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.

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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.

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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.

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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.”

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May 24 2025
The FDA plans to limit access to covid vaccines. Here’s why that’s not all bad.

This week, two new leaders at the US Food and Drug Administration announced plans to limit access to covid vaccines, arguing that there is not much evidence to support the value of annual shots in healthy people. New vaccines will be made available only to the people who are most vulnerable—namely, those over 65 and others with conditions that make them more susceptible to severe disease.

Anyone else will have to wait. Covid vaccines will soon be required to go through more rigorous trials to ensure that they really are beneficial for people who aren’t at high risk.

The plans have been met with fear and anger in some quarters. But they weren’t all that shocking to me. In the UK, where I live, covid boosters have been offered only to vulnerable groups for a while now. And the immunologists I spoke to agree: The plans make sense.

They are still controversial. Covid hasn’t gone away. And while most people are thought to have some level of immunity to the virus, some of us still stand to get very sick if infected. The threat of long covid lingers, too. Given that people respond differently to both the virus and the vaccine, perhaps individuals should be able to choose whether they get a vaccine or not.

I should start by saying that covid vaccines have been a remarkable success story. The drugs were developed at record-breaking speed—they were given to people in clinical trials just 69 days after the virus had been identified. They are, on the whole, very safe. And they work remarkably well. They have saved millions of lives. And they rescued many of us from lockdowns.

But while many of us have benefited hugely from covid vaccinations in the past, there are questions over how useful continuing annual booster doses might be. That’s the argument being made by FDA head Marty Makary and Vinay Prasad, director of the agency’s Center for Biologics Evaluation and Research.

Both men have been critical of the FDA in the past. Makary has long been accused of downplaying the benefits of covid vaccines. He made incorrect assumptions about the coronavirus responsible for covid-19 and predicted that the disease would be “mostly gone” by April 2021. Most recently, he also testified in Congress that the theory that the virus came from a lab in China was a “no-brainer.” (The strongest evidence suggests the virus jumped from animals to humans in a market in Wuhan.)

Prasad has said “the FDA is a failure” and has called annual covid boosters “a public health disaster the likes of which we’ve never seen before,” because of a perceived lack of clinical evidence to support their use.

Makary and Prasad’s plans, which were outlined in the New England Journal of Medicine on Tuesday, don’t include such inflammatory language or unfounded claims, thankfully. In fact, they seem pretty measured: Annual covid booster shots will continue to be approved for vulnerable people but will have to be shown to benefit others before people outside the approved groups can access them.

There are still concerns being raised, though. Let’s address a few of the biggest ones.

Shouldn’t I get an annual covid booster alongside my flu vaccine?

At the moment, a lot of people in the US opt to get a covid vaccination around the time they get their annual flu jab. Each year, a flu vaccine is developed to protect against what scientists predict will be the dominant strain of virus circulating come flu season, which tends to run from October through March.

But covid doesn’t seem to stick to the same seasonal patterns, says Susanna Dunachie, a clinical doctor and professor of infectious diseases at the University of Oxford in the UK. “We seem to be getting waves of covid year-round,” she says.

And an annual shot might not offer the best protection against covid anyway, says Fikadu Tafesse, an immunologist and virologist at Oregon Health & Science University in Portland. His own research suggests that leaving more than a year between booster doses could enhance their effectiveness. “One year is really a random time,” he says. It might be better to wait five or 10 years between doses instead, he adds.

“If you are at risk [of a serious covid infection] you may actually need [a dose] every six months,” says Tafesse. “But for healthy individuals, it’s a very different conversation.”

What about children—shouldn’t we be protecting them?

There are reports that pediatricians are concerned about the impact on children, some of whom can develop serious cases of covid. “If we have safe and effective vaccines that prevent illness, we think they should be available,” James Campbell, vice chair of the committee on infectious diseases at the American Academy of Pediatrics, told STAT.

This question has been on my mind for a while. My two young children, who were born in the UK, have never been eligible for a covid vaccine in this country. I found this incredibly distressing when the virus started tearing through child-care centers—especially given that at the time, the US was vaccinating babies from the age of six months.

My kids were eventually offered a vaccine in the US, when we temporarily moved there a couple of years ago. But by that point, the equation had changed. They’d both had covid by then. I had a better idea of the general risks of the virus to children. I turned it down.

I was relieved to hear that Tafesse had made the same decision for his own children. “There are always exceptions, but in general, [covid] is not severe in kids,” he says. The UK’s Joint Committee on Vaccination and Immunology found that the benefits of vaccination are much smaller for children than they are for adults.

“Of course there are children with health problems who should definitely have it,” says Dunachie. “But for healthy children in healthy households, the benefits probably are quite marginal.”

Shouldn’t healthy people get vaccinated to help protect more vulnerable members of society?

It’s a good argument, says Tafesse. Research suggests that people who are vaccinated against covid-19 are less likely to end up transmitting the infection to the people around them. The degree of protection is not entirely clear, particularly with less-studied—and more contagious—variants of the virus and targeted vaccines. The safest approach is to encourage those at high risk to get the vaccine themselves, says Tafesse.

