Neglected Diseases are Fighting for Attention

Ask a big drug-company boss why he is in the business of making pharmaceuticals, and he will say he wants to "address unmet medical needs". But not all medical needs are equally attractive. Most of the 7,500-Plus medicines currently in development by biotech and pharmaceutical companies are for chronic diseases of the rich world. At the same time, some of humanity's nastiest afflictions get little attention. Tropical diseases, such as sleeping sickness or leishmaniasis, are a turn-off for drugmalcers because they strike mainly in poor countries and offer little hope of an attractive return on investment. Of the 1,5oo or so drugs launched over the past 30 years, fewer than 20 deal specifically with tropical disease.

However, it is not just poor countries that are missing out. For example, there is an urgent need for new antibiotics in industrialised countries as drug-resistant bacteria emerge. Yet antibiotic development-once the cornerstone of the drug industry-has fallen out of favour with Big Pharma firms because of scientific hurdles and regulatory requirements.

One way of getting attention for neglected diseases is for patients to take action. For example, the ALS Therapy Development Foundation, started by James Heywood, whose brother was struck down by this neurodegenerative disease, is using its modest budget to test hundreds of compounds in mice and men in the hope of finding a treatment for ALS.

Another route is to launch public-private partnerships. Drug companies contribute molecules, manpower and machines to not-for-profit groups that co-ordinate product development, funded mainly by private sources such as the Gates Foundation, with some government money. There are now about 20 such partnerships, focused on developing new drugs, vaccines or diagnostics for particular diseases of the developing world that will make them accessible to poor populations.

A few big drugmakers, such as Gsic and Novartis, which inherited an interest in tropical disease from their parent firms, have chosen to invest in at least early-stage R&D in malaria, tuberculosis and dengue, with a view to partnering later on. They are motivated mainly by philanthropy, but also want to polish their image and hope to sell to travellers and to a rising middle class in developing countries.

Many of the partnerships act as virtual pharmaceutical companies, bringing together expertise from far afield. The Drugs for Neglected Diseases initiative, for example, has drawn together basic research from academics in Venezuela, molecules from Japanese and French drugmakers, clinical trials in Ethiopia and manufacturing by Brazilian firms.

The question is how to get the products out of the pipeline and to the people who need them. Development costs can be lower than in Big Pharma, in part because clinical trials for diseases such as malaria can be smaller, faster and therefore cheaper to run than for, say, Alzheimer's disease. Even so, Christopher Hentschel, head of the Medicines for Malaria Venture, reckons it will cost at least $100m to bring just one of its products to market, so much more money is needed.

All together now

One idea under discussion is "advance purchase commitments" meaning that governments promise to buy products that meet certain standards at a pre-arranged price, thereby providing big drug firms with the promise of a certain return. But critics say that governments may well end up overpaying for the goods. Another possibility is paying pharmaceutical firms in kind.

For instance, they could be given longer intellectual-property protection, or faster regulatory approval, on a product of their choice, in exchange for developing one for a neglected disease. But generic drugmakers and consumer groups say this will dent competition and prop up prices.

A more radical proposal is for governments to sign on to an international treaty to devote a certain proportion of their GDP to R&D for drugs and vaccines, particularly for neglected diseases. Part of the plan is to create a prize system, paying a lump sum for an innovation which will then be placed in the public domain. But governments are notoriously bad at valuing innovation properly, and implementing this plan might be tricky.

Yet another tack is the Tropical Disease Initiative, which is trying to harness "open source", an idea pioneered in computer software. The aim is to bring together scientists through the web to trawl through databases and do computer experiments to find promising new molecules to feed into the public-private partnerships-all patent-free.

None of these strategies is perfect, admits Stephen Maurer, a backer of the initiative at the University of California at Berkeley. The important thing, he says, is to move beyond "dreamy first-world arguments" about which approach is more ideologically sound, and start looking at the real costs of what might be done.

Source : Pharmaceuticals Survey, July 2005.

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