This Rogue Company Wants People To Inject Themselves With Untested Drugs 

Aaron Traywick paced the stage like a caged lion. In a few minutes, he would drop trou in front of an audience and thrust a needle containing a highly experimental herpes treatment into his left thigh. For now, though, he stood alone in the spotlight, his slight frame cast in harsh silhouette and face fixed in meditative concern. He had been wearing the same oversized navy suit with a red fabric flower on the lapel for the past three days.

It was a big day for Traywick, the idealistic and theatrical young CEO of Ascendance Biomedical, a biotech outfit that aims to cure cancer, herpes, HIV, and ageing, while simultaneously battling Big Pharma and regulatory agencies like the Food and Drug Administration. Much of this, Traywick believes, will be accomplished by bold, brave individuals resurrecting the scientific tradition of self-experimentation. So on a Sunday at BodyHacking Con in Austin, Texas - a conference dedicated to do-it-yourself healthcare and bodily augmentation - he planned to stage a performance of curing his own disease. Even among a crowd that included a performance artist with an ear implanted on his arm, a mathematician peddling DIY abortion pills and many with various electronic chips implanted into their hands, Traywick's vision was extreme.

Suddenly, Traywick stopped pacing, turned, and placed his hand on his lapel to pose for a photo, as if in salute. The closing event of the conference, with his self-administered injection at the climax, was about to begin. Four biohackers who had worked on the treatment mounted the stage. Traywick took the mic to pitch his vision.

Traywick has a penchant for making the sort of grandiose statements a scientist rarely makes. In fact, he has little scientific background at all. His undergraduate education, at the University of Montevallo in his native Alabama, focused on philosophy, sociology, and the environment. In college and after, he worked in marketing, public relations and community engagement largely associated with environmental causes. Then, while in South America, he became obsessed with solving the problem of death, a fixation that eventually led him to found Ascendance.

The week before Sunday's demonstration, he began running Facebook ads claiming the company had developed both a "vaccine" and a "cure" for herpes. People that have worked with him said that he once proclaimed he wanted the company to cure cancer by this Christmas.

"If we succeed with herpes in even the most minor ways, we can proceed with cancer," he told the conference crowd. The response was sceptical.

"Did you have an ethical commission?" someone in the crowd asked, wondering whether the experiment that was about to take place had undergone any sort of formal review.

"No," Traywick answered.

He added: "We label everything 'not for human consumption,'" shortly before baring his black boxer briefs and injecting his own leg.

Aaron Traywick, just after injecting himself with an unregulated herpes therapy. He asked biohackers working with him whether the small amount of drug had even effectively gone into his body. Image: Kristen V. Brown

This stunt — and it was a stunt — was only the latest in a series of very bold, very public biological experiments bankrolled by Ascendance.

"There are breakthroughs in the world that we can actually bring to market in a way that wouldn't require us to butt up against the FDA's walls, but instead walk around them," 28-year-old Traywick told me when I first met him, in San Francisco last month. This is the central tenet of Ascendance: Science in the U.S. is slow because of regulations, which force what the company views as an overabundance of caution in labs and clinics. So Ascendance aims to do business by getting around regulators, using, as the company website puts it, a "pioneering decentralized research paradigm." That paradigm, it turns out, relies mostly on volunteers to perform experiments on themselves, a loophole that makes it difficult for regulators to intervene. Biohackers, some of whom have no formal science education at all, help the company do the lab work for cheap. According to the company "concept paper," somehow cryptocurrency is also involved.

This flippant attitude toward regulatory bodies tasked with overseeing the safety of drugs and drug testing, and the willingness to expose volunteers to untested remedies, is dangerous thinking masked as merely grandiose. 

"Brute force can accomplish anything," Traywick told me. "That is our motto."

When I met Traywick the first time, he was in San Francisco for the annual JP Morgan Health Conference, in search of investors. His hair had the unwashed look of Harry Potter's Professor Snape. He ordered a plate of hummus, explaining that he typically only eats every 16 hours and the hour to eat had come. He stood for our entire hour-and-a-half-long interview. Traywick strongly dislikes sitting.

Biohacker Gabriel Ilcina preparing the treatment on stage. Image: Kristen V. Brown

I first encountered Ascendance a year ago, when it partnered with a pair of doctors in Greece to spin off a company called Inovium that claimed it had developed a novel fertility treatment. Using a blood treatment called platelet-rich plasma, the doctors had helped a handful of women who had been having difficulty conceiving to get pregnant. At the time, Inovium was launching a clinical trial for the treatment at several fertility clinics in the U.S. and claimed that the treatment could not only help premenopausal women trying to conceive, but also potentially reverse menopause all together. The doctor overseeing it told me that so far four previously poor-prognosis IVF patients have gotten pregnant.

