Aaron Traywick made himself a guinea pig for a never-before-tested gene therapy for herpes made by his own company. Legal experts say that distributing these unproven therapies may be against the law.

Courtesy / Michael Henderson

Aaron Traywick was taking off his pants because, he explained to his audience, he needed access to his thigh muscles. Still wearing a suit jacket, he planted his bare left leg on a table and gingerly eased in a syringe.

As the Facebook Live video rolled on Sunday afternoon, Traywick told the camera he was trying out a highly experimental, never-before-tested, gene-altering herpes treatment made by his own company: Ascendance Biomedical, a 20-person, largely self-funded biotech startup. In November, the Food and Drug Administration explicitly warned consumers about do-it-yourself gene therapies. But as Traywick took the stage at BdyHax, a biohacking and “transhumanism” conference in Austin, he didn’t look too worried about consequences. Traywick, Ascendance’s CEO, says his goal is to get potentially life-saving treatments out of the lab and into patients’ hands faster than pharmaceutical companies can. By making himself a public guinea pig for the company’s herpes cure — he caught the disease five years ago from a partner — he said he’s promoting transparency in science. “I do what has to be done for the science to move forward, and for other people to feel free enough to be able to seek interventions for themselves,” he told BuzzFeed News last week. He likened himself to Jonas Salk, who developed the first effective polio vaccine, and Louis Pasteur, pioneer of pasteurizing bacteria: “I’m a biohacker in the Salk or Pasteurian sense.” To others, such comparisons couldn’t be further from the truth. Ascendance has revealed few details about the science of its herpes treatment, and it hasn’t been tested on animals. Given that other gene therapies have taken decades to develop, experts are skeptical that this one actually works.



“I’m a biohacker in the Salk or Pasteurian sense.”

“To me, it’s just fanciful thinking,” Sam Sternberg, an assistant professor in biochemistry and molecular biophysics at Columbia University, told BuzzFeed News. This wasn’t Ascendance’s first demonstration. In October, Tristan Roberts, another employee, injected himself with an experimental HIV treatment also supplied by the company, and streamed it all on Facebook Live. A month later, the FDA condemned DIY gene therapies in a statement that didn’t name any particular companies: “The sale of these products is against the law. FDA is concerned about the safety risks involved.” The agency also noted that human clinical trials for gene therapies must be registered with the FDA. None of that stopped Ascendance from trying again, even without the FDA’s OK. Its livestream on Sunday got 1,200 views. In a couple weeks, Traywick will examine his blood samples to see if the treatment gene is present and whether the herpes virus has decreased. Later, a company scientist plans to stage a similar demonstration of a home-grown herpes vaccine. It will all be on camera. “Success or failure, we’re going to do it publicly, we’re going to have people know, we’re going to have people engaged,” Traywick said. Ascendance’s public experimentation comes as proposed national legislation would give some patients access to non-FDA-approved drugs, and gene-editing technologies are entering the medical mainstream. Last year, the FDA approved the first gene therapies, which aim to treat or prevent diseases by inserting genetic material into a patient’s cells. But they come at a steep price. Luxturna, which treats a rare form of inherited vision loss, costs $425,000 per eye. Meanwhile, a handful of scientists outside the pharmaceutical industry have been playing around with some of those same gene-editing technologies. In the fall, Josiah Zayner, a self-proclaimed biohacker and CEO of The Odin, a startup that sells lab equipment to other biohackers, gave himself an injection that he hoped would modify his genes to pump up his muscles. A YouTube video of his demonstration has more than 104,000 views. But not even Zayner approves of what Ascendance is up to. He noted that his own self-experimentation is backed up by rigorous research, from pilot tests on human cell lines to conversations with medical and scientific experts, in contrast to what he knows of Ascendance’s process. He also pointed out that his experimentation was about making a cosmetic change, not a medical cure. “I support people’s right to use genetic engineering technology and begrudgingly this means sometimes protecting the rights [of] people who are trying cutting-edge things on themselves with little or no knowledge,” he wrote to BuzzFeed News.

“What I don’t support are unvalidated medical claims made by companies like Ascendance. I also don’t support companies or individuals endangering others’ lives and well-being to test out their product. That’s bullshit.”

Aaron Traywick and Ascendance Biomedical running Facebook ads and promoting another live gene therapy type injectio… https://t.co/7pNxR5mRM7

Traywick denied that he was defying the FDA, noting that its warning condemned the sale of DIY gene therapies. He and his company are aboveboard, he said, because they’re giving away, not selling, experimental treatments. If people want to try the herpes treatment, they can email Ascendance through its website. If the company confirms that the compound is safe and effective, it’ll direct people to its distributor to get it, Traywick said. “Everything we give to the public is a research compound that’s explicitly labeled ‘not for human consumption,’” he told BuzzFeed News. “If a member of the public looks at what we do on camera and looks at clinical research we make available publicly, and puts two and two together, that’s their right by law.” “We are following the FDA’s regulations and federal law 100%,” he added. It’s true that the FDA doesn’t appear to be cracking down on individuals for self-experimenting with medications, said Patti Zettler, an associate law professor at Georgia State University and former associate chief counsel at the FDA. But in her reading of the FDA’s statement, companies that distribute untested gene therapies are, in fact, violating the law — whether money is changing hands or not. “If you had a Big Pharma company using its employees as traditional research subjects, we wouldn’t expect them to be exempt from FDA research requirements,” she told BuzzFeed News. “Just because the language is about self-empowerment or self-decision-making doesn’t necessarily change the circumstances.” What’s more, if an unapproved drug or one of its components has crossed state lines — if, for example, an ingredient in the herpes therapy came from another state — that might still count as an FDA violation, Zettler said. (She doesn’t know enough about Ascendance’s practices, she added, to judge whether it is breaking the law. Traywick said that he does not believe those rules apply to experimental compounds like his.)

News2Share Aaron Traywick and Machiavelli Davis, production specialist at Ascendance