Monday, April 11, 2011

Apologies to Galileo

Luke Timmerman just posted another great Xconomy article about Sage Bionetworks and Open Source Biology. Last year, I blogged about the topic as it relates to intellectual property protections in an age known for open source endeavors such as Napster, Firefox and Linux. I dubbed the generation “Gen-O” (O for “Open”) and ruminated about the implications of that mindset. Luke relays Sage president and co-founder, Steve Friend’s, vision that since the sea of genomic data is effectively impossible to comprehend in any case, and made even more intractable given the maze of intellectual property rights to be navigated, the greater access of a non-profit, open source model will allow a globally diverse pool of great thinkers to parallel process the data, which will result in development of novel therapeutics.

Hold on, because this pendulum is swinging. For a long time, I made my living negotiating rights to intellectual property, and even testified on the importance of protecting those rights. But I’m not one to tilt at windmills. I think a lot of good things really do result from open sharing of information. My concern is that in order to be effective, everyone has to play by the same rules, and that seldom happens. Remember all the rhetoric when the economic markets were about to reopen following the September 11 attacks? Everyone preened about how they were going to do the right thing and exhibit forbearance. What happened when they did finally reopen six days later? The Dow lost a record-setting 7% in one day. Worldwide markets saw billions of dollars evaporate. It’s human nature. Everyone wants everyone else to play nice in the sandbox, but only when it’s not their own dump truck that’s getting smashed by a rock.

And from my experience on both sides of the academia/industry continuum, who are the worst at this game? The academics. While they rail on about crass commercialism and how patents are the bane of their existence, they go to great lengths to obfuscate or be coy about the latest new discovery in their lab because they don’t want to be scooped on the publication by an academic competitor (Remember: to get a publication in the leading journals, the report has to be novel and significant. No top journal wants to publish the confirmatory report. Publications in leading journals lead to tenure and an increased likelihood of grant funding. A well-funded, tenured professorship is the most stable job known to man.) The vast majority of genome data are being generated and disseminated in an open fashion by academic consortia like the Human Genome and HapMap Projects. I can pretty much guarantee you that not all the most recent data are represented there.

There’s an adjunct. Government regulation, which is impossible to implement when the “regulees” are not a handful of companies, but hundreds of thousands of individuals. The age of regulation has been slowly coming to an end – the transportation and communications industries were two of the first – and the movement is working its way towards everything else, including healthcare. My observation is that the whole idea of “Open Source” goes hand in hand with deregulation and personalization – they’re all different species of the same genus. The mindset is that “we’re smart enough to figure this stuff out on our own, thank you very much big government, and we don’t need you interfering and slowing things down.” In general, I agree. I’ve often cited the example of pumping gas. It wasn’t that long ago that if you needed your tank filled, a skilled, specially trained technician had to do it for you. Now, God help you if you want someone to pump your gas. Why? Because we, as a society (especially in the US), are incredibly good at absorbing new technologies. We don’t need paternalistic government agencies telling us what we are or aren’t capable of understanding (now if we could just get the tort lawyers on board…). It’s why I generally oppose government meddling in direct-to-consumer genetic testing. I fully acknowledge that genetic tests to predict balding are likely based on shaky science and are of little value. Some level of government regulation is necessary, but 1) there will always be snake oil salesman, 2) market forces will drive out worthless products and services, and 3) many government agencies, with all due respect, don’t have the most stellar performance records.

Just as I believe that personalized medicine will drive us back to individualized drug compounding at the local pharmacy and that the concern du jour in 100 years will be global cooling, this pendulum will reach its apogee and swing back as well. There will be some thalidomide disaster that will shock everyone into realizing that (at least in the case of healthcare where peoples' lives are at stake) open source without some level of oversight is not such a great thing. Two things need to happen here. First, someone has to develop a viable business model for investing in the development of new therapeutics that rewards innovators and prevents copycats from undermining the effort before the risk-taker has recouped its investment, and second, government oversight needs to get out of the business of being a hindrance to the development of new products and respond to a new climate of groups of motivated individuals with novel approaches taking matters somewhat in their own hands to develop the next generation of new drug products.

1 comment: