Every year, MIT Technology Review puts together a list of some of the brightest and best young minds working across science and technology. Our 35 Innovators Under 35 are the ones to watch—people whose research and technical work stands to shape the future of their fields.

This year, the list includes nine people who are transforming biotech. And this week, I’m going to give you a taste of some of the very cool stuff five of them are working on, which includes lifesaving innovations and groundbreaking “age reversal” tech.  

1. Preventing maternal deaths

Let’s start with Paschal Kija, a 28-year-old who has developed a device to treat postpartum hemorrhage—a dangerous birth complication that contributes to around 29% of maternal deaths in his home country, Tanzania. The Mkanda Salama (“Safe Wrap” in Swahili) is easy to use and costs just $70. A study found that it stopped postpartum bleeding in 73% of women within 20 minutes.

2. Making brain electrodes inspired by Japanese art

For decades, scientists have been developing, testing, and implanting brain electrodes. These devices are literally inserted into people’s brains, so while they can help us understand brain activity and treat various neurological disorders, it’s not totally surprising that they can also cause a bit of damage. Xiao Yang, 34, is working on ultra-small electrodes, which she hopes will have less of an impact on surrounding brain tissue. Her electrodes are flexible, too—in fact, they look a lot like actual neurons.

Yang is also creating sheets of electrodes to study brain cells in the lab. Inspired by kirigami—the traditional Japanese art of cutting paper to form three-dimensional shapes—she’s created a sheet of electrodes with a honeycombed structure shaped like a spiral basket. And she’s already using it to study brain cells.

3. Developing an all-new treatment for baby KJ

In 2024, Kyle “KJ” Muldoon Jr. was born with a rare and potentially fatal genetic disorder. Sarah Grandinette was a member of a team that developed an entirely new, personalized treatment for him—a gene-editing therapy essentially designed to correct a genetic misspelling.

Grandinette, who is now 26, created cells with KJ’s genetic variant and used them to screen gene-editing approaches; then she tested potential medicines in mice and monkeys. KJ ultimately got his first dose of the resulting treatment when he was about seven months old. He responded well and was eventually discharged from hospital. He’s “doing pretty great,” she says.

4. Reversing the aging process to treat eye disease

The buzziest tech in longevity right now centers on reprogramming—attempts to rewind the age of cells by resetting them to a more embryonic-like state. In a study published in 2020, Yuancheng (Ryan) Lu (now 34) and his colleagues showed that a reprogramming therapy reversed vision loss in aged, blind mice. Now an almost identical version of that therapy is being tested in people with eye disease. Life Biosciences, the company developing the drug, dosed its first volunteer in June.

5. Using AI to design new viruses

Last year, Samuel King used a generative AI model to come up with new genetic blueprints for bacteriophages—teeny viruses that can infect bacteria. Once he had those blueprints, he printed them out as strands of DNA. In experiments, he found that those AI-designed viruses could create new copies of themselves, burst out of bacterial cells, and infect other nearby bacteria. Viruses aren’t alive, but King, 27, hopes that AI-designed life forms might one day be used to make drugs or soak up pollution.

You can read more about these innovators, and the others on the biotech list, here.

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.

This week I spoke to scientists who have found a way to turn male mouse embryos female. They’ve developed a CRISPR-based approach to essentially cut out the Y chromosome. It allowed them to create female clones of male mice.

That’s right: female animals that are genetically identical to males, except for the missing Y chromosome. Takashi Ishiuchi, a reproductive biologist at the University of Yamanashi who co-led the work, told me it felt a bit like sci-fi.

Ishiuchi and his colleague Shogo Matoba of the Riken BioResource Research Center hope their approach could be helpful in conservation efforts, especially in cases where we might have only a few individuals of a species left. But cloning has multiple uses, ranging from the cool to the outright creepy.

We can’t talk about cloning without mentioning Dolly, the celebrity sheep born in 1996 and the first mammal successfully cloned from an adult cell. In that case, scientists took the DNA-containing nucleus of an adult mammary cell from one sheep and transferred it into an egg cell that had had its own nucleus removed. The resulting embryo was transferred to a surrogate sheep, which gave birth to Dolly—an animal genetically identical to the DNA donor.

The scientists behind that work were interested in genetically modifying livestock. Farmers have essentially been doing this for thousands of years through selective breeding, but cloning allows scientists to create genetic replicas of animals with desirable traits.

Cloning is also being used to replicate deceased pets, including, famously, those of Barbra Streisand and Tom Brady, among others. For a price somewhere in the tens of thousands of dollars, a company can take cells from your pet and turn them into a living, breathing clone.

Considering that cloning also requires egg cells from another animal, and a surrogate animal to carry the pregnancy, not everyone is on board with this, especially since there is no medical or environmental need for the procedures. One bioethicist, Jessica Pierce, has described this aspect of dog cloning as “the exploitation of the canine underclass.”

The case for cloning is stronger when it comes to conservation—where some argue there is environmental value.

Scientists have been preserving animal tissues for years. Some of these tissues are cryopreserved at low temperatures in “frozen zoos.” The facility at the San Diego Zoo, for example, currently has cells from over 1,300 species. Some of these samples were taken decades ago.

Preserved tissues like these have enabled scientists to create clones of animals considered close to extinction, including black-footed ferrets and Przewalski’s horse. But they might also help us bring back extinct animals.

In 2009, researchers in Spain described how they’d cloned an extinct wild goat, the Pyrenean ibex, using skin cells that had been cryopreserved a decade earlier. In that research, the team used egg cells from domestic goats to create a total of 439 embryos. Ultimately, only one goat—a female—was born. She died minutes later because of a defect in her lungs.

Poor Pyrenean ibex. It’s the only animal we know of that has gone extinct twice.

The biotech company Colossal Biosciences is hoping to use old—and potentially ancient—genetic material to bring back long-extinct species like the thylacine and woolly mammoth. So far, the company’s efforts have largely involved modifying the genomes of modern-day animals.

Technically, it’s also possible to clone humans. As far as we know, no one has done it. But some have played with the idea. One biotech startup founder has pitched an idea for “brainless clones”—human clones that lack a brain but contain all the organs people might need to replace their own in future. My colleague Antonio Regalado described that pitch in March. (I had to pause eating my lunch while rereading it.)

Scientists have done a hell of a lot with cloning over the last few decades. I’m excited—but also slightly nervous—about what the coming decades will bring.

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.

Scientists have deliberately turned male mouse embryos into females for the first time. A team based in Japan used a CRISPR-based approach to remove the Y chromosome from male cells and create female clones of male mice. 

“No one has done this before,” says Monika Ward, a reproductive biologist at the University of Hawaii, who was not involved in the research.

