Why US federal health agencies are abandoning mRNA vaccines

This time five years ago, we were in the throes of the covid-19 pandemic. By August 2020, we’d seen school closures, national lockdowns, and widespread panic. That year, the coronavirus was responsible for around 3 million deaths, according to the World Health Organization.

Then came the vaccines. The first mRNA vaccines for covid were authorized for use in December 2020. By the end of the following month, over 100 million doses had been administered. Billions more have been administered since then. The vaccines worked well and are thought to have saved millions of lives.

The US government played an important role in the introduction of these vaccines, providing $18 billion to support their development as part of Operation Warp Speed.

But now, that government is turning its back on the technology. Funding is being withdrawn. Partnerships are being canceled. Leaders of US health agencies are casting doubt on the vaccines’ effectiveness and safety. And this week, the director of the National Institutes of Health implied that the reversal was due to a lack of public trust in the technology.

Plenty of claims are being thrown about. Let’s consider the evidence.

mRNA is a molecule found in cells that essentially helps DNA make proteins. The vaccines work in a similar way, except they carry genetic instructions for proteins found on the surface of the coronavirus. This can help train our immune systems to tackle the virus itself.

Research into mRNA vaccines has been underway for decades. But things really kicked into gear when the virus behind covid-19 triggered a pandemic in 2020. A huge international effort—along with plenty of funding—fast-tracked research and development.

The genetic code for the Sars-CoV-2 virus was sequenced in January 2020. The first vaccines were being administered by the end of that year. That’s wildly fast by pharma standards—drugs can typically spend around a decade in development.

And they seemed to work really well. Early trials in tens of thousands of volunteers suggested that Pfizer and BioNTech’s vaccine conferred “95% protection against covid-19.” No vaccine is perfect, but for a disease that was responsible for millions of deaths, the figures were impressive.

Still, there were naysayers. Including Robert F. Kennedy Jr., the notorious antivaccine activist who currently leads the US’s health agencies. He has called covid vaccines “unsafe and ineffective.” In 2021, he petitioned the US Food and Drug Administration to revoke the authorization for covid vaccines. That same year, Instagram removed his account from the platform after he repeatedly shared “debunked claims about the coronavirus or vaccines.”

So perhaps we shouldn’t have been surprised when the US Department of Health and Human Services, which RFK Jr. now heads, announced “the beginning of a coordinated wind-down” of mRNA vaccine development earlier this month. HHS is canceling almost $500 million worth of funding for the technology. “The data show these vaccines fail to protect effectively against upper respiratory infections like covid and flu,” Kennedy said in a statement.

Well, as we’ve seen, the mRNA covid vaccines were hugely effective during the pandemic. And researchers are working on other mRNA vaccines for infections including flu. Our current flu vaccines aren’t ideal—they are produced slowly in a process that requires hen’s eggs, based on predictions about which flu strains are likely to be prominent in the winter. They’re not all that protective.

mRNA vaccines, on the other hand, can be made quickly and cheaply, perhaps once we already know which flu strains we need to protect against. And scientists are making progress with universal flu vaccines—drugs that could potentially protect against multiple flu strains.

Kennedy’s other claim is that the vaccines aren’t safe. There have certainly been reports of adverse events. Usually these are mild and short-lived—most people will be familiar with the fatigue and flu-like symptoms that can follow a covid jab. But some are more serious: Some people have developed neurological and cardiovascular conditions. 

These problems are rare, according to an evaluation of adverse outcomes in almost 100 million people who received covid vaccines. Most studies of mRNA vaccines haven’t reported an increase in the risk of Guillain-Barré syndrome, a condition that affects nerves and has been linked to covid vaccines.

Covid vaccines can increase the risk of myocarditis and pericarditis in young men. But the picture isn’t straightforward. Vaccinated individuals appear to have double the risk of myocarditis compared with unvaccinated people. But the overall risk is still low. And it’s still not as high as the risk of myocarditis following a covid infection.

And then there are the claims that mRNA vaccines don’t have the support of the public. That’s what Jay Bhattacharya, director of the NIH, wrote in an opinion piece published in the Washington Post on Wednesday.

“No matter how elegant the science, a platform that lacks credibility among the people it seeks to protect cannot fulfill its public health mission,” Bhattacharya wrote. He blamed the Biden administration, which he wrote “did not manage public trust in the coronavirus vaccines.”

It’s an interesting take from someone who played a pretty significant role in undermining public trust in covid policies, including vaccine mandates. In 2020, Bhattacharya coauthored the Great Barrington Declaration—an open letter making the case against lockdowns. He became a vocal critic of US health agencies, including the NIH, and their handling of the outbreak. Unlike Kennedy, Bhattacharya hasn’t called the vaccines unsafe or ineffective. But he has called vaccine mandates “unethical.”

Curiously, the US government doesn’t seem to be turning away from all vaccine research. Just work on mRNA vaccines. Some of the funding budget originally earmarked for covid vaccines will be redirected to two senior staffers at the NIH who are exploring the use of an old vaccine technology that makes use of inactivated viruses—a move that researchers are describing as “troubling” and “appalling,” according to reporting by Science.

Not all mRNA research is being abandoned, either. Bhattacharya has expressed his support for research into the use of mRNA-based treatments for cancer. Such “vaccine therapeutics” were being explored before covid came along. (Notably, Bhattacharya isn’t referring to them as “vaccines.”)

It is difficult to predict how this will all shake out for mRNA vaccines. We mustn’t forget that this technology helped save millions of lives and shows huge promise for the development of cheap, effective, and potentially universal vaccines. Let’s hope that the recent upsets won’t prevent it from achieving its potential.

This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

How decades-old frozen embryos are changing the shape of families

This week we welcomed a record-breaking baby to the world. Thaddeus Daniel Pierce, who arrived over the weekend, developed from an embryo that was frozen in storage for 30 and a half years. You could call him the world’s oldest baby.

His parents, Lindsey and Tim Pierce, were themselves only young children when that embryo was created, all the way back in 1994. Linda Archerd, who donated the embryo, described the experience as “surreal.”

Stories like this also highlight how reproductive technologies are shaping families. Thaddeus already has a 30-year-old sister and a 10-year-old niece. Lindsey and Tim are his birth parents, but his genes came from two other people who divorced decades ago.

And while baby Thaddeus is a record-breaker, plenty of other babies have been born from embryos that have been frozen for significant spells of time.

Thaddeus has taken the title of “world’s oldest baby” from the previous record-holders: twins Lydia Ann and Timothy Ronald Ridgeway, born in 2022, who developed from embryos that were created 30 years earlier, in 1992. Before that, the title was held by Molly Gibson, who developed from an embryo that was in storage for 27 years.

These remarkable stories suggest there may be no limit to how long embryos can be stored. Even after more than 30 years of being frozen at -196 °C (-321 °F), these tiny cells can be reanimated and develop into healthy babies. (Proponents of cryogenics can only dream of achieving anything like this with grown people.)

These stories also serve as a reminder that thanks to advances in cryopreservation and the ever-increasing popularity of IVF, a growing number of embryos are being stored in tanks. No one knows for sure how many there are, but there are millions of them.

Not all of them will be used in IVF. There are plenty of reasons why someone who created embryos might never use them. Archerd says that while she had always planned to use all four of the embryos she created with her then husband, he didn’t want a bigger family. Some couples create embryos and then separate. Some people “age out” of being able to use their embryos themselves—many clinics refuse to transfer an embryo to people in their late 40s or older.

What then? In most cases, people who have embryos they won’t use can choose to donate them, either to potential parents or for research, or discard them. Donation to other parents tends to be the least popular option. (In some countries, none of those options are available, and unused embryos end up in a strange limbo—you can read more about that here.)

But some people, like Archerd, do donate their embryos. The recipients of those embryos will be the legal parents of the resulting children, but they won’t share a genetic link. The children might not ever meet their genetic “parents.” (Archerd is, however, very keen to meet Thaddeus.)

Some people might have donated their embryos anonymously. But anonymity can never be guaranteed. Nowadays, consumer genetic tests allow anyone to search for family members—even if the people they track down thought they were making an anonymous donation 20 years ago, before these tests even existed.

These kinds of tests have already resulted in surprise revelations that have disrupted families. People who discover that they were conceived using a donated egg or sperm can find multiple long-lost siblings. One man who spoke at a major reproduction conference in 2024 said that since taking a DNA test, he had found he had 50 of them. 

The general advice now is for parents to let their children know how they were conceived relatively early on.

