The DIY Movement Comes to Genetics
Technology throughout history has been the single greatest force for empowering average consumers. Gutenberg’s printing press allowed people to access books and knowledge directly. Centuries later the internet brought a seemingly infinite amount of information and knowledge to many consumer’s fingertips. Smartphones allowed people to take that knowledge with them wherever they went. Each new technology opened the door to more opportunities for more people.
Yet average consumers with curious minds still struggle to access the medical field. Medicine and medical science have historically been overly paternalistic and closed to patient involvement. Thanks to technology, that is beginning to change as Dr. Eric Topol describes in The Patient Will See You Now. He tells how advances in genetic science allow patients to learn new insights about themselves as never before. Now, community labs are popping up to bring hands-on learning opportunities to amateur scientists desiring to learn more about the secrets of DNA. This ability offers exciting opportunities for consumers and patients to participate in the discoveries driving the advancement of next-generation life science. This open-source approach to genetic science could mean radical new breakthroughs that better human lives.
In 2010, Ellen Jorgensen, a molecular biologist with a PhD from New York University, founded a non-profit called Genspace in Brooklyn. Genspace offered the first-ever community biotechnology laboratory that was open to the public. The lab operated almost as a scientific YMCA. Members paid $100 dollars per month for access to the fully equipped lab, supplies, and professional scientific advisors. Genspace also offered free seminars, classes, and speaker events to the general public. Jorgensen believes the best way to educate people about the wonders of biologic science and to prepare them for the future is to involve them in the discovery process. To facilitate this learning, members are encouraged to pursue experiments of their own design. Since 2010, other labs have sprung up around the country and are generally referred to as “biohackerspaces.”
Strong Safety Standards
The Genspace lab meets the Biosafety Level 1 guidelines established by the Centers for Disease Control (CDC) and published in conjunction with the National Institutes of Health. CDC published the latest edition of these guidelines in 2009 in a hefty, four hundred page manual titled Biosafety in Microbiological and Biomedical Laboratories. There are four safety level designations, ascending in terms of how dangerous are the microbes that the lab handles. A level 1 lab, like Genspace, is basically the equivalent of a high school biology lab and can accommodate common microbes that are not known to cause disease in adults with properly functioning immune systems. Examples of common microbes used in these labs include Bacillus subtilis, a bacterium found in soil, and non-pathogenic E. coli. The CDC guidelines also include information on standard practices, special practices, protective equipment, and laboratory facilities for each safety level.
Genspace and other biohackerspaces have viewed the CDC guidelines as minimum safety standards, often implementing their own policies that are even more explicit. BioCurious, a biohackerspace in Silicon Valley, posted a copy of their safety policies online and requires all of their members to pass a safety test before being allowed in the lab. If any BioCurious member has any safety-related question not addressed by the policy, the lab runs a dedicated email account to provide further guidance. BioCurious does not review any of the experiments that its members desire to conduct and exercises no editorial powers. Instead, the staff has chosen to encourage an entrepreneurial and open atmosphere by instilling a deep understand of the safety policy in their members and trusting them to make “responsible decisions, with basic oversight.” The experiments must be legal and in harmony with the safety policy. Outside that, members can pursue whatever they wish.
Common Code of Ethics
To facilitate the growth of these biohackerspaces and amateur biologists, Mackenzie Cowell and Jason Bobe founded a non-profit and website called DIYbio in 2008. Cowell worked for the Genetically Engineered Machine competition at MIT and graduated from Davidson. His cofounder worked on personal genomics research with Harvard genetics legend George Church. Both men believed biology should not be reserved for elite researchers at universities like Harvard and MIT. Cowell pointed to the early computer pioneers who made their first breakthroughs in their garages. In the future, says Cowell, more and more of medicine will be driven by amateur researchers coming out with radical new ideas outside academia or the giants of industry. The two men founded DIYbio as an open platform where anyone who thought like them could exchange ideas and organize their research and experiments.
Both Cowell and Bobe understood that ground rules and best practices would need to be established in order to protect those involved in the movement. From the very beginning, they proclaimed that safety, openness, and responsibility ought to characterize these amateur biologists. In July 2011, DIYbio organized a “congress” that took place in San Francisco in order to craft a code of ethics to serves as a framework for the biohackerspaces that had popped up around the country. Most of the prominent community labs, including Genspace and BioCurious, sent representatives. The assembled biologists drafted a general code of ethics promoting values like transparency, innovation, and safety. The code was meant to be a foundation for the detailed practices that emerged at labs like BioCurious.
