Should biohackers be regulated? Depends on your definition of 'biohackers'

New guidelines for stem cell and gene therapies miss the mark

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Newly released guidelines from an international stem cell advisory group say that biohackers who want to treat themselves with at-home kits should be better regulated.

The International Society for Stem Cell Research (ISSCR) Guidelines have been used by lawmakers, ethicists, and scientists around the world since 2006 for advice on how to manage emerging science like stem cells, embryo research, and gene therapies. 

The fourth and latest update to the influential guidelines suggests, in addition to controversial new advice about embryo research, that biohacking using cell and gene therapy in humans should be “limited to settings with an appropriate level of regulatory oversight to ensure their safe and responsible use.” 

This is the first time the ISSCR guidelines has mentioned biohackers, but because biohacking has no clear definition, no oversight mechanism, and largely exists in a legal grey area in the US and elsewhere, this is impossible. Additionally, the guidelines do not accurately explain “biohacking,” an oversight of the nuance of the landscape that could be problematic for the global Community Bio movement.

What’s the issue?

The Biohacking section of the Guidelines makes a massive nomenclative mistake: In one tiny, three-sentence paragraph it manages to conflate rogue clinics, the Bulletproof Coffee guy’s stem cell obsession, and the DIYbio community—three things that are all sometimes called “biohacking,” but which are distinct groups.

I’ll break it down:

  • Referring to themselves as research institutions, clinics like Medeus in Ukraine and Genome Healing in Australia are examples of commercial “clinics” that use “cell and gene based interventions in humans,” and are available to the public with little or no regulatory oversight. 😤 An ISSCR task force member I spoke to told me this section was meant, in part, to target these clinics.

  • The section also mentions “personal health and wellbeing” optimizers and life hackers, like Dave Asprey, who regularly promote expensive, unproven, and unregulated stem cell treatments from charlatans and call it “biohacking.” 🤯

  • But then, the section also calls out the “do-it-yourself biology movement.” Sometimes also called biohackers, independent researchers, citizen scientists, or Community Bio, 🌍 practitioners are members of a global network of independent labs, start-ups and educational organizations with one or two high profile members who routinely self-experiment and sell mail-order DIY genetic engineering kits. But the other thousands of community members are largely motivated by increased access to science and decreased prices for pharmaceuticals. And they also already have safety guidelines and are developing ethics norms.

What do you think? Should DIYbio be regulated like stem cell clinics?

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Why does this matter?

The ISSCR says commercial kits and genetic engineering equipment should carry a warning that they are not approved for self-administration. Echoing a 2019 California law that required warning labels on biohacker kits sold in that state, the ISSCR task force believes that through these labels, regulators can sound a note of caution to consumers.

The ISSCR allege that biohackers and gene therapy clinics promote their kits "with little acknowledgement of the risks posed by their use,” which is certainly true in the case of clinics and anyone selling these stem cell products on Amazon. In these cases, a warning label that says “buyer beware” would be beneficial.

However, the instances of genetic self-experimentation in the DIY community number less than a dozen, and have been performed by fewer people than I can count on my hands. Whereas there are at least 30 kits meant for educational purposes on the market, some coming out of this same Community Bio movement… Do they need warning labels too?

For those who are determined to treat themselves with these kits regardless of the intended use, what would a label accomplish?

A potential knock-on effect from overzealous regulators

I spoke to Beth Tuck, the Executive Director of the world’s first-ever DIYbio lab, Genspace, who says warning labels on DIY kits would be a waste of time. Anyone willing to self-administer gene therapies will do it anyway, and, she says, advisory groups like ISSCR should decouple the DIYbio community from rogue clinics and commercial “biohacking.”

Tuck points out there are stringent regulations and safety standards already in place to manage unintended use, and that anyone using the current generation of DIY kits will fail “100 percent” if they try to edit themselves. 

Biohacking your own genes from scratch is more difficult than advertised—and it’s more costly. Tuck says, “People ask me all the time, ‘Can’t I DIY my own CRISPR?’ and I am like, ‘Do you have six months and a couple thousand dollars?’” 

Educational outreach programs at community labs use similar low-cost kits from companies like Amino Labs or MiniPCR to entice middle-grade students into careers in biotech, healthcare, and synthetic biology. A knee-jerk reaction from uninformed regulators that tars all kinds of “biohacking” with one brush could have the undesirable effect of destabilizing and chilling a burgeoning bioeconomy.

“At our lab, we don’t encourage any self-experimentation and we definitely don’t have any human subjects research going on,” says Tuck, who urges regulators and ISSCR committee members to visit. “I think [the new guidelines] reflect a pretty profound misunderstanding of what biohacking is.”

Sure, the nod in the ISSCR Guidelines to efforts to create a mechanism for self-regulation in the movement is nice, but it’s unclear why the DIYbio community is included in the Guidelines at all.

To allow space for innovation from within the community while also demanding their adherence to responsible science standards, advisory groups and regulators should differentiate the DIY community from harmful kinds of biohacking, listen to how community members want to move forward, and take a hands-off approach.


Thanks for reading! 💜

Extra Credit:

What happens to grape vines in space? Neo.Life
Should our trash feed the environment instead of contaminate it? Biodesigned
Eric Lander will lead the White House OSTP, Science
Traditional bioethics and state laws are keeping teens from accessing vaccines, National Geographic
The NIH director told the Senate about the therapeutic potential of psychedelics, Yahoo
ISSCR guidelines dropping 14 day rule is a misstep, The Niche
Interview with Sarah Newman about art-science-education intersection, Friends of Friends
Roundup of legislation to criminalize gender-affirming care for trans youth, JAMA
Pandemic silver lining: Concealing pregnancy on Zoom, Insider