When I shared the story of baby Thaddeus on social media, a couple of people commented that they had concerns for the child. One person mentioned the age gap between Thaddeus and his 30-year-old sister. That person added that being donor conceived “isn’t easy.”

For the record, that is not what researchers find when they evaluate donor-conceived children and their families. Studies find that embryo donation doesn’t affect parents’ attachment to a child or their parenting style. And donor-conceived children tend to be psychosocially well adjusted.

Families come in all shapes and sizes. Reproductive technologies are extending the range of those shapes and sizes.

This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

Exclusive: A record-breaking baby has been born from an embryo that’s over 30 years old

A baby boy born over the weekend holds the new record for the “oldest baby.” Thaddeus Daniel Pierce, who arrived on July 26, developed from an embryo that had been in storage for 30 and a half years.

“We had a rough birth but we are both doing well now,” says Lindsey Pierce, his mother. “He is so chill. We are in awe that we have this precious baby!”

Lindsey and her husband, Tim Pierce, who live in London, Ohio, “adopted” the embryo from a woman who had it created in 1994. She says her family and church family think “it’s like something from a sci-fi movie.” 

“The baby has a 30-year-old sister,” she adds. Tim was a toddler when the embryos were first created.

“It’s been pretty surreal,” says Linda Archerd, 62, who donated the embryo. “It’s hard to even believe.”

Three little hopes

The story starts back in the early 1990s. Archerd had been trying—and failing—to get pregnant for six years. She and her husband decided to try IVF, a fairly new technology at the time. “People were [unfamiliar] with it,” says Archerd. “A lot of people were like, what are you doing?”

They did it anyway, and in May 1994, they managed to create four embryos. One of them was transferred to Linda’s uterus. It resulted in a healthy baby girl. “I was so blessed to have a baby,” Archerd says. The remaining three embryos were cryopreserved and kept in a storage tank.

That was 31 years ago. The healthy baby girl is now a 30-year-old woman who has her own 10-year-old daughter. But the other three embryos remained frozen in time.

Archerd originally planned to use the embryos herself. “I always wanted another baby desperately,” she says. “I called them my three little hopes.” Her then husband felt differently, she says. Archerd went on to divorce him, but she won custody of the embryos and kept them in storage, still hopeful she might use them one day, perhaps with another partner.

That meant paying annual storage fees, which increased over time and ended up costing Archerd around a thousand dollars a year, she says. To her, it was worth it. “I always thought it was the right thing to do,” she says. 

Things changed when she started going through menopause, she says. She considered her options. She didn’t want to discard the embryos or donate them for research. And she didn’t want to donate them to another family anonymously—she wanted to meet the parents and any resulting babies. “It’s my DNA; it came from me … and [it’s] my daughter’s sibling,” she says.

Then she found out about embryo “adoption.” This is a type of embryo donation in which both donors and recipients have a say in whom they “place” their embryos with or “adopt” them from. It is overseen by agencies—usually explicitly religious ones—that believe an embryo is morally equivalent to a born human. Archerd is Christian.

There are several agencies that offer these adoption services in the US, but not all of them accept embryos that have been stored for a very long time. That’s partly because those embryos will have been frozen and stored in unfamiliar, old-fashioned ways, and partly because old embryos are thought to be less likely to survive thawing and transfer to successfully develop into a baby.

“So many places wouldn’t even take my information,” says Archerd. Then she came across the Snowflakes program run by the Nightlight Christian Adoptions agency. The agency was willing to accept her embryos, but it needed Archerd’s medical records from the time the embryos had been created, as well as the embryos’ lab records.

So Archerd called the fertility doctor who had treated her decades before. “I still remembered his phone number by heart,” she says. That doctor, now in his 70s, is still practicing at a clinic in Oregon. He dug Archerd’s records out from his basement, she says. “Some of [them] were handwritten,” she adds. Her embryos entered Nightlight’s “matching pool” in 2022.

Making a match

“Our matching process is really driven by the preferences of the placing family,” says Beth Button, executive director of the Snowflakes program. Archerd’s preference was for a married Caucasian, Christian couple living in the US. “I didn’t want them to go out of the country,” says Archerd. “And being Christian is very important to me, because I am.”

It took a while to find a match. Most of the “adopting parents” signed up for the Snowflakes program were already registered at fertility clinics that wouldn’t have accepted the embryos, says Button. “I would say that over 90% of clinics in the US would not have accepted these embryos,” she says.

Expecting parents Tim and Lindsey Pierce.
Lindsey and Tim Pierce at Rejoice Fertility.
COURTESY LINDSEY PIERCE

Archerd’s embryos were assigned to the agency’s Open Hearts program for embryos that are “hard to place,” along with others that have been in storage for a long time or are otherwise thought to be less likely to result in a healthy birth.

Lindsey and Tim Pierce had also signed up for the Open Hearts program. The couple, aged 35 and 34, respectively, had been trying for a baby for seven years and had seen multiple doctors.

Lindsey was researching child adoption when she came across the Snowflakes program. 

When the couple were considering their criteria for embryos they might receive, they decided that they’d be open to any. “We checkmarked anything and everything,” says Tim. That’s how they ended up being matched with Archerd’s embryos. “We thought it was wild,” says Lindsey. “We didn’t know they froze embryos that long ago.”

Lindsey and Tim had registered with Rejoice Fertility, an IVF clinic in Knoxville, Tennessee, run by John Gordon, a reproductive endocrinologist who prides himself on his efforts to reduce the number of embryos in storage. The huge numbers of embryos left in storage tanks was weighing on his conscience, he says, so around six years ago, he set up Rejoice Fertility with the aim of doing things differently.  

“Now we’re here in the belt buckle of the Bible Belt,” says Gordon, who is Reformed Presbyterian. “I’ve changed my mode of practice.” IVF treatments performed at the clinic are designed to create as few excess embryos as possible. The clinic works with multiple embryo adoption agencies and will accept any embryo, no matter how long it has been in storage.

A portrait of Linda Archerd.

COURTESY LINDA ARCHERD

It was his clinic that treated the parents who previously held the record for the longest-stored embryo—in 2022, Rachel and Philip Ridgeway had twins from embryos created more than 30 years earlier. “They’re such a lovely couple,” says Gordon. When we spoke, he was making plans to meet the family for breakfast. The twins are “growing like weeds,” he says with a laugh.

“We have certain guiding principles, and they’re coming from our faith,” says Gordon, although he adds that he sees patients who hold alternative views. One of those principles is that “every embryo deserves a chance at life and that the only embryo that cannot result in a healthy baby is the embryo not given the opportunity to be transferred into a patient.”

That’s why his team will endeavor to transfer any embryo they receive, no matter the age or conditions. That can be challenging, especially when the embryos have been frozen or stored in unusual or outdated ways. “It’s scary for people who don’t know how to do it,” says Sarah Atkinson, lab supervisor and head embryologist at Rejoice Fertility. “You don’t want to kill someone’s embryos if you don’t know what you’re doing.”

Cumbersome and explosive

In the early days of IVF, embryos earmarked for storage were slow-frozen. This technique involves gradually lowering the temperature of the embryos. But because slow freezing can cause harmful ice crystals to form, clinics switched in the 2000s to a technique called vitrification, in which the embryos are placed in thin plastic tubes called straws and lowered into tanks of liquid nitrogen. This rapidly freezes the embryos and converts them into a glass-like state. 

The embryos can later be thawed by removing them from the tanks and rapidly—within two seconds—plunging them into warm “thaw media,” says Atkinson. Thawing slow-frozen embryos is more complicated. And the exact thawing method required varies, depending on how the embryos were preserved and what they were stored in. Some of the devices need to be opened while they are inside the storage tank, which can involve using forceps, diamond-bladed knives, and other tools in the liquid nitrogen, says Atkinson.

Sarah Atkinson, lab supervisor and head embryologist at Rejoice Fertility, directly injects sperm into two eggs to fertilize them.
COURTESY OF SARAH ATKINSON AT REJOICE FERTILITY.

Recently, she was tasked with retrieving embryos that had been stored inside a glass vial. The vial was made from blown glass and had been heat-sealed with the embryo inside. Atkinson had to use her diamond-bladed knife to snap open the seal inside the nitrogen tank. It was fiddly work, and when the device snapped, a small shard of glass flew out and hit Atkinson’s face. “Hit me on the cheek, cut my cheek, blood running down my face, and I’m like, Oh shit,” she says. Luckily, she had her safety goggles on. And the embryos survived, she adds.

