Jul 20 2025
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.

Ecommerce MGMT 0 Comments
Jul 17 2025
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?”

Ecommerce MGMT 0 Comments
Jul 12 2025
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.

Ecommerce MGMT 0 Comments
Jul 1 2025
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.”

Ecommerce MGMT 0 Comments
Jun 28 2025
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.

Ecommerce MGMT 0 Comments
Jun 26 2025
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.

Ecommerce MGMT 0 Comments
Jun 21 2025
Calorie restriction can help animals live longer. What about humans?

Living comes with a side effect: aging. Despite what you might hear on social media or in advertisements, there are no drugs that are known to slow or reverse human aging. But there’s some evidence to support another approach: cutting back on calories.

Caloric restriction (reducing your intake of calories) and intermittent fasting (switching between fasting and eating normally on a fixed schedule) can help with weight loss. But they may also offer protection against some health conditions. And some believe such diets might even help you live longer—a finding supported by new research out this week. (Longevity enthusiast Bryan Johnson famously claims to eat his last meal of the day at 12pm.)

But the full picture is not so simple. Weight loss isn’t always healthy and neither is restricting your calorie intake, especially if your BMI is low to begin with. Some scientists warn that, based on evidence in animals, it could negatively impact wound healing, metabolism and bone density. This week let’s take a closer look at the benefits—and risks—of caloric restriction.

Eating less can make animals live longer. This remarkable finding has been published in scientific journals for the last 100 years. It seems to work in almost every animal studied—everything from tiny nematode worms and fruit flies to mice, rats, and even monkeys. It can extend the lifespan of rodents by between 15% and 60%, depending on which study you look at.

The effect of caloric restriction is more reliable than the leading contenders for an “anti-aging” drug. Both rapamycin (an immunosuppressive drug used in organ transplants) and metformin (a diabetes drug) have been touted as potential longevity therapeutics. And both have been found to increase the lifespans of animals in some studies.

But when scientists looked at 167 published studies of those three interventions in research animals, they found that caloric restriction was the most “robust.” According to their research, published in the journal Aging Cell on Wednesday, the effect of rapamycin was somewhat comparable, but metformin was nowhere near as effective.

“That is a pity for the many people now taking off-label metformin for lifespan extension,” David Clancy, lecturer in biogerontology at Lancaster University, said in a statement. “Let’s hope it doesn’t have any or many adverse effects.” Still, for caloric restriction, so far so good.

At least it’s good news for lab animals. What about people? Also on Wednesday, another team of scientists published a separate review of research investigating the effects of caloric restriction and fasting on humans. That review assessed 99 clinical trials, involving over 6,500 adults. (As I said, caloric restriction has been an active area of research for a long time.)

Those researchers found that, across all those trials, fasting and caloric restriction did seem to aid weight loss. There were other benefits, too—but they depended on the specific approach to dieting. Fasting every other day seemed to help lower cholesterol, for example. Time-restricted eating, where you only eat within a specific period each day (à la Bryan Johnson), by comparison, seemed to increase cholesterol, the researchers write in the BMJ. Given that elevated cholesterol in the blood can lead to heart disease, it’s not great news for the time-restricted eaters.

Cutting calories could also carry broader risks. Dietary restriction seems to impair wound healing in mice and rats, for example. Caloric restriction also seems to affect bone density. In some studies, the biggest effects on lifespan extension are seen when rats are put on calorie-restricted diets early in life. But this approach can affect bone development and reduce bone density by 9% to 30%.

It’s also really hard for most people to cut their caloric intake. When researchers ran a two-year trial to measure the impact of a 25% reduction in caloric intake, they found that the most their volunteers could cut was 12%. (That study found that caloric restriction reduces markers of inflammation, which can be harmful when it’s chronic, and had only a small impact on bone density.)

Unfortunately, there’s a lot we still don’t really understand about caloric restriction. It doesn’t seem to help all animals live longer—it seems to shorten the lifespan of animals with certain genetic backgrounds. And we don’t know whether it extends the lifespan of people. It isn’t possible to conduct a randomized clinical trial in which you deprive people of food from childhood and then wait their entire lives to see when they die.

It is notoriously difficult to track or change your diet. And given the unknowns surrounding caloric restriction, it’s too soon to make sweeping recommendations, particularly given that your own personal biology will play a role in any benefits or risks you’ll experience. Roll on the next round of research.

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.

Ecommerce MGMT 0 Comments
Jun 14 2025
Here’s what food and drug regulation might look like under the Trump administration

Earlier this week, two new leaders of the US Food and Drug Administration published a list of priorities for the agency. Both Marty Makary and Vinay Prasad are controversial figures in the science community. They were generally highly respected academics until the covid pandemic, when their contrarian opinions on masking, vaccines, and lockdowns turned many of their colleagues off them.

