AI and you: Is the promise of personalized nutrition apps worth the hype?
As a type 2 diabetic, Michael Snyder has long been interested in how blood sugar levels vary from one person to another in response to the same food, and whether a more personalized approach to nutrition could help tackle the rapidly cascading levels of diabetes and obesity in much of the western world.
Eight years ago, Snyder, who directs the Center for Genomics and Personalized Medicine at Stanford University, decided to put his theories to the test. In the 2000s continuous glucose monitoring, or CGM, had begun to revolutionize the lives of diabetics, both type 1 and type 2. Using spherical sensors which sit on the upper arm or abdomen – with tiny wires that pierce the skin – the technology allowed patients to gain real-time updates on their blood sugar levels, transmitted directly to their phone.
It gave Snyder an idea for his research at Stanford. Applying the same technology to a group of apparently healthy people, and looking for ‘spikes’ or sudden surges in blood sugar known as hyperglycemia, could provide a means of observing how their bodies reacted to an array of foods.
“We discovered that different foods spike people differently,” he says. “Some people spike to pasta, others to bread, others to bananas, and so on. It’s very personalized and our feeling was that building programs around these devices could be extremely powerful for better managing people’s glucose.”
Unbeknown to Snyder at the time, thousands of miles away, a group of Israeli scientists at the Weizmann Institute of Science were doing exactly the same experiments. In 2015, they published a landmark paper which used CGM to track the blood sugar levels of 800 people over several days, showing that the biological response to identical foods can vary wildly. Like Snyder, they theorized that giving people a greater understanding of their own glucose responses, so they spend more time in the normal range, may reduce the prevalence of type 2 diabetes.
The commercial potential of such apps is clear, but the underlying science continues to generate intriguing findings.
“At the moment 33 percent of the U.S. population is pre-diabetic, and 70 percent of those pre-diabetics will become diabetic,” says Snyder. “Those numbers are going up, so it’s pretty clear we need to do something about it.”
Fast forward to 2022,and both teams have converted their ideas into subscription-based dietary apps which use artificial intelligence to offer data-informed nutritional and lifestyle recommendations. Snyder’s spinoff, January AI, combines CGM information with heart rate, sleep, and activity data to advise on foods to avoid and the best times to exercise. DayTwo–a start-up which utilizes the findings of Weizmann Institute of Science–obtains microbiome information by sequencing stool samples, and combines this with blood glucose data to rate ‘good’ and ‘bad’ foods for a particular person.
“CGMs can be used to devise personalized diets,” says Eran Elinav, an immunology professor and microbiota researcher at the Weizmann Institute of Science in addition to serving as a scientific consultant for DayTwo. “However, this process can be cumbersome. Therefore, in our lab we created an algorithm, based on data acquired from a big cohort of people, which can accurately predict post-meal glucose responses on a personal basis.”
The commercial potential of such apps is clear. DayTwo, who market their product to corporate employers and health insurers rather than individual consumers, recently raised $37 million in funding. But the underlying science continues to generate intriguing findings.
Last year, Elinav and colleagues published a study on 225 individuals with pre-diabetes which found that they achieved better blood sugar control when they followed a personalized diet based on DayTwo’s recommendations, compared to a Mediterranean diet. The journal Cell just released a new paper from Snyder’s group which shows that different types of fibre benefit people in different ways.
“The idea is you hear different fibres are good for you,” says Snyder. “But if you look at fibres they’re all over the map—it’s like saying all animals are the same. The responses are very individual. For a lot of people [a type of fibre called] arabinoxylan clearly reduced cholesterol while the fibre inulin had no effect. But in some people, it was the complete opposite.”
Eight years ago, Stanford's Michael Snyder began studying how continuous glucose monitors could be used by patients to gain real-time updates on their blood sugar levels, transmitted directly to their phone.
The Snyder Lab, Stanford Medicine
Because of studies like these, interest in precision nutrition approaches has exploded in recent years. In January, the National Institutes of Health announced that they are spending $170 million on a five year, multi-center initiative which aims to develop algorithms based on a whole range of data sources from blood sugar to sleep, exercise, stress, microbiome and even genomic information which can help predict which diets are most suitable for a particular individual.
“There's so many different factors which influence what you put into your mouth but also what happens to different types of nutrients and how that ultimately affects your health, which means you can’t have a one-size-fits-all set of nutritional guidelines for everyone,” says Bruce Y. Lee, professor of health policy and management at the City University of New York Graduate School of Public Health.
