First Human Embryos Edited in U.S.: A Bright Red Line Is Crossed

July 28, 2017 • Posted in Blog

“Sooner than we expected”: A friend – a scientist steeped in the bioethics realm – wrote to me of her surprise at the announcement of the first embryonic humans edited in the United States. Steve Connor, writing in the MIT Technology Review, reported the work on 26 July 2017.  Doubtless, the publication of the work in a scientific journal will follow.

The article, “First human embryos edited in U.S.” by Steve Connor, describes the process thusly: “A person familiar with the research says ‘many tens’ of human IVF embryos were created for the experiment using the donated sperm of men carrying inherited disease mutations.” It is not clear which mutation(s) was/were present in the sperm. The gene editing took place at fertilization, and the embryos were allowed to develop for “a few days.”

The work was done by Shoukhrat Mitalipov and his team at the Oregon Health and Science University. Mitalipov has previously been in the news for his cloning work (see here and here), and his application to the FDA to allow him to produce embryos through “mitochondrial replacement,” otherwise known as “three-parent embryos.” There has been some discussion and disagreement about whether or not the three-parent embryos, which dealt primarily with the DNA in mitochondria, constituted germline engineering, whereby genetic changes are passed along to future generations. That is because mitochondria are only passed from mother to child. If only male embryos were produced as “three-parent embryos,” then that genetic change would not be passed along to succeeding generations.

There is no question about the gene-editing of nuclear DNA, however. This work by Mitalipov’s lab is germline engineering, and crosses a line that heretofore has been a bright red line. In fact, as recently as 2008, of the 192 countries in the world, 44 had laws explicitly banning germline modification, and NO nation had any explicit law permitting it (see the testimony of Richard Hays; the countries banning germline modification are listed in the following graphic).

Screen Shot 2017-07-27 at 11.44.05 PM

Should we be surprised?

1) The U.S. does not have laws explicitly banning germline modification/engineering. Indeed, Connor notes in the MIT Technology Review article about Mitalipov:

His team’s move into embryo editing coincides with a report by the U.S. National Academy of Sciences in February that was widely seen as providing a green light for lab research on germline modification.

The report also offered qualified support for the use of CRISPR for making gene-edited babies, but only if it were deployed for the elimination of serious diseases.

2) Although Shoukhrat Mitalipov holds a position in the department of obstetrics and gynecology at the Oregon Health & Science University, he is not a physician. Instead, he holds a Ph.D. in developmental and stem cell biology, and a master’s degree in biology of reproduction from Russian universities. He was a postdoctoral fellow in the department of animal, dairy, and veterinary sciences at Utah State University.

Presumably, he has taken no oath forswearing harm to humans. Even if he had forsworn causing harm to humans, many people, including some physicians, do not regard microscopic embryonic humans as “fully human.”

3) At least in the United States, the stage has been set, gradually, step by step, for such research to take place. (See “CRISPR—Who’s In Charge, Parts I-III” for recent developments).

 

D. Joy Riley, M.D., M.A.
Executive Director