Imizamo yenkampani yaseMidwestern yokwakha izakhi zofuzo izinkomo zokuqala zobisi ezingenazimpondo emhlabeni ifike kwangqingetshe kuleli hlobo lapho i-US Food and Drug Administration ithola izakhi zofuzo ezengeziwe ezinkomeni obekungafanele zibekhona. Amaphutha abanjwe yi-FDA - kepha inkampani ilahlekile - igqamisa ukubaluleka kokuqapha kukahulumeni kokudla okuhleliwe kofuzo ngesikhathi lapho amaqembu embonini efuna ukupheliswa komthetho.
Abakhiqizi bengulube, isibonelo, "bathi uhulumeni wesifundazwe kufanele anciphise imithethonqubo yokusetshenziswa kokuhlelwa kofuzo emfuyweni," abathi kunciphisa ucwaningo nentuthuko, i-Wall Street Journal kubika isonto eledlule. Abakhiqizi bafuna ukwenganyelwa kususwe kwi-FDA kuye eMnyangweni Wezolimo wase-US, okuyi isivele ivumela izitshalo ezihlelwe zofuzo kufanele itshalwe futhi ithengiswe ngaphandle kokubheka okulawulayo.
Kepha i-FDA ihlela ukudinga ukuhlolwa kokuphepha kwangaphambi kwemakethe kwezilwane zokudla ezihlelwe ngofuzo, njengoba benza ngemithi emisha yezilwane. Imithethonqubo izoqinisekisa ukuthi izinguquko zofuzo ziphephile ezilwaneni nakubathengi, futhi zisiza abathengi ukuthi bakhululeke ngobuchwepheshe, okhulumela i-FDA utshele iJournal.
Ukutholakala kwe-FDA yezakhi zofuzo ezengeziwe ezinkomeni ezingenazimpondo, nokunye okusanda kubikwa okubi okubandakanya ulibofuzo olusha amasu wobunjiniyela, aqinise icala lokuthi uhulumeni ahlolisise, futhi abe namaqembu ezimboni alwela ukulawula i-fiasco yobudlelwano bomphakathi.
Izakhi zofuzo ezingeziwe i-Recombinetics zilahlekile
Abaphenyi benkampani ezinze eMinnesota iRecombinetics, Inc., babike ephepheni le-2016 ukuthi badale izinkomo zokuqala ezifakiwe (ezingenazimpondo) besebenzisa inqubo yokuhlela izakhi zofuzo ebizwa ngeTALENS ukushintsha ukulandelana kofuzo ezinkomeni. Abaphenyi babike ukuthi abatholanga imithelela engahlosiwe. Babhala ukuthi, "izilwane zethu azinayo imiphumela ebhekiswe ngaphandle."
Kepha lapho abacwaningi be-FDA behlola kabusha i-DNA kuleli hlobo, besebenzisa ukulandelana kofuzo okwakuthunyelwe ku-inthanethi yiRecombinetics, bathole imiphumela engeyona eyokuqondisa. Izinkomo ezimbili ezihleliwe zaziphatha amakhophi e-plasmid yebhaktheriya asetshenziswe enqubeni yokuhlela, kufaka phakathi izakhi zofuzo zokumelana nama-antibiotic cishe kuwo wonke amaseli emizimba yazo. Izakhi zofuzo azivamile ukuvela ezinkomeni.
Lokhu "kuphakamisa izingqinamba zokuphepha kokuvikela ngoba kunesidingo esiqinile somhlaba wonke sokunciphisa ukusabalala kwezakhi zofuzo ezinikeza ukumelana nemithi elwa namagciwane," kubhala uJonathan Latham, PhD, ku Izindaba Ezizimele Zesayensi. Iphinde iphakamise imibuzo ngokungabi bikho kobuciko bezindlela zokuhlela izakhi zofuzo futhi inikeze isisindo sezimpikiswano zokubhekwa kukahulumeni. Izinhlelo zokufuya izinkomo ezingenazimpondo eBrazil zachithwa ngemuva kokuvela kwemiphumela engeyona eyokuhlosiwe, kubika i-Wired, ngoba abalawuli lapho babekwazi ayisabheki izinkomo njenge-GMO.
Abaphenyi be-FDA bathi ukutholakala kwabo “kugqamisa indawo engaba khona yezindlela ezijwayelekile zokuhlola ukuhlelwa kwezakhi zofuzo,” futhi bathi basola ukuthi amaphutha okuhlanganisa “abikiwe noma awanakwa” ekuhlolweni kokuhlela izakhi zofuzo. Baphawula ezinye izibonelo zezinguquko ezingalindelekile - a Ucwaningo lwegundane lwango-2017 othole ukususwa okuyinkimbinkimbi nokufakwa ku-genome yegundane ehleliwe, futhi ucwaningo lwe-2018 lokho kwabika ukulimala kwe-DNA emigqeni yamangqamuzana omuntu.
Ngakho-ke abacwaningi beRecombinetics bakuphuthelwa kanjani ukuhlanganiswa okungahlosiwe kwe-DNA?