The feat could change the way scientists think about reproduction, says Takashi Ishiuchi, a reproductive biologist at the University of Yamanashi, who co-led the work. The findings were published in a preprint paper shared on bioRxiv earlier this month, which has not yet been through the peer-review process. “There’s a fixed concept in our scientific field that we need both females and males for reproduction,” says Ishiuchi. “I think we could change this concept.”

He and his colleague Shogo Matoba of the Riken BioResource Research Center in Ibaraki also hope their technique could help rescue endangered species, particularly in cases where only a few individuals remain.

“It’s exciting to see,” says Ben Novak, lead scientist at the wildlife conservation organization Revive & Restore, who was not involved in the work. “I am confident there will be plenty of applications, particularly for conservation purposes.”

Sex change

Ishiuchi says he and his colleagues were inspired by the Okinawa rubble goby, a fish that can change its sex in certain situations. If no males are present, a female can do this in order to reproduce with the other females. Males can also change sex to female.

There’s some precedent in the lab too—albeit not intentional. In 2009, researchers reported the accidental birth of a single female pup in a batch of 27 clones created from male mouse cells.

This ability to change sex might be useful. Sometimes the surviving population of a species falls so low that scientists will try to clone those animals. Cloning isn’t perfect—it can be tricky and inefficient, and it creates genetically identical individuals whose offspring might be more vulnerable to disease. But it has helped scientists with efforts to bring some species back from the brink of extinction, including black-footed ferrets and Przewalski’s horse.

Cloning an individual can only replicate its genes, so cloning a male animal will create all male offspring, for example. That won’t help much in the hypothetical situation where only male individuals of a species are left.

Ishiuchi has been working on a way to overcome this challenge by altering the chromosomes in cells. Mammals’ DNA is organized in pairs of chromosomes, including one pair of sex chromosomes. These sex chromosomes are typically XX in females and XY in males.

It’s the Y chromosome that makes mammals male. Ishiuchi and his colleagues have developed a CRISPR-based tool to get rid of it. Their approach targets a section of the Y chromosome that plays an important role in ensuring that, each time a cell divides, the “daughter” cells inherit the Y chromosome.

Cutting the Y

When the researchers tested their technique—which they call Y-CUT—in early-stage mouse embryos, they found they were able to eliminate the Y chromosome. Treated XY embryos were transferred to surrogate mice, which gave birth to female pups. The effect can be described as a “sex reversal,” say the researchers.

The female pups had XO chromosomes, which means they had one X chromosome rather than the usual two. But this didn’t seem to affect the animals, which grew up healthy and fertile, say Ishiuchi and Matoba.

In a second experiment, the researchers found they could also use Y-CUT to create female clones from male mice.

A standard approach to cloning involves taking the DNA-containing nucleus of a cell from an adult animal and inserting it into an egg cell that has had its own DNA removed. Under the right conditions, the resulting cell can develop into an animal that is genetically identical to the original donor.

Matoba and his colleagues used a similar method. Once they had a glut of these cloned cells, they treated some with Y-CUT before transferring them to surrogate mice to carry the pregnancies.

This allowed them to create female clones of male mice. The females are genetically identical to the original male, apart from the missing Y chromosome, says Matoba. “It’s like sci-fi,” says Ishiuchi.

In other experiments, the scientists were able to create female clones from male cells that had been cryopreserved—and the cloned males and females could mate to produce healthy pups. This suggests the Y-CUT approach might allow scientists to create female clones from male samples in “frozen zoos” that store cryopreserved cells and tissues from a range of animal species.

It could have uses beyond conservation efforts, too. “This could be used potentially for producing genetically engineered animals,” says Ward. Creating an animal with multiple genetic edits can be time-consuming and expensive; creating male and female clones of that animal could help scientists time and money. Ward also hopes the technique could be a useful tool to study the biology of sex chromosomes.

Complementary techniques

The Y-CUT approach isn’t perfect. For now, it still requires hollowed-out egg cells, which need to come from females of the same species or at least a closely related one. And it won’t be useful for endangered species in which only females survive.

The technique works well in mice, partly because XO female mice are fertile. But while the approach might help some of the 355 endangered and vulnerable species of rodents, other mammals with XO chromosomes tend to experience infertility.

But other new technologies could complement Y-CUT. In 2023, Katsuhiko Hayashi of Osaka University and his colleagues showed they could turn cells taken from male mice into egg cells. This enabled them to create mice with two dads—but the same approach could also provide the hollowed-out egg cells needed for the Y-CUT technique. “It’s a complementary story,” says Matoba.

Ishiuchi is also working on a technique that involves inserting a second X chromosome into cells, which might restore the fertility of the resulting female animals.

In addition, there might be a work-around for situations where scientists have females but need males. A couple of months ago, Sayaka Wakayama of the University of Yamanashi in Japan and colleagues showed they could insert rat chromosomes into mice. That could potentially be used to create XY male embryos, says Novak.

That would be useful in cases like that of the black-footed ferret, he adds. A conservation team recently cloned a female ferret using cells taken from another animal in the 1980s. That female is considered incredibly valuable, says Novak. But females can produce only a few litters in their lifetime. A male clone, which might be able to contribute to dozens of litters in a lifetime, would be “desirable.”

“It’s really exciting to see more diverse tools being developed,” says Novak. “There are so many different scenarios in which they could be used for rare and endangered species.”

Kris DeVault is desperate.

His son, Brody, was born in March 2023. It wasn’t long before he started to show signs of developmental delay, says DeVault. As time went on, Brody started missing key milestones in speech, movement, and coordination, he says.

When Brody was around two and a half years old, a genetic test revealed creatine transporter deficiency—a rare condition in which the brain and muscles lack the energy they need to develop.

There are no cures for Brody’s condition. But DeVault has learned of a company developing a drug that might help. That drug is still in the early stages of development and has only been tested in animals and a small number of healthy adults. Doctors can’t prescribe it.

DeVault knows the drug might not work. But he’s doing all he can to access it regardless. And a new law in Montana could make it easier for people in his position to get access to treatments—at least in theory.

Today, Brody is three years old. His dad describes him as a happy, curious, and loving little boy who wants to learn. But Brody struggles to communicate. “He’s got no words, really,” says DeVault. “He wants to communicate more than he’s able to … which then turns into frustration.”

It’s difficult for Brody to tell his parents whether he’s hot, cold, hungry, thirsty, uncomfortable, or even in pain, says DeVault. He recently found Brody standing on an anthill in the backyard, being bitten by red ants. “These fire ants were just going to town on his feet … and he was just looking,” he says.

Brody has muscle weakness too. “He can’t move very fast, he doesn’t have a ton of strength … and it takes a lot of energy for him to walk balanced,” says DeVault. “His arms are skinnier than [those of] his nine-month-old sister.”