Given all this, along with recent mass firings of FDA employees, lots of people were pretty anxious to see what this list might include—and what we might expect the future of food and drug regulation in the US to look like. So let’s dive into the pair’s plans for new investigations, speedy approvals, and the “unleashing” of AI.

First, a bit of background. Makary, the current FDA commissioner, is a surgeon and was a professor of health policy at the Johns Hopkins School of Public Health. He initially voiced support for stay-at-home orders during the pandemic but later changed his mind. In February 2021, he incorrectly predicted that the US would “have herd immunity by April.” He has also been very critical of the FDA, writing in 2021 that its then leadership acted like “a crusty librarian” and that drug approvals were “erratic.”

Prasad, an oncologist, hematologist, and health researcher, was named director of the FDA’s Center for Biologics Evaluation and Research last month. He has long been a proponent of rigorous evidence-based medicine. When I interviewed him back in 2019, he told me that cancer drugs are often approved on the basis of weak evidence, and that they can end up being ineffective or even harmful. He has written a book arguing that drug regulators need to raise the bar of evidence for drug approvals. He was widely respected by his peers.

Things changed during the pandemic. Prasad made a series of contrarian comments; he claimed that the covid virus “was likely a lab leak” despite the fact that the vast majority of scientists believe that the virus jumped to humans from animals in a market. He railed against Anthony Fauci, and advised readers of his blog to “break all home Covid tests.” In 2023, he authored a post titled “Do not report Covid cases to schools & do not test yourself if you feel ill.” He has even drawn parallels between the US covid response and fascism in Nazi Germany. Suffice to say he’s lost the support of many of his fellow academics.

Makary and Prasad published their “priorities for a new FDA” in the Journal of the American Medical Association on Tuesday. (Funnily enough, JAMA is one of the journals that their boss, Robert F. Kennedy Jr., described as “corrupt” just a couple of weeks ago—one that he said he’d ban government scientists from publishing in. Lol.)

Let’s go through a few of the points the pair make in their piece. They open by declaring that the US medical system has been “a 50 year failure.” It’s true that the US spends a lot more on health care than other wealthy countries do, and yet has a lower life expectancy. And around 25 million Americans don’t have health insurance.

“In some ways, it is absolutely a failure,” says Christopher Robertson, a professor of health law at Boston University. “On the other hand, it’s the envy of the world [because] it’s very good at delivering high-end care.” Either way, the reasons for failures in health care are not really the scope of the FDA, which has a focus on ensuring the safety and efficacy of food and medicines.

Makary and Prasad then state that they want the FDA to “examine the role of ultraprocessed foods” as well as additives and environmental toxins, suggesting that all these may be involved in chronic diseases. This is a favorite talking point of RFK Jr., who has made similar promises about investigating a possible connection.

But this would also go beyond the current established purview of the FDA, says Robertson. There isn’t a clear, agreed-upon definition of “ultraprocessed food,” for a start, so it’s hard to predict what exactly would be included in any investigation. And as things stand, “the FDA’s role is primarily binary: They either allow or reject products,” adds Robertson. The agency doesn’t really give dietary advice.

Perhaps that could change. At his confirmation hearing, Makary told senators he planned to evaluate school lunches, seed oils, and food dyes. “Maybe three years from now the FDA will change and have much more of a food focus,” says Robertson.

The pair also write that they want to speed up the process of approving new drugs, which can currently take more than 10 years. Their suggestions include allowing drug developers to submit final paperwork early, while testing is still underway, and getting rid of “recipes” that strictly limit what manufacturers can put in infant formula.

Here’s where things get a little more controversial. Most new drugs fail. They might look very promising in cells in a dish, or even in animals. They might look safe enough in a small phase I study in humans. But after that, large-scale human studies reveal plenty of drugs to be either ineffective, unsafe, or both.

Speeding up the drug approval process might mean some of these failures aren’t noticed until a drug is already being sold and prescribed. Even preparing paperwork ahead of time might result in a huge waste of time and money for both drug developers and the FDA if that drug later fails its final round of testing, says Robertson.

And as for infant formula recipes, they are in place for a reason: because we know they’re safe. Loosening that requirement might allow for more innovation. It could lead to the development of better recipes. But, as Robertson points out, innovation is a double-edged sword. “Some innovation saves lives; some innovation kills people,” he says.

Along the same lines, the pair also advocate for reducing the number of clinical trials required for the FDA to approve a drug. Instead of two “pivotal” clinical trials, drugmakers might only need to complete one, they suggest.