If the vaccines are safe, shouldn’t I be able to choose to get one?

Tafesse doesn’t buy this argument. “I know they are safe, but even if they’re safe, why do I need to get one?” People should know if they are likely to benefit from a drug they are taking, he says.

Having said that, the cost-benefit calculation will differ between individuals. Even a “mild” covid infection can leave some people bed-bound for a week. For them, it might make total sense to get the vaccine.

Dunachie thinks people should be able to make their own decisions. “Giving people a top-up whether they need it or not is a safe thing to do,” she says.

It is still not entirely clear who will be able to access covid vaccinations under the new plans, and how. Makary and Prasad’s piece includes a list of “medical conditions that increase a person’s risk of severe covid-19,” which includes several disorders, pregnancy, and “physical inactivity.” It covers a lot of people; research suggests that around 25% of Americans are physically inactive.

But I find myself agreeing with Dunachie. Yes, we need up-to-date evidence to support the use of any drugs. But taking vaccines away from people who have experience with them and feel they could benefit from them doesn’t feel like the ideal way to go about it.

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.

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May 24 2025
Meet Cathy Tie, Bride of “China’s Frankenstein”

Since the Chinese biophysicist He Jiankui was released from prison in 2022, he has sought to make a scientific comeback and to repair his reputation after a three-year incarceration for illegally creating the world’s first gene-edited children. 

While he has bounced between cities, jobs, and meetings with investors, one area of visible success on his comeback trail has been his X.com account, @Jiankui_He, which has become his main way of spreading his ideas to the world. Starting in September 2022, when he joined the platform, the account stuck to the scientist’s main themes, including promising a more careful approach to his dream of creating more gene-edited children. “I will do it, only after society has accepted it,” he posted in August 2024. He also shared mundane images of his daily life, including golf games and his family.

But over time, it evolved and started to go viral. First came a series of selfies accompanied by grandiose statements (“Every pioneer or prophet must suffer”). Then, in April of this year, it became particularly outrageous and even troll-like, blasting out bizarre messages (“Good morning bitches. How many embryos have you gene edited today?”). This has left observers unsure what to take seriously.

Last month, in reply to MIT Technology Review’s questions about who was responsible for the account’s transformation into a font of clever memes, He emailed us back: “It’s thanks to Cathy Tie.”

You may not be familiar with Tie, but she’s no stranger to the public spotlight. A former Thiel fellow, she is a partner in the attention-grabbing Los Angeles Project, which promised to create glow-in-the-dark pets. Over the past several weeks, though, the 29-year-old Canadian entrepreneur has started to get more and more attention as the new wife to (and apparent social media mastermind behind) He Jiankui. On April 15, He announced a new venture, Cathy Medicine, that would take up his mission of editing human embryos to create people resistant to diseases like Alzheimer’s or cancer. Just a few days later, on April 18, He and Tie announced that they had married, posting pictures of themselves in traditional Chinese wedding attire.

But now Tie says that just a month after she married “the most controversial scientist in the world,” her plans to relocate from Los Angeles to Beijing to be with He are in disarray; she says she’s been denied entry to China and the two “may never see each other again,” as He’s passport is being held by Chinese authorities and he can’t leave the country.

Reached by phone in Manila, Tie said authorities in the Philippines had intercepted her during a layover on May 17 and told her she couldn’t board a plane to China, where she was born and where she says she has a valid 10-year visa. She claims they didn’t say why but told her she is likely “on a watch list.” (MIT Technology Review could not independently confirm Tie’s account.) 

“While I’m concerned about my marriage, I am more concerned about what this means for humanity and the future of science,” Tie posted to her own X account.

A match made in gene-editing heaven

The romance between He and Tie has been playing out in public over the past several weeks through a series of reveals on He’s X feed, which had already started going viral late last year thanks to his style of posting awkward selfies alongside maxims about the untapped potential of heritable gene editing, which involves changing people’s DNA when they’re just embryos in an IVF dish. 

“Human [sic] will no longer be controlled by Darwin’s evolution,” He wrote in March. That post, which showed him standing in an empty lab, gazing into the distance, garnered 9.7 million views. And then, a week later, he collected 13.3 million for this one: “Ethics is holding back scientific innovation and progress.” 

In April, the feed started to change even more drastically. 

He’s posts became increasingly provocative, with better English and a unique sensibility reflecting online culture. “Stop asking for cat girls. I’m trying to cure disease,” the account posted on April 15. Two days later, it followed up: “I literally went to prison for this shit.” 

This shift coincided with the development of his romance with Tie. Tie told us she has visited China three times this year, including a three-week stint in April when she and He got married after a whirlwind romance. She bought him a silver wedding ring made up of intertwined DNA strands. 

The odd behavior on He’s X feed and the sudden marriage have left followers wondering if they are watching a love story, a new kind of business venture, or performance art. It might be all three. 

A wedding photo posted by Tie on the Chinese social media platform Rednote shows the couple sitting at a table in a banquet hall, with a small number of guests. MIT Technology Review has been able to identify several people who attended: Cai Xilei, He’s criminal attorney; Liu Haiyan, an investor and former business partner of He; and Darren Zhu, an artist and Thiel fellow who is making a “speculative” documentary about the biophysicist that will blur the boundaries of fiction and reality.