It’s concerning, but DeVault is most worried about Brody’s neurological development. Toddlers’ brains are exceptionally “plastic”—the first years of a child’s life are thought to be crucial for long-term brain development.

A biotechnology company in France is working on a drug to help people like Brody. Creatine usually provides brain cells with energy. People with creatine transporter deficiency (CTD) can’t get creatine into the brain.

The team at Ceres Brain Therapeutics is developing a treatment designed to bypass this issue and effectively deliver creatine directly to the brain. So far, the team has seen promising results in mice, says Ceres CEO Thomas Joudinaud.

The company also recently completed a phase I clinical trial that involved testing various doses of the drug, which is delivered as a nasal spray, in 48 healthy adult volunteers. That trial has not yet been published, says Joudinaud. The drug has not been tested in people with CTD, or in children.

“I look at this, and I’m like, that is my one shot for Brody,” says DeVault.

Joudinaud is planning a phase II trial in people with CTD, as well as others with amyotrophic lateral sclerosis. But that trial will take place in France, and it’s unlikely that Brody will be able to take part, says DeVault.

Ceres can’t make the drug available to Brody under an expanded access scheme run by the US Food and Drug Administration either, because the drug has not been registered with the FDA, and because it is currently manufactured in a way that does not comply with FDA regulations, says Joudinaud.

Even if that phase II trial is successful, and if the drug is ultimately approved, it is unlikely to reach the US market for at least a few years. DeVault is worried that will be too late for Brody—he’ll be “past his plasticity window” by then, he says.

Now, with the adoption of a new law in Montana, he theoretically has another option. Montana has had a “right to try” law—which allows terminally ill people to apply for access to unapproved drugs—in place since 2015. In 2023, a new law technically expanded this option to people who were not terminally ill, providing the drugs have been through preliminary phase I clinical trials. A second law aimed to clarify how clinics could sell and administer those treatments to patients. And last weekend, the state’s department of Health and Human Services finalized a set of rules for those clinics.

An experimental treatment review board (ETRB) has been established to review applications for access to experimental, unproven, and unapproved drugs. And it is set to review its first two applications in the coming weeks.

Ceres could also apply to Montana’s ETRB to sell its experimental treatment to Brody’s parents via a clinic in the state. But Joudinaud is reluctant, at least for the time being. While he thinks that Montana’s setup is “very interesting and very pragmatic” and “suitable for our drug,” he’s worried about getting on the wrong side of the FDA.

DeVault has been pleading with FDA staffers for a written statement essentially promising that biotech companies participating in Montana’s program won’t be penalized later on, especially when they eventually try to get their drugs approved in the US. But he hasn’t made any progress.

Now he’s looking beyond Montana. He’s considering accessing treatment in Próspera, a private city and “special economic zone” in Roatán, Honduras, where a clinic sells unproven stem-cell and gene therapies, among others.

Many scientists have cautioned against the use of such “offshore” clinics. Even when it comes to Montana, scientists, bioethicists, and health law experts will caution that phase I clinical trials don’t prove a drug is safe. And they certainly don’t prove a drug’s efficacy, either.

When I spoke to Aaron Kesselheim, a professor of medicine at Harvard Medical School with expertise in health policy and drug regulation, about the Montana law earlier this week, he made his concerns clear. “Patients who want these kinds of treatments deserve them to be rigorously assessed so that [they] can better understand what they’re getting themselves into, and what they’re paying their hard-earned money for.”

But DeVault pushes back on these arguments. “I’m a full-grown human being,” he says. “I’m capable of going to Vegas right now … blowing it all on the poker table, [or] I can go to the gun shop and buy a silenced [semi-automatic rifle] … how come I can’t make a decision to purchase a potential treatment that might change the entire trajectory of my son’s life?”

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.

As of this week in Montana, any biotech company with an experimental drug has a clear path to selling it to consumers. Companies whose drugs have been through preliminary testing—sometimes in as few as 10 healthy people—can pay $12,500 to apply to a newly established review board for approval. Once its treatment is rubber-stamped, the company can set the price of the drug and sell it via experimental treatment clinics, the first of which is likely to be up and running around the end of this year.  

Montana’s latest right-to-try legislation is unique. While other jurisdictions with similar laws limit access to drugs to people with terminal illness, in Montana access is theoretically available to anyone who gives informed consent and can pay. That includes people desperate for treatments for rare diseases. It also includes those who are interested in longevity and want to try out drugs pitched as preventive therapies.

The state’s Department of Health and Human Services recently finalized rules to implement the law. The rules stipulate that patient consumers provide fully informed consent and that each application be reviewed by a board that includes a Montana-certified doctor, expert scientists, and an ethicist. Supporters of the law stress that they want the process to be responsible. “It will be done in a very rigorous way, with qualified medical professionals and appropriate oversight,” says Matt Kaeberlein, a scientist on the first board, which was formed independently of the state health department.

But other experts are worried about the potential for harm in selling unproven treatments to people without oversight from the US Food and Drug Administration. “I would be concerned,” says Aaron Kesselheim, a professor of medicine at Harvard Medical School with expertise in health policy and drug regulation.

There has been a growing movement to make unapproved drugs more accessible in the US. But the story of Montana’s law is unique. It’s been driven and drafted by longevity enthusiasts instead of the usual libertarian and patient groups.

An unusual origin story

Montana first passed a right-to-try law in 2015. In 2023, with the support of state senator Ken Bogner, the state expanded the law to include all patients, not those just with terminal disease. Last year, Bogner told MIT Technology Review that his vision was to focus “more on preventative medicine” rather than “just treating diseases once they show up.”

Bogner says he had “started working on a bill” that would become the 2023 law when the Alliance for Longevity Initiatives (A4LI), a nonprofit “dedicated to advancing legislation and policies aimed at increasing healthy human lifespan,” got in touch. A4LI connected Bogner with others who helped draft the bill and testified in support of it.

Once that law was in place, the tech entrepreneur and longevity enthusiast Niklas Anzinger got involved. Anzinger has been working to establish a jurisdiction to fast-track the search for drugs that might deliver radical life extension. He is based in Próspera—a private city and “special economic zone” in Roatán, Honduras, which is already home to a separate clinic that sells experimental stem-cell and gene therapies. Anzinger founded a community there called Infinita City; he has also founded an investment company and a “service providing” company, both of which include the name Infinita.

Over the last couple of years, Anzinger has switched his focus to the US. “Now we think that Montana is a better model, because it’s building on … existing regulatory precedents,” he says. Once Montana’s 2023 law was passed, he adds, he worked with a handful of unnamed biotech companies to draft a second bill—one that laid out the specific terms under which clinics can offer unapproved drugs. That law was passed in April 2025 and adopted the following month.

