Next Step Planned in Pig-Organ Transplants

"As part of long-term efforts to address the shortage of lifesaving organs, scientists plan to extend the duration of studies in which genetically modified pig organs are transplanted into brain-dead individuals.

The move could provide crucial data to help launch clinical trials of animal-to-human transplants in living patients -- but it also raises ethical and scientific challenges for the doctors and families involved.

Scientists at NYU Langone Health in New York City plan to study how pig kidneys function in brain-dead individuals for a period of two-to-four weeks, according to Robert Montgomery, director of the NYU Langone Transplant Institute.

In the U.S., brain death is defined as the irreversible cessation of all brain function, even if heart and lung activity can be maintained with machines. The planned NYU research would keep brain-dead individuals on mechanical ventilation for significantly longer than previous research.

In four earlier studies at NYU, families and a university research oversight committee agreed to let scientists study pig hearts and pig kidneys in their loved ones' bodies for up to 72 hours.

The organs came from pigs that had undergone gene edits designed to make them more suitable for transplantation in people.

That research team had chosen the shorter time period to gather information about whether the human immune system would immediately reject the pig organs, and to avoid delaying the families' mourning process, Dr. Montgomery said.

Previous research involving transplanting pig organs into baboons showed that the pig organs can fail in the first few days after transplantation.

Pig-to-baboon organ transplants also have indicated another risky period, at 14 to 30 days after transplant, Dr. Montgomery said.

Studying pig-organ transplants in brain-dead humans during the 14-to-30 day window could provide crucial information about the human immune system and offer a better model than baboons, Dr. Montgomery said.

A spokeswoman for the Food and Drug Administration said data from studies involving the brain-dead could be useful in helping advance the goal of starting clinical trials testing pig organs in people.

Family members say they are certain that Alva Capuano, one of two brain-dead individuals at NYU who received a pig heart over the summer, would have wanted to participate in the study and help advance organ donation. Ms. Capuano herself was the recipient of a kidney donated by her son. "I think it would be important to her to be helpful in any way to save another life," said Tim Capuano, her son.

More than 100,000 people in the U.S. are on the national waiting list for organs, according to the United Network for Organ Sharing, a nonprofit that, under contract with the federal government, helps allocate organs. More than 6,000 people die every year while waiting.

Even so, making the decision to donate Ms. Capuano's body for the pig-heart study "was monumentally hard on the entire family," said Richard Capuano, her husband of over 40 years. "Even though we realized she had already died and wasn't coming back, there is still a respirator on and there is still a heartbeat. Psychologically it plays a game with you."

Research with brain-dead individuals can be controversial in part because of deeply rooted social, cultural and religious traditions about respect for the dignity of the dead and handling of their bodies, said Rebecca Pentz, a professor and bioethicist at Winship Cancer Institute and Emory University School of Medicine. She was a co-author of ethics guidelines for research on the brain-dead, published in 2005, that recommended studies be limited to one day, unless there were valid scientific reasons for going longer. "I can't imagine we can ask a family to do this for four weeks," Dr. Pentz said.

Jayme Locke, director of the Heersink School of Medicine Comprehensive Transplant Institute at the University of Alabama at Birmingham and lead surgeon on three pig-kidney studies in brain-dead individuals, said she thinks longer studies can yield important science.

James Parsons, a 57-year-old carpenter from Huntsville, Ala., who was found to be brain-dead after a motorcycle accident, participated in a pig-kidney transplant study at UAB. Julie O'Hara, Mr. Parsons's former wife, said the family conducted a celebration of his life while the study was still under way, so family and friends could begin mourning. Ms. O'Hara said the family would have allowed the study to continue longer if the scientists requested it. "Jim's soul was gone. He was no longer present in his body," Ms. O'Hara said." [1]

1. U.S. News: Next Step Planned in Pig-Organ Transplants
Marcus, Amy Dockser. 
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 29 Aug 2022: A.3.