This is also controversial. A drug might look promising in one clinical trial and fail in another. That was the case for aducanamab (Aduhelm), the Alzheimer’s drug that was approved by the FDA in 2021 despite the concerns of several senior officials. (Biogen, the company that developed the drug, abandoned it in 2024, and it was later withdrawn from the market.)

At any rate, the FDA has already implemented several pathways for “expedited approval.” The Accelerated Approval Program fast-tracks the process for drugs that treat serious conditions or fulfill an unmet need. (Side note: This approval pathway relies on the very kind of weak evidence that Prasad has campaigned against.)

The Fast Track Program serves a similar purpose. As does the Breakthrough Therapy designation. Some health researchers are worried that programs like these, along with other factors, are responsible for a gradual lowering of the bar of evidence for new drugs in the US. Calling for an acceleration of cures, as the authors do, isn’t really anything new.

Makary and Prasad also list artificial intelligence as a priority—specifically, generative AI. They write that “on May 8, 2025, the agency implemented the first AI-assisted scientific review pilot using the latest generative AI technology.” It’s not clear exactly which technology was used, or how. But this priority didn’t surprise Rachel Sachs, a professor of health law at Washington University in St. Louis.

“Both this administration and the previous administration were very interested in the use of AI technologies,” she says. She points out that as of last year, the FDA had already approved over a thousand medical devices that make use of AI and machine learning. And the agency has also been considering how it might use the technologies in its review process, she adds: “It’s not a new idea.”

There’s another sticking point. Writing a list of priorities in JAMA is one thing. Implementing them amid hugely disruptive and damaging cuts underway across federal health and science agencies is quite another.

Makary and Prasad have both made claims to the effect that they support “gold standard” science and have built their careers on extolling the virtues of evidence-based medicine. But it’s hard to square this position with the actions of the administration, including the huge budget cuts made to the National Institutes of Health, restrictions on government-funded research, and mass layoffs across multiple government health agencies, including the FDA. “It’s almost as if the two sides are talking past each other,” says Sachs.

As a result, it’s impossible to predict exactly what’s going to happen. We’ll have to wait to see how this all pans out.

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.

Ecommerce MGMT 0 Comments
Jun 8 2025
Why doctors should look for ways to prescribe hope

This week, I’ve been thinking about the powerful connection between mind and body. Some new research suggests that people with heart conditions have better outcomes when they are more hopeful and optimistic. Hopelessness, on the other hand, is associated with a significantly higher risk of death.

The findings build upon decades of fascinating research into the phenomenon of the placebo effect. Our beliefs and expectations about a medicine (or a sham treatment) can change the way it works. The placebo effect’s “evil twin,” the nocebo effect, is just as powerful—negative thinking has been linked to real symptoms.

Researchers are still trying to understand the connection between body and mind, and how our thoughts can influence our physiology. In the meantime, many are developing ways to harness it in hospital settings. Is it possible for a doctor to prescribe hope?

Alexander Montasem, a lecturer in psychology at the University of Liverpool, is trying to find an answer to that question. In his latest study, Montasem and his colleagues focused on people with cardiovascular disease.

The team reviewed all published research into the link between hope and heart health outcomes in such individuals. Hope is a pretty tricky thing to nail down, but these studies use questionnaires to try to do that. In one popular questionnaire, hope is defined as “a positive motivational state” based on having agency and plans to meet personal goals.

Montasem’s team found 12 studies that fit the bill. All told, these studies included over 5,000 people. And together, they found that high hopefulness was associated with better health outcomes: less angina, less post-stroke fatigue, a higher quality of life, and a lower risk of death. The team presented its work at the British Cardiovascular Society meeting in Manchester earlier this week.

When I read the results, it immediately got me thinking about the placebo effect. A placebo is a “sham” treatment—an inert substance like a sugar pill or saline injection that does not contain any medicine. And yet hundreds of studies have shown that such treatments can have remarkable effects.

They can ease the symptoms of pain, migraine, Parkinson’s disease, depression, anxiety, and a host of other disorders. The way a placebo is delivered can influence its effectiveness, and so can its color, shape, and price. Expensive placebos seem to be more effective. And placebos can even work when people know they are just placebos.

And then there’s the nocebo effect. If you expect to feel worse after taking something, you are much more likely to. The nocebo effect can increase the risk of pain, gastrointestinal symptoms, flu-like symptoms, and more.  

It’s obvious our thoughts and beliefs can play an enormous role in our health and well-being. What’s less clear is exactly how it happens. Scientists have made some progress—there’s evidence that a range of brain chemicals, including the body’s own opioids, are involved in both the placebo and nocebo effects. But the exact mechanisms remain something of a mystery.