Since then, Anzinger, Bogner, and others have been waiting for the state’s Department of Health and Human Services to finalize specific rules for treatment centers—a set of operational guidelines and requirements that any clinic offering treatments unapproved by the FDA must meet under Montana’s law. “The rules have been taking a very long time,” says Anzinger. “Then on Friday, we heard they were effective … from Saturday [July 25].” The rules have since been published online.

Following the rules

With the new rules in hand, Anzinger and his colleague Stephen Martin, Infinita’s US lead, got to work. The first step was to establish an independent experimental treatment review board—a panel of five experts to evaluate applications for access. Anzinger and Martin started recruiting candidates months ago.

The state’s first board, named the Montana ETRB, was officially announced by Infinita earlier this week. For the time being, it is the state’s only review board, although Anzinger says that other groups are free to establish their own. After Bogner raised concerns that the board’s website wrongly implied that it was an official state body, the site was updated to note that “It is a private service run by Montana Governance Services Inc.” That company is “a local Montana registered entity, but it is under the Infinita umbrella,” says Anzinger. 

Infinita will pay board members a flat fee, funded by the $12,500 companies will have to pay to have their applications reviewed. Anzinger stresses that the board members, and their decisions, will be independent of Infinita.

In accordance with the rules, the board includes a Montana-licensed doctor: James Burke, an oncologist. It also includes a bioethicist: Jessica Flanigan, a libertarian who is known for her strong views in support of self-medication and her book Pharmaceutical Freedom.

The other three members are familiar faces in the longevity community—all of whom are well respected in the field. “When we looked at our own network, these were some of the best guys,” says Martin. They include Felipe Sierra, who formerly held a senior role at the National Institutes of Health’s arm focused on aging. More recently, Sierra served as chief scientific officer at Hevolution Foundation, a nonprofit that funds research into extending healthy lifespan with the support of the government of Saudi Arabia.

Matt Kaeberlein, who formerly led the Dog Aging Project and has studied the potential for rapamycin as a longevity therapeutic, also features. So does Jamie Justice, a gerontologist who is also executive director of the X Prize Healthspan competition, which has $101 million in prize money up for grabs for researchers who find ways to treat the signs of aging.

“I saw an opportunity to help build a safe, transparent, and scientifically rigorous process for implementing Montana’s newly expanded right-to-try legislation, particularly as it applies to longevity medicines and aging-related interventions,” says Justice. “Science is moving quickly, and I wanted to help ensure that as it develops, it does so with real rigor and accountability.”

Kaeberlein, who has a prominent media presence, has long raised his own concerns about access to other unproven treatments, including peptides and stem-cell therapies. He sees Montana’s setup as offering a more regulated environment—one that offers scientific oversight, ensures informed consent, and allows for data collection.

Applications incoming 

While many of the bill’s original supporters were interested in longevity, the initial interest in making drugs more accessible in Montana is coming from companies and individuals looking to treat specific diseases.

“We were actually surprised that much of the interest … is actually more from oncology [and] neurodegenerative disease,” says Anzinger. This focus, he says, is “very compatible” with Infinita’s mission. “We’re not trying to convince everyone … to support radical life extension,” he says. Anything that extends health and human life, including treating cancer and neurodegenerative disease, is part of what longevity means to him, he says.

Martin says that two applications have already been submitted to the newly formed review board. They’ve come from biotech companies that are developing drugs for neuropathy and hearing loss, he says. “I expect we’re going to get started on them this week,” he says.

One of the applications was submitted by Stanley Kim, CEO of WinSanTor. His company is developing a treatment for peripheral neuropathy, a painful nerve condition that can be a consequence of cancer treatment or diabetes. The drug is currently in phase II trials, but Kim says he regularly receives messages from people who are desperate to access it, to the point of being suicidal. He hopes that not only will he be able to make the drug accessible to those people, but he’ll also be able to collect data from them—data that might help accelerate the drug’s approval process.

“We have a newsletter [that is sent to] around 15,000 patients,” says Kim. “Not all of them will be able to go to Montana, but many of them, I think, will.” His company still plans to continue with regular clinical trials as well.

But not all biotech companies with early-stage drugs feel comfortable submitting an application—at least not yet. Thomas Joudinaud, CEO of a French biotechnology company called Ceres Brain Therapeutics, has fielded a request from a person keen to access the company’s experimental drug in Montana. He says that while Montana’s system is “very interesting and very pragmatic” and “suitable for our drug,” he won’t be submitting an application for the time being. He is concerned that if anything goes wrong in Montana, it may jeopardize the company’s standing with the FDA, which wields the power to approve or reject the sale of its treatments to broader populations.  

Martin and others have asked the FDA for some kind of assurance that biotech companies participating in Montana’s program won’t be penalized later on. But the agency hasn’t provided them with more than a restatement of the federal Right to Try Act.

“As a matter of policy, the FDA does not comment on state legislation,” an FDA spokesperson wrote in response to a request for clarification from MIT Technology Review.

Even if the FDA were to provide some kind of assurance, it wouldn’t necessarily protect biotech companies in the long term, cautions Chris Robertson, a specialist in health law at Boston University. The FDA’s position could change with a new presidential administration, he says: “I wouldn’t bet on anything that the FDA is saying today being applicable when the rubber hits the road later.” 

Companies that want to stay on good terms with the FDA would be safest taking the expanded-access route, says Robertson. That’s the pathway the FDA already uses for people who are seriously or terminally ill, have run out of options, and want to try experimental drugs that have not yet been through clinical trials. The FDA approves over 99% of these applications, says Harvard’s Kesselheim. 

“The FDA isn’t a bottleneck but in fact exists to help ensure that expanded-access programs are aboveboard and that patients who receive [the drugs] are able to contribute knowledge about [them],” says Kesselheim. He says he doesn’t think that any “legitimate manufacturer” should fear having to go through the FDA’s expanded-access process, which the agency says takes “less than 45 minutes” to fill out.

The cost of experimenting

There are some key differences between expanded access, which allows seriously ill people to apply for access to experimental drugs that might not have been through any human trials, and Montana’s approach. In theory, a person doesn’t need to be seriously ill to access experimental drugs in Montana. 

“In Montana, patients may be eligible for preventive or earlier-stage interventions if they provide informed consent and meet the program’s requirements, so the breadth of potential therapies and situations is much broader,” says Kaeberlein, the Montana ETRB member, who is an affiliate professor at the University of Washington in Seattle.

Kaeberlein also highlights another key difference, which is cost. Companies that make their treatments available through expanded access are only able to charge for the costs of making, transporting, and monitoring the drug, and they must justify the eventual price to the FDA. In Montana, they can charge whatever price they want. Stanley of WinSanTor says he plans to sell his drugs “at cost.” But Ceres’s Joudinaud says that he’d be more interested in selling his at a market price. When asked what that might be, he hinted that the prices of new drugs for rare diseases can be high. In recent years, the median price of such drugs was $218,872. 

