The nationwide experiment will initially include around 100,000 volunteers.
The stunt, performed at a biohacking conference, was purportedly part of a two-subject trial of the genetically modified vaccine.
February 5, 2018|
Update (Feb. 14): Gizmodo reports that several Ascendance associates, including Andreas Stuermer, who developed the herpes treatment, are no longer working with the company and have publicly criticized Aaron Traywick. Tristan Roberts, who injected himself with Ascendance's purported HIV treatment in October, described Traywick as a "scam artist" in a livestream on Feb. 11.
“I do not do intermuscular injections into any muscles but my thighs . . . so I’ll be taking off my pants,” announced self-described citizen scientist Aaron Traywick 20 minutes into the half-hour broadcast whose denouement would be his self-injection with a purported vaccine against the herpes virus.
The declaration, soon followed by Traywick removing his suit pants, was not the first signal that this event would be an unconventional medical experiment—if, indeed, that was what it was. Advertised on Facebook as a test of “the world’s first gene-therapy based vaccine and cure for herpes” and performed live at a biohacking conference in Austin, the display was engineered by Traywick’s organization, Ascendance Biomedical, which bills its modus operandi as a swift alternative to the usual development process for new therapies.
“If someone uses ordinary materials that are neither drugs nor devices in order to concoct a drug (including a biological drug), and then uses it on his or her own self, then there would appear to be no violation of federal law, merely a violation of common sense,” writes R. Alta Charo, a bioethicist at the University of Wisconsin Law School, in an email to The Scientist.
Charo notes that there is a history of self-experimentation in medicine, a fact Traywick also cites in the lead-up to his own injection. Ascendance itself has previously conducted public self-experimentation; Gizmodo reported last October that a computer programmer and volunteer test subject named Tristan Roberts injected himself with what the company billed as a potential cure for HIV. The US Food and Drug Administration (FDA) issued a statement the following month that reads in part, “Consumers are cautioned to make sure that any gene therapy they are considering has either been approved by FDA or is being studied under appropriate regulatory oversight.”
The herpes injection consisted of a virus modified to lack a protein needed for it to enter host cells, along with a transfection agent, Gizmodo reports, with the idea that it will spur the immune system to generate antibodies against the virus. According to Traywick, the hope was that it could serve both as a cure for people already infected and as a vaccine. Sita Awasthi, an infectious disease expert at the University of Pennsylvania, tells the publication she doubts the vaccine will work: “In the past, similar approaches have not prevented or treated herpes infection.”