In the phone interview, Tie declined to say if she and He are legally married. She also confirmed she celebrated a wedding less than one year ago with someone else in California, in July of 2024, but said they broke up after a few months; she also declined to describe the legal status of that marriage. In the phone call, Tie emphasized that her relationship with He is genuine: “I wouldn’t marry him if I wasn’t in love with him.”

An up-and-comer

Years before Tie got into a relationship with He, she was getting plenty of attention in her own right. She became a Thiel fellow in 2015, when she was just 18. That program, started by the billionaire Peter Thiel, gave her a grant of $100,000 to drop out of the University of Toronto and start a gene testing company, Ranomics. 

Soon, she began appearing on the entrepreneur circuit as a “wunderkind” who was featured on a Forbes “30 Under 30” list in 2018 and presented as an up-and-coming venture capitalist on CNN that same year. In 2020, she started her second company, Locke Bio, which focuses on online telemedicine.

Like Thiel, Tie has staked out contrarian positions. She’s called mainstream genomics a scam and described entrepreneurship as a way to escape the hidebound practices of academia and bioethics. “Starting companies is my preferred form of art,” she posted in 2022, linking to an interview on CNBC. 

By February 2025, Tie was ready to announce another new venture: the Los Angeles Project, a stealth company she had incorporated in 2023 under her legal name, Cheng Cheng Tie. The company, started with the Texas-based biohacker and artist Josie Zayner, says it will try to modify animal embryos; one goal is to make fluorescent glow-in-the-dark rabbits as pets.

The Los Angeles Project revels in explicitly transgressive aims for embryo editing, including a plan to add horn genes to horse embryos to make a unicorn. That’s consistent with Zayner’s past stunts, which include injecting herself with CRISPR during a livestream. “This is a company that should not exist,” Zayner said in announcing the newly public project.

Although the Los Angeles Project has only a tiny staff with uncertain qualifications, it did raise $1 million from the 1517 Fund, a venture group that supports “dropouts” and whose managers previously ran the Thiel Fellowship. 

Asked for his assessment of Tie, Michael Gibson, a 1517 partner, said in an email that he thinks Tie is “not just exceptional, but profoundly exceptional.” He sent along a list of observations he’d jotted down about Tie before funding her company, which approvingly noted her “hyper-fluent competence” and “low need for social approval,” adding: “Thoughts & actions routinely unconventional.” 

A comeback story

He first gained notoriety in 2018, when he and coworkers at the Southern University of Science & Technology in Shenzhen injected the CRISPR gene editor into several viable human embryos and then transferred these into volunteers, leading to the birth of three girls who he claimed would be resistant to HIV. A subsequent Chinese investigation found he’d practiced medicine illegally while “pursuing fame and fortune.” A court later sentenced him to three years in prison.

He has never apologized for his experiments, except to say he acted “too quickly” and to express regret for the trouble he’d caused his former wife and two daughters. (According to a leaked WeChat post by his ex-wife, she divorced him in 2024 “because of a major fault on his side.”)

Since his release from prison, He has sought to restart his research and convince people that he should be recognized as the “Chinese Darwin,” not “China’s Frankenstein,” as the press once dubbed him. 

But his comeback has been bumpy. He lost a position at Wuchang University of Technology, a small private university in Hubei province, after some negative press. In February 2024, He posted that his application for funding from the Muscular Dystrophy Association was rejected. Last September, he even posted pictures of his torn shirt—which he said was the result of an assault by jealous rivals.

One area of clear success, though, was the growing reach of his X profile, which today has ballooned to more than 130,000 followers. And as his public profile rose, some started encouraging He to find ways to cash in. Andrew Hessel, a futurist and synthetic biologist active in US ethics debates, says he tried to get He invited to give a TED Talk. “His story is unique, and I wanted to see his story get more widespread attention, if only as a cautionary tale,” Hessel says. “I think he is a lightning rod for a generation of people working in life sciences.”

Later, Hessel says, he sent him information on how to join X’s revenue-sharing program. “I said, ‘You have a powerful voice. Have you looked into monetization?’” Hessel says.

By last fall, He was also welcoming visitors to what he called a new lab in Beijing. One person who took him up on the offer was Steve Hsu, a Michigan State physics professor who has started several genetics companies and was visiting Beijing. 

They ended up talking for hours. Hsu says that He expressed a desire to move to the US and start a company, and that he shared his idea for conducting a clinical trial of embryo editing in South Africa, possibly for the prevention of HIV. 

Hsu says he later arranged an invitation for He to give a lecture in the United States. “You are a little radioactive, but things are opening up,” Hsu told him. But He declined the offer because the Chinese government is holding his passport—a common tactic it uses to restrict the movement of sensitive or high-profile figures—and won’t return it to him. “He doesn’t even know why. He literally doesn’t know,” says Hsu. “According to the law, they should give it back to him.”