“Instead of simply creating a legal pathway for patients, it also creates a business model that companies may actually be willing to use,” says Kaeberlein.

Beyond the financial cost, there will be risks associated with any experimental drug. Phase I trials don’t conclusively reveal whether a drug is safe. Around 17% of drugs are found to be inadequately safe during phase III trials. “The idea that a drug has been proven safe because it’s been subject to a phase I study is very, very wrong,” says Kesselheim. Bioethicists have raised concerns about the ethics of promoting and selling unproven treatments and the risk of harm should something go wrong.

But the moment when people start spending money on these treatments is already fast approaching. While Montana’s first ETRB prepares to review its first applications, clinics that hope to be part of the program are busy addressing the requirements laid out in the state’s new rules. Treatment rooms are being outfitted. Medical directors are being hired. And experimental treatments should be reaching patients in the coming months.

This week, I covered a fascinating effort to preserve organs outside the body. There’s a huge shortage of donor organs, and one of the main reasons is time—they survive only a matter of hours outside the body, even when they’re kept on ice.

Doctors dream of organ banks—stores of human organs that can be preserved for days, weeks, months, or even longer. That would allow them to run tests on organs, find the best matches for them, and transport the organs to those recipients.

In new research, one team has been able to supercool the kidneys of pigs—animals whose organs are of a similar size to human ones—and preserve them for days. The kidneys survived being stored at −4 °C (25 °F) and eventually reimplanted back into pigs. And that’s just the latest development in a field that is positively buzzing.

It has proved super difficult to freeze organs. Once ice forms in them, they’re done. The ice crystals create all kinds of damage and render the organs unusable. That hasn’t stopped many researchers from trying.

Some have focused on cryopreservation—rapid extreme cooling that essentially leaves cells in a glasslike state. This process is now routine for eggs, sperm, and embryos, which are cooled to −196 °C in less than two seconds and can be used even after decades in storage.

No one has managed to cryopreserve and thaw human organs for transplantation. But plenty of human bodies and brains have been stored at ultra-low temperatures in the hope that they might one day be rewarmed and brought back to life. (You can read more about why some people opt for cryonics here.)

In March, I wrote about Stephen L. Coles, a gerontologist who had opted to cryopreserve his own brain. After the scientist died in 2014, his body was taken to Alcor, a cryonics facility in Arizona. A team at the facility removed Coles’s head, perfused his brain with cryoprotective chemicals (which work like antifreeze), removed the brain from the skull, and cooled it to −146 °C.

When Coles’s friend Greg Fahy, a cryobiologist, studied pieces of his brain years later, he found that the brain cells, which had shrunk, “bounced back” once they were rewarmed. But that doesn’t mean the cells are alive, or that it might one day be possible to reanimate the brain. As Matthew Powell Palm of Texas A&M told me at the time: “There are so many ways those neurons could be toast.”

Powell Palm is working on other ways to preserve organs. It was he, along with his colleagues, who managed to store supercooled pig kidneys and successfully transplant them, in a study described as “a landmark achievement.” Those organs did better than kidneys stored on ice, he says.

His approach didn’t require cryoprotectants. But other teams are exploring potential chemical cocktails that might allow them to store organs at lower temperatures, potentially for longer periods of time. (More on this in The Checkup soon!)

Another way to prolong the lifespan of an organ is to use a machine that perfuses it with nutrients, mimicking what happens inside the body. Machine perfusion devices have become more commonly used over the last decade or so and are typically used to maintain livers and kidneys for up to about 24 hours.

Researchers are now adapting this protocol for a growing list of organs, even eyeballs—a recent feat that might enable whole-eye transplants. In March, I went to visit scientists in Valencia who had developed a perfusion system for uteruses. They had used their device—which they nicknamed “Mother”—to keep a human uterus alive for a day.

It’s an exciting time for organ preservation. Keep an eye out for more coverage from MIT Technology Review in the coming weeks.

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.

When it comes to organ donation, time is everything. As soon as an organ has been carefully removed from a donor’s body, it starts to deteriorate. Surgeons have a matter of hours to get it into a recipient. Leave it too long and the organ will become unusable.

In most cases, organs will be kept on ice during that time, at around 4 °C (39 °F). They cannot be frozen—in previous attempts, ice has formed, causing all kinds of damage.

Matthew Powell Palm at Texas A&M University and his colleagues have an alternative solution—a device that allows organs to be cooled to -4 °C (25 °F) without forming any ice.

Now, in new research with pig organs, his team has shown that kidneys, at least, can be supercooled and preserved in the device for days. Once rewarmed, the organs have been successfully transplanted into animals, and they seem to do better than organs kept on ice.

The work represents “a landmark achievement,” says Kevin Myer, president and CEO of LifeGift, an organ procurement organization based in Texas, who was not involved in the research.

Cooling organs

Powell Palm hopes this approach could ultimately help ease the organ shortage crisis. Today, there are more than 104,000 people waiting for a kidney transplant in the US alone. It is estimated that 17 people die every day in the US while waiting for a transplant. That’s partly due to a lack of donated kidneys, but it’s also because many of those that are available never make it to a recipient. In some years, around one in three donated kidneys end up being discarded, often because they end up too degraded to use by the time they reach a recipient. Kidneys can be stored on ice for around 24 hours or placed in devices that aim to mimic the conditions of the body, also for up to around 24 hours. That’s not always long enough to find a suitable recipient and transport the organ, says Myer.

Scientists around the world have been working on ways to store organs for longer by cooling them to even chillier temperatures. Cooling an organ slows its metabolism—the colder you go, the greater the effect, and the longer you can store it.

We’ve long been able to successfully cryopreserve eggs, sperm, and embryos, but it’s much harder to freeze large organs. Teams have been exploring various temperatures and cryoprotectants (chemicals that essentially work like antifreeze), but so far no one has been able to freeze human organs for transplantation.  

As a thermodynamicist, Powell Palm explored another approach. By keeping an organ submerged at a constant pressure, it should be possible to prevent the formation of ice at temperatures a little below 0 °C, without the need for cryoprotectants (which might have side effects and would need to be approved before being used in human transplants). 

To test this theory, Powell Palm and his colleagues have created a device that does just that. The device itself is essentially a hermetically sealed chamber with a transparent lid. At its base is a device that monitors the organ’s temperature and checks for the formation of ice. Organs are submerged in a solution that is already commonly used to preserve them for transplant. “I always describe this as low-tech high science,” says Powell Palm. “A lot of work has gone into understanding the … kinetics at play in this system, but ultimately … it’s quite simple.”