With the falling costs of genomic sequencing, other precision nutrition clinical trials are choosing to look at whether our genomes alone can yield key information about what our diets should look like, an emerging field of research known as nutrigenomics.
The ASPIRE-DNA clinical trial at Imperial College London is aiming to see whether particular genetic variants can be used to classify individuals into two groups, those who are more glucose sensitive to fat and those who are more sensitive to carbohydrates. By following a tailored diet based on these sensitivities, the trial aims to see whether it can prevent people with pre-diabetes from developing the disease.
But while much hope is riding on these trials, even precision nutrition advocates caution that the field remains in the very earliest of stages. Lars-Oliver Klotz, professor of nutrigenomics at Friedrich-Schiller-University in Jena, Germany, says that while the overall goal is to identify means of avoiding nutrition-related diseases, genomic data alone is unlikely to be sufficient to prevent obesity and type 2 diabetes.
“Genome data is rather simple to acquire these days as sequencing techniques have dramatically advanced in recent years,” he says. “However, the predictive value of just genome sequencing is too low in the case of obesity and prediabetes.”
Others say that while genomic data can yield useful information in terms of how different people metabolize different types of fat and specific nutrients such as B vitamins, there is a need for more research before it can be utilized in an algorithm for making dietary recommendations.
“I think it’s a little early,” says Eileen Gibney, a professor at University College Dublin. “We’ve identified a limited number of gene-nutrient interactions so far, but we need more randomized control trials of people with different genetic profiles on the same diet, to see whether they respond differently, and if that can be explained by their genetic differences.”
Some start-ups have already come unstuck for promising too much, or pushing recommendations which are not based on scientifically rigorous trials. The world of precision nutrition apps was dubbed a ‘Wild West’ by some commentators after the founders of uBiome – a start-up which offered nutritional recommendations based on information obtained from sequencing stool samples –were charged with fraud last year. The weight-loss app Noom, which was valued at $3.7 billion in May 2021, has been criticized on Twitter by a number of users who claimed that its recommendations have led to them developed eating disorders.
With precision nutrition apps marketing their technology at healthy individuals, question marks have also been raised about the value which can be gained through non-diabetics monitoring their blood sugar through CGM. While some small studies have found that wearing a CGM can make overweight or obese individuals more motivated to exercise, there is still a lack of conclusive evidence showing that this translates to improved health.
However, independent researchers remain intrigued by the technology, and say that the wealth of data generated through such apps could be used to help further stratify the different types of people who become at risk of developing type 2 diabetes.
“CGM not only enables a longer sampling time for capturing glucose levels, but will also capture lifestyle factors,” says Robert Wagner, a diabetes researcher at University Hospital Düsseldorf. “It is probable that it can be used to identify many clusters of prediabetic metabolism and predict the risk of diabetes and its complications, but maybe also specific cardiometabolic risk constellations. However, we still don’t know which forms of diabetes can be prevented by such approaches and how feasible and long-lasting such self-feedback dietary modifications are.”
Snyder himself has now been wearing a CGM for eight years, and he credits the insights it provides with helping him to manage his own diabetes. “My CGM still gives me novel insights into what foods and behaviors affect my glucose levels,” he says.
He is now looking to run clinical trials with his group at Stanford to see whether following a precision nutrition approach based on CGM and microbiome data, combined with other health information, can be used to reverse signs of pre-diabetes. If it proves successful, January AI may look to incorporate microbiome data in future.
“Ultimately, what I want to do is be able take people’s poop samples, maybe a blood draw, and say, ‘Alright, based on these parameters, this is what I think is going to spike you,’ and then have a CGM to test that out,” he says. “Getting very predictive about this, so right from the get go, you can have people better manage their health and then use the glucose monitor to help follow that.”
How One University Is Successfully Tackling COVID-19
China, South Korea and other places controlled the SARS-CoV-2 epidemic with the early use of strict lockdown and aggressive electronic contact tracing, monitoring, and enforcement.
The tussles in America over voluntary social distancing and wearing a mask in public suggest that more stringent enforcement methods adopted elsewhere would not work here. But one American university has emerged as a model of tough love pandemic management.
