Tristan Roberts

Patti Zettler

TR: I am Tristan Roberts. I am not a biohacker but I play one on TV. I don't spend time in the lab. I've been working with biohackers. I've been a guinea pig. I tested out a gene therapy for suppressing HIV last year.

JZ: Tristan was the first person to take unapproved gene therapy treatment and try to use it to treat a disease. Namely HIV.

TR: It probably worked for a week or so... we're trying to work out the issues. If we're able to get this proof-of-concept going, then it's interchangeable for other genes. It's effectively plugging in a USB stick into your genome or chromsoomes anyway. That happened towards the end of the year.

JZ: The question I'm interested in or that we are all interested in... and sorry for hitting you with this so early in the talk... I just want to hear, and totally like, truthfully and honestly, what led up to your choice to do this treatment and why did you make that choice and what does that say about our healthcare system and things like that?

TR: I didn't get pissed off until I was visiting Chile and the government cut off my state insurance because I couldn't prove that I had residence because I was on the other part of the planet. I was this white dude and if I wa shomeless I would not have gotten that letter. As a white male in this country with HIV, you live longer than the average US citizen because you go into the doctor every 6 months and the medicine is effective. But I've come to the conclusion that at the systemic levels, there's paper treatments not cures.... and because of all these pressures... there's not one single problem causing this. The net effect of this is that, potentially viable treatments are just left at the paper or research level. I want to take papers that seem successful or with potential and then running with it or replicating it. I had some hesitancy about the injection but I consulted with people that I thought were experts on this matter and they told me it probably wont hurt you but probably wont do anything either... It's a matter of being able to scale it up. If these therapies work out, it's only like a quarter to produce, and they last for months if not indefinitely. Compare this to the current paradigm of charging $2k/month for HIV treatments. It's infuriating. It's as much activism as it is science.

JZ: Were you scared or excited?

TR: I was not that afraid until a week into it. I got red bumps around the injection area. My fear was that the plasmid would be replicating and it would have bacterial DNA and piss off my immune system. For a few days I was thinking shit, I can't go into ER and say hey I injected these plasmids or whatever.

JZ: Yeah what would you even tell them..

TR: Eventually I found out it was bed bus. Normally beg bugs is the worst possible thing but in this case I was like oh thank god.

JZ: Patti, did you read about this story in the press when it was going on? What were you thinking and what were your friends thinking?

PZ: I did read about it in the press. I can't remember if Tristan called me or someone else maybe Stephanie Lee called me and asked me about it. I didn't start paying attention until the FDA made a statement in November of last year about the self-administration of gene therapies and then I started thinking about it more. There's a broad history of self-experimentation in science and in the US there's a strong culture of respecting individual autonomy and respecting individual's abilities to make fhoices for themselves. Albeit that choice is often restricted by financial reasons... So, mostly, I was just curious about the relationship between self-experimentation and business entities. From reading the story at the time, I still don't know, it didn't seem clear to me whether this was a promotional stunt for a company or whether it was self-experimentation.

JZ: When you think about it, the only thing different between those two things is exchange of money.

PZ: I don't think so. There's the exchange of money if you're tlaking about a for-profit business or a not-for-profit or unprofitable business... there's probably money being exchanged. There's a difference between making a choice for yourself and genuine self-experimentation and being tied to distribution of a product or a therapy or an enhancement that other people are going to use and promoting that distribution, whether it's tied to financial gain or not.

TR: So even if you were giving out gene therapy, for self-administration, it would fall under the FDA's purvue?

PZ: Some of you may not be lawyers and didn't parse the statement. The FDA said that the sale of products or self-administration of gene therapy is within their purvue. I think that's because nnormally when we tlak about distribution on top of products, we talk about distribution for an exchange of money, even if it's a physician administrating a drug or implanting a penile implant or whatever. Usually there's some financial relationship even if you're not handing your doctor money at that money. Most of the FDA's statuate authority doesn't have language about direct sales.

PZ: I suspect it's because there's generally no distribution of products for free. There was a case in the 9th circuit.. a legal course in the mid-90s about there was an individual who made some .. at his house.. and he gave.. THG was not a scheduled drug at the time. The DEA couldn't go after him at the time. The federal government charged him with a federal crime under a FDA statuate. It was a guy giving recreational drugs away to his friend. So the court said hmm this isn't in the FDA's authority. Normally the courts are pretty...

JZ: So the guy...

PZ: I think he, was convincted of manslaughter under state law but this was a separate federal crime. I might not be remembering that correctly. That was a long-winded answer.

TR: Another loophole I was thinking about woas that in the 80s.. there were clubs about supplying experimental medication for HIV. Is this no longer a viable method of distribution?

PZ: I'm not sure what the mechanisms of the virus bugs that were... or the virus club movies... but still today there's mechanisms in order to get unapproved investigational products outside of clinical trials for treatment purposes. You can do it with FDA authorization thorugh expanded access. In May, Trump signed "right to try" act which allows companies or anyone to provide unapproved investigationla products to terminally ill patients without FDA authorization.

JZ: I was on twitter when that was happening. It seemed like bioethicists were against the right to try.

PZ: "Right to try" was really good branding on the part of the law. The concern is that the "right to try" thing doesn't do anything. The FDA authorizes 99% of the requests it gets. Those who are excited about using it tend to be I would say purveyors of false hope and maybe profiteers.

TR: Let's talk aout intent. A lot of things are available, but for research purposes only. But as soon as that's not written anywhere... the nyou have problems.

JZ: Same thing with antibiotics. You can purchase those for research purposes only from lots of scientific companies.

PZ: That's potentially troubling for many reasons. I think Tristan's question is, when does something have intent such that the FDA regulates it? It's very broad. Drugs and devices, and biologic drugs, anything intended to effect the structure of function of the body. That could mean cosmetic enhancements, performance enhancement, turning your skin green, whatever it is.

TR: In the longevity community, they say that ....

PZ: Probably not. In the drug space, dietary siupplements are their own categyr and and they can make claims about effecting the body and it is subject to pre-market review.

JZ: I have an interesting question. Let's flip this. Tristan, you're trying to access to thes ethings. I mean, keep it realistic, not like "Dissolve the FDA".

TR: I think we need to shift away from emporium regulations where your orders are backed up by the police. You shoujld probably not take things that are not FDA approved. But they are still backing it by threat of violence. I think a lot of this is going to be unstoppable and regulators are going to have to accept a more sort of advisory role instead of an enforcement role.

JZ: You say that they will have to do advise.. but exactly would you do to do that?

TR: I think we would be working together. Right now it's a huge hurddle from going from proof-of-concept to a stage three trial.. If we can't find a middle ground, then it is going to drive underground.

JZ: Do you plan to talk to any FDA people or have any FDA buddies?

PZ: This doesn't exactly answer your question. To build on what Tristan said, if I were in charge of the world, I'm ont sure I would have advise for what the Tristans of the world should be doing differently but I do wish there was a way to make it easier for regulators at the FDA to engage in conversations with communities that are doing innovative science and pushing the boundaries of how the regulatory paradigm can fit, without triggering ...

JZ: Cutting edge out-reach where they reach out to these scientists and work with them...

PZ: There are public meetings and opportunities for public comment.

JZ: So go to a public FDA meeting and say I want to inject myself..

PZ: You can't speak anonymously at the FDA mpublic meetings... but you could submit an anonymous comment. So for this reason it's hard to engage with communities that are concerned about being regulate.d I wish there was a good way to fix this because I think there's a lot to be learned from both stakeholders that could be learned by talking with each other.

Q: FDA said there needs to be a 15-year follow-up on gene therapy.