Supercooled kidneys

To test their device, Powell Palm and his colleagues first removed single kidneys from pigs. The organs were flushed with the same commonly used solution to remove the blood, just as transplant organs are. The team then kept some kidneys on ice for either two hours or 24 hours, to mimic standard conditions used in human transplantation. They also put some of the removed kidneys in their device for 24, 48, or 72 hours.

The stored kidneys were then each transplanted back into the original donor pigs. Each pig’s second kidney was removed in the same procedure, leaving each animal with only the kidney that had been stored, and reimplanted.

Once the 24-hour supercooled kidneys were transplanted, they immediately began producing urine—a key indication that they were working. The team members also measured other markers of kidney function and found that the organs appeared to be working normally within about 10 days of being transplanted.

That’s slower than kidneys stored on ice for two hours but much quicker than kidneys kept on ice for 24 hours, says Powell Palm.

The organs that were kept supercooled for 48 and 72 hours performed similarly, he says. “Even at three days—triple the clinical standard—we’re getting recovery that is faster than … [what has been] the gold standard for the last three decades,” he says. “So we’re really, really pumped about this.”

“It is impressive,” says Heidi Yeh, a transplant surgeon at Mass General Brigham for Children, who also researches organ preservation technologies. “Often kidneys that have been stored for 48 hours [in other studies] take a week or two before they start working again.”

Organs that grow

The supercooled organs seem to work well in the long term, too. Over a 30-day period, the pigs grew by around 30%—and the kidneys grew with them, almost doubling in size to compensate for both the pigs’ growth and the lack of a second kidney. The team monitored one of the pigs for 200 days before removing and analyzing its kidney. Even at that point the organ looked healthy, says Powell Palm. He and his colleagues presented the findings at the American Transplant Congress in Boston last month.

Earlier this year, researchers in Canada showed they could also cool pig kidneys to below-zero temperatures and transplant them into pigs. The team’s protocol included the use of a cryoprotectant, and organs were stored for up to 48 hours before being transplanted into pigs. Those organs survived for a week.

A couple of years ago, another team presented research in which they preserved pig kidneys for 72 hours at subzero temperatures using cryoprotectants, and successfully transplanted them.

In supercooling organs for 72 hours without cryoprotectants and showing that they do well for 30 days or more, Powell Palm and his colleagues claim to have broken new ground. “It’s the first time this has ever been reported in history,” he says.

Those extra hours could make all the difference, says Myer of LifeGift. The advance could give doctors more time to evaluate the kidneys, match them to the most suitable donors, and physically get the organs to their intended recipients in time. It could enable international donations and open up cheaper transport options, he adds. “Right now, with kidney transplantation the assumed limit is 18 to 24 hours,” he says. “If we can get up to 72 hours … that would change everything.”

Powell Palm and his colleagues think they may even be able to go beyond 72 hours. In preliminary studies, organs that had been stored for up to 120 hours appeared healthy, although those organs have not yet been transplanted.

And because the process doesn’t require any cryoprotective chemicals, the team members are hoping for an accelerated approval from the US Food and Drug Administration, which would allow them to test the device in human transplantations.

The storage device is simple and compact, so Powell Palm thinks it will be easy to transport. It hasn’t been tested for air travel yet, but it has been used to take supercooled kidneys across the US in the back of a Kia Sorento, he says: “From a stability perspective, we view this as an even higher bar.”

Powell Palm and his colleague Sebastian Giwa plan to launch a company dedicated to developing the technology, along with other protocols that “stop biological time,” in the coming months, he says.

Correction: This article has been updated to add that another team has successfully transplanted pig organs preserved for 72 hours at subzero temperatures using cryoprotectants.

Perimenopause has entered the chat. Perimenopause—and its better-known relative, menopause—used to be considered taboo. Not anymore, thanks at least in part to TV doctors and social media influencers. Perhaps it’s my age, but these days, both my algorithm and my conversations with friends increasingly swing toward perimenopause.

Menopause is defined as the life stage that occurs a year after a person has had their last period. Perimenopause is the sometimes years-long period before that point, which can also feature all the symptoms we’d typically associate with menopause.

Today, information about perimenopause is more prevalent and accessible than ever. If you’re a woman in your 40s and you’re not feeling 100%, chances are there’ll be someone online ready to tell you you’re in perimenopause. And that you might want to start spending your money on blood tests, apps, and supplements or demanding hormone replacement therapy. But as regular readers might have guessed by this point, it’s not that simple.

Perimenopause tends to start around the age of 46 or 47. It’s during this time that many women start to experience some symptoms like hot flashes, irregular or unusually heavy periods, or anxiety, for example. And it can be heavy going. “Often symptoms are at their worst in the perimenopause,” says Mary Ann Lumsden, former president of the International Menopause Society.

That’s because hormones can fluctuate wildly. Levels of estrogen, progesterone, luteinizing hormone, and follicle-stimulating hormone can roller-coaster before leveling off after menopause. And that’s why, despite what some marketers will claim, there is no test for perimenopause.

“You can’t interpret hormone [measures] because they change so much,” says Lumsden. “And that is quite normal.”

That doesn’t mean women should have to put up with symptoms. But exactly how those symptoms are treated is another topic that has been clouded by misinformation.

Last week, I told a friend about some unusually bad pelvic pain I’d experienced. Her immediate advice was to find out if I was perimenopausal and, if I was, to request hormone replacement therapy (HRT) as soon as possible. If my doctor wouldn’t prescribe it, she continued, I should simply find another doctor who would.

This line of thinking has been heavily promoted on social media platforms, says Paula Briggs, a former chair of the British Menopause Society who currently leads the menopause service at Liverpool Women’s Hospital. But it’s not helpful.

HRT is essentially designed to top up or replace hormones like estrogen and progesterone, which naturally decline around menopause. There are lots of different drugs that can be taken in lots of different ways and at various doses.

While it does come with some risks and won’t suit everyone, HRT can be immensely helpful for many menopausal women. Not only can it help with many of the common symptoms of menopause, but it can also help prevent osteoporosis and maintain muscle strength.

But these drugs were trialed in, and approved for, menopausal women, says Lumsden. They won’t have the same effects in perimenopausal women. “If you give standard HRT, it may well get swamped by [the woman’s] own hormone production,” she says.

HRT can also cause abnormal bleeding in perimenopausal women, says Briggs.

She’s concerned about the messaging on perimenopause that is being promoted on social media. Particularly worrisome, she says, is the way younger women are being encouraged to assume they are perimenopausal and seek out HRT treatment.

“It’s almost cult-like, this idea that everybody must have HRT,” she says.