While many universities have become hot spots of COVID-19 infections this fall when students returned to campus, the University of Illinois was an exception. It has gotten the virus under control, at least for the moment, at a rate that is far below the national average and with minimal social disruption. Can the program they implemented work in our broader society?
The Illinois model is a comprehensive one which, as elsewhere, includes masking and social distancing, but it also requires a twice-weekly saliva test for SARS-CoV-2. All students and employees are assigned test days when they swipe their ID card and spit in a plastic tube, which is collected hourly and taken to a campus lab.
There a simplified but highly sensitive PCR genetic test goes through many cycles of amplifying the viral RNA. "Tracking three different viral RNA [genes] gives us very high accuracy," explains Martin Burke, the professor who developed the system and is monitoring its implementation at the University of Illinois Urbana-Champaign. They immediately retest any positive sample to confirm the results, "So we think our false positive rate is extremely low. … The goal is to notify the positive person within 30 minutes of a positive test results becoming known."
Testing everyone so frequently, with a sensitive test that can quickly detect small amounts of the virus soon after infection, and isolating those who test positive before the virus can grow to volumes that make it very infectious helps the Illinois system break the chain of transmission.
"The testing we have done is not a silver bullet, it has to be done in combination with other mitigation measures. Our modeling shows that if you have masks, social distancing, and contact tracing you get a very dramatic, in fact synergistic effect with this combination,' says Burke. "So it really has to be a holistic approach with lots of community engagement in order to make this process successful."
The real teeth of enforcement are that people have to display their health status to gain access to campus facilities. A green check mark over their photo on a college ID phone app means they are good to go but a big red X means they are not current on their testing or have tested positive for the virus. Their ID is inactivated and they cannot enter campus facilities until they become compliant. Burke puts it bluntly; "We stop them from going where they want to go, a measure first used successfully with the pandemic in Wuhan, China.
He says they have learned from their experience and evolved their approach. "We never modeled for people who tested positive to ignore that result and go to or host parties, which could spread the infection." But several students did just that, and a few have been suspended for it.
So the university clamped down on enforcing isolation and now requires some higher risk persons to test three times a week to catch any infections earlier. Since more than 95 percent of new infections were among undergraduates, with no crossover from them to the local community, faculty, or graduate students, they have cut back testing of the latter two groups to just once a week.
About a thousand positive tests results have come back so far but no one has been hospitalized. Part of that likely is because the undergraduate population is largely young and healthy with few risk cofactors. But it may also be that with early identification and isolation, about five percent of dorm rooms have been set aside for that purpose, the person adopts healthier patterns of sleeping and eating that allows the immune system to better fight off the virus.
"But when you compare that to the being able to educate our students, perform research, keep our community thriving, our businesses open, if you add it all up, it's a tremendous return on investment."
The logistics are quite impressive for the campus that in ordinary times is home to more than 50,000 students; a lab capable of churning through 20,000 tests a day, with notification of results within hours, not days as is common elsewhere. And the results are equally impressive. The rate of positive test results blipped up to around 3 percent when undergraduates arrived back on campus but that has plummeted to 0.35 percent for the last seven-day period of testing, a tiny fraction of the rate for the nation as a whole. Much of it can be attributed to the closed environment with limited outside contact that might reintroduce the virus.
Still, even while the campus population has dropped by about a third, they are detecting about 250 new infections a week.
The threat of outside contact adding to the risk is why the university amended the undergraduate school calendar to close for Thanksgiving, hold final classes and exams for the semester online, and not return until February.
It doesn't come cheap. Burke estimates it cost $10 million to set up the program and about the same each semester to operate. "But when you compare that to the being able to educate our students, perform research, keep our community thriving, our businesses open, if you add it all up, it's a tremendous return on investment."
Burke acknowledges that they started with some significant advantages. The community is geographically isolated, an electronically linked ID system was already in place for students and employees, they have the ability to control much activity through access to buildings, and they can expel those who do not conform. He believes their system can translate to similar settings but admits, "A big city is very different from a university community." Still, he believes many of those lessons can be translated to different settings.
An alternative story
However, the situation is very different at the University of Colorado, where new infections have surged since undergraduates returned in late August. Administrators recently switched all classes to online only in an attempt to control the virus.
But that wasn't enough for state authorities who cracked down further, just yesterday declaring a two-week lockdown of all students aged 18 to 22, prohibiting gatherings of any size, indoors or out. Students must stay in their rooms except for essential activities, and if any symptoms develop, report for testing. Fraternities and sororities were targeted as past hot spots of infection.
