OAKLAND, Calif. — A few weeks ago, the prominent biohacker Josiah Zayner took to Instagram to break some news: He had received a letter from the California Department of Consumer Affairs saying that officials were investigating him. The reason? A complaint had been made alleging that he had been practicing medicine without a license.

Zayner runs the ODIN, a company here that sells equipment for do-it-yourself science, including a $159 DIY CRISPR kit. He got his own biotech training the conventional way — he has a Ph.D. in biochemistry and biophysics from the University of Chicago — but he’s since become a leader in the biohacking community.

He’s made his name with a series of self-experiments: One time he gave himself a fecal transplant in a hotel room. Another time he tried to genetically engineer cells in the skin on his hand so they would glow. Then, another time, at a synthetic biology industry conference, he CRISPR’d himself up on stage in front of an audience.


Zayner has found himself at odds with regulators before. The FDA took issue a few years ago when he sold a kit for making glow-in-the-dark alcohol. And after he injected himself with CRISPR, the FDA put out a statement saying that DIY kits for gene therapy are illegal.

Zayner denies the new accusation he has acted as an unlicensed medical practitioner. He hasn’t been charged with anything, but it’s a serious allegation to be facing, because it could ultimately be penalized by up to three years of jail time and a $10,000 fine.

In the letter sent to Zayner notifying him of the investigation, California officials asked him to come in for an in-person interview. Zayner agreed to it, and the interview took place in the Bay Area on Tuesday. Zayner chatted with STAT about how it went.

Set the scene for us at your interview with the California investigators.

They told me to park in two-hour parking, which was a good thing because I figured: It’s two hours max we’ve got here. Their office is actually in this nondescript office building.

I sat down with two investigators. We spent about an hour — exactly like you imagine these things taking place — in some room with the three of us sitting around the table. They had their files and opened up their manila envelopes to look through stacks of paper and all their questions and research on me. It was surreal. It kind of felt like I was in an ’80s criminal drama or something like that.

And how did the interview go?

It was pretty stressful. I was still nervous because I had literally no idea what I’m being accused of, what’s going on, what this interview is about.

They told me that a medical doctor apparently watched my YouTube videos and the other stuff I did and wrote a complaint to the Department of Consumer Affairs that I was practicing medicine without a license.

“I think everybody has a right to hope.”

Josiah Zayner

And they started asking me all these questions about the business and why we sell antibiotics and all these things. (They’re all used in genetic engineering, it’s not for people to use for medical conditions).

I had to defend myself a lot. But I think the investigators were pretty reasonable. I don’t know if they’re going to bring charges against me. They didn’t say they weren’t, or they were, or anything like that.

In your Instagram post sharing the news that you were being investigated, you put forward a pretty extensive defense. Can you recap that defense for us?

Here’s the thing: If I wanted to do stupid [expletive], I have plenty of opportunity. I have people email me all the time asking me for help — sometimes with gene therapies. Recently on my YouTube, I did a little video about how to reverse-engineer Zolgensma, the new $2.1 million gene therapy. It’s not hard to get this information and create these drugs for people if they have money to pay for it.

I’ve had many opportunities to provide reasonable medical treatment to people — and I haven’t. I’ve tried hard not to, because I don’t want to break the law. My goal is to help people and educate people — not to wind up in jail. And I want to do it in a way that provides people with the proper standard of care and proper protections that they need, even if it is somewhat biohackery or underground.

About a year and a half ago you did an interview with the Atlantic in which you seem to express some regret over the experiment in which you CRISPR’d yourself on stage. You were quoted saying of the biohacker movement: “There’s no doubt that somebody is going to end up getting hurt eventually.” Do you still feel this way? Is there a tinge of regret?

Oh yeah, man. I totally regret it. I was trying to be an activist, and say: Hey look, we’ve got these gene therapies that are costing ridiculous amounts of money. We need to do something. The system’s gonna break.

To make these gene therapies, it doesn’t cost that much money. Right now, I can go to a company and literally order — for a fraction of the price — the adeno-associated virus and reverse engineer the gene sequence, which is really easy from the patents and scientific papers. I injected myself to make a statement and say: Hey, look, we need to do something. We need to help people. If I can order this gene therapy online for under $500, there’s maybe a little bit more we can do for people.

“You can’t stop this technology. Taking me down isn’t going to do anything.”

Josiah Zayner

And then there were a bunch of followup copycats. People thought it might help get them famous or attention. They started injecting themselves and there have been people who’ve injected themselves and had immune reactions. This is all in the underground, so most people haven’t heard about it or read about it. But this isn’t good. And some people have been hurt, not seriously, but people have been hurt already. And I imagine it’s just going to keep happening.

What do you think is the key philosophical difference between you and regulators?

I think the thing that all these regulators and people don’t understand — even with the CRISPR babies and stuff like that — is you can’t stop this stuff. You can’t stop this technology. Taking me down isn’t going to do anything — especially when I’m the one who’s trying to promote doing things correctly and doing things safely. What you need to do is you need to set up a system that has guardrails and stop lights and stop signs so that people who are doing it aren’t going to hurt themselves badly accidentally.

If you had the power to dream up totally new laws and regulations, what kind of biohacking would you allow? And what, if anything, would be off the table?

Creating a whole governmental system surrounding medical regulation is very complex — and it would take a lot of thought. But I think one thing that I really support is something that I call the right to hope. The right-to-try allows certain terminally ill people to try medications and drugs that have passed through Phase 1 clinical trials. But I think everybody has a right to hope.

