Cau­tion in a new era

Af­ter break­through in gene edit­ing, ex­perts urge more dis­cus­sion about its im­pli­ca­tions.

Los Angeles Times - - THE NATION - By Melissa Healy melissa.healy@la­ Twit­ter: @LATMelis­saHealy

A day af­ter a block­buster re­port that re­searchers had edited harm­ful ge­netic mu­ta­tions out of hu­man em­bryos in an Ore­gon lab, an in­ter­na­tional group of ge­net­ics ex­perts urged sci­en­tists against tak­ing the next step.

A panel of the Amer­i­can So­ci­ety of Hu­man Ge­net­ics, joined by rep­re­sen­ta­tives from 10 or­ga­ni­za­tions scat­tered around the globe, rec­om­mended against genome edit­ing that cul­mi­nates in hu­man preg­nancy. Their views were pub­lished Thurs­day in the Amer­i­can Jour­nal of Hu­man Ge­net­ics.

In the United States, the Food and Drug Ad­min­is­tra­tion for­bids med­i­cal use of gene edit­ing that would af­fect fu­ture gen­er­a­tions, and the agency strictly reg­u­lates ex­per­i­men­tal use of the tech­nol­ogy in labs. But around the world, sci­en­tists some­times cir­cum­vent re­stric­tions like these by con­duct­ing clin­i­cal work in coun­tries that have no such stric­tures.

“Peo­ple who want to gain ac­cess to these tech­niques can find peo­ple will­ing to per­form them in venues where they are able to do so,” said Jef­frey Kahn, di­rec­tor of the Berman Cen­ter for Bioethics at Johns Hop­kins Univer­sity. “That un­der­scores the im­por­tance of in­ter­na­tional dis­cus­sion of what norms we will fol­low.”

In­deed, some of the groups sign­ing on to the new con­sen­sus state­ment ac­knowl­edged that they in­habit parts of the world in which med­i­cal and sci­en­tific reg­u­la­tory bod­ies scarcely ex­ist, or are not ro­bust.

The panel said it sup­ports pub­licly funded re­search of the sort per­formed at Ore­gon Health & Science Univer­sity and re­ported Wed­nes­day in the jour­nal Na­ture. Such work could “fa­cil­i­tate re­search on the pos­si­ble fu­ture ap­pli­ca­tions of gene edit­ing,” ac­cord­ing to its po­si­tion state­ment.

In the Na­ture study, re­searchers cre­ated hu­man em­bryos with a mu­ta­tion in the MYBPC3 gene that causes an of­ten fa­tal con­di­tion called in­her­ited hy­per­trophic car­diomy­opa­thy. Then they edited the DNA of those em­bryos dur­ing the first five days of their devel­op­ment. At that point, the em­bryos were ex­ten­sively an­a­lyzed and used to cre­ate stem cell lines that can be main­tained in­def­i­nitely and used for fur­ther re­search.

But ad­vanc­ing to the next step — al­low­ing preg­nan­cies to pro­ceed with al­tered em­bryos — will re­quire fur­ther de­bate, the ge­net­ics spe­cial­ists said.

They cited per­sis­tent un­cer­tain­ties re­gard­ing the safety of gene-edit­ing tech­niques. They also said the eth­i­cal im­pli­ca­tions of “germ-line” edit­ing, which would af­fect a pa­tient’s off­spring, re­main in­suf­fi­ciently con­sid­ered.

Panel mem­bers raised ques­tions about who would have ac­cess to ther­a­pies made pos­si­ble by ma­nip­u­lat­ing the genome, and how ex­ist­ing in­equities could be ex­ac­er­bated. And they ex­pressed con­cerns that the avail­abil­ity of germ-line edit­ing could en­cour­age ex­per­i­ments in eu­gen­ics — the cre­ation of peo­ple en­gi­neered for qual­i­ties such as in­tel­li­gence, beauty or strength that would set them apart as su­pe­rior.

The po­si­tion state­ment comes on the heels of the Na­ture study re­port­ing the first suc­cess­ful use in hu­man em­bryos of a rel­a­tively new and in­creas­ingly pop­u­lar ge­need­it­ing tech­nique known as CRISPR-Cas9. That study of­fered some re­as­sur­ance that un­fore­seen or “off-tar­get” ef­fects of such ther­a­pies can be avoided with cer­tain prac­tices.

Study leader Shoukhrat Mi­tal­ipov, a bi­ol­o­gist at the Ore­gon univer­sity, said that while “there is a long road ahead,” he hoped to em­ploy these tech­niques in hu­man clin­i­cal tri­als in the com­ing years.

Ore­gon Health & Science Univer­sity

A GENE-EDIT­ING sys­tem cor­rects a harm­ful mu­ta­tion in a hu­man em­bryo.

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