The police will be actively enforcing the lockdown, and violators can face a penalty of up to 90 days in jail and a $1,000 fine.
Skepticism
Public health largely is based upon an appeal to self-interest and altruism, and voluntary compliance with official guidance. Harm reduction often comes into play when an ideal solution meets resistance and coercion plays only a limited role, as when a person with infectious tuberculosis is not compliant with treatment. Many question whether the medical threat of COVID-19 justifies such a sweeping restriction of individual rights of movement and association imposed on everyone simply because of their age and place of residence as is happening in Colorado.
State and federal courts have begun to strike down as an unconstitutional overreach some of the more restrictive decrees to stay at home or close businesses ordered by state and local officials. What was once tolerated as a few weeks or even a few months of restrictions now seems to stretch without an end in sight, and threatens peoples' livelihoods. In this litigious country it seems only a matter of time before someone will challenge some aspects of the Illinois model or similar programs being set up elsewhere as an infringement of their rights.
"I have real concerns about what we have seen over the course of the past several months in terms of going from not enough testing being available to now having more testing [available] because people don't want to be tested, even when they have symptoms," says Michael Osterholm, a noted expert on pandemic preparedness at the University of Minnesota. "We have some college campuses reporting over fifty percent of the students refusing to be tested or refusing to give any of the contacts that might be followed up on."
Often those who have tested positive for the virus "don't want people to know that they're the potential reason there could be an outbreak in their small social circle," says LaQuandra Nesbitt, public health director for Washington, DC. Stigma is one of the main reasons why only 37% of newly infected people have provided names for contact tracing in D.C., and few offer more than a single name.
"We can't test every single person every single day, we would completely go broke, we would be looking at no other health problems. We're not the NFL," says Monica Gandhi. She is a professor of medicine at the University of California San Francisco and works closely with local health officials. "Just because we have a technology doesn't mean that we have to apply it for every purpose that may be indicated. … We would never dream of mass screening the public for influenza."
"Tests don't solve the problem," she argues. Masking is the most crucial piece for Gandhi, along with social distancing, washing hands regularly, and quarantine when testing positive or in contact with someone who is. Those are the actions that break the ongoing spread of transmission. She does support regular testing in high-risk settings such as nursing homes, inpatients in hospitals, and prisons, and periodic surveys in the general population to better understand where the virus is moving.
Drawing from experience with HIV, Gandhi worries that the stigma of a positive result will drive people away from testing. "Low-income persons will be particularly hesitant to get tested, or to share contact information if they do test positive, if they think they may have to quarantine, not work or gain income." That is why San Francisco initially assisted people in isolation with payment of $1285 for two weeks of isolation and other support as part of a right to health program. And this fall, the State of California passed legislation requiring that large businesses continue to pay employees in quarantine.
Tools for self-protection
The American temperament, decentralization, size, administrative complexity, and sheer cost make it highly unlikely that a coercive one-size-fits-all Illinois approach will ever be rolled out from a university campus to the entire nation. People make different decisions in trading off between safety and personal freedom or autonomy, and many are likely to embrace a rapid, inexpensive self-test if one becomes available, much like a home pregnancy test, to proactively monitor their own health.
OraSure Technologies pioneered the first home test for HIV. It is the only over-the-counter saliva test for HIV approved for sale in the U.S. Results show in about 20 minutes. The company went on to develop versions of this test for hepatitis C and Ebola. Thus it came as no surprise when in April the Department of Health and Human Services awarded it a $710 thousand contract to develop a rapid antigen home test for SARS-CoV-2.
Initial optimization studies for the antigen test showed that a nasal sample rather than an oral one generated better results, OraSure president and CEO Stephen Tang told LeapsMag. A test using a nasal swab is expected to be available later this year while work continues to develop an antibody test that uses saliva. He says, "the fundamental challenge is not only to develop the tests but to get it to scale quickly. That's the only way it's really going to matter." The company has manufacturing capacity to produce 35 million tests a year, with about half for SARS-CoV-2, and will double that capacity in steps within the next twelve months, with all of the increased capacity dedicated to COVID-19.
