This material was originally posted on the Project Archivist web page, October, 2016.  

We just got a look at the world to come.  Three-parent babies are a reality; the announcement a few weeks ago the use of a mitochondrial replacement method had resulted in the birth of an apparently healthy a baby boy created a new media sensation (1).  Two weeks later we were informed that two more women are currently carrying babies created with a similar method (2).

The scientific work involved in creating 3-parent babies is amazing, but other parts of these stories are equally interesting and important.  The first baby was created to avoid a deadly disease transmitted by the mother’s faulty mitochondria.  The second babies were constructed to solve infertility problems.  Obviously, the first stages of the experiments have worked as planned.  However, while it is hoped these children will be healthy, we will have to wait to see if any problems emerge in the future.  The uncertainty surrounding the ultimate outcome of the embryo construction methods has generated controversy.  In addition, concerns have been raised over employing 3-parent embryos as an infertility treatment because other measures with fewer unknowns are available.

Who decides whether 3-parent embryo technologies are acceptable for clinical use?  That depends entirely on where the clinic is located.  The United Kingdom has decided some mitochondrial substitution therapies were allowable under regulated situations. In the U.S., any proposals to alter the genetics of human embryos must be reviewed by the Food and Drug Administration (FDA).  Because of a specific Congressional funding ban (1), it was not possible to get FDA approval and the U.S. group elected to perform the work at an associated facility in Mexico.  The efforts to treat infertility with 3-parent methods were conducted in Ukraine.  The situations have prompted questions over safety and ethical propriety.

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This tale of technological leaps and controversy in a crisis atmosphere should sound familiar.  We just went through something similar with the CRISPR editing of genomes.  Within days of a proposed moratorium on editing the human germline (3), a group of Chinese scientists announced they had altered the DNA of non-viable human embryos with this new method and it seemed certain more work would be forthcoming shortly.  Regulations currently governing gene modification of human embryos vary wildly across the world (4).  This diversity strongly suggests ethical issues regarding genetic modification of human embryos will be addressed in many different ways. 

Science, like so many other human activities, has become globalized and the implications of this development are enormous.  In addition, how many scientists go about their work has changed as well.  Many researchers at the forefront of the new genetic manipulation technologies are also directly involved with commercial enterprises seeking to profit from their use.  Will the private funders of research and development demand their work heed free market principles?  If some nations impose regulations deemed restrictive, will efforts simply shift to areas of the world where oversight is less strict or nonexistent?  News stories reveal at least one group relocated embryo manipulation operations in response to a static U.S. regulatory approval situation.  The last paragraph of the article by Andy Coghlan (2) offers an absolutely fascinating quotation regarding the potential of 3-parent embryo procedures.  A method originally developed to cure a fatal genetic condition may soon be re-purposed to serve a larger market as a new infertility treatment.  Just like the new genetic manipulation technologies, the science business future seems to have arrived before we were ready.                                         

(1) Sara Reardon. Nature, 28 September 2016. http://www.nature.com/news/three-parent-baby-claim-raises-hopes-and-ethical-concerns-1.20698

(2) Andy Coghlan, New Scientist, 10 October 2016. https://www.newscientist.com/article/2108549-exclusive-3-parent-baby-method-already-used-for-infertility/

(3) David Baltimore et al., Science, 19 March 2015. A Prudent Path Forward for Genomic Engineering and Germline Gene Modification.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4394183/    

(4)   Heidi Ledford.  Where in the World Could the First CRISPR Baby be Born?   Nature, 13 October 2015.  http://www.nature.com/news/where-in-the-world-could-the-first-crispr-baby-be-born-1.18542

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