A curious triangle

Despite any plans by He and Tie to advance the idea, creating designer babies is currently illegal in most of the world, including China and the US. Some experts, however, fret that forbidding the technology will only drive it underground and make it attractive to biohackers or scientists outside the mainstream. 

That’s one reason Tie’s simultaneous connection to two notable biotech renegades—He and Zayner—is worth watching. “There is clearly a triangle forming in some way,” says Hessel.

With Tie stuck outside China and He being kept inside the country, their new gene-editing venture, Cathy Medicine, faces an uncertain future. Tie posted previously on Rednote that she was “helping Dr. He open up the U.S. market” and was planning to return to the US with him for scientific research. But when we spoke on the phone, she declined to disclose their next steps and said their predicament means the project is “out of the window now.”

Even as the couple remain separated, their social media game is stronger than ever. As she waited in Manila, Tie sought help from friends, followers, and the entire internet. She blasted out a tweet to “crypto people,” calling them “too pussy to stand up for things when it matters.” Within hours, someone had created a memecoin called $GENE as a way for the public to support the couple. 

On May 20, Tie posted on X claiming that the amount donated to them is now worth almost $2 million. “I may need to retract my last statement about crypto,” she wrote. 

He’s X account also retweeted to express support: “I only want to reunite with my wife @CathyTie, and continue my gene editing research.” He added the hashtag $GENE.

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May 17 2025
Access to experimental medical treatments is expanding across the US

A couple of weeks ago I was in Washington, DC, for a gathering of scientists, policymakers, and longevity enthusiasts. They had come together to discuss ways to speed along the development of drugs and other treatments that might extend the human lifespan.

One approach that came up was to simply make experimental drugs more easily accessible. Let people try drugs that might help them live longer, the argument went. Some groups have been pushing bills to do just that in Montana, a state whose constitution explicitly values personal liberty.

A couple of years ago, a longevity lobbying group helped develop a bill that expanded on the state’s existing Right to Try law, which allowed seriously ill people to apply for access to experimental drugs (that is, drugs that have not been approved by drug regulators). The expansion, which was passed in 2023, opened access for people who are not seriously ill. 

Over the last few months, the group has been pushing further—for a new bill that sets out exactly how clinics can sell experimental, unproven treatments in the state to anyone who wants them. At the end of the second day of the event, the man next to me looked at his phone. “It just passed,” he told me. (The lobbying group has since announced that the state’s governor Greg Gianforte has signed the bill into law, but when I called his office, Gianforte’s staff said they could not legally tell me whether or not he has.)

The passing of the bill could make Montana something of a US hub for experimental treatments. But it represents a wider trend: the creep of Right to Try across the US. And a potentially dangerous departure from evidence-based medicine.

In the US, drugs must be tested in human volunteers before they can be approved and sold. Early-stage clinical trials are small and check for safety. Later trials test both the safety and efficacy of a new drug.

The system is designed to keep people safe and to prevent manufacturers from selling ineffective or dangerous products. It’s meant to protect us from snake oil.

But people who are seriously ill and who have exhausted all other treatment options are often desperate to try experimental drugs. They might see it as a last hope. Sometimes they can volunteer for clinical trials, but time, distance, and eligibility can rule out that option.

Since the 1980s, seriously or terminally ill people who cannot take part in a trial for some reason can apply for access to experimental treatments through a “compassionate use” program run by the US Food and Drug Administration (FDA). The FDA authorizes almost all of the compassionate use requests it receives (although manufacturers don’t always agree to provide their drug for various reasons).

But that wasn’t enough for the Goldwater Institute, a libertarian organization that in 2014 drafted a model Right to Try law for people who are terminally ill. Versions of this draft have since been passed into law in 41 US states, and the US has had a federal Right to Try law since 2018. These laws generally allow people who are seriously ill to apply for access to drugs that have only been through the very first stages of clinical trials, provided they give informed consent.

Some have argued that these laws have been driven by a dislike of both drug regulation and the FDA. After all, they are designed to achieve the same result as the compassionate use program. The only difference is that they bypass the FDA.

Either way, it’s worth noting just how early-stage these treatments are. A drug that has been through phase I trials might have been tested in just 20 healthy people. Yes, these trials are designed to test the safety of a drug, but they are never conclusive. At that point in a drug’s development, no one can know how a sick person—who is likely to be taking other medicines— will react to it.

Now these Right to Try laws are being expanded even more. The Montana bill, which goes the furthest, will enable people who are not seriously ill to access unproven treatments, and other states have been making moves in the same direction.

Just this week, Georgia’s governor signed into law the Hope for Georgia Patients Act, which allows people with life-threatening illnesses to access personalized treatments, those that are “unique to and produced exclusively for an individual patient based on his or her own genetic profile.” Similar laws, known as “Right to Try 2.0,”  have been passed in other states, too, including Arizona, Mississippi, and North Carolina.

And last year, Utah passed a law that allows health care providers (including chiropractors, podiatrists, midwives, and naturopaths) to deliver unapproved placental stem cell therapies. These treatments involve cells collected from placentas, which are thought to hold promise for tissue regeneration. But they haven’t been through human trials. They can cost tens of thousands of dollars, and their effects are unknown. Utah’s law was described as a “pretty blatant broadbrush challenge to the FDA’s authority” by an attorney who specializes in FDA law. And it’s one that could put patients at risk.

