Drug trials take a new tack
The volunteers who were injected last week with a new vaccine for tuberculosis appeared like any other group taking part in a clinical trial of a new medicine. The elaborate tests of safety and efficacy required before approval are routine in the drugs business.
But the volunteers at St Louis University in Missouri were at the forefront of an experiment in drug development, led by a new generation of non-profit organisations, that is challenging many of the assumptions that underpin the pharmaceuticals industry.
In the traditional model of drug and vaccine development, academic researchers and medical charities focused on uncovering insights into the underlying science of a disease. Companies then took those ideas and tried to turn them into effective drugs that passed the expensive hurdles regulators demand.
But recently, several non-profit groups have been formed to do exactly the sort of development work that was the industry's forte. The TB trial, for instance, is being run by Aeras Global TB Vaccine Foundation which has just received an $83m grant from the Bill & Melinda Gates Foundation to conduct the work. Indeed, the Gates Foundation is the principal backer of many such non-profit ventures.
"This grant is for the development of a product, rather than the basic research which usually gets the headlines," says Jerry Sadoff, president of Aeras.
The emergence of these new groups is essentially the result of a failure in the market. Diseases that affect only the poor do not provide big profits, which means the pharmaceuticals industry concentrates on the rich-country ailments. According to M