There are so many people who are suffering from diseases and illnesses out there that can’t get access to anything. We need a system where people can get access to this stuff, where people can have medical doctors and scientists help them get access to this stuff — because what’s the other option? They just die? They just suffer and die? Every single person I’ve talked to who is suffering from a terminal illness — If you ask them: would you take a drug that has a chance of killing you but also has the chance of saving your life, would you do it?

Every single one I’ve talked to has said yes. And we need to find a way to make that happen.

You mentioned before that it’s technically feasible to reverse engineer Zolgensma, which treats a rare neuromuscular disease that’s fatal in a lot of people. Is it a good idea for patients to try to get access to a reverse-engineered Zolgensma — or do you think that should be off the table?

I think it’s going to happen. I think the system’s going to break. Once a gene therapy comes out that can treat enough people that’s not for a rare disease, the system’s just going to break, because everyone’s going to want it, and they’re going to be trying to charge $2 million. People aren’t going to get their insurance to approve it, and they’re going to be flying to clinics in the Dominican Republic where somebody reverse-engineered it or pirated the drug.

You’re going to see a lot of gene therapy piracy, providing it to the person for a fraction of the price. And it’s going to work because it has already been through clinical trials. This isn’t like doing experimental research on people. It’s the same drug — it’s just like burning a copy of Windows back in the day and giving it to somebody.

Let’s circle back to the investigation you’re facing. What’s next for you in this saga?

I don’t know, man. A lot of these things disappear into the government ether. I don’t know if they’ve got a file on me or whatever, and they’re just waiting.

The stuff I do lends itself to just more of this stuff happening. I don’t want to be a martyr, but all I can see in my future is: I better get a lawyer on retainer now for this stuff, because it’s only going to happen more and more often.

I’m just trying to educate and help people. That’s it. I’ve never given anybody a drug. I’ve never administered a drug to anybody — except for weed. Maybe I’ve passed a joint to a friend or something.

And have you hired a lawyer as you’re dealing with this investigation?

No. I know a lot of people who are lawyers, and I’ve talked to them about it.

Especially for this investigation, it’s so niche. And there’s very few people who can actually understand what’s going on. People just say: Don’t say anything. Don’t say anything incriminating.

Do they also say ‘Don’t go on a podcast’?

No. It’s totally fine. But lawyers are expensive. I’m not rich. The ODIN is doing well, but it’s not doing so well that I have tens or hundreds of thousands of dollars to throw around at lawyers. I’m just a normal person here trying to survive.

Josiah Zayner
Biohacker Josiah Zayner posted this selfie to Instagram on Tuesday upon arriving for a meeting with California investigators. Courtesy Josiah Zayner

You posted a photo on Instagram on Tuesday when you were arriving for the interview with California investigators. In that photo, you’re wearing a “Rage Against The Machine” T-shirt. So was that the obvious, automatic choice — or was there a second-choice T-shirt?

The second-choice T-shirt was actually the words “Why always me?”

That’s the Mario Balotelli shirt?

Yeah, that’s the Mario Balotelli shirt. Nice catch.

What was your thinking behind the “Rage Against The Machine” T-shirt?

[Expletive] you. I won’t do what you tell me. People are trying to tell me to do stuff, and I’m not even breaking the law. And I can’t even imagine what’s going to happen in the future when things get more crazy. And I’m scared, but I can’t stop. I’m not going to stop. So rage against the machine, right? I just got to keep raging.

And did the investigators comment on your shirt?

No. They didn’t comment on my shirt. Their look was pretty suit and tie. I’m sure they probably looked at it, and just thought: Mmmm, this guy ….

This is a lightly edited transcript from a recent episode of STAT’s biotech podcast, “The Readout LOUD.” Like it? Consider subscribing to hear every episode.

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  • For the dis-infrachised, for the ones that pray for a cure. For the ones that will be the “Ginny-pig” so a break thru will happen-death happens to all-death sooner than latter when someone wants to see daughter get married, graduate from high school or PHD program they want to LIVE for that moment-don’t take that moment from them-try-try-try again just like the Manhattan project. If you do nothing-nothing happens but each failure in a way is a success because try something else-as Marines motto goes: Never Give Up.

  • What really is there to gain from giving a lot of attention to a hacker who ought to be best ignored ? Is this a STAT popularity ploy? Are readers to expect that STAT will next also succumb to low-level ignorant aggression-festering tweets? Drop this nonsense, and ignore the hacker as the illegal operator that he is.

  • You keep giving credit to this guy, whom if anything has proven to be a very lousy biohacker. In fact, I don’t think any of his own biohacks has amounted to anything. And indeed, makes me question how he got a PhD with such poor skills, and sketchy scientific competence

  • Sure, people will try to reverse engineer gene therapy. But teaching people how to do it is another thing. If the profit drops, pharmaceutical companies will stop doing research in this area, then new treatment won’t be developed. That’s why IP exists, that’s why the system allows them to charge a ridiculous fee for a limited time. So there is enough incentive to continue research, and to cover the lost when it didn’t work (which happens more often than not).

    • Without going into the merit of biohacking, the recurrent connection of high prices to research is just a blatant falsity. The budget for research of pharma companies is just a few percent of the overall expenses. Besides, almost the totality of advanced immunotherapies are licensed from academic institutions, whose research is largely funded by taxpayers money.
      If anything, companies are spending relatively a lot in Development of a therapy. A very loose term covering everything, from repeating over and over experiments to ensure they are robust and reproducible, overpaying agencies to handle clinical trials, to bribing opinion leaders and physicians.

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