The FDA is Not Happy about Home Gene Editing

CRISPR-Cas9, (short for Clustered Regularly Interspaced Short Palindromic Repeats), is a gene editing tool that has been on the radar of scientists, investors, and the general public in recent years because of its potential to edit human genes to treat genetic diseases and revolutionize agriculture. However, two companies have been distributing this technology in do-it-yourself home kits, despite a strong warning from the U.S. Food and Drug Administration (FDA). 

DIY Disaster?

In recent years, CRISPR has been offered on the commercial markets, making gene editing a reality in anyone’s home. Two companies, The Odin and Ascendance Biomedical, are responsible for distributing these home kits. The Odin, for example, sells gene editing kits from $159, all the way to $1,699, along with different equipment for additional money. Products from The Odin focus largely on gene editing bacteria like yeast and E. coli. Ascendance Biomedical, on the other hand, requires customers to join a waitlist, and focuses its products on biohacking herpes, HIV/AIDS, muscular/metabolic optimization, and aging mitigation. In Ascendance Biomedical’s concept paper, the Ascendance model “provide[s] an alternative to the established biomedical industry. It is able to scale up rapidly while minimizing malevolent interference.”

Upon notice, the FDA released a statement about the commercial usage of these home-kits, saying that the distribution of these products is illegal. Their website reads:

“The FDA is aware that gene therapy products intended for self-administration and “do it yourself” kits to produce gene therapies for self-administration are being made available to the public. The sale of these products is against the law. FDA is concerned about the safety risks involved. Consumers are cautioned to make sure that any gene therapy they are considering has either been approved by FDA or is being studied under appropriate regulatory oversight.”

However, in response, individuals associated with the companies have argued that there is no law that prohibits consumers from self-administering the products. In an article published by MIT Technology Review, Josiah Zayner, the CEO of The Odin, says that the products he sells are “kind of to inspire people, and maybe people will buy the DNA and use it. I don’t really have a problem with that.” Zayner added that The Odin’s products cannot be directly used to alter human genes, and that they “place at least a small barrier for entry where someone has to at least know what they’re doing before they can just inject it.”

Aaron Traywick, the late CEO of Ascendance Biomedical, said that “the FDA believes we’re doing something that we’re not. They believe we’re providing a compound and marketing a compound for a specific health purpose and providing it for sale, and we are not.” Instead, Traywick argued that Ascendance’s products are for research purposes.

As of May 2018, the FDA has published a list of approved cellular and gene therapy products, which does not include The Odin or Ascendance Biomedical’s products.

Recent Studies 

As of June 11, 2018, STAT News, a national publication on medicine and health, reported on two studies published in Nature Medicine that found that cells successfully edited by CRISPR may increase the risk that the altered cells will trigger cancer.

According to STAT News, “standard CRISPR-Cas9 works by cutting both strands of the DNA double helix. That injury causes a cell to activate a biochemical first-aid kit orchestrated by a gene called p53, which either mends the DNA break or makes the cell self-destruct.” Since CRISPR does not work once p53 is present, the studies’ researchers inhibited p53, which made CRISPR more effective, but also created dysfunctional p53 genes. As STAT news reports, p53 mutations are “responsible for nearly half of ovarian cancers; 43 percent of colorectal cancers; 38 percent of lung cancers; nearly one-third of pancreatic, stomach, and liver cancers; and one-quarter of breast cancers, among others.”

However, in a statement to CNBC, CRISPR Therapeutics, a leading CRISPR research company, said “We do not believe the theoretical risks described in these papers apply to CRISPR Therapeutics’ programs. We apply CRISPR for gene disruption or high-efficiency gene correction, neither of which are the focus of these reports. In any case, we seek to evaluate all potential risks carefully and assess thoroughly as we advance our programs to the clinic.”

For more information about CRISPR-Cas9, read Consumers’ Research article that appeared in our Spring 2016 magazine issue.

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