Should Self-Experimentation With Gene Editing Be Banned by the FDA?
Do-it-yourself genetic engineering has made the headlines on multiple occasions the last couple of months. Last fall, HIV-positive Tristan Roberts became the first to inject himself with an unproven gene therapy for HIV, while the well-known biohacker Josiah Zayner injected himself with a gene to promote muscle growth at a San Francisco biotech conference.
New genetic engineering technologies have encouraged a growing movement of biohackers taking experiments outside of the lab.
Flying in the face of warnings from the federal government about do-it-yourself gene therapy, two companies have stated they’ll continue to offer DNA-altering materials to the public.
Although very much disagreeing with such practices, and strongly discouraging them, the FDA has never actually intervened themselves with individuals. Should they?
Writing for Scientific American, bioethicist Eleonore Pauwels considers this question.
“Advances could be unprecedented with the next generation learning how to turn their own ideas and know-how into new bio-constructs,” Pauwels writes. “Just like algorithms in software engineering, our cells have become intelligent-design material.”
Pauwels suggests that we are at a turning point. Such public displays of DIY have brought the movement out of the shadowy fringes.
“We could build adaptive regulatory support that ensures safe and responsible citizen participation in health research, or we could drive these emerging communities of innovators underground or out of existence,” she argues.
“The path forward is not to promote radical, unregulated science, but to develop engagement channels that force citizens, patients, ethicists and regulators to rethink and design an adaptive oversight system—one that fosters empowerment and responsibility rather than just adherence to the status quo. The only way to avoid a blanket ban on all self-experiments is to engage stakeholders, and it is worth it…. I fear that without a robust structure for conducting risk assessment, self-experimentation using untested gene therapies will transfer the burden of weighing complex risk-benefit trade-offs to individuals at their own cost and peril.”
Pauwels is by no means alone in her thinking. The FDA issued a warning in December noting that selling supplies intended for DIY gene therapy is illegal and actually performing it is unsafe.
What’s concerning is how people (outside of the biohacker community) that might understand the risks of a therapy less, might copy what extreme biohackers have done.
Cancer patients, for example, who are running very short on time, are taking matters into their own hands, by turning to self-made versions of highly experimental cancer therapies, without the oversight of doctors or regulators.
Despite a danger, for them, this is a small glimmer of hope of survival. And it is for that reason, that they are continuing to carry out such methods.
Pauwels continues by saying that community bio-labs are the perfect place to start a continuing dialogue about how to adapt our regulatory standards to an increasingly democratised form of biomedical innovation.
“We need empoverment, but also greater collective intellgence”, she writes. “If risks are properly managed without dampering the energy of this new movement, we might all gain in thep process.”
Materials provided by Eleanore Pauwels / Scientific American.