In 2018, a Chinese scientist shocked the world by revealing that he had surreptitiously created the first gene-edited infants.
Because gene-editing was still relatively new and the full consequences of the technology were unknown, among other reasons, his study was criticized as being irresponsible and immoral.
He Jiankui, a scientist, was sentenced to three years in prison by China for breaking medical laws.
Let’s fast-forward to the present: In order to investigate gene editing and human reproduction, mainstream scientific institutions are promoting extremely cautious basic research. However, they continue to caution that any efforts to produce additional genetically altered offspring in the near future should be tightly prohibited.
But now, pronatalists, East Coast businesspeople, futurists, and venture capitalists from Silicon Valley are keen to advance technology because they believe that declining birth rates represent an existential threat to humanity. And that is igniting both intense anxieties and lofty ambitions.
Fresh interest from private companies
R. Alta Charo, a professor emerita at the University of Wisconsin, lawyer, and bioethicist who currently consults with government agencies and private companies, said, “You’ve got a convergence of people who are thinking that they can improve their children — whether it’s their children’s health, their children’s appearance, or their children’s intelligence, along with people who are comfortable using the newest technologies and people who have the money and the chutzpah the daring to try and do this.”
Editing genes in embryos that could develop into kids is prohibited by U.S. regulations. However, some analysts believe that could change given the Trump administration’s support for reproductive technology like in vitro fertilization and its deregulatory posture.
Additionally, the first business to openly declare its intention to attempt genetically altering human embryos in order to produce gene-edited offspring has just revealed its ambitions.
In an interview with NPR, biotech entrepreneur Cathy Tie stated, “We want to be the company that does this in the light, with transparency and with good intentions,” on her new business, the Manhattan Project.
“I think the timing is right for having this conversation,” Tie replied. “There’s a lot of promise in this technology.”
“We chose our name deliberately,” Tie told NPR about the company’s moniker. We think the scope of our effort to eradicate genetic illness is equally important as the initial Manhattan Project science. Tie stated that she intends to investigate a range of gene-editing technologies gradually and cautiously, under strict bioethical supervision.
In a lab in Manhattan, a small scientific team has already been put together to carry out systematic studies. Before working with human embryos, the team intends to first research mice, then primates, and finally human cells.
“The company hopes to provide enough evidence to convince regulators to approve moving forward and federal officials to fund the research,” she said.
“Right now the goal is really just to inform regulators and the public what this technology is capable of and what it’s not and hopefully empower regulators in the future, when proven safe and efficient, to allow research in this space,” said Tie. “We hope to support that regulatory approval process.”
“First and foremost,” she stated, is safety.
She stated that preventing severe genetic illnesses is her ultimate objective.
“There are so many diseases that have no cures and there’s not going to be a cure for them for many more decades,” Tie stated. And it is our duty, in my opinion, to discuss this with patients who do suffer from these horrible illnesses and find out if they would like to avoid passing those conditions on to future generations. Parents ought to have the option.
However, she stated the company will only prevent diseases like inherited blood disorders like beta thalassemia and the genetic lung ailment cystic fibrosis.
“Our focus is on disease prevention,” she stated. “We draw the line at disease prevention.”
She co-founded the company with Erina Hysolli, the chief of biological sciences at Colossal Biosciences, which is engaged in a contentious endeavor to revive extinct creatures, such as the wooly mammoth, by genome editing.
In an interview with NPR, Hysolli, who previously worked in George Church’s Harvard genetics lab. “I’m absolutely very excited about this project,” he said. “I truly believe that these tools are very powerful and can lead to benefits to human health.”
Additional information was not disclosed by the Manhattan Project, such as the investors, the amount of money raised, or a deadline.
Investors see an opportunity
The business is by no means alone, though.
“We are definitely evaluating whether it makes sense to actually incubate and help build a company that we think could do this safely and responsibly,” co-founder of the San Francisco venture capital firm SciFounders, Lucas Harrington, stated. “I think there’s huge benefit if it can be done safely and responsibly.”
Harrington wants to alter embryos to create infants using “base editing,” a more recent and presumably safer gene-editing technology. He stated that preventing illnesses would be his main goal as well.
The Chinese researcher employed the gene-editing method known as CRISPR, which makes it more easier than ever for researchers to make extremely precise modifications to DNA but can also result in potentially harmful random mutations.
“I think how we’ve been going about it until now has really been burying our head in the sand and not wanting to talk about it because it’s too controversial,” Harrington stated. “The tools over the past decade have dramatically changed.”
But some discuss going beyond preventing diseases before they arise by employing state-of-the-art genetic research.
According to Chase Denecke, CEO of the California business Bootstrap Bio, Inc., “the good that Bootstrap Bio can do is basically speed up the development of this technology and also expand people’s conception of what biotech is actually good for,” as said on the OpenSocietyWTF podcast. Interview requests from NPR were turned down by Denecke, whose company is purportedly also looking to modify human embryos. “I don’t believe that simply saying, ‘We’re going to make you not sick,’ is sufficient. On the show, he stated, “We genuinely want to improve people’s lives.”
Some investors in advanced reproductive technologies, at least, concur.
