The gene therapy Roberts self-administered was not approved by the FDA: It was an experimental compound developed by a tiny startup called Ascendance Biomedical.
Roberts’s public self-experiment drew a new wave of attention to the practice of biohacking, an ill-defined term that means, in essence, biological research conducted outside of institutions like universities and pharmaceutical companies.
Ascendance Biomedical’s business model is based on a regulatory loophole: While it’s illegal to market something as medicine if it hasn’t been approved by the FDA, chemical research compounds, typically for use in science experiments, are openly bought and sold all the time — and, legally speaking, people are free to make the individual decision to test them on themselves.
But, like any other startup, Ascendance Biomedical is plagued by infighting, and their philosophical divisions reveal a deeper rift in the biohacking community: While some biohackers are motivated by a desire to subvert a drug approval process they believe has been corrupted by big pharma and the profit motive, others are simply entrepreneurs at heart
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