Drug research must aim for health care benefits, not just commercial returns
Representatives from the UK-based Wellcome Trust one of the world''s largest funders of health research and the virtual drug research and development organization, the Drugs for Neglected Diseases Initiative (DNDi), launched in July 2003, described efforts to encourage a priority shift in health research agendas from commercial viability to potential health care benefits, during the annual meeting of the Global Forum for Health Research on 4 December.
One of the greatest obstacles in addressing the 10/90 gap in which only 10% of the US$ 73.5 billion spent on health research every year is used for research into 90% of the world's health problems has been the need for drug research to be profitable. A study in the Lancet (2002;359:2188-94) showed that between 1975 and 1999, just 16 of the 1393 new medicines launched on the market were for tropical diseases such as malaria which kills over 1 million people every year. Diseases like malaria and tuberculosis have been dubbed "neglected diseases" because of the disproportionately low level of spending allocated for research into their prevention and treatment by pharmaceutical companies.
At the close of the seventh Global Forum for Health Research, Dr Ted Bianco, Director of the Wellcome Trust's Technology Transfer division stated that the policy of the Trust was to "give priority to potential health care benefits over and above considerations of commercial return."
In March 2003, the Wellcome Trust's Technology and Transfer division called for proposals for its "translation awards" programme. The translation awards which have an annual budget of approximately US$ 14 million a year are based on the experience that fundamental research is often "too early" or "too high-risk" to be pursued by corporate health care or investment sectors. In other words, new discoveries and technologies might fail to realize their potential because they are not attractive to industry.
"We want to take an invention out of the lab to a point where it becomes credible to those who have commercial drivers," said Bianco. In an attempt to move away from the traditional objective of scientific research which, according to Bianco, is geared towards publication rather than products, he explained that proposals would not be assessed by conventional peer review but by commercial due diligence. "Whereas peer review emphasizes the qualities of the individual practitioner, due diligence also considers the environment this invention is going to be placed in and asks if it is likely to attract commercial interest," he said.
Dr Bernard Pécoul, Director of DNDi reported that it would first concentrate on three killer diseases leishmaniasis, sleeping sickness and Chagas disease which together threaten the lives and health of 350500 million people every year.
Supported by Médecins Sans Frontières, among others, DNDi works in close collaboration with the UN Development Programme (UNDP), the World Bank and WHO's Special Programme for Research and Training in Tropical Diseases (TDR). It aims to encourage researchers in academic institutions and scientists in pharmaceutical companies to resurrect work on drugs which could have potential against neglected diseases but did not make clinical trials because of lack of potential profit.
"In 12 years, at an estimated cost of US$ 255 million, DNDi hopes to develop six or seven drugs to combat neglected diseases," said Pécoul. "At the end of this same period, DNDi also hopes to have seven or eight new drugs in the development pipeline." To increase the chances of short- and mid-term success, the initiative will develop drugs from existing compounds, as well as coordinate research to identify new chemical entities for drug development.
A call for letters of interest was sent out to the scientific community in February 2003 and again in November 2003. Seven projects are already under way but Pécoul hopes that this will increase to 12 next year.
"DNDi's success will depend not only on government and private donations, but also on the contribution of pharmaceutical companies in the form of access to compound libraries, expertise and research and development facilities," said Pécoul. The DNDi intends to publish details of any drugs it develops so that anybody can make and distribute them to patients in developing countries.
Cathy Garner, Chief Executive of a global initiative called the Management of Intellectual Property in Health Research and development (MIHR) highlighted the importance of intellectual property management in increasing access to health technologies for the poor. "There is a huge demand for [intellectual property] skills among researchers in developing countries who feel isolated," she said. They don't know how to connect the knowledge they have to the product cycle and the commercial world, she explained, adding: "We're offering a new resource to bring people the lessons we've learned and help them avoid past mistakes."
MIHR aims to support and complement the work of organizations promoting health research in order to address the diseases of the poor. "We need [research] institutions to understand the pros and cons of different licensing strategies," said Bianco.
For more information on the Wellcome initiative, visit their web page: http://www.wellcome.ac.uk/techtransfer and for more information on the Drugs for Neglected Diseases Initiative (DNDi) visit their web site at http://www.dndi.org. For information on MIHR, visit www.mihr.org