Loyola University Chicago School of Law, JD 2022
It’s been nearly two years since Chinese researcher He Jiankui shocked the scientific community and the world when he claimed to have genetically modified the genome of two human babies for resistance to HIV using CRISPR technology. Jiankui operated under the guise of reducing the HIV/AIDS disease burden in Africa, a seemingly admirable pursuit. But geneticists and ethicists considered the experiment , and done in pursuit of personal gain.
While Jiankui was sentenced to three years in prison, the remainder of the genetics community frantically scrambled to figure out how to regulate such powerful technology. On the other end of the spectrum, notorious biohacker Josiah Zayner contemplated the futile nature of trying to contain gene editing from both a scientific and regulatory perspective. A recently published report addresses many of the scientific concerns in gene editing in human embryos but largely leaves the regulatory landscape untouched.
What is CRISPR?
CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats, is a simple technology with a potentially incomprehensible impact. Discovered in 2012, the tool allows geneticists to target, cut and edit genetic material. Scientists are using it to create a better-tasting tomato, self-terminating mosquitoes, and even a potential vaccine for COVID-19.
Editing human DNA is where CRISPR becomes more controversial. Jennifer Doudna, a researcher at UC-Berkeley who is widely touted as the face of modern CRISPR, identifies a key distinction in the two ways that it can be used clinically in human patients; in individuals and in embryos. Using CRISPR in individuals alters only their DNA and not that of future generations. Positive results in preliminary trials of sickle cell therapies are one promising development. The method used to engineer the CRISPR babies manipulates DNA in embryos which results in heritable changes. These types of changes, called germline gene editing, stand to alter human lineage as a whole.
The current global regulatory framework
Jianku’s experiment was met with a flurry of international efforts to address the ethical and regulatory loopholes in gene editing. China formed a national ethics committee for advising and enforcing research-ethics regulations. The World Health Organization published an interim recommendation for all nations to put a hold on human germline genome editing experiments. Russia issued a statement that microbiologist Denis Revrikov would not get regulatory approval to edit the gene for heritable deafness.
In the United States, a short provision known as a budget rider bans the Food and Drug Administration (“FDA”) from considering any studies that would use genetically modified embryos in new pregnancies. This ban prevents sci fi-esque genetic editing but also blocks the oversight of clinical trials on a range of devastating mitochondrial diseases with genetic causes. Last summer, a Democrat-led subcommittee of the House of Representatives dropped the ban from a routine spending bill. Although it was reinstated by the House Appropriations Committee a month later, the subcommittee indicated dropping the rider was a way to generate a larger conversation on how the U.S. should regulate genetic modification in embryos.
In early September 2020, an international commission assembled in response to the CRISPR babies published a 200-page report with explicit scientific standards for heritable gene editing in humans. The report ultimately states that science isn’t ready to establish pregnancies with genetically edited embryos – yet. International regulatory bodies have generally not responded, but if history repeats itself, science will not wait for the law to catch up.
One thing both biohackers and ethicists alike agree on is that even a moratorium on genetic editing won’t stop rogue scientists. There may be a moment in time to capture and unite the power of government agencies, funders, ethical oversight committees to shape the future of powerful technology. Unlike similar ‘then-controversial’ biotechnologies like gene therapy and recumbent DNA, CRISPR technology is too accessible and inexpensive to leave unregulated. Further, it offers too much potential for life-altering medical advances to leave on a blacklist for long. The recently published report indicates that the science is simply not ready for gene editing in embryos. But when it is, it does not seem like lawmakers or the government will be.