In the meantime, researchers are working on ways to harness the power of positive thinking. There have been long-running debates over whether it is ever ethical for a doctor to deceive patients to make them feel better. But I’m firmly of the belief that doctors have a duty to be honest with their patients.

A more ethical approach might be to find ways to build patients’ hope, says Montasem. Not by exaggerating the likely benefit of a drug or by sugar-coating a prognosis, but perhaps by helping them work on their goals, agency, and general outlook on life.

Some early research suggests that this approach can help. Laurie McLouth at the University of Kentucky and her colleagues found that a series of discussions about values, goals, and strategies to achieve those goals improved hope among people being treated for advanced lung cancer.

Montasem now plans to review all the published work in this area and design a new approach to increasing hope. Any approach might have to be tailored to an individual, he adds. Some people might be more responsive to a more spiritual or religious way of thinking about their lives, for example.

These approaches could also be helpful for all of us, even outside clinical settings. I asked Montasem if he had any advice for people who want to have a positive outlook on life more generally. He told me that it’s important to have personal goals, along with a plan to achieve them. His own goals center on advancing his research, helping patients, and spending time with his family. “Materialistic goals aren’t as beneficial for your wellbeing,” he adds.

Since we spoke, I’ve been thinking over my own goals. I’ve realized that my first is to come up with a list of goals. And I plan to do it soon. “The minute we give up [on pursuing] our goals, we start falling into hopelessness,” he says.

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.

Ecommerce MGMT 0 Comments
Jun 6 2025
Crypto billionaire Brian Armstrong is ready to invest in CRISPR baby tech

Brian Armstrong, the billionaire CEO of the cryptocurrency exchange Coinbase, says he’s ready to fund a US startup focused on gene-editing human embryos. If he goes forward, it would be the first major commercial investment in one of medicine’s most fraught ideas.

In a post on X June 2, Armstrong announced he was looking for gene-editing scientists and bioinformatics specialists to form a founding team for an “embryo editing” effort targeting an unmet medical need, such as a genetic disease.

“I think the time is right for the defining company in the US to be built in this area,” Armstrong posted. 

The announcement from a deep-pocketed backer is a striking shift for a field considered taboo following the 2018 birth of the world’s first genetically edited children in China—a secretive experiment that led to international outrage and prison time for the lead scientist.

According to Dieter Egli, a gene-editing scientist at Columbia University whose team has briefed Armstrong, his plans may be motivated in part by recent improvements in editing technology that have opened up a safer, more precise way to change the DNA of embryos.

That technique, called base editing, can deftly change a single DNA letter. Earlier methods, on the other hand, actually cut the double helix, damaging it and causing whole genes to disappear. “We know much better now what to do,” says Egli. “It doesn’t mean the work is all done, but it’s a very different game now—entirely different.”  

Shoestring budget

Embryo editing, which ultimately aims to produce humans with genes tailored by design, is an idea that has been heavily stigmatized and starved of funding. While it’s legal to study embryos in the lab, actually producing a gene-edited baby is flatly illegal in most countries.

In the US, the CRISPR baby ban operates via a law that forbids the Food and Drug Administration from considering, or even acknowledging, any application it gets to attempt a gene-edited baby. But that rule could be changed, especially if scientists can demonstrate a compelling use of the technique—or perhaps if a billionaire lobbies for it.

In his post, Armstrong included an image of a seven-year-old Pew Research Center poll showing Americans were strongly favorable to altering a baby’s genes if it could treat disease, although the same poll found most opposed experimentation on embryos.  

Up until this point, no US company has openly pursued embryo editing, and the federal government doesn’t fund studies on embryos at all. Instead, research on gene editing in embryos has been carried forward in the US by just two academic centers, Egli’s and one at the Oregon Health & Science University.

Those efforts have operated on a shoestring, held together by private grants and university funds. Researchers at those centers said they support the idea of a well-financed company that could advance the technology. “We would honestly welcome that,” says Paula Amato, a fertility doctor at Oregon Health & Science University and the past president of the American Society for Reproductive Medicine. 

“More research is needed, and that takes people and money,” she says, adding that she doesn’t mind if it comes from “tech bros.”

Editing embryos can, in theory, be used to correct genetic errors likely to cause serious childhood conditions. But since in most cases genetic testing of embryos can also be used to avoid those errors, many argue it will be hard to find a true unmet need where the DNA-altering technique is actually necessary.

Instead, it’s easy to conclude that the bigger market for the technology would be to intervene in embryos in ways that could make humans resistant to common conditions, such as heart disease or Alzheimer’s. But that is more controversial because it’s a type of enhancement, and the changes would also be passed through the generations.