The two embryos that were transferred to Lindsey Pierce.

Atkinson has a folder in her office with notes she’s collected on various devices over the years. She flicks through it over a video call and points to the notes she made about the glass vial. “Might explode; wear face shield and eye protection,” she reads. A few pages later, she points to another embryo-storage device. “You have to thaw this one in your fingers,” she tells me. “I don’t like it.”

The record-breaking embryos had been slow-frozen and stored in a plastic vial, says Atkinson. Thawing them was a cumbersome process. But all three embryos survived it.

The Pierces had to travel from their home in Ohio to the clinic in Tennessee five times over a two-week period. “It was like a five-hour drive,” says Lindsey. One of the three embryos stopped growing. The other two were transferred to Lindsey’s uterus on November 14, she says. And one developed into a fetus.

Now that the baby has arrived, Archerd is keen to meet him. “The first thing that I noticed when Lindsey sent me his pictures is how much he looks like my daughter when she was a baby,” she says. “I pulled out my baby book and compared them side by side, and there is no doubt that they are siblings.”

She doesn’t yet have plans to meet the baby, but doing so would be “a dream come true,” she says. “I wish that they didn’t live so far away from me … He is perfect!”

“We didn’t go into it thinking we would break any records,” says Lindsey. “We just wanted to have a baby.”

The deadly saga of the controversial gene therapy Elevidys

It has been a grim few months for the Duchenne muscular dystrophy (DMD) community. There had been some excitement when, a couple of years ago, a gene therapy for the disorder was approved by the US Food and Drug Administration for the first time. That drug, Elevidys, has now been implicated in the deaths of two teenage boys.

The drug’s approval was always controversial—there was a lack of evidence that it actually worked, for starters. But the agency that once rubber-stamped the drug has now turned on its manufacturer, Sarepta Therapeutics. In a remarkable chain of events, the FDA asked the company to stop shipping the drug on July 18. Sarepta refused to comply.

In the days since, the company has acquiesced. But its reputation has already been hit. And the events have dealt a devastating blow to people desperate for treatments that might help them, their children, or other family members with DMD.

DMD is a rare genetic disorder that causes muscles to degenerate over time. It’s caused by a mutation in a gene that codes for a protein called dystrophin. That protein is essential for muscles—without it, muscles weaken and waste away. The disease mostly affects boys, and symptoms usually start in early childhood.

At first, affected children usually start to find it hard to jump or climb stairs. But as the disease progresses, other movements become difficult too. Eventually, the condition might affect the heart and lungs. The life expectancy of a person with DMD has recently improved, but it is still only around 30 or 40 years. There is no cure. It’s a devastating diagnosis.

Elevidys was designed to replace missing dystrophin with a shortened, engineered version of the protein. In June 2023, the FDA approved the therapy for eligible four- and five-year-olds. It came with a $3.2 million price tag.

The approval was celebrated by people affected by DMD, says Debra Miller, founder of CureDuchenne, an organization that funds research into the condition and offers support to those affected by it. “We’ve not had much in the way of meaningful therapies,” she says. “The excitement was great.”

But the approval was controversial. It came under an “accelerated approval” program that essentially lowers the bar of evidence for drugs designed to treat “serious or life-threatening diseases where there is an unmet medical need.”

Elevidys was approved because it appeared to increase levels of the engineered protein in patients’ muscles. But it had not been shown to improve patient outcomes: It had failed a randomized clinical trial.

The FDA approval was granted on the condition that Sarepta complete another clinical trial. The topline results of that trial were described in October 2023 and were published in detail a year later. Again, the drug failed to meet its “primary endpoint”—in other words, it didn’t work as well as hoped.

In June 2024, the FDA expanded the approval of Elevidys. It granted traditional approval for the drug to treat people with DMD who are over the age of four and can walk independently, and another accelerated approval for those who can’t.

Some experts were appalled at the FDA’s decision—even some within the FDA disagreed with it. But things weren’t so simple for people living with DMD. I spoke to some parents of such children a couple of years ago. They pointed out that drug approvals can help bring interest and investment to DMD research. And, above all, they were desperate for any drug that might help their children. They were desperate for hope.

Unfortunately, the treatment does not appear to be delivering on that hope. There have always been questions over whether it works. But now there are serious questions over how safe it is. 

In March 2025, a 16-year-old boy died after being treated with Elevidys. He had developed acute liver failure (ALF) after having the treatment, Sarepta said in a statement. On June 15, the company announced a second death—a 15-year-old who also developed ALF following Elevidys treatment. The company said it would pause shipments of the drug, but only for patients who are not able to walk.

The following day, Sarepta held an online presentation in which CEO Doug Ingram said that the company was exploring ways to make the treatment safer, perhaps by treating recipients with another drug that dampens their immune systems. But that same day, the company announced that it was laying off 500 employees—36% of its workforce. Sarepta did not respond to a request for comment.

On June 24, the FDA announced that it was investigating the risks of serious outcomes “including hospitalization and death” associated with Elevidys, and “evaluating the need for further regulatory action.”

There was more tragic news on July 18, when there were reports that a third patient had died following a Sarepta treatment. This patient, a 51-year-old, hadn’t been taking Elevidys but was enrolled in a clinical trial for a different Sarepta gene therapy designed to treat limb-girdle muscular dystrophy. The same day, the FDA asked Sarepta to voluntarily pause all shipments of Elevidys. Sarepta refused to do so.

The refusal was surprising, says Michael Kelly, chief scientific officer at CureDuchenne: “It was an unusual step to take.”

After significant media coverage, including reporting that the FDA was “deeply troubled” by the decision and would use its “full regulatory authority,” Sarepta backed down a few days later. On July 21, the company announced its decision to “voluntarily and temporarily” pause all shipments of Elevidys in the US.

Sarepta says it will now work with the FDA to address safety and labeling concerns. But in the meantime, the saga has left the DMD community grappling with “a mix of disappointment and concern,” says Kelly. Many are worried about the risks of taking the treatment. Others are devastated that they are no longer able to access it.

Miller says she knows of families who have been working with their insurance providers to get authorization for the drug. “It’s like the rug has been pulled out from under them,” she says. Many families have no other treatment options. “And we know what happens when you do nothing with Duchenne,” she says. Others, particularly those with teenage children with DMD, are deciding against trying the drug, she adds.

The decision over whether to take Elevidys was already a personal one based on several factors, he says. People with DMD and their families deserve clear and transparent information about the treatment in order to make that decision.

The FDA’s decision to approve Elevidys was made on limited data, says Kelly. But as things stand today, over 900 people have been treated with Elevidys. “That gives the FDA… an opportunity to look at real data and make informed decisions,” he says.

“Families facing Duchenne do not have time to waste,” Kelly says. “They must navigate a landscape where hope is tempered by the realities of medical complexity.”

A version of this article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

A brief history of “three-parent babies”

This week we heard that eight babies have been born in the UK following an experimental form of IVF that involves DNA from three people. The approach was used to prevent women with genetic mutations from passing mitochondrial diseases to their children. You can read all about the results, and the reception to them, here

But these eight babies aren’t the first “three-parent” children out there. Over the last decade, several teams have been using variations of this approach to help people have babies. This week, let’s consider the other babies born from three-person IVF.

I can’t go any further without talking about the term we use to describe these children. Journalists, myself included, have called them “three-parent babies” because they are created using DNA from three people. Briefly, the approach typically involves using the DNA from the nuclei of the intended parents’ egg and sperm cells. That’s where most of the DNA in a cell is found.

But it also makes use of mitochondrial DNA (mtDNA)—the DNA found in the energy-producing organelles of a cell—from a third person. The idea is to avoid using the mtDNA from the intended mother, perhaps because it is carrying genetic mutations. Other teams have done this in the hope of treating infertility.

mtDNA, which is usually inherited from a person’s mother, makes up a tiny fraction of total inherited DNA. It includes only 37 genes, all of which are thought to play a role in how mitochondria work (as opposed to, say, eye color or height).

That’s why some scientists despise the term “three-parent baby.” Yes, the baby has DNA from three people, but those three can’t all be considered parents, critics argue. For the sake of argument, this time around I’ll use the term “three-person IVF” from here on out.

So, about these babies. The first were reported back in the 1990s. Jacques Cohen, then at Saint Barnabas Medical Center in Livingston, New Jersey, and his colleagues thought they might be able to treat some cases of infertility by injecting the mitochondria-containing cytoplasm of healthy eggs into eggs from the intended mother. Seventeen babies were ultimately born this way, according to the team. (Side note: In their paper, the authors describe potential resulting children as “three-parental individuals.”)

