant to commit itself alone given the lack of a guaranteed return on the investment,’ stressed Commissioner Philippe Busquin in Barcelona.

This public commitment has largely taken shape already. ‘The EDCTP is not being set up in abstracto,’ points out Michèle Boccoz of the Institut Pasteur (FR), member of the initiative’s Management Group. The project aims to federate the various approaches already adopted by clinical research in sub-Saharan Africa. These are being pursued by the WHO and UNSIDA as part of bilateral or multilateral initiatives supported by various countries or foundations, or by European programmes.

The EDCTP’s aim is to provide a coherent response which draws on Community and national efforts. Such an open and concrete approach reflects the philosophy of the European Research Area. This project can in fact be seen as a kind of advance ‘pilot test’ of the ‘new instrument of Article 169’ which will enter into force under the 2002-2006 Framework Programme.

This provision enables the Commission to fund research and development projects carried out by Member States and associated countries (14 EU countries plus Norway in this specific case). The Community is contributing €200 million to implementing the EDCTP initiative. Additional resources will come from funds invested in national programmes and from international organisations, whether public or private, which decide to help finance clinical trials.

Creating a translational dynamic

‘In addition to networking all those involved in the project, which from the outset plans to actively involve the biopharmaceutical industry, the EDCTP wants to encourage new avenues of research, in particular through progress in genomics and proteomics. It is a matter of accelerating the “translational” dynamic between the most recent knowledge and its applications,’ explains Antoni Trilla.

The financial resources provided by the Union will make it possible to support pilot test sites which may be proposed at European level or by African health officials. Within a vast co-operative network, these sites will ensure the synergy and convergence of research – which, at present, is too disseminated or isolated – with the aim of joint enhancement and emulation. The aim is to develop new and appropriate treatments which are easy to use and inexpensive. The project also wants to encourage the coherency of initiatives in the field, by providing a reference for the validation of the results of clinical trials which is applicable to the medical samples and the patients treated.

Essential North-South partnership

Finally, a crucial foundation for the EDCTP is to create a long-term and clearly affirmed partnership with African scientists and health officials who are currently in the front line of the fight against the three pandemic diseases. Antoni Trilla believes that ‘the know-how, knowledge and experience of the Africans working in the field is indispensable. It would be unthinkable – and impossible – to conduct clinical trials without recourse to these able local players who are in direct contact with the affected populations. This partnership is, moreover, central to the current task of identifying the geographical and social sites of a size and nature to be validly used for clinical trials.’

‘It is very significant that the African representatives were involved in the very conception of the EDCPT initiative,’ adds Fred Binka, lecturer at Ghana University’s School of Public Health. ‘This is a first as the other programmes we knew about were prepared without us and we were simply invited to participate. In the present case, we are bringing in our African knowledge and experience and have the assurance that the programme will consider our real needs and expectations.’

‘In this context, one of the tasks during the project’s preparatory stage is to provide the necessary training in terms of good laboratory and clinical practices at every level of health policy implementation. The EDCTP can also be the means by which African specialists can find opportunities to use their skills in their own countries, therefore putting a brake on the brain drain which is robbing Africa of valuable skills,’ concludes Antoni Trilla.


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African delegation

The EDCTP met with a very favourable response in Africa, as illustrated by the presence of key political figures at the conference to launch the project, last April in Barcelona. The African delegation included Mozambique’s Prime Minister Pascoal Mocumbi together with the country’s senior public health official Richard Thompson, Cameroon Health Minister Awa Coll-Seck, and many leading scientific experts recognised by international organisations, such
as Fred Binka and Francis Nkrumah (School of Public Health, University of Ghana), Wen Kilama and Hassan Mshinda (African Malaria Network Trust and Ifakara Research Centre, Tanzania), Solomon Benatar (University of Cape Town, South Africa), Omou Y Sow (Conakry, Guinea), Souleymane M’Boup (Hôpital Le Dantec, Senegal) and Leopold Zekeng (Cameroon).

These leading scientists, together with Francine N’Toumi (Gabon), and Voahangy Rasolofo (Madagascar), constitute the ‘coordinating group of Southern countries’ within the EDCTP which is working in partnership with European scientists.

