Events like the biohacking convention in Texas have recently highlighted Biohacking in the media. The CEO of Ascendance Biomedical injected himself with a herpes treatment in front of a live audience. This stunt has raised many questions regarding the legality of their products and their legitimacy as a company.
What is DIY Biology?
There is no strict definition of biohacking, but the term can be applicable to editing the genome or adding technology into the human body. For the purpose of this article, biohacking is synonymous with Do-It-Yourself Biology (DIY Bio) where people utilize their own personal equipment to perform biological experiments, including conducting experiments on themselves, usually operating outside of a registered company or institution. The aim of biohacking is to be free of the restrictions of universities and companies, to push the boundaries of innovation, and to advocate for an open science. This means policies that help sharing information with anyone who wants it.
Famous cases of self-experimentation
A famous example of biohacking is one of the 2005 Nobel Prize winners in Physiology and Medicine, Barry Marshall, who discovered the bacteria H. pylori, which causes peptic ulcer disease, by ingesting a mixture containing the bacteria when the tests with mice failed. After he recorded his resulting ulcer, he had the proof to proceed onto more tests. While Marshall is not a self-proclaimed biohacker, he has inspired the DIY Bio community to emulate him in the hopes of making their own discoveries.
There are two types of biohackers: those who are motivated by curiosity and the pursuit of knowledge, and those who aim to create the next up-and-coming product on which they can build a business. Some even fit into both categories, such as Aaron Traywick from Ascendance Biomedical and Josiah Traynor from ODIN. The two individuals, who are also the CEOs of their own biohacking companies, have been very vocal and have been featured prominently in the news.
An online store dedicated to selling DIY biology kits, including gene editing kits.
Company creating new vaccines and cures for HIV and Herpes and testing them in volunteers.
|Credentials||Former Visiting Research Fellow at NASA - National Aeronautics and Space Administration||Sustainable Systems Design and Implementation Major, University of Montevallo|
|Biochemistry/Biophysics Major, University of Chicago|
|Cell and Molecular Biology Major, Appalachian State University|
|Plant Biology/Biochemical & Molecular Physiology Major, Southern Illinois University Carbondale|
|Claim to Fame||Being the first human to attempt to edit his own DNA using CRISPR technology and encouraging others to edit their own DNA.||Injecting himself with in front of live audience with DIY treatment for herpes.|
The major concern for both of these companies is the use, or advertised use, of non-FDA approved therapeutics. The FDA has even issued a warning regarding the use of gene therapies that are not FDA approved or a part of registered clinical trials at www.clinicaltrials.gov/. Whether it’s injecting yourself with CRISPR or volunteering for unregistered trials, these biohacking companies are operating outside the usual health and safety guidelines and therefore is it unknown what the potential side effects could be.
Can biohacking create a legal product from a legitimate and profitable company?
The sale of such DIY treatments is illegal, and its use constitutes a great risk for consumers. Regulations laid out by the FDA and other similar entities are placed so that by the time a treatment is on the market, the potential side effects and the associated risks have been examined thoroughly and this information is available to the consumer.
The beauty of biohacking is that it’s not limited to creating therapies. Currently companies are being built to bring new innovations forward, ones without the great risks and controversy associated with the non-FDA approved therapies. An example of this is Modern Meadow, a biotechnology start-up that aims to provide animal-free leather to the clothing industry, and expand the use of this technology to create other materials. Their innovative bioleather is made from animal-free collagen, which is combined with other materials. They now have a backing of $40 million from various investors to bring cruelty-free clothing to the market. The fact that they have financial support from people such as Tony Fandell, who was once the head of Apple’s iPod division and the founder of Nest Labs, is a good indication of the legitimacy and potential of a company.
It seems that biohacking companies aiming to create therapies are treading on shaky ground. Even Barry Marshall, a Nobel Laureate, tested on himself to verify a well-researched claim to promote a real clinical trial. Regulations such as those outlined by the FDA aim to protect participants of clinical trials and the patients that will use it. Modern Meadow has support from external investors and has a product that will not cause harm and even aims to prevent it. This is the type of biohacking that can bring the practice into a more positive light.
*Disclaimer: This article was written before the tragic death of Aaron Traywick, we at Synbiologue wish to offer the family and friends our condolences.