People may say, ‘Well, by employing this kind of technology, you’re playing God.’ ‘People would say that with any technology of the past,'” declared self-described pronatalist Malcolm Collins. Collins and his spouse, Simone, stated that they are in favor of a range of experimental reproductive methods, from gene-edited offspring to “artificial” wombs and lab-created embryos.
Some futurists call these “Gattaca Stack” technologies, referring to the 1997filmabout genetically engineered people, that could transform human reproduction. The goal of these advancements, according to pronatalists, is to combat the decline in births.
“I’m really excited for a future within human history where there are some people that have decided to really lean into technologies like this,” Malcolm Collins told NPR in an interview.
His spouse concurs.
“We fundamentally believe in reproductive choice and we also very much support parents’ rights to give their children every privilege they can,” Simone Collins told NPR. “And for some people, that means, obviously, eliminating risks of very dangerous diseases. But for other people that means investing in education and tutoring to make them smarter or athletically better. And if people would like to start to do that at a genetic level they should have every right to do so.”
Room for painstaking science
Many scientists favor carefully exploring the editing of DNA in human sperm, eggs and embryos to learn more about human reproduction and possibly someday prevent diseases. And some U.S. scientists working in this field are glad to see private players helping what they consider underfunded research.
The National Institutes of Health “doesn’t typically support embryo research. So if thetechnology bros are interested, that would be welcome in the field,” said Dr.Paula Amato, a professor of obstetrics and gynecology at the Oregon Health & Science University in Portland. She has beenworking on embryo editingwith her colleagueShoukhrat Mitalipov.
Amato and others stress, however, that whoever is working on this has to first make sure it can be done safely and should focus, at least initially, on preventing disease.
“What I think is positive is: The discussion that will be stimulated through this activity. There is clearly a need for that,” saidDietrich Egli, a Columbia University professor of developmental cell biology. He has raised questions about the safety of CRISPR embryo editing through hisexperiments.
Egli said he’s talked about this withBrian Armstrong, a billionaire cryptocurrency entrepreneur who recentlyannounced interest in startingan embryo-editing company. Armstrong initially agreed to an interview with NPR through a spokeswoman but then indefinitely postponed.
The moment could be ripe for another look at gene-editing embryos that could be taken to term.
“There’s a president who has some advisers and some political forces whispering in his ear that have a decidedly pronatalist bent that are interested in these technologies,” saidL. Glenn Cohen, director of the Harvard Law School’s Center for Health Law Policy, Biotechnology and Bioethics. “All of that is opening up a moment where some of what would have been unthinkable may now become possible.”
There’s also talk about trying this technology in places likeProspera, a city on an island off the coast of Honduras. Prospera has looser regulations for business involved in fields ranging from cryptocurrency to biotechnology.
Bioethicists warn the risks are concerning
The emphasis on charging ahead worries many observers.
“Move fast and break things has not worked very well for Silicon Valley in health care,” saidHank Greely, a Stanford University bioethicist. “When you talk about reproduction, the things you are breaking are babies. So I think that makes it even more dangerous and even more sinister.”
This new push comes as He Jiankui, the CRISPR babies scientist, has shifted from repentant to defiant since being released from prison.
“AI is threatening humanity, we must fight back by gene editing,” he recentlywrote on X.
Tie was briefly married to He, but Tie told NPR they recently divorced. He will have nothing to do with her new company, she said.
“The nature of my relationship with him was personal, not professional and I’m also no longer married to him. He is not involved,” Tie said. “I wish him all the best.”
Nevertheless, all the renewed interest has contributed to anxiety among opponents of gene-edited babies.
“I do think this is a dangerous moment,” saidBen Hurlbut, a bioethicist at Arizona State University who recently helped organize aninternational meetingon inheritable human gene-editing.
“Just because you can do it doesn’t mean you should do it,” he said. “Do we need to tell us ourselves again that we shouldn’t go there?”
Others agree.
“Human heritable gene editing is clearly a terrible solution in search of a problem,” saidTim Hunt, chief executive officer at theAlliance for Regenerative Medicine, which along with theInternational Society for Cell & Gene Therapyand theAmerican Society of Gene & Cell Therapyrecentlycalled for a 10-year moratoriumon inheritable gene-editing. “If you make a mistake, the mistake passes onto all future generations. So that’s a pretty big ethical roll of the dice.”
Many critics argue that this movement is today’s version of eugenics, the long-discredited pursuit of supposedly genetically superior people.
“I think we should be deeply worried about this,” saidFrancoise Baylis, a bioethicist and professor emerita at Dalhousie University in Canada. “This is a continuation of the eugenic project that has been sort of in vogue at different times throughout civilization. This is just the modern incarnation of that idea.”
Others fear turning human reproduction into just another consumer product.
“We’re going to mass-produce genetically engineered human beings. And I think that’s a very dangerous way to approach these technologies,” saidKatie Hasson, the associate director of theCenter for Genetics and Society, a genetics technology watchdog group in Berkeley, Calif. “I’m very worried that all of this together means we’re headed straight into a new era of high-tech, market-based eugenics.”
But the Manhattan Project’s Hysolli argues it would be unethical not to use the technology if it’s safe.
“If we have the tools to prevent a disease that will be passed down for generations, is it more ethical to do it or not do it?” Hysolli said. “I would argue it would be more ethical to stop the mutation.”
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