New non-profit organization will support research to combat neglected diseases
Of 1393 new pharmaceuticals marketed between 1975 and 1999, only 16 were for tropical diseases and tuberculosis. This finding from an exhaustive review of international, European and American medical databases was published in The Lancet, 2002, 359: 2188-94. There will be "no sustainable solution" for diseases that predominantly affect poor people in the South without an international pharmaceutical policy for all neglected diseases, say the authors. They have been working for the past three years on a Drugs for Neglected Diseases Working Group for the medical charity Médecins Sans Frontières (MSF), which aims to set up a new body to tackle this problem.
Piero Olliaro of the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), who was one of the authors, told the Bulletin: "In the first place you have to distinguish between diseases where publicprivate partnerships have a chance of working, like malaria and tuberculosis, and diseases which are not prevalent enough, which aren't visible enough, which have no advocacy; and they don't stand a chance. That's where we are saying something new is needed. The public sector really has to take the lead for neglected diseases like sleeping sickness or Chagas disease."
However Olliaro admits there can still be publicprivate breakthroughs as there was recently for visceral leishmaniasis (kala azar). TDR, the Indian Council for Medical Research and the German company Zentaris (previously ASTA Medica) supported research in India which earlier this year yielded oral miltefosine, a failed cancer drug which has now been shown to cure kala azar 98% of the time, with few side-effects.
"So even for the neglected diseases you will bump occasionally into something you can develop" said Olliaro; "but to do that systematically we're saying that the public sector must take the lead with significant amounts of money to discover those products, and then to make sure they are turned into effective and affordable drugs".
In partial response, MSF is catalysing the creation of a new entity the Drugs for Neglected Diseases initiative, known as DNDi to help do the research and create the needed products. The body will be a joint undertaking of MSF and several public research institutes in the North and the South. The actual drug development work is to be done by a wide range of public and private partners, including the pharmaceutical industry.
While DNDi primarily aims to build on public responsibility and public sector research capacity, industry remains important because of its massive catalogues of active compounds, compound development and testing schemes and scientists.
"We have met extensively with the pharmaceutical industry we are looking for their close attention and support, through the cooperation of individual groups in the pharmaceutical industry" said Yves Champey, director of the feasibility study for DNDi. "Because what we will need, project by project, will be clearly not money, but access to industry expertise and special tools."
Champey told the Bulletin that the organization should be ready to go into operation by mid-2003. He and the DNDi team have been in close contact with TDR and WHO "from the very beginning", and they are now working to see how the two can be "active members" of the initiative.
Seed money for setting up DNDi will come from MSF, but the bulk of the actual R&D work will be financed project by project, with funding from governments, international organizations and large foundations. "And there will be one additional funding path: raising money from ordinary individuals, at $20, $50 a time, will be one of our big sources of money. I don't know what proportion. This will be one of our striking differences" Champey said.
Apart from the fund-raising techniques, DNDi's objectives may seem little different from those of existing organizations like TDR. "We do not pretend to be better, we will simply try to add to their efforts" said Champey.
Carlos Morel, Director of TDR, told the Bulletin: "TDR, WHO and DNDi are working on a memorandum of understanding between us. MSF have been in drug access issues for a long time, but the DNDi is a different kind of venture. There'll be a DND Working Group meeting in Rio de Janeiro in December, and we hope by then any remaining issues will be resolved."
DNDi will be a separate organization from MSF - which will be only one of the six to eight founding organizations. MSF is a fieldwork and campaigning organization, often opposed to the special interests of the pharmaceutical industry, whereas DNDi needs to establish friendly relations with companies.
TDR believes the best approach is to squeeze the most out of each source, both public and private, says Rob Ridley, Coordinator for Product Research and Development at TDR. "Our experience is that if you have a very specific proposal that may do some good, that's professionally thought through, then very often companies are more than willing to participate. In fact most of TDR's successes have resulted from major input from industrial partners."
TDR is already working with industry on two scientifically related neglected diseases leishmaniasis and trypanosomiasis, both caused by "kinetoplastid" organisms. "We received a fairly substantial sum from Aventis for work related to African trypanosomiasis (sleeping sickness); and we've had some seed funding from industry to push forward and try to identify products for kinetoplastids as a whole" said Ridley.
David Heymann, Executive Director for Communicable Diseases at WHO, adds "We need better tools for neglected diseases, but we shouldn't forget that we've also had some great donations of existing drugs. We need to use every tool we've got. To see an end to diseases that have been around for centuries is an opportunity we just can't miss."
Robert Walgate, Bulletin