Citizen Science, Microfinanced Research, Patent Trolls, and Pharma Prizes
A final dispatch from the Open Science Summit.
Berkeley, California—The Open Science Summit, which wrapped up on Saturday evening, seesawed between egalitarian and libertarian impulses. The more egalitarian faction of open science advocates want free intellectual property and free subscriptions to scientific journals. The more libertarian bloc focused on the freedom to research and plans for alternative ways to finance that research. Despite their disparate views, the summiteers do have in common a brewing rebellion against the strictures imposed by the reigning academic-government-corporate research complex. The summit covered a wide range of topics, so I will take brief looks at various aspects that particularly struck me. Let's start with more libertarian-leaning proposals, specifically, the freedom to research and microfinancing of research.
Freedom to Research
Jason Bobe, the co-founder of the DIYBio.org, described it as a "community that wants to turn biotechnology into a hobby." Bobe is also the director of community for the Personal Genome Project founded by Harvard biologist George Church, which aims to boost genomic research by recruiting thousands of volunteers who will make their genetic and medical information available to researchers. (Disclosure: I have applied.) Bobe illustrated what he called the "emergence of bio-natives" by citing cases such as the 2005 instance where a 15-year-old boy used genetic testing to trace his sperm donor dad. More recently, two New York City high school students found that 25 percent of the sushi whose genes they tested wasn't as advertised. Trailing behind these sushi citizen scientists, academic researchers later confirmed their results. Bobe also pointed to the advent of biohacker community labs in Boston, New York, and the San Francisco Bay Area.
Regarding the BioCurious community lab (slogan: "Experiment with friends") near San Francisco, biohacker Tito Jankowski argued that such labs are the future of science, the future of creativity, and the future of curiosity. Jankowski and colleagues founded Pearl Biotech which makes and sells relatively inexpensive open hardware scientific equipment such as an electrophoresis gel box and a polymerase chain reaction (PCR) thermocycler. The thermocycler amplifies DNA samples and the gel box separates out DNA molecules for identification. Jankowski showcased a short video in which an experimenter in the garage lab was figuring out compounds to kill metastatic ovarian cancer cells.
Computer technologist and dining room biohacker Meredith Patterson clad in a full length black leather coat recited a rousing rendition of the Biopunk Manifesto (explicitly modeled on the Cypherpunk Manifesto). Favorite lines include: "The lawmakers who wish to curtail individual freedom of inquiry do so out of ignorance and its evil twin, fear—the natural prey and the natural predator of scientific investigation, respectively. If we can prevail against the former, we will dispel the latter." The manifesto further declares: "We assert that the right of freedom of inquiry, to do research and pursue understanding under one's own direction, is as fundamental a right as that of free speech or freedom of religion." And another is: "We reject outright the admonishments of the precautionary principle, which is nothing more than a paternalistic attempt to silence researchers by inspiring fear of the unknown."
Bioinformatics guru Raymond McCauley described a citizen scientist DIYGenomics project that he and some friends are putting together. Their question: Do vitamins work for me? In this case, his fellow DIY bio enthusiasts are using their genotype scanning test results from 23andMe to focus on the effects of variants in the MTHFR gene that are associated with higher levels of the amino acid homocysteine in blood plasma. Higher homocysteine levels correlate with greater risk of cardiovascular disease, among other conditions. The question McCauley and friends want to explore is how do homocysteine levels respond to various vitamin regimens? A trial run of five participants found that the activated version of folic acid (vitamin B9) reduced the homocysteine levels of subject #2. Subject #2 is McCauley. McCauley sees what he is doing as a kind of crowd-sourced clinical trial. (Disclosure: I have volunteered to participate in the follow-on DIY research.)
The summit devoted one panel to three non-profit groups that are trying to provide private funding to early career researchers: Fund Science, Sciflies, and the Eureka Fund. The federal government dispenses billions every year for research, but very little trickles down to projects originated by younger scientists. The average age for receiving a first National Institutes of Health grant is 42. Inspired by the popular Kiva microlending site, these funds offer researchers grants in the thousands of dollars. The Sciflies project will enable researchers to post their proposals online with the goal of attracting contributions from individual donors. Although the Sciflies site is at the "pre-Beta" stage, eventually donors will be able to choose a category of research and then scan through a list of projects that might interest them. Sciflies has hired a journalist to turn proposals into readable prose. No money will be disbursed until a project has been fully funded. All three funds are about a year old, so it is far from proven that this kind of microfinancing of research will be successful.
On the more egalitarian side, the summit featured a panel of scholars who really, really hate gene patents. The panel included Australian National University law professor Luigi Palombi, University of Delft (Netherlands) philosopher David Koepsell, and New York University law professor Rochelle Cooper Dreyfuss. Their main objection is that patents are supposed to be granted only to novel inventions whereas genes are natural substances. The mere purification of a natural substance is not patentable, they argue.
