Rules out­run by stem cell re­search

The grow­ing im­por­tance of stem-cell re­search is in­creas­ing the need for eth­i­cal and other guide­lines, re­ports Science writer Leigh Day­ton

The Weekend Australian - Travel - - Health -

RE­MEM­BER Woo Suk Hwang, Korea’s dis­graced ‘‘ king of cloning’’? Be­tween Fe­bru­ary 2004 and Novem­ber 2005 the sci­en­tist’s star rose and blazed in in­ter­na­tional glory. It ended in tears, of course, af­ter mul­ti­ple in­ves­ti­ga­tions re­vealed that the King and his col­leagues had faked most of the data they pub­lished in two breath­tak­ing pa­pers pub­lished in the jour­nal Science .

No, the group had not cloned the first hu­man em­bryo. No, they had not crafted cus­tomised em­bry­onic stem (ES) cells from 11 peo­ple. The only re­sult from that sci­en­tific an­nus hor­ri­bilis left stand­ing — and on four legs — was Snuppy the Afghan puppy, the world’s first cloned dog.

The rev­e­la­tions rocked stem cell re­searchers from Seoul to Syd­ney, and Lon­don to Los An­ge­les. Why did Hwang do it? How did he get away with it? What can be done to pre­vent fu­ture fraud? And are there other eth­i­cal clouds loom­ing on the stem cell hori­zon?

Such ques­tions are of grow­ing im­por­tance as the fund­ing pool for ES cell re­search deep­ens. For in­stance, this week the NSW Gov­ern­ment com­mit­ted $13 mil­lion over four years to spinal cord re­search in its bud­get state­ment. Lab­o­ra­to­ries con­duct­ing ES cell work in the area will soon be able to ap­ply.

The ques­tions are of par­tic­u­lar sig­nif­i­cance to Korean-Amer­i­can philoso­pher and bioethi­cist In­soo Hyun of Case West­ern Re­serve Univer­sity in Cleve­land, Ohio. Hyun had spent the sum­mer of 2005 in Hwang’s lab­o­ra­tory — at the pin­na­cle of the group’s fame— study­ing the eth­i­cal, le­gal and cul­tural di­men­sions of hu­man ther­a­peu­tic cloning, also known as so­matic cell nu­clear trans­fer, or SCNT. Hyun claims he didn’t see it com­ing.

‘‘ The news was dev­as­tat­ing for me per­son­ally when I found out the re­search was fab­ri­cated,’’ says Hyun, in Aus­tralia for this week’s an­nual meet­ing of the In­ter­na­tional So­ci­ety for Stem Cell Re­search (ISSCR) in Cairns, and to meet Aus­tralian sci­en­tists and ethi­cists at the be­hest of the Aus­tralian Stem Cell Cen­tre (ASCC) in Melbourne and the Men­zies Foun­da­tion. ‘‘ I was ex­tremely shocked, to say the least.’’ To this day, Hyun’s not cer­tain why Hwang did it. He’s not even sure Hwang acted alone. While he con­demns Hwang’s de­ceit as ‘‘ un­for­giv­able’’, Hyun says the roots of the fraud lie in the com­plex­ity of the new field of ES cell re­search. ‘‘ So­ci­ety sets up the crime and the crim­i­nal com­mits it,’’ he says.

For starters, as stem cell sci­en­tist Me­gan Mun­sie notes, no re­search group can tackle big ES cell projects alone. ‘‘ The skill sets re­quired to do nu­clear trans­fer, ES cell deriva­tion and cloning are (spe­cialised),’’ says Mun­sie, ASCC di­rec­tor of sci­en­tific af­fairs and pol­icy.

Lit­tle won­der, then, that bio­med­i­cal re­searchers such as Sung-il Roh of Seoul’s MizMedi Hospi­tal en­cour­aged Hwang to join them. As a vet­eri­nary re­searcher Hwang had suc­cess­fully cloned farm an­i­mals. If cows and pigs, why not peo­ple? A large col­lab­o­ra­tion was es­tab­lished and the Hospi­tal and Seoul Na­tional Univer­sity groups got to work.

