Sunday, June 13, 2004

seriously considering subscribing to the economist

subscribing to the economist is the bourgeois equivalent of hitting the long ball -- and chicks dig the long ball.

the latest article to go yard is this one on applying the open-source model to the pharmaceutical field. while in the crease is busy painting toe nails and circling 'problem areas' with his sharpie-clutching sorority sisters, i'm actually interested in doing something productive, e.g., lowering health care costs and passing the dutch to alan greenspan.

the article talks about distributing the cost/risk of pharma research by using the open-source model.

CAN goodwill, aggregated over the internet, produce good medicine? The current approach to drug discovery works up to a point, but it is far from perfect. It is costly to develop medicines and get regulatory approval. The patent system can foreclose new uses or enhancements by outside researchers. And there has to be a consumer willing (or able) to pay for the resulting drugs, in order to justify the cost of drug development. Pharmaceutical companies have little incentive to develop treatments for diseases that particularly afflict the poor, for example, since the people who need such treatments most may not be able to afford them.
Open-source research could indeed, it seems, open up two areas in particular. The first is that of non-patentable compounds and drugs whose patents have expired. These receive very little attention from researchers, because there would be no way to protect (and so profit from) any discovery that was made about their effectiveness. To give an oft-quoted example, if aspirin cured cancer, no company would bother to do the trials to prove it, or go through the rigmarole of regulatory approval, since it could not patent the discovery.
The second area where open source might be able to help would be in developing treatments for diseases that afflict small numbers of people, such as Parkinson's disease, or are found mainly in poor countries, such as malaria. In such cases, there simply is not a large enough market of paying customers to justify the enormous expense of developing a new drug. America's Orphan Drug Act, which provides financial incentives to develop drugs for small numbers of patients, is one approach.
In a paper presented this week in San Francisco at BIO 2004, the Biotechnology Industry Organisation's annual conference, Stephen Maurer, Arti Rai and Andrej Sali—two lawyers and a computational biologist, respectively—called for an open-source approach to invent drugs to fight tropical diseases. It would work like this: a website they call the Tropical Disease Initiative would allow biologists and chemists to volunteer their expertise on certain areas of a specific disease. They would examine and annotate shared databases, and perform experiments. The results would be fully transparent and discussed in chat rooms.
Eric von Hippel, a professor at the Massachusetts Institute of Technology's Sloan School of Management, is investigating how secondary uses for drugs are discovered, with a view to harnessing doctors and patients to record data. Many medications are approved for one purpose, but are regularly prescribed for another, “off-label” use. In many instances, new uses for a drug are discovered only after it is on the market, when a sort of natural experimentation takes place. For instance, Botox was approved in America for treating eye-muscle disorders, and only later found to remove wrinkles. In Europe and America, as many as half of all drug prescriptions for certain diseases fall into this category. The drugs often do not go through the formal process for other uses because the cost of regulatory approval is so high.
Dr von Hippel's idea is to decentralise the process of obtaining data on the off-label use, by collaborating with volunteer doctors and patients. By defraying costs in this way, it might then be possible to obtain regulatory approval. It is, in effect, an open-source clinical trial. Because the drug has already been approved, it has passed first-phase tests for safety. These do not have to be repeated. Second and third-phase drug-approvals test for efficacy and side-effects—and these are the very areas where getting formal approval for off-label use is sensible.
Peter Lansbury's...research is examining the therapeutic effect of a thousand approved drugs, on which the patent has expired in most cases.
Dr Lansbury refers to the work as “not-for-profit drug discovery”, but he sees direct parallels with the open-source approach. For one thing, his group places much of its data in the public domain. Secondly, though the research is mainly happening among different research labs within the confines of Harvard at the moment, the goal is to involve other scientists around the world. Only through this sort of collaborative, distributed approach will treatments be found for these diseases, he says.

if you are interested in the concept of advancement through the distribution of risk & costs, i think you'll find this mitworld lecture by noam chomsky interesting.

UPDATE: here's a pdf of the essay the maurer et al. people wrote for the bio conference. jhc


At 8:26 PM, Blogger In the Crease said...

But it's the beautiful people who have to sell the drugs. Who else would do it, you and your Real Doll?

At 2:14 AM, Blogger Jesus Henry Christos said...

you can take shots at me, but leave my realdoll out of this!


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