The anti-gene patent narrative features a villain, Myriad Genetics. Myriad developed and has been peddling a test for the BRCA1 and BRCA2 breast cancer genes. Women with the BRCA1 or BRCA2 gene variants have a 60 percent risk of breast cancer during their lifetimes (normal risk is about 12 percent). Myriad reportedly charges more than $4,000 for the test. In March, a federal district court accepted the argument made by the American Civil Liberties Union that genes are natural substances that are not patentable and ruled that Myriad's patent was invalid. Myriad is appealing this verdict.
Whatever one may think about the patentability of genes, the crucial question is, do such patents hurt or help innovation? "My theory is that intellectual property is interfering significantly in the innovation process," asserted Palombi. But is he right? Numerous studies have so far failed to find that gene patents are a big impediment to either research or innovation.
Keith Bergelt, the CEO of the Open Invention Network, argued that the increase in "patent trolls" is becoming a big problem for innovators. Bergelt described the Open Invention Network as an intellectual property company that defends against patent trolls by acquiring and sharing patents related to the open source Linux computer operating system. The pejorative term "patent troll" refers to groups that acquire potentially useful patents, wait for someone to independently develop and create a market for the patented technology, then emerge to claim infringement and demand payment. One of the more recent high profile cases involved Research In Motion, the maker of Blackberry wireless devices, which paid more than $600 million for infringing wireless communication patents owned by NTP, Inc., the privately-held intellectual property firm based in Richmond, Virginia. In July, NTP announced new infringement suits against Apple, Google, HTC, Microsoft, and Motorola over email patents. Bergelt asserted that patent trolls have invested more than $6 billion to aggregate patents for which they lie in wait for the unwary to develop into successful products.
Open Access to Research Journals
The Right to Research Coalition, a student lobbying group based in Washington, D.C., wants Congress to mandate that access to research funded by taxpayers be free to everyone. The ebullient Nick Shockey, who manages the student group under the aegis of the Scholarly Publishing and Academic Resources Coalition, detailed a hearing last week about mandating access before the House Subcommittee on Information Policy, Census, and National Archives.
Two years ago, the National Institutes of Health required that all its grantees make their research publicly available 12 months after it appears in a scientific journal. In one of the more clueless comments made at the hearing, one member of Congress worried that providing free access to journals would amount to giving away our country's intellectual property to foreign competitors. A lobbyist for journal publishers apparently argued that mandating open access would destroy American jobs. The coalition favors the passage of the Federal Research Public Access Act which would extend the NIH policy to 11 other government agencies that fund research and shorten the embargo time from 12 to 6 months. "You can't build on cutting edge science if you don't know where the cutting edge is," quipped Shockey.
Cheap Drugs for Poor People
Nobody, egalitarians and libertarians alike, showed much love for Big Pharma. One of the concerns is that the current model of drug development means that drug companies must focus on developing pharmaceuticals that they can later sell for high prices. High prices mean that poor people can't get access to life saving treatments. To overcome this problem Aiden Hollis described the Health Impact Fund (HIF) proposal [pdf]. The proposal would offer drug companies a choice between seeking to recoup their investments using high prices as usual or registering their drugs with the HIF, which would require the firm to sell its product worldwide at an administered price near the average cost of production and distribution. The company would be compensated by a stream of payments based on the assessed global health impact of its drug. The HIF would be funded by governments to the tune of about $6 billion annually. James Love of Knowledge Ecology International wants to accomplish much the same thing by offering big prizes to the developers of medicines that aim to treat diseases rife in developing countries such as malaria, TB, and HIV. He would fund his prizes through a one percent tax on pharmaceutical sales which would raise about $4 billion annually in the U.S.
Many of the summiteers are oddly unaware of the role that Food and Drug Administration (FDA) regulation plays in creating high drug prices. For example, a PR consultant for the summit argued that the chief problem is that Big Pharma and Big Finance want to protect their unconscionable profits by crushing the nascent biotech open science movement. Perhaps so, but what summiteers miss is why this particular dysfunctional business ecosystem exists. Three letters: FDA. As annoying as the FDA regulators are to Big Pharma, the truth is that FDA regulation creates a huge barrier to entry for any new competing firm. This means that start-up biotechs have no chance of getting any therapeutic product approved since it takes years and hundreds of millions of dollars to get it past the hypercautious FDA.
A contrast with the IT industry is instructive. With information technology, a company develops a cool product, runs it out the door, and makes billions (or flops quickly). In biotech and pharmaceuticals, a company can't do that. Developers of new treatments have to run an expensive and time consuming regulatory gauntlet before they can sell a single pill or shot. I suspect that if the information technology industry was regulated by the FDA we would still be using 50-lb. IBM 5100 "portable" computers costing over $80,000 in today's dollars.
The foregoing is a taste of the smorgasbord of topics offered at the summit. Others included how do academic researchers get credit for open source contributions, how cure entrepreneurs are reshaping the research enterprise to focus on the development of new treatments, how open source biotechnology can enhance biosecurity, and how open source drug discovery can advance innovation. The summit wrapped up this weekend, having made a slight bit of progress toward its stated goal of organizing the various sub-communities of the Open Science Movement into an effective global force for rapid change in science and innovation policy. It's a start.
Ronald Bailey is Reason's science correspondent. His book Liberation Biology: The Scientific and Moral Case for the Biotech Revolution is now available from Prometheus Books.