“Asibukanga”
"Bekungeyona into ebilindelekile, futhi besingayifunanga," kusho uTad Sonstegard, isikhulu esiphezulu senkampani yezolimo iRecombinetics 'Acceligen, ngokusho kwe Ukubuyekezwa kwe-MIT Technology. Isheke eliphelele “bekufanele ngabe lenziwe,” kusho yena. Umagazini ophefumulelwe kucashunwe uSonstegard echaza, “Besingafuni ukuhlanganiswa kweplasmid. Bekufanele sibe nayo. ”
Lokho bekufanele kube yindawo esobala yokubheka, kusho uMichael Hansen, PhD, Senior Scientist, Advocacy, weMibiko yabathengi. "Ukuthi noma iyiphi i-DNA evela ku-bacterial plasmid esetshenzisiwe ohlelweni lokuhlela izakhi zofuzo yathathwa yadluliselwa kuzoba ngenye yezinto zokuqala obuzozibheka uma unentshisekelo yokuthola imiphumela engeyona eyokuhlosiwe," kusho uHansen.
Ngokubona kwakhe, iqiniso lokuthi iRecombinetics ilahlekelwe yinkinga kusikisela ukuthi, “abenzanga ukwengamela okudingekayo. Yingakho sidinga ukwenganyelwa nguhulumeni, ”kubandakanya izidingo zokuhlolwa kwezokuphepha ngaphambi kwezimakethe, esho.
U-Latham, ongusosayensi wezinto eziphilayo nowayengunjiniyela wezakhi zofuzo, naye ukhomba kokutholakele kwakamuva okuvela eJapane akholelwa ukuthi kungaba nomphumela omkhulu kunalokho okutholwe yi-FDA, futhi kungaba nomthelela omkhulu ekulawulweni komhlaba. Esifundweni se2019, Abaphenyi baseJapan babika ukuthi ama-genome wegundane ahleliwe athole i-DNA ku-E.coli genome, kanye ne-DNA yezimbuzi nezinkomo. Le DNA elahlekile yavela kuma-reagents wokuhlela izakhi zofuzo, indlela yokulethwa esetshenziselwa ukwenza ukuhlela.
Lokhu okutholakele "kulula kakhulu: ukusika i-DNA ngaphakathi kwamaseli, kungakhathalekile ukuthi yiluphi uhlobo oluhlelekile lokuhlelwa kwezakhi zofuzo, kubeka ama-genome ukuthola i-DNA engafuneki,", kubhala uLatham kuzindaba ze-Independent Science. Uthe lokhu okutholakele “kusho ukuthi, okungenani, isidingo sezinyathelo eziqinile zokuvimbela ukungcoliswa yi-DNA elahlekile, kanye nokuhlolisiswa ngokuphelele kwamangqamuzana ahlelwe izakhi zofuzo kanye nezinto eziphilayo ezihlelwe ngezakhi zofuzo. Futhi, njengoba icala leRecombinetics liphakamisa, lezi yizidingo abathuthukisi uqobo abangase bangahlangabezani nazo.
Isinyathelo esilandelayo esinengqondo
I-Recombinetics inayo “Uphikise ngomsindo” ukwengamela kwe-FDA sonke isikhathi futhi wacela ukuphathwa kukaTrump ukulwa namandla okwengamela kude ne-ejensi yokuphepha kokudla, ngokusho kweMIT Technology Review. Futhi ngenkathi iRecombinetics isho ngo-2016 ukuthi izinkomo zayo ezingenazimpondo ezihlelwe ngofuzo "bezingenayo imiphumela engeyona eyokuhlasela," lokho kutholwa kwasetshenziswa njengethuluzi lokwamukela izivakashi emkhankasweni wokulwa nokuhlolwa kwe-FDA.
Phakathi ku ukuhlaziya ebisebenza eceleni kocwaningo lwale nkampani, abacwaningi abahlanu baseyunivesithi baphikise ngokuthi ukuhlolwa kokuphepha kwangaphambi kwemakethe kwezilwane zokudla ezihlelwe ngofuzo kuyasinda futhi akudingeki. Omunye wabalobi, U-Alison Van Eenennaam PhD, uchwepheshe wezokwelulwa kwezilwane e-UC Davis kanye nommeli ohola phambili wokuqedwa komthetho, uchaze uhlelo lwe-FDA lokufuna ukuhlolwa kokuphepha kwangaphambi kwemakethe “njengohlanya.”
"Imiphumela yokuhlelwa kwezakhi zofuzo ifana kakhulu nezinqubo zemvelo," kubhala abacwaningi ekuphawuleni kwabo. Noma imiphi "imiphumela engemihle engancishiswa ingancishiswa ngokwakhiwa ngokucophelela nangokuhlolwa okuningiliziwe," besho, bephawula ukuthi abacwaningi abavela eRecombinetics "abatholanga" ezinkomeni zabo ezihlelwe ngezakhi zofuzo.