It got more ambitious from there. The money from the IVF trial helped to fund other work. A few months later, Ascendance cropped up again, planning to collaborate with a body hacker who was developing a vibrating penis implant, with plans to commercialize it as a couples' sex toy. (That deal ultimately fell through and the implant has not yet been finished.) Then in October, I got a text telling me to drop what I was doing and log on to Facebook. There in my feed was a livestream of Traywick sitting on the couch in a dimly lit apartment as a 27-year-old programmer named Tristan Roberts injected himself with a totally unproven, untested gene therapy that Ascendance claimed was capable of curing Roberts' HIV.

The demonstration felt like a turning point. Initially, Ascendance seemed like the sort of fly-by-night operation that would pop up to make a few headline-grabbing claims, maybe raise some Kickstarter funding, and then fade away quietly when it ran out of money. But there it was, live-streaming a gene therapy trial from someone's apartment in Washington D.C.

Before Ascendance, Traywick had helped his cousin, a former D.C. lobbyist, start the Global Health Policy Institute, a firm that lobbied on behalf of anti-ageing science, pouring effort into causes like gaining federal funding for anti-ageing research. Traywick left the group in part because his ideas and expectations were just a little too radical.

"Aaron is sincere and a great salesman, but he doesn't understand the science or the risks…and that is dangerous," said Kevin Perrott, an entrepreneur who worked with Traywick at GHPI. "I hope he finds credible people willing to work with him to avoid the worst case scenarios, for all our benefit."

A few months after the livestream, Eleonore Pauwels, a bioethicist at the Wilson Center, wrote in Scientific American that such extreme DIY demonstrations moving out of the shadows and into our social feeds was a potentially troubling trend.

"Self-experimentation with unregulated gene therapies raises troubling safety and ethical questions, from the potential for infections and immunological reactions to lack of understanding of the risks involved and unrealistic expectations from patients," she wrote.

There is a long and rich tradition of self-experimentation in medicine. One of Traywick's heroes, Jonas Salk, who developed the first effective polio vaccine, volunteered himself and his entire family for a vaccine trial. Salk's vaccine is still today one of the most rapidly developed treatments, making it to patients in just six years. Even so, the polio vaccine underwent extensive testing in lab animals before making it to people.

The ethics of these experiments become even murkier when a corporation like Ascendence is paying for them to happen and the scientists who developed the work aren't the only ones experimenting on themselves. It can be harder to tell what's motivating the experiments, and whether those who volunteer themselves understand all the risks.

Andreas Stuermer, who came up with the idea for the herpes vaccine. Image: Kristen V. Brown

Brute force, it turned out, was at the heart of Traywick's on-stage extravaganza.

The idea for the vaccine had come from Andreas Stuermer, a 25-year-old Austrian biohacker who had approached Ascendance about trying to make a herpes vaccine after stumbling across one especially intriguing paper. It seemed simple enough. In order to enter cells in the human body, herpes relies on a protein on its surface known as 'glycoprotein D.' Delete the protein from the virus, and the virus cannot spread. Presto! He theorised that just as weakened forms of live viruses are used to prevent cases of measles and mumps and chicken pox, this disarmed herpes could be turned into a vaccine to prevent against the millions of new cases of herpes that occur each year. It had worked in mice, anyway. Stuermer worked with other biohackers Ascendance had partnered with in the U.S. to develop a vaccine. He planned to test it out on himself, and Traywick planned for that test to happen in front of a live audience at BodyHacking Con.

"It works in lots of animals," Stuermer told me, of the study that inspired the vaccine. "I am also an animal, so why wouldn't it work in me?"

But science, especially when it concerns the human body, can move slowly. A few weeks before the conference, the vaccine was not ready and posts made by Stuermer in a biohacking group on Facebook suggested he might be getting cold feet.

Traywick and Stuermer surprised everyone when it turned out that Stuermer had backed out and Traywick — who has herpes — took the stage instead.