But two fetuses appeared to have genetic abnormalities. And one of the children started to show signs of a developmental disorder. In 2002, the US Food and Drug Administration put a stop to the research.

The babies born during that study are in their 20s now. But scientists still don’t know why they saw those abnormalities. Some think that mixing mtDNA from two people might be problematic.

Newer approaches to three-person IVF aim to include mtDNA from just the donor, completely bypassing the intended mother’s mtDNA. John Zhang at the New Hope Fertility Center in New York City tried this approach for a Jordanian couple in 2016. The woman carried genes for a fatal mitochondrial disease and had already lost two children to it. She wanted to avoid passing it on to another child.

Zhang took the nucleus of the woman’s egg and inserted it into a donor egg that had had its own nucleus removed—but still had its mitochondria-containing cytoplasm. That egg was then fertilized with the woman’s husband’s sperm.

Because it was still illegal in the US, Zhang controversially did the procedure in Mexico, where, as he told me at the time, “there are no rules.” The couple eventually welcomed a healthy baby boy. Less than 1% of the boy’s mitochondria carried his mother’s mutation, so the procedure was deemed a success.

There was a fair bit of outrage from the scientific community, though. Mitochondrial donation had been made legal in the UK the previous year, but no clinic had yet been given a license to do it. Zhang’s experiment seemed to have been conducted with no oversight. Many questioned how ethical it was, although Sian Harding, who reviewed the ethics of the UK procedure, then told me it was “as good as or better than what we’ll do in the UK.”

The scandal had barely died down by the time the next “three-person IVF” babies were announced. In 2017, a team at the Nadiya Clinic in Ukraine announced the birth of a little girl to parents who’d had the treatment for infertility. The news brought more outrage from some quarters, as scientists argued that the experimental procedure should only be used to prevent severe mitochondrial diseases.

It wasn’t until later that year that the UK’s fertility authority granted a team in Newcastle a license to perform mitochondrial donation. That team launched a trial in 2017. It was big news—the first “official” trial to test whether the approach could safely prevent mitochondrial disease.

But it was slow going. And meanwhile, other teams were making progress. The Nadiya Clinic continued to trial the procedure in couples with infertility. Pavlo Mazur, a former embryologist who worked at that clinic, tells me that 10 babies were born there as a result of mitochondrial donation.

Mazur then moved to another clinic in Ukraine, where he says he used a different type of mitochondrial donation to achieve another five healthy births for people with infertility. “In total, it’s 15 kids made by me,” he says.

But he adds that other clinics in Ukraine are also using mitochondrial donation, without sharing their results. “We don’t know the actual number of those kids in Ukraine,” says Mazur. “But there are dozens of them.”

In 2020, Nuno Costa-Borges of Embryotools in Barcelona, Spain, and his colleagues described another trial of mitochondrial donation. This trial, performed in Greece, was also designed to test the procedure for people with infertility. It involved 25 patients. So far, seven children have been born. “I think it’s a bit strange that they aren’t getting more credit,” says Heidi Mertes, a medical ethicist at Ghent University in Belgium.

The newly announced UK births are only the latest “three-person IVF” babies. And while their births are being heralded as a success story for mitochondrial donation, the story isn’t quite so simple. Three of the eight babies were born with a non-insignificant proportion of mutated mitochondria, ranging between 5% and 20%, depending on the baby and the sample.

Dagan Wells of the University of Oxford, who is involved in the Greece trial, says that two of the seven babies in their study also appear to have inherited mtDNA from their intended mothers. Mazur says he has seen several cases of this “reversal” too.

This isn’t a problem for babies whose mothers don’t carry genes for mitochondrial disease. But it might be for those whose mothers do.

I don’t want to pour cold water over the new UK results. It was great to finally see the results of a trial that’s been running for eight years. And the births of healthy babies are something to celebrate. But it’s not a simple success story. Mitochondrial donation doesn’t guarantee a healthy baby. We still have more to learn, not only from these babies, but from the others that have already been born.

This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

Researchers announce babies born from a trial of three-person IVF

Eight babies have been born in the UK thanks to a technology that uses DNA from three people: the two biological parents plus a third person who supplies healthy mitochondrial DNA. The babies were born to mothers who carry genes for mitochondrial diseases and risked passing on severe disorders. The eight babies are healthy, say the researchers behind the trial.

“Mitochondrial disease can have a devastating impact on families,” Doug Turnbull of Newcastle University, one of the researchers behind the study, said in a statement. “Today’s news offers fresh hope to many more women at risk of passing on this condition, who now have the chance to have children growing up without this terrible disease.”

The study, which makes use of a technology called mitochondrial donation, has been described as a “tour de force” and “a remarkable accomplishment” by others in the field. In the team’s approach, patients’ eggs are fertilized with sperm, and the DNA-containing nuclei of those cells are transferred into donated fertilized eggs that have had their own nuclei removed. The new embryos contain the DNA of the intended parents along with a tiny fraction of mitochondrial DNA from the donor, floating in the embryos’ cytoplasm. 

“The concept of [mitochondrial donation] has attracted much commentary and occasionally concern and anxiety,” Stuart Lavery, a consultant in reproductive medicine at University College Hospitals NHS Foundation Trust, said in a statement. “The Newcastle team have demonstrated that it can be used in a clinically effective and ethically acceptable way to prevent disease and suffering.”

Not everyone sees the trial as a resounding success. While five of the children were born “with no health problems,” one developed a fever and a urinary tract infection, and another had muscle jerks. A third was treated for an abnormal heart rhythm. Three of the babies were born with a low level of the very mitochondrial-DNA mutations the treatment was designed to prevent.

Heidi Mertes, a medical ethicist at Ghent University, says she is “moderately optimistic.” “I’m happy that it worked,” she says. “But at the same time, it’s concerning … it’s a call for caution and treading carefully.”

Pavlo Mazur, a former embryologist who has used a similar approach in the conception of 15 babies in Ukraine, believes that trials like this one should be paused until researchers figure out what’s going on. Others believe that researchers should study the technique in people who don’t have mitochondrial mutations, to lower the risk of passing any disease-causing mutations to children.

Long time coming

The news of the births has been long awaited by researchers in the field. Mitochondrial donation was first made legal in the UK in 2015. Two years later, the Human Fertility and Embryology Authority (HFEA), which regulates fertility treatment and research in the UK, granted a fertility clinic in Newcastle the sole license to perform the procedure. Newcastle Fertility Centre at Life launched a trial of mitochondrial donation in 2017 with the aim of treating 25 women a year.

That was eight years ago. Since then, the Newcastle team have been extremely tight-lipped about the trial. That’s despite the fact that other teams elsewhere have used mitochondrial donation to help people achieve pregnancy. A New York–based doctor used a type of mitochondrial donation to help a Jordanian couple conceive in Mexico in 2016. Mitochondrial donation has also been trialed by teams in Ukraine and Greece.

But as the only trial overseen by the HFEA, the Newcastle team’s study was viewed by many as the most “official.” Researchers have been itching to hear how the work has been going, given the potential implications for researchers elsewhere (mitochondrial donation was officially made legal in Australia in 2022). “I’m very glad to see [the results] come out at last,” says Dagan Wells, a reproductive biologist at the University of Oxford who worked on the Greece trial. “It would have been nice to have some information out along the way.”

At the Newcastle clinic, each patient must receive approval from the HFEA to be eligible for mitochondrial donation. Since the trial launched in 2017, 39 patients have won this approval. Twenty-five of them underwent hormonal stimulation to release multiple eggs that could be frozen in storage.

Nineteen of those women went on to have mitochondrial donation. So far, seven of the women have given birth (one had twins), and an eighth is still pregnant. The oldest baby is two years old. The results were published today in the New England Journal of Medicine.

“As parents, all we ever wanted was to give our child a healthy start in life,” one of the mothers, who is remaining anonymous, said in a statement. “Mitochondrial donation IVF made that possible. After years of uncertainty this treatment gave us hope—and then it gave us our baby … Science gave us a chance.”

When each baby was born, the team collected a blood and urine sample to look at the child’s mitochondrial DNA. They found that the levels of mutated DNA were far lower than they would have expected without mitochondrial donation. Three of the mothers were “homoplasmic”—100% of their mitochondrial DNA carried the mutation. But blood tests showed that in the women’s four babies (including the twins), 5% or less of the mitochondrial DNA had the mutation, suggesting they won’t develop disease.

