As much as I loathe to quote Rumsfeld, there’s something inside the concept of known unknowns versus unknown unknowns. This is at the root of much of the work that I do, and this post is meant to address the role of the unknowns in the life sciences generally, but pharmaceutical development specifically.

Quite simply, the google searches work pretty well for the “unknown knowns” – stuff that someone else has posted somewhere on the web, something that is known or at least believed, something that is hyperlinked and indexable. This is the modern version of common knowledge, and some commentors in my earlier posts support that idea. Since google works to index the unknown knowns, it’s therefore the main thing we need.

In culture, I agree. We are not trying to figure out the basic rules of culture on the web (well, anthropologists are probably doing that, but that’s a different can of worms). We are not trying to figure out the fundamental rules of sales, either. Or the Newtonian physics of how the networks operate, or the electrical rules of signal transmission, or the computational protocols of the network, or the display protocols of the Web. All of that stuff’s pretty well figured out.

But the pharma world is different. We’re actually trying to figure out the rules as we go. The world is filled with the known unknowns, which we try to puzzle out via the NIH funding process and through other R&D funding. But those are the easy parts compared to the unknown unknowns.

Think about the impact for a second. Because we have so little insight into the way that our liver breaks down drugs – toxicity – the only FDA-approved method we have for testing if a drug will kill people is to give it to people and see if they die or not. That’s the impact of the unknown. And google is of no help.

I spent most of my week this week hacking at this problem. Yesterday I sat down with a batch of social entrepeneurs and cure entrepeneurs at a FasterCures meeting in Los Angeles (in a ridiculously swank house in the Hollywood Hills – why don’t we ever book meetings in these places?) and we kept coming back to this problem. The scale of the unknown information, the unknown processes, forces us into a world where drugs cost $1B or more.

No one can be a disruptive innovator when the cost of entry is $1B. Not even Bill Gates, who has put at least that much money to play in malaria and TB and HIV.

Another funny comment came from a gentleman commenting on the way that we fund the science – imagine if you commissioned a house via the NIH funding process. As I recall, his take was that we’d get a house with 72 showers, one toilet, and no roof (although perhaps we’d get a schema for a roof) – because the shower was the trendiest thing going in design at the time.

Most of what we do in science is inspired by engineering. But engineering is a system based on understanding of the rules – a knowledge application effort. And those processes – for funding, for business models, for philanthropy – are systematically breaking down in the face of what is inherently a knowledge creation effort.

Open source is a good starting point for a new design of process. We can’t port it naively – again, it’s derived from a place where the rules are known – but it at least draws on the power of the network and standards and modularization, and that’s the best start I can see at this point.

More on this later, time to make the donuts.