Ascendance presented several varying accounts of how the treatment was made to Gizmodo, but what occurred was some version of this: They modified the virus' code to delete the glycoprotein D gene, then inserted that code into a DNA construct known as a bacterial artificial chromosome that would spur the modified viral DNA code to replicate. From there, the plasmid got purified and sent out to an external lab to make sure that it didn't contain any contaminants. To make the vaccine, the plasmid coding for the modified virus got mixed with a transfection reagent, something called Lipofectamine intended to allow the plasmid to enter the body's cells. In the original plan, the modified virus would begin replicating in the body and to float around until the immune system killed it off, generating antibodies to herpes. Those antibodies, Traywick hoped, might also help his body defeat the herpes that was already inside of him.

Sita Awasthi, a professor in the infectious disease division at the University of Pennsylvania, was doubtful. She told me there are lots of reasons why it might not work.

"This study is promising," Awasthi said of the mouse study that inspired the DIY work, "but there is a lot of work that needs to be done before it is ready for humans."

For one, herpes, like HIV, is hard to get rid of because it hides dormant in the body for long periods of time. The DIY version didn't use the herpes virus to enter the body's cells, as the mouse work did, but instead a transfection reagent. It was unclear whether that would even work to deliver the modified viral code, let alone be effective enough to treat a tricky disease.

"This vaccine is not clinically proven to be safe and effective in preventing or treating herpes infection in humans," she said. "In the past, similar approaches have not prevented or treated herpes infection."

Traywick, she said, could wind up seriously hurting himself. It's certainly unlikely to cure him of herpes.

"Multiple things can go wrong," she said. "Whether this is illegal or not, doing this is just wrong."

Traywick was unmoved by the potential for risk. The company had taken "insane levels" of precaution he said. But even after the injection, he seemed confused about what he had actually injected. He told me the injection had used "nanorobotic delivery of genes" and a "live attenuated virus" when in fact, at least according to the people who made the treatment, it did not. It's hard to assess risk when you don't know what you're assessing.

Traywick's grand vision is to create a "transparent" and "decentralized" drug development pipeline — one where things get done, essentially, by cutting corners. The process is "decentralized" by blurring the lines between patient and scientist, asking patients to participate more actively in research. On the Ascendance website, people are asked to "upvote" the company's next research project. Potential projects listed include a "cocaine vaccine" to make quitting the drug easier; a "plasmid vector" for gender reassignment that is both "superior to routine injections" and could potentially help you live longer; and, most confusingly, research into whether "signature fruit chemicals increase sexual desirability."

On its website and Facebook, Ascendance also shares video updates on progress, as well as data associated with the trial. (That data, it's worth mentioning, has certainly not been peer-reviewed.)

While in Austin, I visited one of the several biohacker labs associated with Ascendance. In the back of an industrial park maker space, Prophase Labs was the size of a very spacious walk-in closet and smelled like decomposing shrimp. It is here that Traywick plans his operation will "scale." Prophase is working on manufacturing the treatment for HIV en masse. Machines in the lab are constantly whirring, with bacteria producing massive amounts of the DNA for the HIV "cure." The company is currently inviting people to join a waiting list to receive one of 14 treatments it claims are in development. Research compounds for three treatments that are "Not for human consumption," Traywick told me, will be available for sale by May.

A Prophase Labs biohacker with the DNA that forms the basis of the HIV vaccine. Image: Kristen V. Brown

If any of their experiments actually work, though, Traywick admits, distributing a therapy widely will still eventually require going through the FDA. But if Ascendance can cut out some of the research and regulatory steps on the way to an FDA-approved clinical trial, he argues, that trial might happen a lot faster.

It can be hard to tell how much seriousness to afford any of Ascendance's claims. Traywick has a habit of spouting off goals that seem completely impossible — including to some of the biohackers behind the company's science. In January, he told me that in the spring he plans to take several hundred doses of the company's HIV vaccine to Venezuela to distribute to people who cannot afford medication for HIV.

"We believe that this treatment, even if it can't cure HIV, it will cure AIDS. It will eliminate AIDS and it will bring the person back to HIV levels," he told me.

When Traywick made a similar claim on camera for a Netflix film crew, I watched as one of the biohackers working with him visibly cringed. At that point, the initial test of the HIV gene therapy on Roberts had failed. Its designers had gone back to the drawing board to design a more complex therapy. There was no way anything would be ready by spring.

Whether or not Ascendance survives long enough to create any lasting legacy, it represents the opportunity that new biotechnologies have created for new forms of exploitation.

After the HIV demonstration, the FDA put out a strongly worded statement advising that selling supplies for DIY gene therapy is flatly illegal, though the agency declined to comment on Ascendance's work specifically.

