USE OF UNAPPROVED GENE THERAPY PRODUCTS, DRUGS, BIOLOGICS, AND MEDICAL DEVICES (BIOHACKING)

To advocate for enhanced government oversight and regulation of use of gene therapy, drugs, biologic products, and medical devices created outside of the Food and Drug Administration approval process (i.e., “biohacking”), and aggressive enforcement of those regulations; further,

To oppose the use of biohacking on vulnerable and at-risk populations and those unable to provide consent; further,

To promote education of healthcare professionals regarding use of biohacking and its implications in the medical setting; further,

To encourage the pharmacy workforce to include questions about the use of biohacking when obtaining medication histories; further,

To encourage the pharmacy workforce to ensure that patients using biohacking are educated about the risks and benefits of these treatments, including lack of regulatory oversight; further,

To recommend that health systems use a consistent method for documenting the use of biohacking in the electronic health record.

Rationale

Biohacking has been defined as “do-it-yourself biology or “do-it-yourself citizen science merging body modification with technology” (Yetisen AK. Trends Biotechnol. 2018; 36:744-7). Biohacking is performed by biology enthusiasts, citizen scientists, and other like-minded individuals and includes neurohacking (focuses on brain stimulation for change); manufacturing of pharmaceutical products; implantation of modified technology; and the genetic modification of bacteria, yeast, plants, and humans (as a form of self-experimentation) to improve oneself or treat a disease.

  Genetic biohacking in particular has proven to be easy and affordable, with individuals using inexpensive, semi-professional and portable labs to carry out their experiments, including Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology, which permits the user to edit the genome by removing, adding, or altering sections of DNA. It is estimated that more than 30,000 people are involved in do-it-yourself biology in the United States alone. Furthermore, many see themselves as serving the greater health interests of the patient community at large with the right to experiment and create treatments such as gene therapy as a form of social justice. However, many of these biohackers have little to no formal training in safety and do not obtain ethical reviews of their work as one would in an institution with an internal review board. Although most biohackers currently experiment only on themselves, concern about the practice may grow as the cost of traditional therapies, particularly biologics, increases, luring sick and desperate patients to biohackers in hopes of cheaper or more accessible treatments.

The other concern about the biohacking movement is bioterrorism. The Federal Bureau of Investigation continues to form relationships with labs where genetic experimentation occurs to police this threat, but the concern remains.

Currently in the United States, there is no ban on genome editing outside of licensed laboratories. Although the Food and Drug Administration (FDA) does have jurisdiction over regular raw biological products, traditional drug products, and do-it-yourself CRISPR kits, they have not taken public enforcement action against those conducting genome editing. This may be due to practicality, however, as many biohackers are individuals or work within a small community and are hard to track. Additionally, many current laws are outdated and apply only to agricultural genetic modification. The FDA has issued draft guidance for the regulation of intentionally altered genomic DNA in animals and stated that “any use of CRISPR/Cas9 gene editing in humans [is] gene therapy” and therefore subject to regulation.

Another facet of biohacking that must be addressed is its potential impact on manufacturing. For example, due to the high cost of biosimilar insulins, a community of biohackers has created the Open Insulin Project to develop an insulin production method for personal use. This and similar projects may lead to intellectual property, regulatory, patent, and legal issues that could impact manufacturing.

Another aspect of do-it-yourself biology is implantation of devices into one’s body for medical purposes. Many of these devices are used to monitor a medical condition or to optimize drug delivery to manage disease, such as implantation of veterinary chips for monitoring vital signs, use of a wearable artificial kidney that performs dialysis via a coated skin port, and homemade insulin pumps. Pharmacists need to be aware of these devices, as they impact how patients receive medications and how they are treated. At some point in their health journey, patients using these devices are likely to be admitted to a hospital, a mechanism for documentation of this information in the electronic health record is necessary. Furthermore, pharmacists will need to understand the impact these devices have on the pharmacokinetics, pharmacodynamics, and other aspects of drug therapy.

  An overall approach that should be considered is that of education of those engaged in the biohacking movement regarding the role of the federal agencies in consumer protection, risks and benefits and establish practice standards and norms that minimize harm.