New hope in developing drugs for the poor
“BIG pharmaceuticals...right up there with the arms dealers,” says a character in “The Constant Gardener”, a newly released film of John le Carré's novel about drugmakers' dodgy dealings in Africa (see article). In fact, as well as fiction, pharmaceutical firms have been lambasted for their approach towards the developing world—be it prices and patents hampering access to existing medicines, or negligible investment in new drugs for diseases that mainly afflict the poorer parts of the planet.
But research by Mary Moran and her colleagues at the London School of Economics, published in Public Library of Science Medicine, paints a brighter picture. Dr Moran's team looked at the state of drug research and development for ten “neglected” diseases of the developing world, including malaria and tuberculosis, which kill roughly 3m people a year and debilitate millions more. These have not been particularly interesting markets for big pharmaceutical firms to spend their R&D cash on, compared with, say, new anti-cancer drugs for the rich world. Between 1975 and 1999, only 13 new drugs for neglected diseases were developed, and many big drugmakers got out of the business of tropical disease altogether.
According to Dr Moran, however, there has been a significant increase in activity since 2000. There are now at least 63 active drug-development projects for neglected diseases, with 18 potential drugs in clinical trials. Given normal levels of success (drug development has a high attrition rate), this could mean that eight or nine new drugs will be ready for use over the next five years, a distinct improvement on past performance. Indeed, two are already sitting in the “in” trays of the regulators, awaiting their blessing.
The main reason for all this renewed activity seems to be the emergence in the field of public-private partnerships. These serve to co-ordinate contributions from companies and academic centres, manage R&D portfolios and, crucially, raise money to fund the entire enterprise from sources such as charitable foundations. They account for three-quarters of the neglected-disease drug projects. This means that big drugmakers can shift much of the cost of R&D—particularly the risky business of clinical trials in developing countries—to the partnerships, leaving them to concentrate on the less costly business of early-stage research. So, although they may have little expectation of big profits, the firms are managing to limit their costs. That allows them to repair the tattered public image that gave rise to “The Constant Gardener”, build good government relations, and even cultivate commercial partners in countries that might one day become paying markets without having to shell out too much shareholders' money.
Mixing for-profit and not-for-profit cultures is never easy, of course, and the partnerships are sometimes tricky to manage. However, as Dr Moran argues, they are starting to deliver the goods at reasonable cost. Between 2000 and 2004, the partnerships managed to take 40 development projects forward on a paltry $112m. But starting is not finishing. As these projects go into the later, costlier stages of development—particularly large-scale clinical trials—the partnerships will need money on a scale that, in the absence of the profit motive, only governments are likely to be able to satisfy.
At the moment, government funding accounts for less than 20% of the partnerships' finance. Indeed, in Dr Moran's opinion, current proposals—such as advanced-purchase commitments, in which governments try to create a paying market by promising to buy large amounts of new products designed to combat neglected diseases—run the risk of swaying industry toward for-profit, do-it-yourself drug development. It is indeed an irony that, in the area of tropical disease, the wicked drug firms have discovered the value of not-for-profit business at precisely the point when governments are contemplating the idea that the best way forward is the use of incentives more attuned to red-in-tooth-and-claw capitalism.