“That’s not good enough”
Some groups, like ETC Group, doubt the effectiveness of these self-regulatory practices. ETC Group, a watchdog organization that addresses socioeconomic and environmental issues surrounding emerging technologies, advocates for an international governmental evaluation process “based on the Precautionary Principle” that all new biotechnology must go through before it is released to the public. In 2013, the group responded to an early experiment for which a group of biohackers sought funding on Kickstarter by sending a petition to the US Department of Agriculture (USDA) asking the department to regulate this and similar future experiments done by the amateur biologists. The petition called the experiment the “antithesis” of the precautionary principle and stated that it “must be stopped.” The USDA rightly declined to intervene, saying it was not equipped to regulate the venture.
New Consumer Products
In the four years since the petition, biohackerspaces have not caused any major deaths, injuries, or adverse events. In fact, several new products have grown out of experiments conducted at these biohackerspaces. Jorgensen, in a piece for HuffPost, described how she is seeing more and more entrepreneurs showing up at Genspace seeking a low cost facility to pursue their ideas. She also notes that while the crowd of amateur biologists continues to populate the lab, there has been an influx of professionally trained scientists becoming members over the last couple years. These scientists are drawn to community labs for obvious reasons like low-cost space and being able to retain intellectual property rights over what they create, but also for less obvious reasons like being able to interact with average biology enthusiasts who are likely to be consumers of the products the scientists create.
For example, the experiment against which ETC Group protested eventually grew into a company called TAXA that focuses on genetically engineered plants. Antony Evans, the company’s CEO, says his mission is to produce products that eliminate waste and “tread lightly” on the earth. The bioluminescent plant that started the company offers an opportunity to produce natural light without electricity in an organism that is completely biodegradable. The company is also developing an engineered fragrant moss called Orbella. Like the glowing plant, Orbella is waste-free, safe, and requires no electricity or other man-made energy to function. Evans has also designed an open-source platform to allow anyone to try their hand at metabolically engineering plants to create countless consumer applications.
Another company incubated in a biohackerspace called Counter Culture Labs is working on making cheese without a cow. Benjamin Rupert, a chemist and longtime vegan, hated that he had to give up cheese in order to comply with his vegan diet. As he tinkered in the Counter Culture lab, he wondered if he could create a cheese that would be acceptable. Rupert assembled a team composed of “a biologist, a bioethicist, a retired clinical psychologist, an accountant, and a former Apple marketer,” all fellow lab members, to tackle the problem. The team inserts DNA with the information to synthesize milk proteins into baker’s yeast. The yeast then goes through a process similar to making beer except instead of alcohol, the yeast secrets milk. Rupert and his colleagues can then use that milk to make their cheese, allowing about 3 million vegans in the United States to eat cheese without regret.
In contrast to the recent regulatory saga of direct-to-consumers firm 23andMe, the story of Genspace and other biohackerspaces illustrates several principles that regulators ought to keep in mind when approaching the democratization of emerging technology.
Allow industry actors space to act responsibly before restricting any freedoms. The vast majority of scientists and amateurs involved in biohackerspaces knew what they were doing and how to do it safely. They emphasized safety from the beginning and developed detailed standard practices of their own accord. They used resources that were provided by a government entity, but that were not required because they valued being as safe as possible. In addition to creating an online space through which collaboration and coordination could occur, Cowell and Bobe physically brought together leaders from several labs to develop common principles. These practices have allowed biohackerspaces to fly under the mainstream radar by preventing newsworthy adverse events like serious injuries or death.
Avoid regulatory action motivated by panic-filled rhetoric. Because lab members demonstrated a constant commitment to safety and a thoughtful approach to their experiments, apocalyptic arguments like those made by ETC Group sounded far-fetched and unlikely. They also convinced the USDA that their activity posed a low amount of risk and that the department’s scarce resources would be better spent on enforcement elsewhere. Also, the USDA rightly displayed regulatory humility in the Kickstarter experiment case and admitted that the law did grant them jurisdiction over the experiment’s product. More widespread humility is needed on the part of regulators to know what cases the law gives them authority over and, in grey areas, what practicality and prudence allow.
Finally, the discussion of risk must be had in the context of potential benefits and vice versa. Often it seems that emerging technology is unfairly afforded a one-sided treatment. In his book Radical Evolution, Joel Garreau describes the two opposite views on new technology that he often confronts. Enthusiasts sing only the praises of technology and see the future as a perfect heaven, while pessimists only see the flaws and imagine a disastrous, hellish future. Emerging technology is somewhere in the middle; it offers immense benefits, but also possess some serious risks. Deliberately thinking through both benefits and risks will lead to the best regulation possible.