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In October, for example, 27-year-old computer programmer Tristan Roberts injected himself with a DIY HIV treatment on Facebook Live. "You can't stop it, you can't regulate these things," he said while preparing for the injection. "But you can create an environment where there's transparency." Biohacker Josiah Zayner did something similar, injecting himself with a CRISPR modified gene to promote muscle growth in front of 150 people at a San Francisco biotech conference. Desperate cancer patients are also hopping aboard the DIY train. Alarmed by these developments, the U.S. Food and Drug Administration warned biohackers that what they're doing is against the law, and alarmed scientists made a similar case.
Alarmed by these developments, the U.S. Food and Drug Administration warned biohackers that what they're doing is against the law,
I'm curious what behavior, and what law, exactly they are referring to.
And the selling of kits, it seems, would be considered illegal because, in broad terms, the agency would consider it the sale of any unapproved "gene therapy product" akin to the sale of an unapproved drug. If someone wants to test an unapproved drug in humans, they must first clear a clinical investigation with the FDA. Per the agency:QuoteA clinical investigation, described in title 21 of the Code of Federal Regulations, part 312.2 is defined as: any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.
A clinical investigation, described in title 21 of the Code of Federal Regulations, part 312.2 is defined as: any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.
The main problem with these "biohackers" is that they obviously don't know shit. Injecting plasmids into your bloodstream is equally useless to injecting toilet water into your bloodstream. Can they just please fucking stop?
Quote from: TLEILAXU on January 09, 2018, 06:57:00 pmThe main problem with these "biohackers" is that they obviously don't know shit. Injecting plasmids into your bloodstream is equally useless to injecting toilet water into your bloodstream. Can they just please fucking stop? All knowledge has a cost. They aren't forcing it upon people, and they might discover something useful.The Wright Brothers learned to fly .
Quote from: Wilshire on January 09, 2018, 07:03:07 pmQuote from: TLEILAXU on January 09, 2018, 06:57:00 pmThe main problem with these "biohackers" is that they obviously don't know shit. Injecting plasmids into your bloodstream is equally useless to injecting toilet water into your bloodstream. Can they just please fucking stop? All knowledge has a cost. They aren't forcing it upon people, and they might discover something useful.The Wright Brothers learned to fly .The Wright Brothers didn't learn how to fly by attaching wings to their own bodies and jumping off cliffs tho.