Baphinde bathi, ngokungahambisani nalokhu, ukuthi izinkomo ezihlelwe ngofuzo ziphethe i-DNA efanayo "esetshenziswe abantu iminyaka engaphezu kwengu-1,000." "Isinyathelo esilandelayo esinengqondo," babhala, kungaba ukusabalalisa ukulandelana okuhleliwe kwe-genome "kubantu bezimbuzi zomhlaba wonke."
Ukunqanyulwa phakathi kokujaha ukuthengisa ukudla okwenziwe ngezakhi zofuzo, kanye nesidingo sokuzikhandla okufanelekile ukuqonda imiphumela engeyona eqondiwe yokusetshenziswa kofuzo kanye nemithelela engaba nayo empilweni nasemvelweni, sekuyisikhathi eside kuyiphuzu elinamathelayo empikiswaneni ye-GMO. Ngokudla okuningi kwe-GMO, izinkampani beziphethe ukuhlolwa kokuphepha sonke isikhathi, ngaphandle kokubheka okuncane kukahulumeni. Kepha yiziphi izikhuthazo izinkampani okufanele zibheke kuzo izinkinga?
Emuva ngo-1998, ku ingxoxo noMichael Pollan yeNew York Times, UMonsanto owayengumqondisi wezokuxhumana ngaleso sikhathi wayengaqondile ekuhloleni kwakhe ukuthi izimfuno zemboni zikhona kuphi: ”IMonsanto akufanele ukuthi ivikele ukuphepha kokudla kwe-biotech. Intshisekelo yethu ukuthengisa okuningi ngangokunokwenzeka. Ukuqinisekisa ukuphepha kwayo kungumsebenzi we-FDA. ”
Ukufundwa Okwengeziwe
Ukuhlelwa kwezakhi zofuzo kudinga ukucaciswa kakhudlwana ukuze kufezekiswe isithembiso sayo - nguDavid Edgell, Ingxoxo (10.7.19)
Ukuhlelwa kwe-Gene ngokungenhloso kungeza i-DNA yezinkomo, i-DNA yezimbuzi, ne-DNA yebhaktheriya, abacwaningi begundane bathola - nguJonathan Latham, PhD, Independent ScienceNews (9.23.19)
Izinkomo ezihlelwe ngezakhi zofuzo zine-screwup enkulu kwi-DNA yazo - ngu-Antonio Regalado, Ukubuyekezwa kweMIT Technology (8.28.19)
I-FDA ithola izakhi zofuzo zokumelana namagciwane ezingalindelekile ezinkomeni ezinezimpondo 'ezihleliwe' - nguJonathan Latham, PhD, no-Allison Wilson, PhD, Independent Science News (8.12.19)
Izinguquko ezenziwa ngaphandle kokuqondisa akukhona ukuphela kokukhathazeka ezitshalweni ezihlelwe ngofuzo - Ukubuka kwe-GM (7.10.19)
Kungani isifaniso esithi “isikelo samangqamuzana” seCRISPR sidukisa - ngu-Elinor Hortle, Ingxoxo (7.4.19)
I-CRISPR ibangela imiphumela engalindelekile ngisho nasendaweni ehlosiwe yokuguqulwa kofuzo - Ukubuka kwe-GM (4.16.19)
Ukukhishwa kwe-CRISPR kubangela ukuguqulwa okungahlosiwe ku-DNA - Ukubuka kwe-GM (3.13.19)
Ukuhlelwa kwesisekelo se-CRISPR, okwaziwa ngokunemba, kushaya i-snag ngokuguqula okungu-off-target - nguSharon Begley, STAT (2.28.19)
Izilimi ezinkulu nama-vertebrae angeziwe: Imiphumela engahlosiwe yokuhlelwa kofuzo lwesilwane - NguPreetika Rana noLucy Craymer, Wall Street Journal (12.14.18)
Ukulimala okungenzeka kwe-DNA okuvela ku-CRISPR 'kubhekelwe phansi kakhulu,' ucwaningo luthola - nguSharon Begley, STAT (7.16.18)
Kuvela ukuthi ukuhlela kwe-CRISPR kungalimaza nama-genomes - Ukubuyekezwa kweMIT Technology (7.16.2018)
Isithiyo esisha esibucayi se-CRISPR: Amaseli ahleliwe angadala umdlavuza, kutholakala izifundo ezimbili - nguSharon Begley, STAT (6.11.18)
Abahleli bezakhi zofuzo basePulazini bafuna izinkomo ezingenazimpondo, izingulube ezingenamsila, nebhizinisi ngaphandle kwemithetho - ngu-Antonio Regalado, Ukubuyekezwa kweMIT Technology (3.12.18)
Umbiko: Izilwane ezihlelwa yizakhi zofuzo zizoqinisa ukulima kwasezimboni kanye nenkinga yesimo sezulu, kungalimaza impilo yabantu - Abangane Bomhlaba (9.17.19)
Ngabe ulilungele igagasi elisha lokudla okwenziwe ngezakhi zofuzo? - nguStacy Malkan, USRTK (3.16.18)