Laws like these spark a lot of very sensitive debates. Some argue that it’s a question of medical autonomy, and that people should have the right to choose what they put in their own bodies.

And many argue there’s a cost-benefit calculation to be made. A seriously ill person potentially has more to gain and less to lose from trying an experimental drug, compared to someone who is in good health.

But everyone needs to be protected from ineffective drugs. Most ethicists think it’s unethical to sell a treatment when you have no idea if it will work, and that argument has been supported by numerous US court decisions over the years. 

There could be a financial incentive for doctors to recommend an experimental drug, especially when they are granted protections by law. (Right to Try laws tend to protect prescribing doctors from disciplinary action and litigation should something go wrong.)

On top of all this, many ethicists are also concerned that the FDA’s drug approval process itself has been on a downward slide over the last decade or so. An increasing number of drug approvals are fast-tracked based on weak evidence, they argue.

Scientists and ethicists on both sides of the debate are now waiting to see what unfolds under the new US administration.  

In the meantime, a quote from Diana Zuckerman, president of the nonprofit National Center for Health Research, comes to mind: “Sometimes hope helps people do better,” she told me a couple of years ago. “But in medicine, isn’t it better to have hope based on evidence rather than hope based on hype?”

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.

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May 16 2025
This baby boy was treated with the first personalized gene-editing drug

Doctors say they constructed a bespoke gene-editing treatment in less than seven months and used it to treat a baby with a deadly metabolic condition.

The rapid-fire attempt to rewrite the child’s DNA marks the first time gene editing has been tailored to treat a single individual, according to a report published in the New England Journal of Medicine.

The baby who was treated, Kyle “KJ” Muldoon Jr., suffers from a rare metabolic condition caused by a particularly unusual gene misspelling.

Researchers say their attempt to correct the error demonstrates the high level of precision new types of gene editors offer. 

“I don’t think I’m exaggerating when I say that this is the future of medicine,” says Kiran Musunuru, an expert in gene editing at the University of Pennsylvania whose team designed the drug. “My hope is that someday no rare disease patients will die prematurely from misspellings in their genes, because we’ll be able to correct them.”

The project also highlights what some experts are calling a growing crisis in gene-editing technology. That’s because even though the technology could cure thousands of genetic conditions, most are so rare that companies could never recoup the costs of developing a treatment for them. 

In KJ’s case, the treatment was programmed to correct a single letter of DNA in his cells.

“In reality, this drug will probably never be used again,” says Rebecca Ahrens-Nicklas, a physician at the Children’s Hospital of Philadelphia who treats metabolic diseases in children and who led the overall effort to treat the child.

That effort involved more than 45 scientists and doctors as well as pro bono assistance from several biotechnology companies. Musunuru says he cannot estimate how much it had cost in time and effort.

Eventually, he says, the cost of custom gene-editing treatments might be similar to that of liver transplants, which is around $800,000, not including lifelong medical care and drugs.

The researchers used a new version of CRISPR technology, called base editing, that can replace a single letter of DNA at a specific location. 

Previous versions of CRISPR have generally been used to delete genes, not rewrite them to restore their function.

The researchers say they were looking for a patient to treat when they learned about KJ. After he was born in August, a doctor noted that the infant was lethargic. Tests found he had a metabolic disorder that leads to the buildup of ammonia, a condition that’s frequently fatal without a liver transplant.

In KJ’s case, gene sequencing showed that the cause was a misspelled letter in the gene CPS1 that stopped it from making a vital enzyme.

The researchers approached KJ’s parents, Nicole and Kyle Muldoon, with the idea of using gene editing to try to correct their baby’s DNA. After they agreed, a race ensued to design the editing drug, test it in animals, and get permission from the US Food and Drug Administration to treat KJ in a one-off experiment.

The team says the boy, who hasn’t turned one yet, received three doses of the gene-editing treatment, of gradually increasing strength. They can’t yet determine exactly how well the gene editor worked because they don’t want to take a liver biopsy, which would be needed to check if KJ’s genes have really been corrected.

But Ahrens-Nicklas says that because the child is “growing and thriving,” she thinks the editing has been at least partly successful and that he may now have “a milder form of this horrific disease.”

“He’s received three doses of the therapy without any complications, and is showing some early signs of benefit,” she says. “It’s really important to say that it’s still very early, so we will need to continue to watch KJ closely to fully understand the full effects of this therapy.”

The case suggests a future in which parents will take sick children to a clinic where their DNA will be sequenced, and then they will rapidly receive individualized treatments. Currently, this would only work for liver diseases, for which it’s easier to deliver gene-editing instructions, but eventually it might also become a possible approach for treating brain diseases and conditions like muscular dystrophy.

The experiment is drawing attention to a gap between what gene editing can do and what treatments are likely to become available to people who need them.