The FDA does not typically intervene when individuals carry out experiments on themselves. But Patti Zettler, an associate law professor at Georgia State University and former associate chief counsel at the FDA, said that the agency could potentially take action in the case of Ascendance, since the intent is to eventually distribute the therapies.

"If someone were doing a genuinely do-it-yourself gene therapy themselves I think would be difficult for FDA to intervene," she said. "But if you have companies distributing gene therapies for self-administration, they may be breaking the law."

"If a traditional drug company provided its investigational drug to employees, we would expect that the FDA would cover that," she added.

Then again, said Zettler, just because the agency can intervene, doesn't mean it will. This creates the same sort of regulatory environment that allows supplement companies to sell you things that claim to make your hair grow faster or your skin glow but may not actually work. Only in this case, we're talking about someone injecting random genes and viruses into their body.

"I get hundreds of emails every month from people saying they're devastated by herpes and they're willing to do anything. People are suffering and they are emotional about it," Awasthi, the infectious disease professor at the University of Pennsylvania, told me. "People who are not suffering should not be using that population who are in desperate need to experiment on like this."

A vat of DNA growth medium in Prophase Labs. Image: Kristen V. Brown

Take Roberts, the guinea pig for the HIV therapy. Roberts has been HIV positive for six years, but two years ago, went off drugs and has relied on strategies like diet to maintain low levels of the virus. He hated the drugs and wanted a cure. Meanwhile, Ascendance had happened across research from the National Institutes of Health that suggested a gene called N6 could spur the body to produce an antibody that would fight HIV. Traywick wanted to turn it into a gene therapy, and he wanted Roberts to be the first test subject. Roberts bought what Traywick was selling.

In the months since, as tests have shown that the initial low therapy dose has had no significant effect on his HIV levels, Roberts has dug into the research and talked to many scientists investigating a similar approach. When I talked to him in late January on the phone, as he rollerbladed up a hill in Florida, he seemed sceptical.

"Aaron has always been as optimistic as possible," he told me. "But it's hard to do biology, right?"

It now seems to him that the single antibody the gene he had injected was supposed to produce was unlikely to ever cure him, even at a higher dose. Worse, it could potentially make his HIV evolve resistance to the antibody. Current research, he said, points to a combination of antibodies as a better attack strategy, perhaps even used alongside typical HIV drugs. He is now considering going back on HIV drugs.

"I admit, I should have done some more research," Roberts told me, "That's probably my bad."

He is still, however, optimistic about the Ascendance approach.

"I'm still confident that a combination of these things should work," he said.

Pauwels, the bioethicist, thinks that public displays of DIY could come at a large cost if those experiments are poorly designed, unlikely to succeed, or harmful.

"I am all for democratizing research and including patients, but moving directly into experimental phase with blinders is irresponsible and useless at best," she told me.

"There are still substantial unknowns about how to use gene-editing therapies inside a patient's body. Will the patient contract a harmful immune reaction? An inflammatory reaction? Skin injection at home or on the stage at a conference is not the same as modifying the genomes of specific cells and re-injecting them under clinical scrutiny!" she said. "So is this just a stunt? Hype and media attention is not what patients need."

Even Josiah Zayner, an infamous biohacker widely known for pulling his own DIY gene injection stunts, said that the events at BodyHacking Con had gone too far.

"The idea that any scientist, biohacker or not, has created a cure for a disease with no testing and no data is more ridiculous than believing jet fuel melts steel beams," he told me, after watching the event's livestream.

Later, Zayner posted a long-winded takedown of the stunt on Facebook.

Zayner included in his post a mea culpa of sorts: "Looking at my actions in the past, which unfortunately did include a public injection in a semi-ridiculous manner, I want to apologise, in that I could have inspired people to think I was doing things on a whim when I was not."

The day before Traywick got on stage, he told me that he refuses to let Ascendance become yet another flashy biotech company that talks up grand plans without ever delivering.

"We could get up here and just inject water," Traywick had told the audience. Rather than fake the experiment on Steurmer, though, Traywick explained he had stepped up to volunteer himself.  

"We knew we could not delay," he told the crowd, explaining the change in plans. "Luckily I have herpes, so I volunteered myself to make our narrative and our production schedule."

It occurred to me that Traywick could have easily injected water into his thigh - the entire act was theatre, it was not a stretch to imagine that it was also an illusion. In the end, though, I'm not sure it would have been any different if he had.

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