At the beach club, I met Tristan Roberts, the co-founder of Minicircle who had left the company, and asked him what else would attract people to conduct human trials here. According to him, despite the decision of the Honduran government, soft regulation remains in place for now. American company active Prosper does not require the use of CGMP certified products, stamp quality control, which takes over high costs (CGMP stands for Current Good Manufacturing Practice) and could theoretically start a small study at any time if they accepted responsibility for everything that went wrong. “This situation is ideal for a pilot study, even before Phase I, where it was just the founders and maybe investors, maybe one or two friends, people you trust not to sue you,” Roberts said. The other option, working with the GARM clinic and getting approval from its IRB, took only a few weeks in Roberts' experience.
As we dined, I realized that I had heard of Roberts before; in 2017 he had injected himself on Facebook Live with an experimental gene therapy designed to treat HIV. Ultimately, his viral load increased instead. IN videoRoberts is joined by Davis and Aaron Traywick, another biohacker who self-administered unapproved herpes vaccine on stage at a conference and tried to get Roberts to take another dose of the HIV vaccine in front of the media. (Trayvik died drown in a sensory deprivation chamber in 2018.) Given his history, Roberts might be more likely than others to appreciate the limitations of medical fraud, I thought. He acknowledged that obtaining laboratory and clinical materials is difficult: “Follow-up and consistent testing are difficult.” He planned to focus on follistatin gene therapy for dogs, he said. Later I read piece from auto fiction, he wrote about the funeral of futurist Ray Kurzweil. According to Roberts, Vitalia's downfall was due to the sociopathic personalities she attracted and their mission to prevent death.
But Roberts still believed that when it came to making drugs, the status quo was flawed and the financial and logistical barriers to testing new medical ideas were too high. “We like to think that Latin American countries are corrupt,” he said. “You can bribe officials. But in the United States, we just have the most sophisticated version of this: If you don't pay $80,000 to a lawyer who plays golf with the FDA, they won't consider your application.”