So far, biotechnology companies testing gene editing are working only on fairly common gene conditions, like sickle cell disease, leaving hundreds of ultra-rare conditions aside. One-off treatments, like the one helping KJ, are too expensive to create and get approved without some way to recoup the costs.

The apparent success in treating KJ, however, is making it even more urgent to figure out a way forward. Researchers acknowledge that they don’t yet know how to scale up personalized treatment, although Musunuru says initial steps to standardize the process are underway at his university and in Europe.

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May 15 2025
A US court just put ownership of CRISPR back in play

The CRISPR patents are back in play.

On Monday, the US Court of Appeals for the Federal Circuit said scientists Jennifer Doudna and Emmanuelle Charpentier will get another chance to show they ought to own the key patents on what many consider the defining biotechnology invention of the 21st century.

The pair shared a 2020 Nobel Prize for developing the versatile gene-editing system, which is already being used to treat various genetic disorders, including sickle cell disease. 

But when key US patent rights were granted in 2014 to researcher Feng Zhang of the Broad Institute of MIT and Harvard, the decision set off a bitter dispute in which hundreds of millions of dollars—as well as scientific bragging rights—are at stake.

The new decision is a boost for the Nobelists, who had previously faced a string of demoralizing reversals over the patent rights in both the US and Europe.

“This goes to who was the first to invent, who has priority, and who is entitled to the broadest patents,” says Jacob Sherkow, a law professor at the University of Illinois. 

He says there is now at least a chance that Doudna and Charpentier “could walk away as the clear winner.”

The CRISPR patent battle is among the most byzantine ever, putting the technology alongside the steam engine, the telephone, the lightbulb, and the laser among the most hotly contested inventions in history.

In 2012, Doudna and Charpentier were first to publish a description of a CRISPR gene editor that could be programmed to precisely cut DNA in a test tube. There’s no dispute about that.

However, the patent fight relates to the use of CRISPR to edit inside animal cells—like those of human beings. That’s considered a distinct invention, and one both sides say they were first to come up with that very same year. 

In patent law, this moment is known as conception—the instant a lightbulb appears over an inventor’s head, revealing a definite and workable plan for how an invention is going to function.

In 2022, a specialized body called the Patent Trial and Appeal Board, or PTAB, decided that Doudna and Charpentier hadn’t fully conceived the invention because they initially encountered trouble getting their editor to work in fish and other species. Indeed, they had so much trouble that Zhang scooped them with a 2013 publication demonstrating he could use CRISPR to edit human cells.

The Nobelists appealed the finding, and yesterday the appeals court vacated it, saying the patent board applied the wrong standard and needs to reconsider the case. 

According to the court, Doudna and Charpentier didn’t have to “know their invention would work” to get credit for conceiving it. What could matter more, the court said, is that it actually did work in the end. 

In a statement, the University of California, Berkeley, applauded the call for a do-over.  

“Today’s decision creates an opportunity for the PTAB to reevaluate the evidence under the correct legal standard and confirm what the rest of the world has recognized: that the Doudna and Charpentier team were the first to develop this groundbreaking technology for the world to share,” Jeff Lamken, one of Berkeley’s attorneys, said in the statement.

The Broad Institute posted a statement saying it is “confident” the appeals board “will again confirm Broad’s patents, because the underlying facts have not changed.”

The decision is likely to reopen the investigation into what was written in 13-year-old lab notebooks and whether Zhang based his research, in part, on what he learned from Doudna and Charpentier’s publications. 

The case will now return to the patent board for a further look, although Sherkow says the court finding can also be appealed directly to the US Supreme Court. 

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May 15 2025
The first US hub for experimental medical treatments is coming

A bill that allows medical clinics to sell unproven treatments has been passed in Montana. 

Under the legislation, doctors can apply for a license to open an experimental treatment clinic and recommend and sell therapies not approved by the Food and Drug Administration (FDA) to their patients. Once it’s signed by the governor, the law will be the most expansive in the country in allowing access to drugs that have not been fully tested. 

The bill allows for any drug produced in the state to be sold in it, providing it has been through phase I clinical trials—the initial, generally small, first-in-human studies that are designed to check that a new treatment is not harmful. These trials do not determine if the drug is effective.

The bill, which was passed by the state legislature on April 29 and is expected to be signed by Governor Greg Gianforte, essentially expands on existing Right to Try legislation in the state. But while that law was originally designed to allow terminally ill people to access experimental drugs, the new bill was drafted and lobbied for by people interested in extending human lifespans—a group of longevity enthusiasts that includes scientists, libertarians, and influencers.  

These longevity enthusiasts are hoping Montana will serve as a test bed for opening up access to experimental drugs. “I see no reason why it couldn’t be adopted by most of the other states,” said Todd White, speaking to an audience of policymakers and others interested in longevity at an event late last month in Washington, DC. White, who helped develop the bill and directs a research organization focused on aging, added that “there are some things that can be done at the federal level to allow Right to Try laws to proliferate more readily.” 

Supporters of the bill say it gives individuals the freedom to make choices about their own bodies. At the same event, bioethicist Jessica Flanigan of the University of Richmond said she was “optimistic” about the measure, because “it’s great any time anybody is trying to give people back their medical autonomy.” 

