A global alliance bringing together academia, public health agencies and the pharmaceutical industry has launched a fresh onslaught against the scourge of tuberculosis.
At a meeting of the Global Forum for Health Research in Bangkok this week, officials unveiled a blueprint for the discovery and development of new anti-tuberculosis drugs.
Co-sponsored by the Rockefeller Foundation and the U.S. National Institutes of Health, the Global Alliance for TB Drug Development has managed to secure over $150 million in funding for the next five years.
Tuberculosis, along with other so-called diseases of poverty such as malaria and AIDS, is at the heart of discussions between the pharmaceutical industry, governments and public health agencies to foster private-public partnerships.
It is an area fraught with difficulty. Not only is there a lack of new medicines being developed for certain diseases, but when they are available their high cost often makes them unaffordable to those who need them most.
A lack of resources and faulty health-care infrastructure often mean that even when medicines are available, they fail to reach sufferers.
There has not been a new drug developed to treat tuberculosis for more than 30 years, despite the fact that 2 million people die from the disease every year. And although diseases such as tuberculosis, together with malaria and sleeping sickness, kill 6 million people each year, the pharmaceutical industry has focused the bulk of its research on diseases of the developed world.
Robert Ridley, manager of drug discovery research for the World Health Organization, says there has been a reduction in research and development into tropical diseases such as tuberculosis and malaria over the past two decades as competition in the industry has increased and companies have faced difficulties justifying committing R&D into these areas.
According to pharmaceuticals expert Patrice Trouiller, between 1975 and 1996 1,233 new chemical entities were registered--but of that number only 11 were for tropical diseases such as malaria.
Pharmaceutical companies dispute accusations that research into diseases of poverty has been abandoned, arguing that other drugs, such as antibiotics, are also relevant to the developing world. They also note that even if existing drugs were made available, many of these countries lack the necessary health infrastructure to distribute them efficiently.
At a meeting last month of the European Commission and various stakeholders to discuss the issue of communicable diseases in developing countries, Jean Stephenne, president of SmithKline Beecham Biologicals, pointed to the commercial difficulties faced by drugs firm. According to Stephenne, while a single vaccine candidate for malaria would cost about $600 million to develop, the world would pay less than $1 per dose for the product.
"Without the support of the public sector, specifically the G7 nations and charities, there is no possible commercial model that would provide industry with a way to recover its investment," he said.
In order to overcome the R&D and market risks, the public sector "must support industry's R&D efforts or provide committed funds to create a market for the hoped-for vaccine," he added.
Experts such as Ridley believe there are two key issues that need to be tackled--R&D into new medicines and the accessibility of these drugs. Ridley identifies certain "push and pull" mechanisms that need to be strengthened both to encourage companies to invest in these disease areas and to ensure there is a genuine market for new medicines. Companies also need to be assured that their intellectual property rights will be protected.
Ideas under consideration include extending so-called orphan drug legislation, which fosters the development of drugs to treat diseases that affect only small numbers of people. In the U.S., orphan drug laws allow the government to offer tax credits and market exclusivity.
Another incentive being discussed is allowing a producer of a drug for an orphan disease to transfer a period of exclusivity to a big- selling drug used in the developed world.
Win Gutteridge, chief of product research and development in tropical diseases at the WHO, points out that companies will not get involved if there is no guaranteed market for their products and if these are not made accessible to sufferers.
"For example, the average cost to treat a TB sufferer for six months is $40," he says. "Of that, only $4 to $5 is the cost of the medication. The rest is ensuring access and compliance issues."
So far, the increased dialogue has resulted in several public- private partnerships. Late last year, the WHO announced a Medicines for Malaria Venture PPP to develop anti-malaria drugs under which public-sector scientists can access not just the vast libraries of chemicals owned by multinationals but also their expertise.