A mixed result

The researchers see this as a positive result. “Children who would otherwise have inherited very high levels are now inheriting levels that are reduced by 77% to 100%,” coauthor Mary Herbert, a professor of reproductive biology at Newcastle University and Monash University, told me during a press briefing.

But three of the eight babies had health symptoms. At seven months, one was diagnosed with a rare form of epilepsy, which seemed to resolve within the following three months. Another baby developed a urinary tract infection.

A third baby developed “prolonged” jaundice, high levels of fat in the blood, and a disturbed heart rhythm that required treatment. The baby seemed to have recovered by 18 months, and doctors believe that the symptoms were not related to the mitochondrial mutations, but the team members admit that they can’t be sure. Given the small sample size, it’s hard to make comparisons with babies conceived in other ways. 

And they acknowledge that a phenomenon called “reversal” is happening in some of the babies. In theory, the children shouldn’t inherit any “bad” mitochondrial DNA from their mothers. But three of them did. The levels of “bad” mitochondrial DNA in the babies’ blood ranged between 5% and 16%. And they were higher in the babies’ urine—the highest figure being 20%.

The researchers don’t know why this is happening. When an embryologist pulls out the nucleus of a fertilized egg, a bit of mitochondria-containing cytoplasm will inevitably be dragged along with it. But the team didn’t see any link between the amount of carried-over cytoplasm and the level of “bad” mitochondria. “We continue to investigate this issue,” Herbert said.

“As long as they don’t understand what’s happening, I would still be worried,” says Mertes.

Such low levels aren’t likely to cause mitochondrial diseases, according to experts contacted by MIT Technology Review. But some are concerned that the percentage of mutated DNA could be higher in different tissues, such as the brain or muscle, or that the levels might change with age. “You never know which tissues [reversal] will show up in,” says Mazur, who has seen the phenomenon in babies born through mitochondrial donation to parents who didn’t have mitochondrial mutations. “It’s chaotic.”

The Newcastle team says it hasn’t looked at other tissues, because it designed the study to be noninvasive.

There has been at least one case in which similar levels of “bad” mitochondria have caused symptoms, says Joanna Poulton, a mitochondrial geneticist at the University of Oxford. She thinks it’s unlikely that the children in the trial will develop any symptoms but adds that “it’s a bit of a worry.”

The age of reversal

No one knows exactly when this reversal happens. But Wells and his colleagues have some idea. In their study in Greece, they looked at the mitochondrial DNA of embryos and checked them again during pregnancy and after birth. The trial was designed to study the impact of mitochondrial donation for infertility—none of the parents involved had genes for mitochondrial disease.

The team has seen mitochondrial reversal in two of the seven babies born in the trial, says Wells. If you put the two sets of results together, mitochondrial donation “seems to have this possibility of reversal occurring in maybe about a third of children,” he says.

In his study, the reversal seemed to occur early on in the embryos’ development, Wells says. Five-day-old embryos “look perfect,” but mitochondrial mutations start showing up in tests taken at around 15 weeks of pregnancy, he says. After that point, the levels appear to be relatively stable. The Newcastle researchers say they will monitor the children until they are five years old.

People enrolling in future trials might opt for amniocentesis, which involves sampling blood from the fetus’s amniotic sac at around 15 to 18 weeks, suggests Mertes. That test might reveal the likely level of mitochondrial mutations in the resulting child. “Then the parents could decide what to do,” says Mertes. “If you could see there was a 90% mutation load [for a] very serious mitochondrial disease, they would still have an option to cancel the pregnancy,” she says.

Wells thinks the Newcastle team’s results are “generally reassuring.” He doesn’t think the trials should be paused. But he wants people to understand that mitochondrial donation is not without risk. “This can only be viewed as a risk reduction strategy, and not a guarantee of having an unaffected child,” he says.

And, as Mertes points out, there’s another option for women who carry mitochondrial DNA mutations: egg donation. Donor eggs fertilized with a partner’s sperm and transferred to a woman’s uterus won’t have her disease-causing mitochondria. 

That option won’t appeal to people who feel strongly about having a genetic link to their children. But Poulton asks: “If you know whose uterus you came out of, does it matter that the [egg] came from somewhere else?”

The first babies have been born following “simplified” IVF in a mobile lab

This week I’m sending congratulations to two sets of parents in South Africa. Babies Milayah and Rossouw arrived a few weeks ago. All babies are special, but these two set a new precedent. They’re the first to be born following “simplified” IVF performed in a mobile lab.

This new mobile lab is essentially a trailer crammed with everything an embryologist needs to perform IVF on a shoestring. It was designed to deliver reproductive treatments to people who live in rural parts of low-income countries, where IVF can be prohibitively expensive or even nonexistent. And it seems to work!

While IVF is increasingly commonplace in wealthy countries—around 12% of all births in Spain result from such procedures—it remains expensive and isn’t always covered by insurance or national health providers. And it’s even less accessible in low-income countries—especially for people who live in rural areas.

People often assume that countries with high birth rates don’t need access to fertility treatments, says Gerhard Boshoff, an embryologist at the University of Pretoria in South Africa. Sub-Saharan African countries like Niger, Angola, and Benin all have birth rates above 40 per 1,000 people, which is over four times the rates in Italy and Japan, for example.

But that doesn’t mean people in Sub-Saharan Africa don’t need IVF. Globally, around one in six adults experience infertility at some point in their lives, according to the World Health Organization. Research by the organization suggests that infertility rates are similar in high-income and low-income countries. As the WHO’s director general Tedros Adhanom Ghebreyesus puts it: “Infertility does not discriminate.”

For many people in rural areas of low-income countries, IVF clinics simply don’t exist. South Africa is considered a “reproductive hub” of the African continent, but even in that country there are fewer than 30 clinics for a population of over 60 million. A recent study found there were no such clinics in Angola or Malawi.  

Willem Ombelet, a retired gynecologist, first noticed these disparities back in the 1980s, while he was working at an IVF lab in Pretoria. “I witnessed that infertility was [more prevalent] in the black population than the white population—but they couldn’t access IVF because of apartheid,” he says. The experience spurred him to find ways to make IVF accessible for everyone. In the 1990s, he launched The Walking Egg—a science and art project with that goal.

In 2008, Ombelet met Jonathan Van Blerkom, a reproductive biologist and embryologist who had already been experimenting with a simplified version of IVF. Typically, embryos are cultured in an incubator that provides a sterile mix of gases. Van Blerkom’s approach was to preload tubes with the required gases and seal them with a rubber stopper. “We don’t need a fancy lab,” says Ombelet.

a sleeping infant in a hat and fuzzy sweater
Milayah was born on June 18.
COURTESY OF THE WALKING EGG

Eggs and sperm can be injected into the tubes through the stoppers, and the resulting embryos can be grown inside. All you really need is a good microscope and a way to keep the tube warm, says Ombelet. Once the embryos are around five days old, they can be transferred to a person’s uterus or frozen. “The cost is one tenth or one twentieth of a normal lab,” says Ombelet.

Ombelet, Van Blerkom, and their colleagues found that this approach appeared to work as well as regular IVF. The team ran their first pilot trial at a clinic in Belgium in 2012. The first babies conceived with the simplified IVF process were born later that year.

More recently, Boshoff wondered if the team could take the show on the road. Making IVF simpler and cheaper is one thing, but getting it to people who don’t have access to IVF care is another. What if the team could pack the simplified IVF lab into a trailer and drive it around rural South Africa?

“We just needed to figure out how to have everything in a very confined space,” says Boshoff. As part of the Walking Egg project, he and his colleagues found a way to organize the lab equipment and squeeze in air filters. He then designed a “fold-out system” that allowed the team to create a second room when the trailer was parked. This provides some privacy for people who are having embryos transferred, he says.

People who want to use the mobile IVF lab will first have to undergo treatment at a local medical facility, where they will take drugs that stimulate their ovaries to release eggs, and then have those eggs collected. The rest of the process can be done in the mobile lab, says Boshoff, who presented his work at the European Society of Human Reproduction and Embryology’s annual meeting in Paris earlier this month.

The first trial started last year. The team partnered with one of the few existing fertility clinics in rural South Africa, which put them in touch with 10 willing volunteers. Five of the 10 women got pregnant following their simplified IVF in the mobile lab. One miscarried, but four pregnancies continued. On June 18, baby Milayah arrived. Two days later, another mother welcomed baby Rossouw. The other babies could come any day now.