Ultimately, they hope that the new law will enable people to try unproven drugs that might help them live longer, make it easier for Americans to try experimental treatments without having to travel abroad, and potentially turn Montana into a medical tourism hub.

But ethicists and legal scholars aren’t as optimistic. “I hate it,” bioethicist Alison Bateman-House of New York University says of the bill. She and others are worried about the ethics of promoting and selling unproven treatments—and the risks of harm should something go wrong.

Easy access?

No drugs have been approved to treat human aging. Some in the longevity field believe that regulation has held back the development of such drugs. In the US, federal law requires that drugs be shown to be both safe and effective before they can be sold. That requirement was made law in the 1960s following the thalidomide tragedy, in which women who took the drug for morning sickness had babies with sometimes severe disabilities. Since then, the FDA has been responsible for the approval of new drugs.  

Typically, new drugs are put through a series of human trials. Phase I trials generally involve between 20 and 100 volunteers and are designed to check that the drug is safe for humans. If it is, the drug is then tested in larger groups of hundreds, and then thousands, of volunteers to assess the dose and whether it actually works. Once a drug is approved, people who are prescribed it are monitored for side effects. The entire process is slow, and it can last more than a decade—a particular pain point for people who are acutely aware of their own aging. 

But some exceptions have been made for people who are terminally ill under Right to Try laws. Those laws allow certain individuals to apply for access to experimental treatments that have been through phase I clinical trials but have not received FDA approval.

Montana first passed a Right to Try law in 2015 (a federal law was passed around three years later). Then in 2023, the state expanded the law to include all patients there, not just those with terminal illnesses—meaning that any person in Montana could, in theory, take a drug that had been through only a phase I trial.

At the time, this was cheered by many longevity enthusiasts—some of whom had helped craft the expanded measure.

But practically, the change hasn’t worked out as they envisioned. “There was no licensing, no processing, no registration” for clinics that might want to offer those drugs, says White. “There needed to be another bill that provided regulatory clarity for service providers.” 

So the new legislation addresses “how clinics can set up shop in Montana,” says Dylan Livingston, founder and CEO of the Alliance for Longevity Initiatives, which hosted the DC event. Livingston built A4LI, as it’s known, a few years ago, as a lobbying group for the science of human aging and longevity.

Livingston, who is exploring multiple approaches to improve both funding for scientific research and to change drug regulation, helped develop and push the 2023 bill in Montana with the support of State Senator Kenneth Bogner, he says. “I gave [Bogner] a menu of things that could be done at the state level … and he loved the idea” of turning Montana into a medical tourism hub, he says. 

After all, as things stand, plenty of Americans travel abroad to receive experimental treatments that cannot legally be sold in the US, including expensive, unproven stem cell and gene therapies, says Livingston. 

“If you’re going to go and get an experimental gene therapy, you might as well keep it in the country,” he says. Livingston has suggested that others might be interested in trying a novel drug designed to clear aged “senescent” cells from the body, which is currently entering phase II trials for an eye condition caused by diabetes. “One: let’s keep the money in the country, and two: if I was a millionaire getting an experimental gene therapy, I’d rather be in Montana than Honduras.”

“Los Alamos for longevity”

Honduras, in particular, has become something of a home base for longevity experiments. The island of Roatán is home to the Global Alliance for Regenerative Medicine clinic, which, along with various stem cell products, sells a controversial unproven “anti-aging” gene therapy for around $20,000 to customers including wealthy longevity influencer Bryan Johnson. 

Tech entrepreneur and longevity enthusiast Niklas Anzinger has also founded the city of Infinita in the region’s special economic zone of Próspera, a private city where residents are able to make their own suggestions for medical regulations. It’s the second time he’s built a community there as part of his effort to build a “Los Alamos for longevity” on the island, a place where biotech companies can develop therapies that slow or reverse human aging “at warp speed,” and where individuals are free to take those experimental treatments. (The first community, Vitalia, featured a biohacking lab, but came to an end following a disagreement between the two founders.) 

Anzinger collaborated with White, the longevity enthusiast who spoke at the A4LI event (and is an advisor to Infinita VC, Anzinger’s investment company), to help put together the new Montana bill. “He asked if I would help him try to advance the new bill, so that’s what we did for the last few months,” says White, who trained as an electrical engineer but left his career in telecommunications to work with an organization that uses blockchain to fund research into extending human lifespans. 

“Right to Try has always been this thing [for people] who are terminal[ly ill] and trying a Hail Mary approach to solving these things; now Right to Try laws are being used to allow you to access treatments earlier,” White told the audience at the A4LI event. “Making it so that people can use longevity medicines earlier is, I think, a very important thing.”

The new bill largely sets out the “infrastructure” for clinics that want to sell experimental treatments, says White. It states that clinics will need to have a license, for example, and that this must be renewed on an annual basis. 

“Now somebody who actually wants to deliver drugs under the Right to Try law will be able to do so,” he says. The new legislation also protects prescribing doctors from disciplinary action.