Initial use will be limited to health care workers and by prescription, but the company hopes to make it available over the counter soon after the FDA finalizes its rules on these types of tests for COVID-19. Importantly, OraSure believes its nasal swab test will be able to meet the current FDA standards for at-home tests. No such tests have yet been approved.
Tang says they envision using a phone app with the test, but that's tied to "the question of our century; who owns the data? If you are an individual buying the test, are you really compelled to report to anybody? If you are an employer and you buy the test and your employees take it, are you then entitled to the information because you're the one administering the test? That's all still being debated as well" by regulators, lawyers, and ethicists.
The price hasn't been set but Tang notes that they have "vast experience" in selling directly to the consumer, physicians, and public health systems in the U.S. and in lower-income companies. "We are very aware of what the economics are and what the need is today. We're trying to make this product as widely available to as many people as possible."
Another tool that may help protect the self-motivated are cell phone apps that alert you to potential exposure to others with the virus. Apple, Google and others have developed versions of the app that all work on the same principle and, miraculously, are compatible between the Apple and Android operating system universes. At first glance they look promising.
The glitch is that where they have been available the longest, only about 15-20 percent of users bother to download it, says Bennett Cyphers, a staff technologist with the Electronic Freedom Foundation (EFF), a nonprofit that advocates for privacy and other concerns in cyberspace. He explains, "If 1 in 10 people have the app installed, then only 1 in 100 interactions between everyone is going to be captured by the app. It scales that way; the fewer people you have, then a really, really small fraction of contacts are actually detected."
It is important to remember that much of public health is not the result of policy but of what people do in their daily lives.
Importantly, about 20 percent of Americans do not own a smart phone with the capacity to handle the app; that percentage is even higher among lower income, less educated, older folks who often are most at risk for suffering a severe case of COVID-19. So the value of this tool is likely to remain largely theoretical.
Divining the future
"It's tough to make predictions, especially about the future," the great baseball sage Yogi Berra is reported to have said. Will the COVID-19 pandemic in the U.S. follow the path of Illinois or Colorado?
The recent past often is no guide to such predictions. France, Spain, and Israel once earned plaudits for early and strict enforcement of lockdowns to control spread of the virus and then eased up on those restrictions. At the same time the world watched with condemnation and fascination as Sweden chose to follow a more laissez faire approach, urging voluntary distancing and masking but no major curtailing of activity.
Today the rates of new infections of COVID-19 in the first three countries have exploded to equal or multiples of the rate in Sweden. Which approach was the correct policy? Most people say it is still too early to tell for sure. The same can be said for the examples of Illinois and Colorado.
And then there is the puzzling example of Manaus, the Brazilian city of 1.8 million in the middle of the Amazon which was slammed with infections as hard as New York City; without the medical infrastructure to cope with the virus, 4000 have died. But then, suddenly, new infections began to taper off, and nobody claims to understand why, it certainly wasn't because official policies changed. One guess is that perhaps the region reached herd immunity, but that is simply speculation.
One can pick and choose examples of tough enforcement of quarantine or none to prove their point for the short term. But draconian measures will not be tolerated for long in a free society, and there is no clear, overwhelming evidence that over the long run one policy approach works better than another.
It is important to remember that much of public health is not the result of policy but of what people do in their daily lives. We have come remarkably far in what is still only months since we first heard the name of the virus. Death rates have fallen dramatically as we have learned how to better manage severe disease, often by adapting treatments for other diseases. And there is reason for optimism with the large number of vaccine candidates already in human trials.
We also have learned that we can control much of our own fate through simple but concerted actions in our daily lives such as social distancing, wearing masks, and washing hands. Let's not only remember those facts, but practice them.
Artificial Wombs Are Getting Closer to Reality for Premature Babies
In 2017, researchers at the Children's Hospital of Philadelphia grew extremely preterm lambs from hairless to fluffy inside a "biobag," a dark, fluid-filled bag designed to mimic a mother's womb.
"There could be quite a lot of infants that would benefit from artificial womb technologies."
This happened over the course of a month, across a delicate period of fetal development that scientists consider the "edge of viability" for survival at birth.
In 2019, Australian and Japanese scientists repeated the success of keeping extremely premature lambs inside an artificial womb environment until they were ready to survive on their own. Those researchers are now developing a treatment strategy for infants born at "the hard limit of viability," between 20 and 23 weeks of gestation. At the same time, Dutch researchers are going so far as to replicate the sound of a mother's heartbeat inside a biobag. These developments signal exciting times ahead--with a touch of science fiction--for artificial womb technologies. But is there a catch?
