There are a diverse range of approaches to Biohacking. Some are using a pharmacological approache such as trialing nootropics, trying to achieve new traits like nights vision, or modifying our needs for sleep. Others are approaching human augmentation via genetics. People have already begun trialing genetic treatments on themselves in the hopes of curing otherwise incurable diseases, reversing aging, and gaining new abilities. Biohacking draws from and will inevitably influence fields like Neurology, Psychology, and Exercise Physiology amongst many others. Each of these areas of study have some way to determine who’s allowed to do what and how it has to be done.
In the United States, each state has a board tasked with the licensing of pharmacologists. These boards determine the scope of practice and professional ethics through the interpretation of provisions from Business and Professions Code, Penal code, Health and Safety Code, Welfare and Institution Code, as well as through the interventions and influence of powerful private groups such as the American Pharmacists Association. Each field has some kind of similar governing body. These regulatory systems are good for a number of reasons. They help us to receive safe and effective products and services applied in the safest and most effective manner by people who have been deemed competent. However, these bodies also slow if not inhibit all together research and innovations that may challenge the Status Quo and prevents the participation of those outside of academia or big business.
Biohacking is antithetical to the existing regulatory system. It’s not an adversarial relationship. Lawmakers and regulatory agencies are interested in what we’re doing. They’ve come to biohacking events and different members of the community have sat down with representatives from the FDA to discuss these issues. As of now, our approaches are mutually incompatible. Fortunately for us, it seems we’re being given a chance. People are receiving implanted devices with forms nearly indistinguishable from biomedical implants. People are taking drugs that studies have shown promising but were discarded by the pharmaceutical industry often due more to economic concerns than concerns of safety or efficacy. Biohackers are self-administering gene therapies to cure diseases which medicine has as of yet failed to cure. Yet, no one has been arrested. I don’t believe for a minute we’ve just stayed off their radar. I think they know what we’re doing. I think they understand and want to see us succeed. That, or at the very least, they’re letting us hang ourselves.
The reason we Biohackers have had so few failures is that we can stand on the shoulders of giants. Those agencies and regulatory bodies have told us the safest way to do much of what we do. Our implants look so similar to medical technology for a reason; we use the same materials and technologies they do. But we’re doing it without permission or oversight. Ethically, this puts the obligation on us to create safe and effective devices. We’re obligated make sure implementation and implantation is safe, and we have an obligation to become competent at these tasks. One of the best way to do this is by knowing and fulfilling the same requirements demanded by these regulatory agencies for industry.
This section is an overview of the requirements and suggestions for biomedical technologies by pertinent agencies and commissions such as the American Food and Drug Administration regarding the coating of implants; however, this isn’t meant as advice for getting anything approved or staying out of trouble. Rather we’re going to be looking at the types of tests used to determine if an implant is biocompatible and safe. We’ll also be looking at methods one can use test the integrity of a coating, explore many material which have been shown safe to use, and I’ll be sharing some of the results I’ve gotten with various coatings.