And then there are the supplements. There’s been an explosion in marketing for vitamins and supplements specifically targeted to middle-aged and menopausal women. But the evidence for these, too, is either limited or nonexistent. “I can’t see a mechanism for a lot of them,” says Lumsden.

Women who take these supplements don’t always know what they’re getting. Some of Lumsden’s patients have told her they take testosterone supplements to manage their symptoms. But blood tests revealed no increase in testosterone levels. “Whatever they’re getting, it’s not testosterone,” she says.

At any rate, not all the symptoms women experience in midlife can be blamed on hormones. The lengthy lists of perimenopause symptoms shared on social media include fatigue, brain fog, aches and pains, digestive issues, and more. “These do not link closely to the obvious menstrual cycle changes and hormone changes … across menopause,” says Nanette Santoro, a professor of obstetrics and gynecology at the University of Colorado Anschutz who studies menopause.

If you’re experiencing any symptoms, it’s worth getting them checked out to make sure they’re not being caused by something else. My own pelvic pain, for example, is almost definitely the result of endometriosis—a condition that can be made worse by HRT, Lumsden tells me.

At any rate, by the time women reach their 40s, many are already juggling care for children and aging parents, often while holding down a job (and dealing with pressures from societies that don’t appear to value older women). It’s an exhausting time—and not all of that exhaustion can be blamed on hormones.

As Santoro puts it: “Attributing everything unpleasant that happens to a woman over 35 to perimenopause is not based on any scientific evidence.”

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.

Ties van der Meer doesn’t know how many siblings he has.

The 47-year-old was conceived at a private fertility clinic in the Netherlands using sperm provided by an anonymous donor. After the Netherlands banned anonymous donation in 2004, the doctor who ran the clinic destroyed records that might have identified those donors, he says.

He describes the situation as “problematic.” Children have a right to know their biological parents, he says. While he did ultimately track down one sibling, who helped him identify his father along with other genetic relatives, he may have others he’ll never find.

Other donor-conceived people who have been able to track down siblings have found they have tens or even hundreds of them. One donor-conceived woman who found 25 half-siblings over the course of seven years told the Guardian, “It does make you feel a bit mass-produced.”

We need international limits on the number of children a single donor can contribute to, a European fertility organization argued yesterday. At a conference in London, members laid out plans to start with a Europe-wide limit.

Today many countries, including the UK, have banned anonymous egg and sperm donation. But anonymity can’t be guaranteed even in places where it is technically allowed. Genetic tests offered by companies like Ancestry and 23andMe, along with genetic registries, have made it much easier for donor-conceived people to find parents and siblings who share their genes.

And because sperm can be frozen and stored for years before it is eventually used, the current set-up can result in situations where donor-conceived people discover the identity of a genetic parent only after the person’s death. They might also find that they have siblings of very different ages, all around the world.

Some people are finding hundreds of siblings. Sperm from Jonathan Meijer, a Dutch man who began donating in 2007, was used to conceive between 550 and 600 children. (Stichting Donorkind, a foundation and advocacy group for donor-conceived people that’s chaired by van der Meer, took him to court, and he was ordered to stop donating in 2023.)

Stories like these can be distressing for donor-conceived people. And there are other reasons why limits are considered important. The offspring of a prolific donor might be at risk of unknowingly forming romantic or sexual relationships, for instance. And some people are concerned that a donor with a harmful genetic mutation might pass that down to many children.

This is unlikely, given the level of screening that most donors undergo. But it has happened. A man who donated his sperm to a sperm bank in Denmark was found to have a genetic mutation that significantly increased the risk of multiple cancers. But his sperm had already been used to conceive at least 197 children across Europe. Some of those children developed cancer. Some died.

Many countries already have legal limits for donors. In Malta and Cyprus, for example, both egg and sperm donors are allowed to contribute to the birth of just a single child, according to data presented at the European Society of Human Reproduction and Embryology (ESHRE) meeting in London on July 8.

Other countries set limits based on the number of families a single donor can contribute to, allowing recipients to have children who share a genetic link. In the UK, that limit is set at 10 families per donor.

But these limits are difficult to enforce, partly because donated gametes don’t necessarily stay in their original country. In Denmark, the national limit is set at 12 families. But the country is a major exporter of sperm. In the UK, for example, more than half of sperm donations in 2020 were imported—with most of those coming from either Denmark or the US.

“The only thing that really makes sense is a transnational limit,” Jackson Kirkman-Brown, a professor of reproductive biology at the University of Birmingham, said at the meeting.

Kirkman-Brown and his colleagues have spent months putting together a document that represents ESHRE’s position on these limits. After consulting with fertility specialists, clinics, sperm and egg banks, donors, and donor-conceived people, the team has developed a plan to start with a Europe-wide limit on sperm and egg donations.

ESHRE is calling on sperm and egg banks, as well as fertility clinics, to respect an initial limit of 50 families per donor. That’s still very high, according to a handful of people I spoke to at the meeting. But at least it’s a start.

Europe should move toward setting limits at 15 families per donor, Kirkman-Brown said. “We may find that 15 is also too high,” says Vasanti Jadva, who studies the psychological well-being of people conceived using donated eggs, sperm, and embryos at City St George’s in London. “We still don’t know what the right number is.”

It will be difficult to enforce these limits, too. And if they end up limiting the supply of donor sperm, there’s a chance that some people will turn to unregulated sperm donations from people who do not undergo health screening. Unregulated donations can lead to other problems for prospective parents, including the possibility that donors will seek parental rights over the children conceived using their sperm.

And it will be even harder to establish international limits. When I asked the American Society of Reproductive Medicine for its thoughts on ESHRE’s proposed limits, a representative directed me to a guidance document saying “it has been suggested” that for a population of 800,000, single donors should be limited to “no more than 25 births” in order to avoid the risk that relatives will have children together. (Considering the US has a population of over 340 million, the total figure could be pretty high, but many sperm banks opt to limit the number of families contributed to by a single donor at around 25.)

Van der Meer thinks that even a limit of five families from a single donor would be high. International donation makes it even harder for donor-conceived people to connect with genetic relatives, so the limit for international contributions should be set at two families, he says.

Still, he thinks ESHRE’s suggested limit is a “positive first step.” Van der Meer has managed to track down a sibling, his father, and nephews, aunts, and uncles. He hopes that future policies respect the rights of donor-conceived children to know, and be in contact with, their genetic relatives.

“But,” he says, “you have to start somewhere.”

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.

It’s not easy to transplant a whole human eye. The surgery is difficult. And the eyes themselves start to degenerate as soon as they’ve left the body. When surgeons attempted it a few years ago, the newly transplanted eye wasn’t able to see.

