The biggest bioethics story of the year, topping off the 200thanniversary of the publication of Frankenstein (see: https://frankenstein2018.com) was the announcement by Dr. He Jiankui on November 25ththat he had just created the world’s first genetically modified babies using the gene editing tool known as CRISPR cas9. He announced this at the 2ndinternational gene summit (see: http://www.nationalacademies.org/gene-editing/2nd_summit/index.htm); the story officially broke in MIT Technology Review (see: https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/).
I also discussed this case earlier this month on a University of Kentucky podcast (http://uknow.uky.edu/research/ethics-crispr-twins-week-behind-blue)
What did He do?
Dr. He claims to have eliminated the gene that makes us susceptible to HIV in an effort to create HIV-resistant babies since the father is HIV-positive. (The gene is called CCR5). He also claims to have created another pregnancy which is still in the early stages.
This was a staggering announcement because it means Dr. He reportedly edited human embryos that were implanted back into the mother. This is called human germline editing – also known as human germline engineering. Human germline editing involves changing the DNA of sperm, eggs or embryos – which is passed down through generations, and which have unknown consequences to the human genome overall. Essentially, Dr. He may have changed the human DNA sequence for generations to come by creating a heritable mutation and genetically modified descendants. The babies in question are called Lulu and Nana (pseudonyms); when they grow up and have children of their own, they will pass on this changed DNA sequence to their children, who will pass it on their grandchildren. This could affect untold thousands of people in the future. Nobody knows the consequences of the mutation Dr. He has introduced – it could have altered the genome in significant and negative ways.
Several scientific peers have raised serious questions:
- He has not published his data for scientific scrutiny. Nobody can verify what, exactly, he did, or if he is telling the truth.
- This was conducted without IRB approval, ethical oversight or informed consent. Dr. He’s institution –Southern University of Science and Technology, in Shenzhenhad no knowledge of his work; the hospital where the embryos were implanted and eventually born states it had no knowledge of what he was doing (see: http://asia.blob.euroland.com/press-releases-attachments/1108747/HKEX-EPS_20181127_003332422-0.PDF)
- It will be difficult to get this research published in a peer reviewed journal because it doesn’t meet the publication standard of IRB-approval. There are also several conflicts of interest in his research.
- There appears to be no scientific or clinical rationale for this particular gene edit because there are many ways to reduce HIV transmission in newborns, and HIV experts stated that these babies were at very low risk of contracting HIV in the first place. This trial did not even meet the standard of “unmet medical need”. So even if these girls remain HIV negative life long, we’ll never know if this apparent gene edit was responsible. Dr. He actually introduced new mutations into the babies’ genomes that could alter how CCR5 works. We just don’t know.
Ultimately, every bioethicist around the world has called this research completely unethical, including over 100 Chinese scientists who have stepped forward. Dr. He also violated an international moratorium on creating live births with human germline editing. In December 2015, the first international summit on gene editing took place in which the scientific community agreed that while research on human germline editing could be done on discarded embryos– so we could study and learn more about this — it could not be used to create live births because it was years away from practical application. In fact, I discussed this moratorium in December 2015 (see: http://endocrineethicsblog.org/editing-ourselves-2015-and-crispr/).
Creating live births using germline editing is illegal in several countries, including the UK and Canada. China has now declared this illegal, too. In the U.S., federal funds cannot be used for intentionally creating a human embryo that is edited or modified.
The bioethics consensus is that until sufficient public debate surrounding the ELSI consequences – the ethical, legal and social implications — of human germline editing takes place, this research is not only premature, but may not even be an acceptable scientific pursuit.
In a year where ethics violations in government without “checks and balances” have dominated the news, it seems the science news was no exception. The CRISPR twin research violated the Nuremberg Code, the Declaration of Helsinki and the Belmont Report.
Although some bioethicists question if we should respond to what “He Says” in the absence of any data, if someone is even claiming to have altered the human genome, science must provide a strong and swift rebuke. Because the last thing we want is (ahem) a copycat.