Only last week, several biotech trade and academic groups demanded a 10-year moratorium on heritable human genome editing, saying the technology has few real medical uses and “introduces long-term risks with unknown consequences.”

They said the ability to “program” desired traits or eliminate bad ones risked a new form of “eugenics,” one that would have the effect of “potentially altering the course of evolution.”

No limits

Armstrong did not reply to an email from MIT Technology Review seeking comment about his plans. Nor did his company Coinbase, a cryptocurrency trading platform that went public in 2021 and is the source of his fortune, estimated at $10 billion by Forbes.

The billionaire is already part of a wave of tech entrepreneurs who’ve made a splash in science and biology by laying down outsize investments, sometimes in far-out ideas. Armstrong previously cofounded NewLimit, which Bloomberg calls a “life extension venture” and which this year raised a further $130 million to explore methods to reprogram old cells into an embryonic-like state.

He started that company with Blake Byers, an investor who has said a significant portion of global GDP should be spent on “immortality” research, including biotech approaches and ways of uploading human minds to computers.

Then, starting late last year, Armstrong began publicly telegraphing his interest in exploring a new venture, this time connected to assisted reproduction. In December, he announced on X that he and Byers were ready to meet with entrepreneurs working on “artificial wombs,” “embryo editing,” and “next-gen IVF.”

The post invited people to apply to attend an off-the-record dinner—a kind of forbidden-technologies soiree. Applicants had to fill in a Google form answering a few questions, including “What is something awesome you’ve built?”

Among those who attended the dinner was a postdoctoral fellow from Egli’s lab, Stepan Jerabek, who has been testing base-editing in embryos. Another attendee, Lucas Harrington, is a gene-editing scientist who trained at the University of California, Berkeley under Jennifer Doudna, a winner of the Nobel Prize in chemistry for development of CRISPR gene editing. Harrington says a venture group he helps run, called SciFounders, is also considering starting an embryo-editing company.

“We share an interest in there being a company to empirically evaluate whether embryo editing can be done safely, and are actively exploring incubating a company to undertake this,” Harrington said in an email. “We believe there need to be legitimate scientists and clinicians working to safely evaluate this technology.”

Because of how rapidly gene editing is advancing, Harrington has also criticized bans and moratoria on the technology. These can’t stop it from being applied but, he says, can drive it into “the shadows,” where it might be used less safely. According to Harrington, “several biohacker groups have quietly raised small amounts of capital” to pursue the technology.

By contrast, Armstrong’s public declaration on X represents a more transparent approach. “It seems pretty serious now. They want to put something together,” says Egli, who hopes the Coinbase CEO might fund some research at his lab. “I think it’s very good he posted publicly, because you can feel the temperature, see what reaction you get, and you stimulate the public conversation.”

Editing error

The first reports that researchers were testing CRISPR on human embryos in the lab emerged from China in 2015, causing shock waves as it became clear how easy, in theory, it was to change human heredity. Two years later, in 2017, a report from Oregon claimed successful correction of a dangerous DNA mutation present in lab embryos made from patients’ egg and sperm cells.

But that breakthrough was not what it seemed. More careful testing by Egli and others showed that CRISPR technology actually can cause havoc in a cell, often deleting large chunks of chromosomes. That’s in addition to mosaicism, in which edits occur differently in different cells. What looked at first like precise DNA editing was in fact a dangerous process causing unseen damage.

While the public debate turned on the ethics of CRISPR babies—especially after three edited children were born in China—researchers were discussing basic scientific problems and how to solve them.

Since then, both US labs, as well as some in China, have switched to base editing. That method causes fewer unexpected effects and, in theory, could also endow an embryo with a number of advantageous gene variants, not just one change.

Company job

Some researchers also feel certain that editing an embryo is simpler than trying to treat sick adults. The only approved gene-editing treatment, for sickle-cell disease, costs more than $2 million. By contrast, editing an embryo could be incredibly cheap, and if it’s done early, when an embryo is forming, all the body cells could carry the change.

“You fix the text before you print the book,” says Egli. “It seems like a no-brainer.”

Still, gene editing isn’t quite ready for prime time in making babies. Getting there requires more work, including careful design of the editing system (which includes a protein and short guide molecule) and systematic ways to check embryos for unwanted DNA changes. That is the type of industrial effort Armstrong’s company, if he funds one, would be suited to carry out.

“You would have to optimize something to a point where it is perfect, to where it’s a breeze,” says Egli. “This is the kind of work that companies do.”

Ecommerce MGMT 0 Comments