But researchers believe they might have a solution: a device that maintains and revives freshly removed eyeballs using a technique called perfusion. Perfusion works by providing surgically removed organs with some of the oxygen and nutrients they typically get when they’re inside a body. Treated eyes don’t degrade as quickly; they also appear to retain the ability to transmit electrical signals and potentially see. The device could one day make eye transplants a viable possibility.

“It’s really cool,” says Shannon Tessier at Massachusetts General Hospital, who was not involved in the research but studies perfusion of other organs. “It could be a new frontier for retina preservation.”

Pia Cosma at the Centre for Genomic Regulation at the Barcelona Institute of Science and Technology in Spain and her colleagues have spent years developing their device. The Eye-in-a-Care-Box (ECaBox), as they call it, delivers an oxygen-rich supply of fluid through the artery that normally supplies the eye with blood.

The eye itself sits on a “bed,” and excess fluids are drained away. And while the device is sealed to maintain a specific temperature and pressure, a clear window on its side allows researchers to study and image the eye while it’s inside.

Cosma and her colleagues started experimenting with pig eyes, which are anatomically similar to human eyes but easier to get hold of (the team got theirs from a local slaughterhouse).

Pig eyes that are kept at room temperature outside the device start to degenerate pretty quickly. The team found that cells in the eye shrank, and the eyes started to lose their structure. Cooling the organs didn’t help preserve them, either—the eyes degenerated within 24 hours even when they were kept at 4 °C (39 °F).

But eyes kept in the EcABox fared much better; 24 hours later, tests suggested the prefused eyes were “significantly more viable” than eyes that hadn’t been maintained in the device.

The perfused eyes also seemed to be able to respond to light, suggesting they might technically be able to see if they were transplanted. Untreated pig eyes lost this ability as soon as they were removed from the animal. But it came back after about 15 minutes of perfusion, according to the scientists behind the work. A few of the treated eyes kept going for 10 hours or more.

Cosma and her colleagues described the work in a preprint article that has not yet been peer-reviewed and did not want to comment on the work.

After success with the pig eyes, the team members then tested their device on human eyes. They first collected 12 eyes from six people who had died. In each case, one of each pair of eyes was put in the device, while the other was not. Again, the perfused eyes did better—and their retinas were preserved.

Cosma and her colleagues hope that their device could offer scientists a new way to study eye treatments—one that doesn’t involve experimenting on living animals. They also hope that with some improvements, the ECaBox might provide a way to maintain and revive donated human eyes for whole-eye transplantation.

Whole-eye transplants have been attempted in the past, mostly in research animals, with limited success. In May 2023, a team at NYU Langone transplanted an eye along with part of a face to a man who two years earlier had survived a high-voltage electrical accident that resulted in the loss of much of the left side of his face, including his left eye Although the man recovered well, he wasn’t able to see out of the transplanted eye.

We won’t know whether eyes treated in the ECaBox could do any better until they have been transplanted, says Tessier. 

In the meantime, Cosma and her colleagues plan to use a newer version of their device to collect more human eyes for research. “We are planning to develop a portable, surgery-room ECaBox to minimize [degradation] in heart-beating donor eyes, when they become available,” they write.

As the parent of two little girls, I often think about how their childhood is different from mine. The seven-year-old is learning about AI at school. The five-year-old is given internet-based homework every week. And they are both absolutely repulsed by the idea of smoking.

That was not the prevailing sentiment when I was young. My parents smoked. The customers at our family’s restaurant smoked. Cartoon characters smoked. My friends and I would buy little cigarette-box-shaped packets of sugary white sticks and pretend to smoke in the playground. Smoking was a central part of our culture.

Which is why the UK’s recent passing of a generational sales ban on tobacco products feels like such a big deal. As part of the Tobacco and Vapes Act 2026, retailers are prohibited from selling tobacco products to anyone born after January 1, 2009, in perpetuity. It doesn’t matter when those people turn 18—or 38 or 68, for that matter. It will always be illegal to sell to anyone born after that date.

This is what’s described as an “endgame” approach. While many tobacco control strategies—such as taxation or gory imagery—aim to reduce consumption, policies like the UK’s are designed to eliminate it entirely. It’s a new approach, and no one knows whether it will work.

The Maldives was the first country to implement a generational smoking ban, in November last year. It’s too soon to say how that has panned out.

Nor do we know if these laws will even last. In 2022, New Zealand passed a similar generational sales ban as part of a broader anti-smoking law. But it was never enacted—the law was repealed by a new government in February 2024.

In the UK, both major parties support the ban. But Nigel Farage, whose right-wing party has seen a recent surge in support, has promised that “the generational smoking ban will not last long if Reform gets the chance to start rebuilding our mismanaged country.”

Chris Bostic, an attorney and former policy director for the advocacy group Action on Smoking and Health, says he and his colleagues began promoting the idea of a generational ban in the United States 11 years ago. Back then, they struggled to win support, even from major health charities. “People said we were crazy … [and] that this was impossible,” he says. Opponents argued that bans would infringe on personal freedoms.

“The public health argument is: Well, what about freedom from addiction?” says Britta Matthes, a tobacco control researcher at the University of Bath in the UK. Most people who smoke began when they were teenagers, want to quit, and wish they’d never started. Tobacco is arguably the most harmful consumer product of all time. It will kill half its users who don’t quit, according to the World Health Organization.

It also kills people who don’t smoke. Of the 7 million who die from tobacco every year, 1.6 million are nonsmokers who were exposed to secondhand smoke, according to the WHO.

Generational sales bans are a long-term strategy that will only protect future smokers. Most experts agree that people who already smoke should be a main consideration for any policy, and that a multipronged approach is probably the best way to go. Janet Hoek at the University of Otago, who has explored tobacco control policies in New Zealand, believes that enforcing very low limits on nicotine levels and banning filters—an environmental scourge that does not make smoking safer, as many people believe—might be a “powerful combination,” for example.

But preventing teenagers from starting to smoke in the first place is an enticing prospect, even among the majority of people who smoke. And it’s starting to look a lot less radical.

The US has quietly been making progress on a smaller scale. Since 2021, Brookline, a town in the Boston area, has banned the sale of tobacco products to anyone born after January 1, 2000. The idea has spread. Today there are 23 towns in Massachusetts with similar bans, says Bostic. Nine towns across Minnesota, New York, and California have implemented other endgame policies.

The UK law has normalized the idea more than ever, he adds. His colleagues are already fielding calls from health agencies around the world. “People [are] saying, Wow I can’t believe the UK just did this—can we do this here?” he says.

Norms change. Like many other millennials, I vividly remember my first night out after a ban on indoor smoking took effect. My clothes didn’t stink! My hair still felt clean! And my throat wasn’t scratchy the next morning! Now that’s just normal. I hope a tobacco-free world can be the new normal for my kids.