 

Startuoliai visur

  „Likusių iškilimas

    Autorius Steve'as Case'as

    (Avid Reader, 246 puslapiai, 28 doleriai)

 

    Steve'as Case'as, vienas iš AOL įkūrėjų, buvo vienas iš pirmųjų interneto pionierių. Bet jis nėra Silicio slėnio padaras. AOL, jis nurodo savo knygoje „The Rise of Rest: How Entrepreneurs in Surprising Places Are Building the New American Dream“, buvo įsikūrusi Vašingtone, DC, o daugelis ankstyvųjų technologijų įmonių, pavyzdžiui, „Dell“, nebuvo įsteigtos Silicio slėnyje. Iš čia jo įsitikinimas, kad sėkmingas verslumas gali vykti bet kur.

 

    Norėdamas tai įrodyti, jis pradėjo iniciatyvą „Likusiųjų iškilimas“. Nuo 2014 m. P. Case'as autobusu važinėja į keletą kelionių po JAV, kad pamatytų, kaip veikia vietinis verslumas. Ekskursijose yra tai, kas skamba, kaip „American Idol“ ir „Shark Tank“ mišinys. Kiekvieno iš jų pabaigoje ponas Case'as surengia viešą 10 vietos startuolių konkursą ir „aukšto oktaninio skaičiaus finale“ nugalėtojui dovanoja 100 000 dolerių investiciją. Knygoje aprašomi kai kurie žmonės, su kuriais jis susipažino, ir įmonės, apie kurias sužinojo savo kelionėje.

 

    Savo iniciatyva ir dabar susieta knyga P. Case'as sprendžia dvi svarbias problemas. Pirma, verslumas, bėgant metams, mažėjo. Antra, tam tikros geografinės sritys, daugiausia dideli pakrantės metro miestai, sparčiai augo, suteikdamos puikių galimybių, bet palikdamos likusią šalies dalį užpakalyje.

 

 Ambicingiems, išsilavinusiems žmonėms persikėlimas į San Franciską ar Niujorką tapo labai svarbus sėkmės veiksnys.

 

    Atrodo, kad jei galėsime įžiebti verslumo ugnį po likusia šalies dalimi, galime turėti platesnę gerovę. Galbūt, ponas Case'as suteiks kibirkštį. Ne todėl, kad jis turi pakankamai pinigų kiekvienai įmonei finansuoti, o todėl, kad tikisi, kad galės įkvėpti žmones visoje šalyje pradėti verslą arba įtikinti talentingus žmones grįžti namo iš didmiesčio.

 

    Ponas Case'as mano, kad įžengiame į naują technologijų naujovių etapą. Dabar sėkmei reikia ne tik programinės įrangos išradingumo, bet ir pramonės patirties.

 

    Jei tai tiesa, mums gali prireikti vietinių verslininkų bangos, nes tai yra žmonės, kurie žino apie problemas, su kuriomis susiduria jų bendruomenės. Dabar, kai technologijų darbuotojai gali dirbti bet kur, vietos žinios ir patirtis bus aukščiausios kokybės vertybė.

 

    Autorius supažindina mus su Carteriu Malloy, kuris vaikystę praleido ūkyje Štutgarte, Arkanzase, bet galiausiai išvyko dirbti į rizikos draudimo fondą San Franciske. Būdamas fonde, jis pastebėjo, kad į dirbamą žemę investuojama per mažai: investuotojai nežinojo, kaip rasti gerų galimybių Amerikos kaimuose, o ūkininkai nepasitiki finansų rinkomis. M. Malloy pamatė galimybę modernizuoti žemės ūkio finansavimą ir persikėlė į Fajetvilį, Arkanzaso universiteto namus, kad įkurtų investicinį žemės ūkio paskirties žemės fondą. Jo žinios ir ryšiai paskatino vietinius ūkininkus juo pasitikėti ir padėjo sukurti investuotojų patikimumą.