“We’ve proven that a very cheap and easy [IVF] method can be used even in a mobile unit and have comparable results to regular IVF,” says Ombelet, who says his team is planning similar trials in Egypt and Indonesia. “The next step is to roll it out all over the world.”

This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

Meet Jim O’Neill, the longevity enthusiast who is now RFK Jr.’s right-hand man

When Jim O’Neill was nominated to be the second in command at the US Department of Health and Human Services, Dylan Livingston was excited. As founder and CEO of the lobbying group Alliance for Longevity Initiatives (A4LI), Livingston is a member of a community that seeks to extend human lifespan. O’Neill is “kind of one of us,” he told me shortly before O’Neill was sworn in as deputy secretary on June 9. “And now [he’s] in a position of great influence.”

As Robert F. Kennedy Jr.’s new right-hand man, O’Neill is expected to wield authority at health agencies that fund biomedical research and oversee the regulation of new drugs. And while O’Neill doesn’t subscribe to Kennedy’s most contentious beliefs—and supports existing vaccine schedules—he may still steer the agencies in controversial new directions. 

Although much less of a public figure than his new boss, O’Neill is quite well-known in the increasingly well-funded and tight-knit longevity community. His acquaintances include the prominent longevity influencer Bryan Johnson, who describes him as “a soft-spoken, thoughtful, methodical guy,” and the billionaire tech entrepreneur Peter Thiel. 

In speaking with more than 20 people who work in the longevity field and are familiar with O’Neill, it’s clear that they share a genuine optimism about his leadership. And while no one can predict exactly what O’Neill will do, many in the community believe that he could help bring attention and resources to their cause and make it easier for them to experiment with potential anti-aging drugs. 

This idea is bolstered not just by his personal and professional relationships but also by his past statements and history working at aging-focused organizations—all of which suggest he indeed believes scientists should be working on ways to extend human lifespan beyond its current limits and thinks unproven therapies should be easier to access. He has also supported the libertarian idea of creating new geographic zones, possibly at sea, in which residents can live by their own rules (including, notably, permissive regulatory regimes for new drugs and therapies). 

“In [the last three administrations] there weren’t really people like that from our field taking these positions of power,” says Livingston, adding that O’Neill’s elevation is “definitely something to be excited about.”

Not everyone working in health is as enthusiastic. If O’Neill still holds the views he has espoused over the years, that’s “worrisome,” says Diana Zuckerman, a health policy analyst and president of the National Center for Health Research, a nonprofit think tank in Washington, DC. 

“There’s nothing worse than getting a bunch of [early-stage unproven therapies] on the market,” she says. Those products might be dangerous and could make people sick while enriching those who develop or sell them. 

“Getting things on the market quickly means that everybody becomes a guinea pig,” Zuckerman says. “That’s not the way those of us who care about health care think.” 

The consumer advocacy group Public Citizen puts it far more bluntly, describing O’Neill as “one of Trump’s worst picks” and saying that he is “unfit to be the #2 US health-care leader.” His libertarian views are “antithetical to basic public health,” the organization’s co-president said in a statement. Neither O’Neill nor HHS responded to requests for comment. 

“One of us”

As deputy secretary of HHS, O’Neill will oversee a number of agencies, including the National Institutes of Health, the world’s biggest funder of biomedical research; the Centers for Disease Control and Prevention, the country’s public health agency; and the Food and Drug Administration, which was created to ensure that drugs and medical devices are safe and effective. 

“It can be a quite powerful position,” says Patricia Zettler, a legal scholar at Ohio State University who specializes in drug regulation and the FDA.

It is the most senior role O’Neill has held at HHS, though it’s not the first. He occupied various positions in the department over five years during the early 2000s, according to his LinkedIn profile. But it is what he did after that has helped him cultivate a reputation as an ally for longevity enthusiasts. 

O’Neill appears to have had a close relationship with Thiel since at least the late 2000s. Thiel has heavily invested in longevity research and has said he does not believe that death is inevitable. In 2011 O’Neill referred to Thiel as his “friend and patron.” (A representative for Thiel did not respond to a request for comment.) 

O’Neill also served as CEO of the Thiel Foundation between 2009 and 2012 and cofounded the Thiel Fellowship, which offers $200,000 to promising young people if they drop out of college and do other work. And he spent seven years as managing director of Mithril Capital Management, a “family of long-term venture capital funds” founded by Thiel, according to O’Neill’s LinkedIn profile. 

O’Neill got further stitched into the longevity field when he spent more than a decade representing Thiel’s interests as a board member of the SENS Research Foundation (SRF), an organization dedicated to finding treatments for aging, to which Thiel was a significant donor. 

O’Neill even spent a couple of years as CEO of SRF, from 2019 to 2021, when its founder Aubrey de Grey, a prominent figure in the longevity field, was removed following accusations of sexual harassment. As CEO, O’Neill oversaw a student education program and multiple scientific research projects that focused on various aspects of aging, according to the organization’s annual reports. And in a 2020 SRF annual report, O’Neill wrote that Eric Hargan, then the deputy secretary of HHS, had attended an SRF conference to discuss “regulatory reform.” 

“More and more influential people consider aging an absurdity,” he wrote in the report. “Now we need to make it one.” 

While de Grey calls him “the devil incarnate”—probably because he believes O’Neill “incited” two women to make sexual harassment allegations against him—the many other scientists, biotech CEOs, and other figures in the longevity field contacted by MIT Technology Review had more positive opinions of O’Neill, with many claiming they were longtime friends or acquaintances of the new deputy secretary (though, at the same time, many were reluctant to share specific views about his past work). 

Longevity science is a field that’s long courted controversy, owing largely to far-fetched promises of immortality and the ongoing marketing of creams, pills, intravenous infusions, and other so-called anti-aging treatments that are not supported by evidence. But the community includes people along a spectrum of beliefs (with the goals of adding a few years of healthy lifespan to the population at one end and immortality at the other), and serious doctors and scientists are working to bring legitimacy to the field

Pretty much everyone in the field that I spoke with appears to be hopeful about what O’Neill will do now that he’s been confirmed. Namely, they hope he will use his new position to direct attention and funds to legitimate longevity research and the development of new drugs that might slow or reverse human aging. 

Johnson, whose extreme and expensive approaches to extending his own lifespan have made him something of a celebrity, calls O’Neill a friend and says they’ve “known each other for a little over 15 years.” He says he can imagine O’Neill setting a goal to extend the lifespans of Americans.

Eric Verdin, president of the Buck Institute for Research on Aging in Novato, California, says O’Neill has “been at the Buck several times” and calls him “a good guy”—someone who is “serious” and who understands the science of aging. He says, “He’s certainly someone who is going to help us to really bring the longevity field to the front of the priorities of this administration.”

Celine Halioua, CEO of the biotech company Loyal, which is developing drugs to extend the lifespan of dogs, echoes these sentiments, saying she has “always liked and respected” O’Neill. “It’ll definitely be nice to have somebody who’s bought into the thesis [of longevity science] at the FDA,” she says. 

And Joe Betts-LaCroix, CEO of the longevity biotech company Retro Biosciences, says he’s known O’Neill for something like 10 years and describes him as “smart and clear thinking.” “We’ve mutually been part of poetry readings,” he says. “He’s been definitely interested in wanting us as a society to make progress on age-related disease.”

After his confirmation, the A4LI LinkedIn account posted a photo of Livingston, its CEO, with O’Neill, writing that “we look forward to working with him to elevate aging research as a national priority and to modernize regulatory pathways that support the development of longevity medicines.”

“His work at SENS Research Foundation [suggests] to me and to others that [longevity] is going to be something that he prioritizes,” Livingston says. “I think he’s a supporter of this field, and that’s really all that matters right now to us.”

Changing the rules

While plenty of treatments have been shown to slow aging in lab animals, none of them have been found to successfully slow or reverse human aging. And many longevity enthusiasts believe drug regulations are to blame. 

O’Neill is one of them. He has long supported deregulation of new drugs and medical devices. During his first tour at HHS, for instance, he pushed back against regulations on the use of algorithms in medical devices. “FDA had to argue that an algorithm … is a medical device,” he said in a 2014 presentation at a meeting on “rejuvenation biotechnology.” “I managed to put a stop to that, at least while I was there.”

During the same presentation, O’Neill advocated lowering the bar for drug approvals in the US. “We should reform [the] FDA so that it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” he said. “Let’s prove efficacy after they’ve been legalized.”