‘‘ There were over 40 peo­ple in­volved in the Hwang team. I don’t know how many at the MizMedi team,’’ says Hyun. ‘‘ There was very bad co-or­di­na­tion and lack of over­sight over the en­tire re­search team.’’

He adds that gov­ern­ment reg­u­la­tions were made on the run to keep up with the re­sults ap­par­ently pour­ing out of Hwang’s lab.

For Hyun, good reg­u­la­tion, over­sight and eth­i­cal rules — gov­er­nance — might have pre­vented the scan­dal. It’s also the best way to re­duce fu­ture fraud. Fur­ther, he be­lieves proper gov­er­nance will en­hance sci­en­tific col­lab­o­ra­tion, pro­duc­ing bet­ter and faster re­sults, and give re­searchers and the pub­lic con­fi­dence that fraud­sters will be caught.

That’s cru­cial in prom­i­nent fields like ES cell re­search, claims Aus­tralian-born molec­u­lar and cell bi­ol­o­gist El­iz­a­beth Black­burn, now with the Univer­sity of Cal­i­for­nia at San Fran­cisco. ‘‘ Hav­ing the set­tings [right] will be the key to mak­ing some of th­ese prob­lems less likely to hap­pen,’’ says Black­burn, who sat on the US Pres­i­dent’s Bioethics Coun­cil un­til she blew the whis­tle on gov­ern­ment mis­rep­re­sen­ta­tion of science.

Gov­er­nance is also linked to de­bates about the po­ten­tial of stem cell re­search to de­liver new treat­ments for con­di­tions such as Parkin­son’s dis­ease and spinal cord in­jury, claims Black­burn. That’s so since ‘‘ over­sim­pli­fied’’ al­le­ga­tions from op­po­nents can push equally over­sim­pli­fied claims from pro­po­nents. ‘‘ The ter­ri­ble prob­lems of the [ Hwang] fraud were fu­elled in part by enor­mous [pub­lic] ex­pec­ta­tions which grew out of the po­lar­i­sa­tion of de­bate,’’ she says. ‘‘ This is not a good way to get good science done.’’

Lead­ing ex­perts couldn’t agree more. Yet set­ting re­gional, na­tional and in­ter­na­tional rules that fit to­gether is enor­mously dif­fi­cult. Just get­ting off the start­ing blocks can be tough. While sci­en­tists in coun­tries such as China and Sin­ga­pore have no re­stric­tions on SCNT, and those in Bri­tain have tight reg­u­la­tions al­low­ing it, their coun­ter­parts in Aus­tralia and the US weather on­go­ing storms over any use of em­bryos, cloned or not.

The in­ten­sity of Aus­tralia’s storms was felt in 2002. That’s when fed­eral Par­lia­ment de­bated and passed the na­tion’s first leg­is­la­tion per­mit­ting and reg­u­lat­ing stem cell and em­bryo re­search, while ban­ning re­pro­duc­tive or ther­a­peu­tic cloning. The Lock­hart Re­view re­assessed the laws and in 2005 rec­om­mended changes to tighten and clar­ify gov­er­nance. Con­tro­ver­sially, one of the 54 rec­om­men­da­tions called for le­gal­i­sa­tion of SCNT.

Af­ter heated de­bate in­volv­ing ‘‘ over­sim­pli­fied’’ claims that SCNT was the slip­pery slope to an­i­mal-hu­man hy­brids, the tech­nique was al­lowed and this month the re­vised na­tional laws came into force. Al­ready Vic­to­ria has passed leg­is­la­tion en­abling the na­tional laws, NSW has be­gun the process, and WA and Queens­land are ex­pected to do so soon.