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An increasingly alarming health situation

Poverty-related diseases are not exclusive to sub-Saharan Africa. But the death toll in this region is assuming catastrophic proportions, currently estimated at nearly 5 million a year.

The latest UNAIDS(1) figures show that, of an estimated 40 million people carrying the HIV virus worldwide, 28.5 million inhabit this subcontinent. Every year in Africa, Aids kills 2 million people, a sixth of them children. There are also 14 million orphans in Africa whose young parents have died of Aids.

Tuberculosis affects 1.5 million people in sub-Saharan Africa and its spread is clearly closely linked to the spread of HIV/Aids. This contagious disease, of global dimensions and now on the increase, causes 2 million deaths a year.

Finally, the return of malaria is mainly affecting Black Africa, with more than 400 million suffering from the disease and almost a million deaths a year.

This devastation of the population – and its cost in terms of health care and the loss of individuals able to contribute to society – constitutes a genuine brake on development. The growing cost of disease is to the detriment of resources available for education. The circle is all the more vicious as it is education more than anything else which holds the key to ending the misery and improving health. In its alarming report, the United Nations stated that the overwhelming majority of young people are unaware of how Aids is transmitted and how to protect themselves against it.

(1) Highlighted at the HIV/AIIDS conference in Barcelona last July.

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Ethics and clinical trials

The Helsinki Declaration (1964), adopted by the World Medical Association, is the principal ethical code governing clinical trials on human beings. It lays down three major principles: the well-being of the subject must take precedence over the interests of science; subjects must give their consent freely and in full knowledge of the facts; and subjects must be assured of benefiting from the best treatment on conclusion of the trials.

Although the first of these rules is clearly respected in the case of clinical research in southern countries, the matter of informing the populations in question and obtaining their consent must always be borne in mind in cultural contexts which are ill-prepared for this kind of approach. The third principle is currently the subject of debate. Many clinical trials carried out on Aids in developing countries during recent years related to treatments more likely to be applied in rich countries and beyond the reach of local socio-economic resources.

The EDCTP should not stand accused of this as its goal is the development of treatment of direct use by these countries. ‘But the time it takes before they become available and the way local health authorities make them available are also very important parameters when evaluating the ethical aspects linked to the carrying out of trials,’ stresses Antoni Trilla. ‘In any event, the criteria applied will be those habitually applied in developed countries, but the reality of the situation facing Africa must also be taken into account.

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Malaria: decisive clinical trial in Mozambique

At the beginning of July, under the direction of Dr Ricardo Thompson, specialist in research on malaria and director of public health, Mozambique carried out further clinical trials on a promising potential vaccine developed by GlaxoSmithKline (GSK). These phase I trials follow previous trials in Gambia and are intended to confirm the harmlessness of vaccines, established in Gambia, on a limited group of children. Once this is confirmed, the specialists will launch phase II to determine the likely initial treatment benefits of the tested molecule among a wider population. These trials are being carried out in partnership with the Malaria Vaccine Initiative network and the International Health Centre at the Hospital Clinic of Barcelona, under the direction of Dr Pedro Alonso. Negotiations have also been initiated with the Bill and Melinda Gates foundation to reduce the production costs of treatment developed by GSK.

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To find out more

Presentation of the EDCTP project
/comm/research/
info/conferences/edctp/edctp_en.html

Commission action programme
Accelerated action in the fight against HIV/AIDS, malaria and tuberculosis in the context of poverty reduction
/comm/development/
document/com_en.htm

Information on Aids
http://www.unaids.org/

Information on tuberculosis
http://www.who.int/tdr/diseases/tb/default.htm
http://www.hopkins-tb.org/

Information on malaria
http://www.who.int/tdr/diseases/malaria/default.htm
http://www.who.int/inf-fs/fr/am203.html
http://www.malaria.org/whatismalaria.html

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Contacts :

Antoni Trilla, Hospital Clíníco
University of Barcelona (ES)
atrilla@clinic.ub.es

Stephane Hogan,
Research DG
stephane.hogan@ec.europa.eu


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