CA Leads the Way in Regulating Amateur use of Gene-Editing Therapy

By: Emily Chen

While the scientific world buzzed about the December conviction of Chinese scientist He Jiankui for gene-editing human embryos, California quietly and unanimously passed Senate Bill 180 (SB 180) on July 30, 2019 — the first U.S. bill to expressly regulate the amateur use of gene-editing therapy.

Image by vchalup on Adobe Stock.

SB 180, authored by Senator Ling Ling Chang, seeks to protect consumers by requiring companies that sell gene-therapy kits, known as “Do-It-Yourself (DIY) CRISPR Kits,” to include a conspicuous notice stating that these kits are not to be used for self-administration. Sellers must display such notices on their websites where consumers can see them prior to the point of sale as well as on a label on the kits’ packaging.

CRISPR, formally known as “Clustered Regularly Interspaced Short Palindromic Repeats,” are specialized sequences of DNA that enable microorganisms, like bacteria, to “remember” prior viruses and fight off future attacks. Since its discovery in 1987, CRISPR has been harnessed for many other uses — most commonly, to research treatment for diseases.

However, a recent uptick in the amateur use of CRISPR techniques has caused concern for the state legislature. In May 2018, the New York Times published an article chronicling the rise in genetic coding across the country, including Josiah Zayner, founder and CEO of The Odin, a biohacking startup in Oakland. In 2017, Zayner famously injected himself with DNA encoding CRISPR in his garage and livestreamed the event.

“The technology is moving faster than regulations,” Senator Chang said in a July 2019 press release for SB 180. “So, it’s important to be proactive about preventing safety mishaps by amateur users of CRISPR kits.”

SB 180 comes on the heels of an investigation by California’s Department of Consumer Affairs (DCA) into DIY CRISPR kits sold by The Odin, whose company tagline reads: “Making Science and Genetic Engineering Accessible and Affordable.” In a May 8, 2019 letter, the DCA accused Zayner of practicing medicine without a license. The DCA declined to comment for this story.

Zayner, who posted the letter on his Instagram page, maintained that he had “never given anyone anything to inject or use, never sold any material meant to treat a disease and never claimed to provide treatments or cures.”

Indeed, the product description for The Odin’s DIY CRISPR Kits, sold directly on its website, only claims to include “everything you need to make precision genome edits in bacteria at home, including Cas9, gRNA and Template DNA template for an example experiment.”

“The law is pretty nonsensical,” Zayner said of SB 180. “Human gene therapy products are already regulated by the [Food and Drug Administration] and can’t be sold for human use without FDA approval. I don’t see how this bill does anything other than making something illegal, more illegal.”

Hank T. Greely, a Stanford University law professor and bioethicist, agrees that the statutory framework provided by the FDA is sufficient for ensuring that gene-editing research remains within necessary legal and moral boundaries. Under federal law, experiments using gene-editing on non-reproductive cells are generally allowed with prior FDA approval. But not on germline ones, like egg cells, sperm cells, embryos and mitochondria.

“What people mainly worry about is when [gene-editing] is used as enhancement to make X-Men and so on,” Greely said.

This is what led Jiankui, who used gene-editing in order to protect the embryos of twin girls against HIV, to a three-year prison sentence and approximately $429,000 in fines, according to NPR News.

Congress has even barred the FDA from acknowledging receipt of an application to conduct clinical trials involving modified gametes or embryos since 2016, Santa Clara University law professor, Kerry Macintosh, explained.

“In effect, Congress has imposed a temporary moratorium,” said Macintosh, who is the author of Enhanced Beings: Human Germline Modification and the Law, which analyzes and critiques the objections to human germline editing on biological and political grounds.

“Congress may eventually relent and allow the FDA to receive such applications,” Macintosh added. “But even then, the FDA will not allow such trials to proceed until it is confident that the technology is safe.”

However, Greely believes that the legislative concerns around germline gene-editing are premature.

“We’re not going to make super babies because we don’t know how,” Greely said. “I don’t think the enhancement fear which is driving a lot of people’s concerns is going to be realistic for the next several decades, at least.”

But progress on using gene-editing to operate on the non-germline DNA of humans continues to gain traction. In March 2020, a patient at the Casey Eye Institute in Oregon underwent surgery to insert a gene-editing mechanism, made possible by CRISPR technology, behind her eyes to cure the blindness she developed at birth as a result of a rare genetic disease.

Doctors believe they won’t know whether the surgery is successful for about a month, but they remain optimistic about similar uses for CRISPR in the future. Dr. Jason Comander, a Massachusetts surgeon who is an eye specialist, intoned hopefully when he stated, “[this marks] a new era in medicine.”

(Editor's Note: This article was originally published in the March 2020 [Volume 50, Issue 3] version of The Advocate.)