Designer Babies: Delivering Soon in the United States

August 2, 2017

According to an article published by American Health Line earlier this week, a team of biologists inDNA online Oregon have conducted the first known experiment in the United States using the gene-editing technique CRISPR to genetically modify viable human embryos. Officials at the Oregon Health and Science University said results are pending publication in a journal.CRISPR is a technology that can modify genes quickly and efficiently by working as a type of molecular scissors that can trim away unwanted parts of the genome, and replace it with new DNA.

According to MIT’s Technology Review, the study recently conducted centered on a process known as germliine engineering, which entails altering human embryos’ DNA in an effort to eradicate or correct genes that cause inherited diseases.  The embryos used in this experiment were created using donated sperm from men with a specific genetic mutation that researchers planned to repair with CRISPR. None of the embryos involved in the study developed for more than a few days and researches never intended to implant any of them into a womb.

Scientists and ethicists have expressed a range of sentiments over such experiments—from awe to alarm, the Technology Review reports.

As with any new technology, if not regulated, addressed by judicial review, or discussed among ethicists, CRISPR could easily be used for good or for evil. Technology Review explained, ”while scientists say the approach could one day be used to avoid genetic diseases, some have raised concerns that it could lead to ‘designer babies.’ “And, some have even called CRISPR a potential “weapon of mass destruction. “

With regard to regulation, according to an article by Jordon Paradise, U.S. Regulatory Challenges for Gene Editing: recent federal legislation, the Consolidate Appropriations Act, 2016, (Pub. L. No. 114-113), “prohibits use of federal funds by the FDA to ‘acknowledge receipt of a submission to initiate clinical trials of a drug or biological product’ involving ‘research in which a human embryo is intentionally created or modified to include a heritable genetic modification.’”

With regard to judicial review, the Supreme Court has been open to adoption a jurisprudence of scientific empiricism, as illustrated by 2013 Supreme Court decision Association for Molecular Pathology v. Myriad Genetics, Inc.. While the Myriad decision dealt with the patentability of two types of DNA models under 35 USC 101, it was a novel opinion in that the court was able to unanimously rule and describe complex scientific principles.

According to an article, from Spring, 2017, by Paul Enriquez, Genome Editing and the Jurisprudence of Scientific Empiricism:

Many questions will be raised and answered regarding numerous aspects of genome editing biotechnologies in the near future. Lawyers and scientists must be careful to properly frame those questions rationally and fairly. An example of a legitimate issue regarding genome editing is whether the technology will be safe for clinical use in the near future. However, constructing arguments based on impracticalities when supporting or opposing technological advances should have no place in jurisprudential calculus. Seeking to ban a genome editing technology because of a perceived threat of the possibility of introducing designer babies, when no evidence exists to suggest that the technology is capable of delivering such outcomes, makes as much sense as seeking to ban space travel because we might encounter an extraterrestrial race that will want to annihilate humankind. At this moment in time, designer babies are as hypothetical as extraterrestrial monsters.

As of early this week however, designer babies, may be more than a hypothetical. It will be interesting to look out for the published results from the Oregon Health and Science University about their experimentation using CRISPR to alter genes in human embryos.

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