Gene-editing equipment and techniques have become more affordable and easier to use in recent years, giving birth to a new wave of "biohackers" who experiment with gene editing at home—a trend that some experts worry could be extremely dangerous, as these "citizen-scientists" operate with little regulatory oversight, Emily Baumgaertner reports for the New York Times.
Here are 8 clinical technologies that could transform health care delivery
According to Baumgaertner, biohackers today have access to advanced technology and seemingly endless stores of DNA that allows them "to re-engineer DNA in surprising ways." While many of these at-home experiments currently fizzle out (Baumgaertner recalls the biohacker who unsuccessfully injected himself with modified DNA at a conference to improve his muscle mass), experts such as George Church—a synthetic biologist and researcher at Harvard University—worry about the potential for abuse as technology advances and biohackers become more skilled.
A potentially dangerous venture
Experts particularly worry that biohackers could use advancing technology and data to design a bioweapon, Baumgaertner reports. While a number of experts say that it would be very difficult for a biohacker to create a bioweapon, some say it's not outside the realm of possibility.
Church said, "To unleash something deadly, that could really happen any day now—today," adding, "The pragmatic people would just engineer drug-resistant anthrax or highly transmissible influenza. Some recipes are online."
For instance, many experts raised an alarm when a research team at the University of Alberta published "an in-depth description of the methods used" to recreate horsepox, an extinct relative of smallpox, as well as "a series of new tips and tricks for bypassing roadblocks," Baumgaertner reports.
The team was able to purchase overlapping DNA fragments from a commercial company, glue the full genome together, and introduce it to cells infected by a different type of poxvirus—all without any interference from law enforcement, Baumgaertner reports.
One expert said the article was "unwise, unjustified, and dangerous," while a report from the World Health Organization (WHO) noted that the researchers "did not require exceptional biochemical knowledge or skills, significant funds, or significant time."
Josiah Zayner, a former scientist with NASA and one of the pioneers of biohacking, said that an accident with dangerous consequences could conceivably happen. "I guess I can see why they don't let the entire public have access to Ebola," he said. "The risk is, if they're working with Ebola and their house burns down, the Ebola could somehow get out."
Zayner added that he has "no doubt that someone is going to get hurt," because biohackers "are trying to one-up each other, and it's moving faster than any one of us could have ever imagined—it's almost uncontrollable."
A largely unregulated field
Despite the risk, federal authorities have little regulatory oversight over biohackers' experiments. According to Baumgaertner, the U.S. government has "been hesitant to undertake actions that could squelch innovation or impinge on intellectual property." As a result, the patchwork of laws and regulations that govern biotechnology are decades old, and significant gaps have opened up as technology has advanced.
Even Keoni Gandall, a biohacker himself, worries that things could go wrong, saying that "the level of DNA synthesis regulation … isn't good enough." He added that the current regulations "aren't going to work when everything is decentralized—when everybody has a DNA synthesizer on their smartphone."
According to Baumgaertner, academic researchers looking to get federal funding for what's called "dual-use research of concern"—that is, research that could theoretically be used for good or bad purposes—face intense scrutiny. However, she reports, federally funded research accounts for less than half of all scientific research and development in the United States.
According to William So, a biological countermeasures specialist at the FBI, there currently "isn't a national governance per se for those who are not federally or government funded." Rather, So said, the FBI relies on biohackers themselves to report suspicious behavior.
Thomas Inglesby, director of the Johns Hopkins Center for Health Security in Baltimore, said that he believes the FBI is doing the best they can, "but if you really want to do this, there isn't a whole lot stopping you."
Lawrence Gostin, an adviser on pandemic influenza preparedness at WHO, said, "There are really only two things that could wipe 30 million people off of the planet: a nuclear weapon, or a biological one. Somehow the U.S. government fears and prepares for the former, but not remotely for the latter" (Baumgaertner, New York Times, 5/14).
Here are 8 clinical technologies that could transform health care delivery
Our new report explores the clinical technology pipeline to help health care leaders become more conversant in the major vectors of innovation, leading applications of new technologies, and the business implications for established providers. Read on to unpack the new innovation agenda.