"There could be quite a lot of infants that would benefit from artificial womb technologies," says Josephine Johnston, a bioethicist and lawyer at The Hastings Center, an independent bioethics research institute in New York. "These technologies can decrease morbidity and mortality for infants at the edge of viability and help them survive without significant damage to the lungs or other problems," she says.
It is a viewpoint shared by Frans van de Vosse, leader of the Cardiovascular Biomechanics research group at Eindhoven University of Technology in the Netherlands. He participates in a university project that recently received more than $3 million in funding from the E.U. to produce a prototype artificial womb for preterm babies between 24 and 28 weeks of gestation by 2024.
The Eindhoven design comes with a fluid-based environment, just like that of the natural womb, where the baby receives oxygen and nutrients through an artificial placenta that is connected to the baby's umbilical cord. "With current incubators, when a respiratory device delivers oxygen into the lungs in order for the baby to breathe, you may harm preterm babies because their lungs are not yet mature for that," says van de Vosse. "But when the lungs are under water, then they can develop, they can mature, and the baby will receive the oxygen through the umbilical cord, just like in the natural womb," he says.
His research team is working to achieve the "perfectly natural" artificial womb based on strict mathematical models and calculations, van de Vosse says. They are even employing 3D printing technology to develop the wombs and artificial babies to test in them--the mannequins, as van de Vosse calls them. These mannequins are being outfitted with sensors that can replicate the environment a fetus experiences inside a mother's womb, including the soothing sound of her heartbeat.
"The Dutch study's artificial womb design is slightly different from everything else we have seen as it encourages a gestateling to experience the kind of intimacy that a fetus does in pregnancy," says Elizabeth Chloe Romanis, an assistant professor in biolaw at Durham Law School in the U.K. But what is a "gestateling" anyway? It's a term Romanis has coined to describe neither a fetus nor a newborn, but an in-between artificial stage.
"Because they aren't born, they are not neonates," Romanis explains. "But also, they are not inside a pregnant person's body, so they are not fetuses. In an artificial womb the fetus is still gestating, hence why I call it gestateling."
The terminology is not just a semantic exercise to lend a name to what medical dictionaries haven't yet defined. "Gestatelings might have a slightly different psychology," says Romanis. "A fetus inside a mother's womb interacts with the mother. A neonate has some kind of self-sufficiency in terms of physiology. But the gestateling doesn't do either of those things," she says, urging us to be mindful of the still-obscure effects that experiencing early life as a gestateling might have on future humans. Psychology aside, there are also legal repercussions.
The Universal Declaration of Human Rights proclaims the "inalienable rights which everyone is entitled to as a human being," with "everyone" including neonates. However, such a legal umbrella is absent when it comes to fetuses, which have no rights under the same declaration. "We might need a new legal category for a gestateling," concludes Romanis.
But not everyone agrees. "However well-meaning, a new legal category would almost certainly be used to further erode the legality of abortion in countries like the U.S.," says Johnston.
The "abortion war" in the U.S. has risen to a crescendo since 2019, when states like Missouri, Mississippi, Kentucky, Louisiana and Georgia passed so-called "fetal heartbeat bills," which render an abortion illegal once a fetal heartbeat is detected. The situation is only bound to intensify now that Justice Ruth Bader Ginsburg, one of the Supreme Court's fiercest champions for abortion rights, has passed away. If President Trump appoints Ginsburg's replacement, he will probably grant conservatives on the Court the votes needed to revoke or weaken Roe v. Wade, the milestone decision of 1973 that established women's legal right to an abortion.
"A gestateling with intermediate status would almost certainly be considered by some in the U.S. (including some judges) to have at least certain legal rights, likely including right-to-life," says Johnston. This would enable a fetus on the edge of viability to make claims on the mother, and lead either to a shortening of the window in which abortion is legal—or a practice of denying abortion altogether. Instead, Johnston predicts, doctors might offer to transfer the fetus to an artificial womb for external gestation as a new standard of care.