 

    Kita įmonė, apie kurią kalba ponas Case'as, yra „Catalyte“, programinės įrangos įmonė, įsikūrusi Baltimorėje. Įkūrėjas Michaelas Rosenbaumas buvo įsitikinęs, kad „sistema, kuri vertina kilmę, o ne įgimtus gebėjimus, nepastebi potencialių talentų“, ir sukūrė samdymo metodą, kuris ignoruotų tradicinius gyvenimo aprašymo taškus, o darbuotojus atitiktų „pagal jų gebėjimus ir potencialą, kuris būtų nustatytas per kruopščiai sukalibruota metrika ir DI dizainą. Tuo tikslu ponas Rosenbaumas nusprendė pradėti savo verslą Baltimorėje, „postindustriniame mieste... su didele, išstumtų darbuotojų, nesusijusių su ateities darbo galimybėmis, populiacija“. Jo metodai pasiteisino, todėl darbo jėga buvo įvairi, o darbo rezultatai buvo „tarp geriausių“.

 

    Pono Case'o teigimu, norint paskatinti regioninį verslumą, reikia remtis universitetais ir kurti daugiau „inovacijų rajonų“.

 

    Tačiau šios zonos, kuriose yra vienas kitą remiantys startuoliai, verslo inkubatoriai ir investiciniai fondai, turi nevienodą pasiekimų sąrašą. Jis mano, kad vyriausybės dalyvavimas yra labai svarbus, tačiau nesiginčija su savo praeities nesėkmėmis ir neaiškina, kaip esamos institucijos, pvz., Smulkaus verslo administracija, galėtų geriau patenkinti šiuolaikinių steigėjų poreikius. Prieš skirstydami vyriausybės lėšas, atrodo, turėtume išsiaiškinti, kodėl apskritai esame tokioje nelygioje padėtyje.

 

    Pasaulinė ekonomika šiandien yra negailestinga mažoms įmonėms, o žvaigždžių atsiranda nedaug, nes masto ekonomija yra svarbesnė, nei bet kada anksčiau, o norint konkuruoti, reikia greitai plėstis. Mažam vaikinui sunku konkuruoti.

 

    Galbūt, rizikos fondai neinvestuoja Dulute, Min., dėl šių ekonominių iššūkių, o ne vien dėl to, kad jie nežino apie puikius verslininkus Dulute.

 

    Ponas Case neaptaria daugumos šių struktūrinių jėgų. Jo konkursų nugalėtojai gavo didelį finansavimą, bet mums niekada nepasakojama, kaip jų idėjos buvo įgyvendintos. Autorius teisus, kad naujam verslui reikalingas kapitalas, o jam tai reiškia, kad rizikos fondai investuotų į kitas vietas, ne vien į  pakrantes. Tačiau jis neaiškina, kodėl nuosavo kapitalo pardavimas besikuriančioje įmonėje yra geriau nei, tarkime, skolos paėmimas.

 

     Dažnai skola yra geresnis pasiūlymas steigėjams, kurie nenori atsisakyti kontrolės ar papildomos naudos gavimo.

 

     Be to, sunku nepritarti žmonėms ir bendruomenėms „Likusių iškilime“, ypač atsižvelgiant į ekonomikos dinamiškumo nuosmukį šioje šalyje. „American Idol“ buvo kažko didelio pradžia, nes parodė, kad talentas yra visur ir nereikia vykti į Los Andželą ar Nešvilį, kad save atrastum muzikos versle. Galbūt Steve'as Case'as su savo turu po šalį pradeda tą pačią verslumo tendenciją.

     ---

     M. Schrager yra Manheteno instituto vyresnioji bendradarbė ir knygos „Ekonomistas vaikšto į viešnamį ir kitas netikėtas vietas, kad suprastų riziką“ autorė" [1].

1.  Startups Across America
Schrager, Allison. 
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 12 Sep 2022: A.15.

Startups Everywhere

"The Rise of the Rest

By Steve Case

(Avid Reader, 246 pages, $28)

Steve Case, a co-founder of AOL, was one of the early internet pioneers. But he is not a creature of Silicon Valley. AOL, he points out in "The Rise of the Rest: How Entrepreneurs in Surprising Places Are Building the New American Dream," was based in the Washington, D.C., area, and many of the early tech firms, like Dell, were not started in Silicon Valley. Hence his conviction that successful entrepreneurship can happen anywhere.

