Why US federal health agencies are abandoning mRNA vaccines

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

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

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

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 Funding is being withdrawn.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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The deadly saga of the controversial gene therapy Elevidys

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A brief history of “three-parent babies”

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

COURTESY OF THE WALKING EGG

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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.

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.