Aaron Traywick, 28, who leads biotech firm Ascendance Biomedical, used an experimental herpes treatment that did not go through the typical route of clinical trials to test its safety.
Instead of being developed by research scientists in laboratories, it was created by a biohacker named Andreas Stuermer, who “holds a masters degree and is a bioentrepreneur and science lover,” according to a conference bio. This is typical of the Ascendance approach. The company believes that FDA regulations for developing treatments are too slow and that having biohackers do the research and experiment on themselves can speed up the process to everyone’s benefit. In the past, the company’s plans have included trying to reverse menopause, a method that is now actually in clinical trials.
Experts say any gene therapy prepared by amateurs would probably not be potent enough to have much effect, but it could create risks such as an immune reaction to the foreign DNA. “I think warning people about this is the right thing,” says David Gortler, a drug safety expert with the consulting group Former FDA. “The bottom line is, this hasn’t been tested.”
The problem facing regulators is that interest in biohacking is spreading, and it’s increasingly easy for anyone to obtain DNA over the internet.
The last sentence is key. As in the tech industry, once you trigger bottom-up adoption the process is irreversible. And disruptive.