And it sets out requirements for informed consent that go further than those of existing Right to Try laws. Before a person takes an experimental drug under the new law, they will be required to provide a written consent that includes a list of approved alternative drugs and a description of the worst potential outcome.

On the safe side

“In the Montana law, we explicitly enhanced the requirements for informed consent,” Anzinger told an audience at the same A4LI event. This, along with the fact that the treatments will have been through phase I clinical trials, will help to keep people safe, he argued. “We have to treat this with a very large degree of responsibility,” he added.

“We obviously don’t want to be killing people,” says Livingston. 

But he also adds that he, personally, won’t be signing up for any experimental treatments. “I want to be the 10 millionth, or even the 50 millionth, person to get the gene therapy,” he says. “I’m not that adventurous … I’ll let other people go first.”

Others are indeed concerned that, for the “adventurous” people, these experimental treatments won’t necessarily be safe. Phase I trials are typically tiny, and they often involve less than 50 people, all of whom are typically in good health. A trial like that won’t tell you much about side effects that only show up in 5% of people, for example, or about interactions the drug might have with other medicines.

Around 90% of drug candidates in clinical trials fail. And around 17% of drugs fail late-stage clinical trials because of safety concerns. Even those that make it all the way through clinical trials and get approved by the FDA can still end up being withdrawn from the market when rare but serious side effects show up. Between 1992 and 2023, 23 drugs that were given accelerated approval for cancer indications were later withdrawn from the market. And between 1950 and 2013, the reason for the withdrawal of 95 drugs was “death.”

“It’s disturbing that they want to make drugs available after phase I testing,” says Sharona Hoffman, professor of law and bioethics at Case Western Reserve University in Cleveland, Ohio. “This could endanger patients.”

“Famously, the doctor’s first obligation is to first do no harm,” says Bateman-House. “If [a drug] has not been through clinical trials, how do you have any standing on which to think it isn’t going to do any harm?”

But supporters of the bill argue that individuals can make their own decisions about risk. When speaking at the A4LI event, Flanigan introduced herself as a bioethicist before adding “but don’t hold it against me; we’re not all so bad.” She argued that current drug regulations impose a “massive amount of restrictions on your bodily rights and your medical freedom.” Why should public officials be the ones making decisions about what’s safe for people? Individuals, she argued, should be empowered to make those judgments themselves.

Other ethicists counter that this isn’t an issue of people’s rights. There are lots of generally accepted laws about when we can access drugs, says Hoffman; people aren’t allowed to drink and drive because they might kill someone. “So, no, you don’t have a right to ingest everything you want if there are risks associated with it.”

The idea that individuals have a right to access experimental treatments has in fact failed in US courts in the past, says Carl Coleman, a bioethicist and legal scholar at Seton Hall in New Jersey. 

He points to a case from 20 years ago: In the early 2000s, Frank Burroughs founded the Abigail Alliance for Better Access to Developmental Drugs. His daughter, Abigail Burroughs, had head and neck cancer, and she had tried and failed to access experimental drugs. In 2003, about two years after Abigail’s death, the group sued the FDA, arguing that people with terminal cancer have a constitutionally protected right to access experimental, unapproved treatments, once those treatments have been through phase I trials. In 2007, however, a court rejected that argument, determining  that terminally ill individuals do not have a constitutional right to experimental drugs.

Bateman-House also questions a provision in the Montana bill that claims to make treatments more equitable. It states that “experimental treatment centers” should allocate 2% of their net annual profits “to support access to experimental treatments and healthcare for qualifying Montana residents.” Bateman-House says she’s never seen that kind of language in a bill before. It may sound positive, but it could in practice introduce even more risk to the local community. “On the one hand, I like equity,” she says. “On the other hand, I don’t like equity to snake oil.”

After all, the doctors prescribing these drugs won’t know if they will work. It is never ethical to make somebody pay for a treatment when you don’t have any idea whether it will work, Bateman-House adds. “That’s how the US system has been structured: There’s no profit without evidence of safety and efficacy.”

The clinics are coming

Any clinics that offer experimental treatments in Montana will only be allowed to sell drugs that have been made within the state, says Coleman. “Federal law requires any drug that is going to be distributed in interstate commerce to have FDA approval,” he says.

White isn’t too worried about that. Montana already has manufacturing facilities for biotech and pharmaceutical companies, including Pfizer. “That was one of the specific advantages [of focusing] on Montana, because everything can be done in state,” he says. He also believes that the current administration is “predisposed” to change federal laws around interstate drug manufacturing. (FDA commissioner Marty Makary has been a vocal critic of the agency and the pace at which it approves new drugs.)

At any rate, the clinics are coming to Montana, says Livingston. “We have half a dozen that are interested, and maybe two or three that are definitively going to set up shop out there.” He won’t name names, but he says some of the interested clinicians already have clinics in the US, while others are abroad. 

Mac Davis—founder and CEO of Minicircle, the company that developed the controversial “anti-aging” gene therapy—told MIT Technology Review he was “looking into it.”

“I think this can be an opportunity for America and Montana to really kind of corner the market when it comes to medical tourism,” says Livingston. “There is no other place in the world with this sort of regulatory environment.”

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