In con­trast, Mar­i­anne Horn — a nurse, lawyer and head of the US state of Con­necti­cut’s re­search and de­vel­op­ment of­fice — says US sci­en­tists work in leg­isla­tive limbo. There’s no na­tional frame­work reg­u­lat­ing ES cell science, so 11 states, in­clud­ing Con­necti­cut and Cal­i­for­nia, have le­galised it. To help sim­plify mat­ters, Horn has spear­headed ef­forts to find com­mon leg­isla­tive ground. ‘‘ We want an un­der­stand­ing so dif­fer­ent stan­dards don’t get in the way of shar­ing re­search [na­tion­ally and in­ter­na­tion­ally].’’

To get the gov­er­nance ball rolling, the USbased ISSCR has re­leased the first guide­lines on hu­man ES cell re­search. Ac­cord­ing to Hyun, who chairs the ISCCR ethics com­mit­tee which pro­duced the guide­lines, they’re not legally bind­ing. But they do carry the weight of sci­en­tific opin­ion and pro­vide a start­ing point for es­tab­lish­ing reg­u­la­tions that will en­cour­age in­ter­na­tional co-op­er­a­tion yet re­spect re­gional sci­en­tific and cul­tural tra­di­tions.

‘‘ It’s not go­ing to be sorted out overnight,’’ says Hyun. ‘‘ But I’m hop­ing ISCCR will be the cen­tral clear­ing house for pol­icy.’’

A plank of any pol­icy, Hyun sug­gests, in­volves the in­formed con­sent of peo­ple do­nat­ing eggs or cells for re­search. In Aus­tralia hu­man eggs — for now, an es­sen­tial in­gre­di­ent of SCNT— can only be do­nated by IVF cou­ples who do not need them. There is no ques­tion, like else­where, that non-IVF women should be paid to do­nate them.

While Hyun says it’s im­por­tant to nut out re­gional de­tails of egg do­na­tion, he says no ju­ris­dic­tion has dealt with the ‘‘ com­ing cloud’’. It is, he warns, the seem­ingly in­nocu­ous prac­tice of do­nat­ing ‘‘ so­matic’’ cells, or­di­nary cells like skin or mus­cle cells. Th­ese cells will al­ways be the main SCNT in­gre­di­ent be­cause sci­en­tists want to clone ES cells from them to study the molec­u­lar un­der­pin­nings of dis­eases such as Alzheimer’s or mul­ti­ple scle­ro­sis.

Be­cause ex­perts also hope ul­ti­mately to tai­lor treat­ments for such con­di­tions for in­di­vid­ual peo­ple from their per­sonal cells, Hyun fears teams will be flooded with po­ten­tial donors, ea­ger to be first in line for pos­si­ble ther­a­pies for them­selves or their dis­ease group. He fears peo­ple will give their con­sent with­out fully un­der­stand­ing im­pli­ca­tions, such as the fact they’ll be mon­i­tored for life or that per­sonal de­tails and cells may be shared be­tween groups.

Af­ter all, back when it looked like Hwang had the goods, 3500 peo­ple filled in on­line do­na­tion forms in one hour. ‘‘ There was a frenzy,’’ Hyun says. ‘‘ It was amaz­ing to me.’’

Thank­fully, Hwang’s fraud was de­tected, in part by rev­e­la­tions that eggs were be­ing do­nated un­eth­i­cally, and in part by the in­her­ent scep­ti­cism of sci­en­tists trawl­ing over his ex­tra­or­di­nary claims. The up­side to the ruckus is that sci­en­tists and reg­u­la­tors are get­ting their acts to­gether.

‘‘ Things have moved on,’’ says Black­burn. So too has Hwang. Fired from the univer­sity, last year he opened a pri­vately funded lab fo­cus­ing on cross-species or­gan trans­plants. And you can bet Korean reg­u­la­tors are keep­ing a close watch, a very close watch.

Hyun: Had no inkling he was watch­ing a fraud of in­ter­na­tional pro­por­tions

Newspapers in English

Newspapers from Australia

© PressReader. All rights reserved.