But the legal conundrum does not stop there. The viability threshold is an estimate decided by medical professionals based on the clinical evidence and the technology available. It is anything but static. In the 1970s when Roe v. Wade was decided, for example, a fetus was considered legally viable starting at 28 weeks. Now, with improved technology and medical management, "the hard limit today is probably 20 or 21 weeks," says Matthew Kemp, associate professor at the University of Western Australia and one of the Australian-Japanese artificial womb project's senior researchers.
The changing threshold can result in situations where lots of people invested in the decision disagree. "Those can be hard decisions, but they are case-by-case decisions that families make or parents make with the key providers to determine when to proceed and when to let the infant die. Usually, it's a shared decision where the parents have the final say," says Johnston. But this isn't always the case.
On May 9th 2016, a boy named Alfie Evans was born in Liverpool, UK. Suffering seizures a few months after his birth, Alfie was diagnosed with an unknown neurodegenerative disorder and soon went into a semi-vegetative state, which lasted for more than a year. Alfie's medical team decided to withdraw his ventilation support, suggesting further treatment was unlawful and inhumane, but his parents wanted permission to fly him to a hospital in Rome and attempt to prolong his life there. In the end, the case went all the way up to the Supreme Court, which ruled that doctors could stop providing life support for Alfie, saying that the child required "peace, quiet and privacy." What happened to little Alfie raised huge publicity in the UK and pointedly highlighted the dilemma of whether parents or doctors should have the final say in the fate of a terminally-ill child in life-support treatment.
"In a few years from now, women who cannot get pregnant because of uterine infertility will be able to have a fully functional uterus made from their own tissue."
Alfie was born and, thus had legal rights, yet legal and ethical mayhem arose out of his case. When it comes to gestatelings, the scenarios will be even more complicated, says Romanis. "I think there's a really big question about who has parental rights and who doesn't," she says. "The assisted reproductive technology (ART) law in the U.K. hasn't been updated since 2008....It certainly needs an update when you think about all the things we have done since [then]."
This June, for instance, scientists from the Wake Forest Institute for Regenerative Medicine in North Carolina published research showing that they could take a small sample of tissue from a rabbit's uterus and create a bioengineered uterus, which then supported both fertilization and normal pregnancy like a natural uterus does.
"In [a number of] years from now, women who cannot get pregnant because of uterine infertility will be able to have a fully functional uterus made from their own tissue," says Dr. Anthony Atala, the Institute's director and a pioneer in regenerative medicine. These bioengineered uteri will eventually be covered by insurance, Atala expects. But when it comes to artificial wombs that externally gestate premature infants, will all mothers have equal access?
Medical reports have already shown racial and ethnic disparities in infertility treatments and access to assisted reproductive technologies. Costs on average total $12,400 per cycle of treatment and may require several cycles to achieve a live birth. "There's no indication that artificial wombs would be treated any differently. That's what we see with almost every expensive new medical technology," says Johnston. In a much more dystopian future, there is even a possibility that inequity in healthcare might create disturbing chasms in how women of various class levels bear children. Romanis asks us to picture the following scenario:
We live in a world where artificial wombs have become mainstream. Most women choose to end their pregnancies early and transfer their gestatelings to the care of machines. After a while, insurers deem full-term pregnancy and childbirth a risky non-necessity, and are lobbying to stop covering them altogether. Wealthy white women continue opting out of their third trimesters (at a high cost), since natural pregnancy has become a substandard route for poorer women. Those women are strongly judged for any behaviors that could risk their fetus's health, in contrast with the machine's controlled environment. "Why are you having a coffee during your pregnancy?" critics might ask. "Why are you having a glass of red wine? If you can't be perfect, why don't you have it the artificial way?"
Problem is, even if they want to, they won't be able to afford it.
In a more sanguine version, however, the artificial wombs are only used in cases of prematurity as a life-saving medical intervention rather than as a lifestyle accommodation. The 15 million babies who are born prematurely each year and may face serious respiratory, cardiovascular, visual and hearing problems, as well as learning disabilities, instead continue their normal development in artificial wombs. After lots of deliberation, insurers agree to bear the cost of external wombs because they are cheaper than a lifetime of medical care for a disabled or diseased person. This enables racial and ethnic minority women, who make up the majority of women giving premature birth, to access the technology.
Even extremely premature babies, those babies (far) below the threshold of 28 weeks of gestation, half of which die, could now discover this thing called life. In this scenario, as the Australian researcher Kemp says, we are simply giving a good shot at healthy, long-term survival to those who were unfortunate enough to start too soon.