This sentiment appears to be shared by Robert F. Kennedy Jr. In a recent podcast interview with Gary Brecka, who describes himself as a “longevity expert,” Kennedy said that he wanted to expand access to experimental therapies. “If you want to take an experimental drug … you ought to be able to do that,” he said in the episode, which was published online in May.

But the idea is divisive. O’Neill was essentially suggesting that drugs be made available after the very first stage of clinical testing, which is designed to test whether a new treatment is safe. These tests are typically small and don’t reveal whether the drug actually works.

That’s an idea that concerns ethicists. “It’s just absurd to think that the regulatory agency that’s responsible for making sure that products are safe and effective before they’re made available to patients couldn’t protect patients from charlatans,” says Holly Fernandez Lynch, a professor of medical ethics and health policy at the University of Pennsylvania who is currently on sabbatical. “It’s just like a complete dereliction of duty.”

Robert Steinbrook, director of the health research group at Public Citizen, largely agrees that this kind of change to the drug approval process is a bad idea, though notes that he and his colleagues are generally more concerned about O’Neill’s views on the regulation of technologies like AI in health care, given his previous efforts on algorithms. 

“He has deregulatory views and would not be an advocate for an appropriate amount of regulation when regulation was needed,” Steinbrook says.

Ultimately, though, even if O’Neill does try to change things, Zettler points out that there is currently no lawful way for the FDA to approve drugs that aren’t shown to be effective. That requirement won’t change unless Congress acts on the matter, she says: “It remains to be seen how big of a role HHS leadership will have in FDA policy on that front.” 

A longevity state

A major goal for a subset of longevity enthusiasts relates to another controversial idea: creating new geographic zones in which people can live by their own rules. The goal has taken various forms, including “network states” (which could start out as online social networks and evolve into territories that make use of cryptocurrency), “special economic zones,” and more recently “freedom cities.” 

While specific details vary, the fundamental concept is creating a new society, beyond the limits of nations and governments, as a place to experiment with new approaches to rules and regulations. 

In 2023, for instance, a group of longevity enthusiasts met at a temporary “pop-up city” in Montenegro to discuss plans to establish a “longevity state”—a geographic zone with a focus on extending human lifespan. Such a zone might encourage healthy behaviors and longevity research, as well as a fast-tracked system to approve promising-looking longevity drugs. They considered Rhode Island as the site but later changed their minds.

Some of those same longevity enthusiasts have set up shop in Próspera, Honduras—a “special economic zone” on the island of Roatán with a libertarian approach to governance, where residents are able to make their own suggestions for medical regulations. Another pop-up city, Vitalia, was set up there for two months in 2024, complete with its own biohacking lab; it also happened to be in close proximity to an established clinic selling an unproven longevity “gene therapy” for around $20,000. The people behind Vitalia referred to it as “a Los Alamos for longevity.” Another new project, Infinita City, is now underway in the former Vitalia location.

O’Neill has voiced support for this broad concept, too. He’s posted on X about his support for limiting the role of government, writing “Get government out of the way” and, in reference to bills to shrink what some politicians see as government overreach, “No reason to wait.” And more to the point, he wrote on X last November, “Build freedom cities,” reposting another message that said: “I love the idea and think we should put the first one on the former Alameda Naval Air Station on the San Francisco Bay.” 

And up until March of last year, according to his financial disclosures, he served on the board of directors of the Seasteading Institute, an organization with the goal of creating “startup countries” at sea. “We are also negotiating with countries to establish a SeaZone (a specially designed economic zone where seasteading companies could build their platforms),” the organization explains on its website.

“The healthiest societies in 2030 will most likely be on the sea,” O’Neill told an audience at a Seasteading Institute conference in 2009. In that presentation, he talked up the benefits of a free market for health care, saying that seasteads could offer improved health care and serve as medical tourism hubs: “The last best hope for freedom is on the sea.”

Some in the longevity community see the ultimate goal as establishing a network state within the US. “That’s essentially what we’re doing in Montana,” says A4LI’s Livingston, referring to his successful lobbying efforts to create a hub for experimental medicine there. Over the last couple of years, the state has expanded Right to Try laws, which were originally designed to allow terminally ill individuals to access unproven treatments. Under new state laws, anyone can access such treatments, providing they have been through an initial phase I trial as a preliminary safety test.

“We’re doing a freedom city in Montana without calling it a freedom city,” says Livingston.

Patri Friedman, the libertarian founder of the Seasteading Institute, who calls O’Neill “a close friend,” explains that part of the idea of freedom cities is to create “specific industry clusters” on federal land in the US and win “regulatory carve-outs” that benefit those industries. 

A freedom city for longevity biotech is “being discussed,” says Friedman, although he adds that those discussions are still in the very early stages. He says he’d possibly work with O’Neill on “changing regulations that are under HHS” but isn’t yet certain what that might involve: “We’re still trying to research and define the whole program and gather support for it.”

Will he deliver?

Some libertarians, including longevity enthusiasts, believe this is their moment to build a new experimental home. 

Not only do they expect backing from O’Neill, but they believe President Trump has advocated for new economic zones, perhaps dedicated to the support of specific industries, that can set their own rules for governance. 

While campaigning for the presidency in 2023, Trump floated what seemed like a similar idea: “We should hold a contest to charter up to 10 new cities and award them to the best proposals for development,” he said in a recorded campaign speech. (The purpose of these new cities was somewhat vague. “These freedom cities will reopen the frontier, reignite the American imagination, and give hundreds of thousands of young people and other people—all hardworking families—a new shot at homeownership and in fact the American dream,” he said.)

But given how frequently Trump changes his mind, it’s hard to tell what the president, and others in the administration, will now support on this front. 

And even if HHS does try to create new geographic zones in some form, legal and regulatory experts say this approach won’t necessarily speed up drug development the way some longevity enthusiasts hope. 

“The notion around so-called freedom cities, with respect to biomedical innovation, just reflects deep misunderstandings of what drug development entails,” says Ohio State’s Zettler. “It’s not regulatory requirements that [slow down] drug development—it’s the scientific difficulty of assessing safety and effectiveness and of finding true therapies.”

Making matters even murkier, a lot of the research geared toward finding those therapies has been subject to drastic cuts.The NIH is the largest funder of biomedical research in the world and has supported major scientific discoveries, including those that benefit longevity research. But in late March, HHS announced a “dramatic restructuring” that would involve laying off 10,000 full-time employees. Since Trump took office, over a thousand NIH research grants have been ended and the administration has announced plans to slash funding for “indirect” research costs—a move that would cost individual research institutions millions of dollars. Research universities (notably Harvard) have been the target of policies to limit or revoke visas for international students, demands to change curricula, and threats to their funding and tax-exempt status.

The NIH also directly supports aging research. Notably, the Interventions Testing Program is a program run by the National Institutes of Aging (a branch of the NIH) to find drugs that make mice live longer. The idea is to understand the biology of aging and find candidates for human longevity drugs.

The ITP has tested around five to seven drugs a year for over 20 years, says Richard Miller, a professor of pathology at the University of Michigan, one of three institutes involved in the program. “We’ve published eight winners so far,” he adds.

The future of the ITP is uncertain, given recent actions of the Trump administration, he says. The cap on indirect costs alone would cost the University of Michigan around $181 million, the university’s interim vice president for research and innovation said in February. The proposals are subject to ongoing legal battles. But in the meantime, morale is low, says Miller. “In the worst-case scenario, all aging research [would be stopped],” he says.

The A4LI has also had to tailor its lobbying strategy given the current administration’s position on government-funded research. Alongside its efforts to change Montana state law to allow clinics to sell unproven treatments, the organization had been planning to push for an all-new NIH institute dedicated to aging and longevity research—an idea that O’Neill voiced support for last year. But current funding cuts under the new administration suggest that it’s “not the ideal political climate for this,” says Livingston.

Despite their enthusiasm for O’Neill’s confirmation, this has all left many members of the longevity community, particularly those with research backgrounds, concerned about what the cuts mean for the future of longevity science.

“Someone like [O’Neill], who’s an advocate for aging and longevity, would be fantastic to have at HHS,” says Matthew O’Connor, who spent over a decade at SRF and says he knows O’Neill “pretty well.” But he adds that “we shouldn’t be cutting the NIH.” Instead, he argues, the agency’s funding should be multiplied by 10.

“The solution to curing diseases isn’t to get rid of the organizations that are there to help us cure diseases,” adds O’Connor, who is currently co-CEO at Cyclarity Therapeutics, a company developing drugs for atherosclerosis and other age-related diseases. 