To prove it, he launched an initiative called Rise of the Rest. Since 2014 Mr. Case has been taking a coach bus on a series of tours all over the United States to see local entrepreneurship in action. The tours feature what sounds like a mashup of "American Idol" and "Shark Tank." At the end of each one, Mr. Case holds a public competition for 10 local startups and, in a "high-octane finale," awards the winner a $100,000 investment. The book describes some of the people he met and the companies he learned about on his journey.

With his initiative and now a tie-in book, Mr. Case is addressing two important problems. The first is that entrepreneurship has been trending down over the years. The second is that certain geographical areas, mainly big coastal metro cities, have grown fast, offering great opportunities but leaving the rest of the country behind. For ambitious, educated people, moving to San Francisco or New York has become critical for success.

It seems that if we can light an entrepreneurial fire under the rest of the country, we can have broader prosperity. Perhaps Mr. Case will provide the spark. Not because he has enough money to fund every venture, but because he hopes he can inspire people all over the country to start a business or persuade talented people to move back home from the big city to do so.

Mr. Case reckons that we are entering a new phase of tech innovation. Success now requires not only software ingenuity but also industry expertise.

If true, we could be due for a wave of local entrepreneurs because these are the people who are aware of the problems their communities face. Now that tech workers can work anywhere, local knowledge and expertise will be at a premium.

The author introduces us to Carter Malloy, who spent his childhood on a farm in Stuttgart, Ark., but eventually left to work for a hedge fund in San Francisco. While at the fund, he noticed that there was underinvestment in farmland: Investors didn't know how to find good opportunities in rural America, and farmers were distrustful of financial markets. Mr. Malloy saw a chance to modernize agriculture finance and moved to Fayetteville, home of the University of Arkansas, to start a farmland investment fund. His knowhow and connections got local farmers to trust him -- and helped build credibility among investors.

Another firm that Mr. Case discusses is Catalyte, a software company based in Baltimore. Founder Michael Rosenbaum was convinced that "potential talent was being overlooked by a system that valued pedigree over innate ability" and devised a hiring approach that would ignore traditional resume points and instead match employees "according to their abilities and potential, which would be determined through carefully calibrated metrics and AI design." To that end, Mr. Rosenbaum decided to launch his startup in Baltimore, "a postindustrial city . . . with a large, dislocated population of workers who were not connected to the future job opportunities." His methods paid off, resulting in a diverse workforce and one that produced "off the charts" performance results.

According to Mr. Case, spurring regional entrepreneurship requires leaning on universities and building more "innovation districts."

But these zones, which contain startups, business incubators and investment funds that support one another, have a mixed record. He sees government involvement as crucial but doesn't contend with its past failures or explain how existing institutions like the Small Business Administration could better serve modern founders' needs. Before we lay out government funds, it seems we should figure out why we are in this unequal state in the first place.

The global economy today is ruthless to small businesses, with few stars emerging because economies of scale are bigger than ever and to compete you must scale fast. It is hard for the little guy to compete.

Perhaps venture funds aren't making investments in Duluth, Minn., because of these economic challenges, not simply because they don't know about great entrepreneurs in Duluth.

Mr. Case doesn't discuss most of these structural forces. The winners of his contests have received significant financing, but we're never told how their ideas were made to scale. The author is right that new businesses need capital, and for him that means getting venture funds to invest in places other than the coasts. But he doesn't articulate why selling equity in a nascent venture is better than, say, taking on debt.

Often debt is a better deal for founders who don't want to give up control or upside.

That said, it's hard not to root for the people and communities in "The Rise of the Rest," especially given the decline of economic dynamism in this country. "American Idol" was the start of something big, because it showed that talent was everywhere and that you didn't need to go to Los Angeles or Nashville to be discovered in the music business. Perhaps Steve Case, with his tour across the country, is starting the same trend for entrepreneurship.

---

Ms. Schrager is a senior fellow at the Manhattan Institute and the author of "An Economist Walks Into a Brothel and Other Unexpected Places to Understand Risk."” [1]

1.  Startups Across America
Schrager, Allison. 
Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 12 Sep 2022: A.15.