But it’s still just too soon to confidently predict how, if at all, O’Neill will shape the government health agencies he will oversee. 

“We don’t know exactly what he’s going to be doing as the deputy secretary of HHS,” says Public Citizen’s Steinbrook. “Like everybody who’s sworn into a government job, whether we disagree or agree with their views or actions … we still wish them well. And we hope that they do a good job.”

We’re learning more about what weight-loss drugs do to the body

Weight-loss drugs are this decade’s blockbuster medicines. Drugs like Ozempic, Wegovy, and Mounjaro help people with diabetes get their blood sugar under control and help overweight and obese people reach a healthier weight. And they’re fast becoming a trendy must-have for celebrities and other figure-conscious individuals looking to trim down.

They became so hugely popular so quickly that not long after their approval for weight loss, we saw global shortages of the drugs. Prescriptions have soared over the last five years, but even people who don’t have prescriptions are seeking these drugs out online. A 2024 health tracking poll by KFF found that around 1 in 8 US adults said they had taken one.

We know they can suppress appetite, lower blood sugar, and lead to dramatic weight loss. We also know that they come with side effects, which can include nausea, diarrhea, and vomiting. But we are still learning about some of their other effects.

On the one hand, these seemingly miraculous drugs appear to improve health in other ways, helping to protect against heart failure, kidney disease, and potentially even substance-use disorders, neurodegenerative diseases, and cancer.

But on the other, they appear to be harmful to some people. Their use has been linked to serious conditions, pregnancy complications, and even some deaths. This week let’s take a look at what weight-loss drugs can do.

Ozempic, Wegovy, and other similar drugs are known as GLP-1 agonists; they mimic a chemical made in the intestine, GLP-1, that increases insulin and lowers blood levels of glucose. Originally developed to treat diabetes, they are now known to be phenomenal at suppressing appetite. One key trial, published in 2015, found that over the course of around a year, people who took one particular drug lost between around 4.7% and 6% of their body weight, depending on the dose they took.

Newer versions of that drug were shown to have even bigger effects. A 2021 trial of semaglutide—the active ingredient in both Ozempic and Wegovy—found that people who took it for 68 weeks lost around 15% of their body weight—equivalent to around 15 kilograms.

But there appear to be other benefits, too. In 2024, an enormous study that included 17,604 people in 41 countries found that semaglutide appeared to reduce heart failure in people who were overweight or obese and had cardiovascular disease. That same year, the US approved Wegovy to “reduce the risk of cardiovascular death, heart attack, and stroke in [overweight] adults with cardiovascular disease.” This year, Ozempic was approved to reduce the risk of kidney disease.

And it doesn’t end there. The many users of GLP-1 agonists have been reporting some unexpected positive side effects. Not only are they less interested in food, but they are less interested in alcohol, tobacco, opioids, and other addictive substances.

Research suggests they might protect men from prostate cancer. They might help treat osteoarthritis. Some scientists think the drugs could be used to treat a range of pain conditions, and potentially help people with migraine. And some even seem to protect brain cells from damage in lab studies, and they are being explored as potential treatments for neurological disorders like Alzheimer’s and Parkinson’s (although we don’t yet have any evidence they can be useful here).

The more we learn about GLP-1 agonists, the more miraculous they seem to be. What can’t they do?! you might wonder. Unfortunately, like any drug, GLP-1 agonists carry safety warnings. They can often cause nausea, vomiting, and diarrhea ,and their use has also been linked to inflammation of the pancreas—a condition that can be fatal. They increase the risk of gall bladder disease.

There are other concerns. Weight-loss drugs can help people trim down on fat, but lean muscle can make up around 10% of the body weight lost by people taking them. That muscle is important, especially as we get older. Muscle loss can affect strength and mobility, and it also can also leave people more vulnerable to falls, which are the second leading cause of unintentional injury deaths worldwide, according to the World Health Organization.

And, as with most drugs, we don’t fully understand the effects weight-loss drugs might have in pregnancy. That’s important; even though the drugs are not recommended during pregnancy, health agencies point out that some people who take these drugs might be more likely to get pregnant, perhaps because they interfere with the effects of contraceptive drugs.

And we don’t really know how they might affect the development of a fetus, if at all. A study published in January found that people who took the drugs either before or during pregnancy didn’t seem to face increased risk of birth defects. But other research due to be presented at a conference in the coming days found that such individuals were more likely to experience obstetrical complications and preeclampsia.

So yes, while the drugs are incredibly helpful for many people, they are not for everyone. It might be fashionable to be thin, but it’s not necessarily healthy. No drug comes without risks. Even one that 1 in 8 American adults have taken.

This article first appeared in The Checkup, MIT Technology Review’s weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

Google’s new AI will help researchers understand how our genes work

When scientists first sequenced the human genome in 2003, they revealed the full set of DNA instructions that make a person. But we still didn’t know what all those 3 billion genetic letters actually do. 

Now Google’s DeepMind division says it’s made a leap in trying to understand the code with AlphaGenome, an AI model that predicts what effects small changes in DNA will have on an array of molecular processes, such as whether a gene’s activity will go up or down. It’s just the sort of question biologists regularly assess in lab experiments.

“We have, for the first time, created a single model that unifies many different challenges that come with understanding the genome,” says Pushmeet Kohli, a vice president for research at DeepMind.

Five years ago, the Google AI division released AlphaFold, a technology for predicting the 3D shape of proteins. That work was honored with a Nobel Prize last year and spawned a drug-discovery spinout, Isomorphic Labs, and a boom of companies that hope AI will be able to propose new drugs.

AlphaGenome is an attempt to further smooth biologists’ work by answering basic questions about how changing DNA letters alters gene activity and, eventually, how genetic mutations affect our health. 

“We have these 3 billion letters of DNA that make up a human genome, but every person is slightly different, and we don’t fully understand what those differences do,” says Caleb Lareau, a computational biologist at Memorial Sloan Kettering Cancer Center who has had early access to AlphaGenome. “This is the most powerful tool to date to model that.”

Google says AlphaGenome will be free for noncommercial users and plans to release full details of the model in the future. According to Kohli, the company is exploring ways to “enable use of this model by commercial entities” such as biotech companies. 

Lareau says AlphaGenome will allow certain types of experiments now done in the lab to be carried out virtually, on a computer. For instance, studies of people who’ve donated their DNA for research often turn up thousands of genetic differences, each slightly raising or lowering the chance a person gets a disease such as Alzheimer’s.

Lareau says DeepMind’s software could be used to quickly make predictions about how each of those variants works at a molecular level, something that would otherwise require time-consuming lab experiments. “You’ll get this list of gene variants, but then I want to understand which of those are actually doing something, and where can I intervene,” he says. “This system pushes us closer to a good first guess about what any variant will be doing when we observe it in a human.”

Don’t expect AlphaGenome to predict very much about individual people, however. It offers clues to nitty-gritty molecular details of gene activity, not 23andMe-type revelations of a person’s traits or ancestry. 

“We haven’t designed or validated AlphaGenome for personal genome prediction, a known challenge for AI models,” Google said in a statement.

Underlying the AI system is the so-called transformer architecture invented at Google that also powers large language models like GPT-4. This one was trained on troves of experimental data produced by public scientific projects.

Lareau says the system will not broadly change how his lab works day to day but could permit new types of research. For instance, sometimes doctors encounter patients with ultra-rare cancers, bristling with unfamiliar mutations. AlphaGenome could suggest which of those mutations are really causing the root problem, possibly pointing to a treatment.

“A hallmark of cancer is that specific mutations in DNA make the wrong genes express in the wrong context,” says Julien Gagneur, a professor of computational medicine at the Technical University of Munich. “This type of tool is instrumental in narrowing down which ones mess up proper gene expression.” 

The same approach could apply to patients with rare genetic disease, many of whom never learn the source of their condition, even if their DNA has been decoded. “We can obtain their genomes, but we are clueless as to which genetic alterations cause the disease,” says Gagneur. He thinks AlphaGenome could give medical scientists a new way to diagnose such cases. 

Eventually, some researchers aspire to use AI to design entire genomes from the ground up and create new life forms. Others think the models will be used to create a fully virtual laboratory for drug studies. “My dream would be to simulate a virtual cell,” Demis Hassabis, CEO of Google DeepMind, said this year. 

Kohli calls AlphaGenome a “milestone” on the road to that kind of system. “AlphaGenome may not model the whole cell in its entirety … but it’s starting to sort of shed light on the broader semantics of DNA,” he says.