“A patient should not have to undergo forcible explantation of a device,” says Nita Farahany, a legal scholar and ethicist at Duke University in North Carolina, who has written a book about neuro rights.
“If there is evidence that a brain-computer interface could become part of the self of the human being, then it seems that under no condition besides medical necessity should it be allowed for that BCI to be explanted without the consent of the human user,” says Ienca. “If that is constitutive of the person, then you’re basically removing something constitutive of the person against their will.” Ienca likens it to the forced removal of organs, which is forbidden in international law.
Mark Cook, a neurologist who worked on the trial Leggett volunteered for, has sympathy with the company, which he says was “ahead of its time.” “I get a lot of correspondence about this; a lot of people inquiring about how wicked it was,” he says. But Cook feels that outcomes like this are always a possibility in medical trials of drugs and devices. He stresses that it’s important for participants to be fully aware of these possibilities before they take part in such trials.
Ienca and Gilbert, however, think something needs to change. Companies should have insurance that covers the maintenance of devices should volunteers need to keep them beyond the end of a clinical trial, for example. Or perhaps states could intervene and provide the necessary funding.
Burkhart has his own suggestions. “These companies need to have the responsibility of supporting these devices in one way or another,” he says. At minimum, companies should set aside funds that cover ongoing maintenance of the devices and their removal only when the user is ready, he says.
Burkhart also thinks the industry could do with a set of standards that allow components to be used in multiple devices. Take batteries, for example. It would be easier to replace a battery in one device if the same batteries were used by every company in the field, he points out. Farahany agrees. “A potential solution … is making devices interoperable so that it can be serviced by others over time,” she says.
“These kinds of challenges that we’re now observing for the first time will become more and more common in future,” says Ienca. Several big companies, including Blackrock Neurotech and Precision Neuroscience, are making significant investments in brain implant technologies. And a search for “brain-computer interface” on an online clinical trials registry gives more than 150 results. Burkhart believes around 30 to 35 people have received brain-computer interfaces similar to his.
Leggett has expressed an interest in future trials of brain implants, but her recent stroke will probably render her ineligible for other studies, says Gilbert. Since the trial ended, she has been trying various combinations of medicines to help manage her seizures. She still misses her implant.
“To finally switch off my device was the beginning of a mourning period for me,” she told Gilbert. “A loss—a feeling like I’d lost something precious and dear to me that could never be replaced. It was a part of me.”
Matt Kaeberlein is what you might call a dog person. He has grown up with dogs and describes his German shepherd, Dobby, as “really special.” But Dobby is 14 years old—around 98 in dog years.
Kaeberlein is co-director of the Dog Aging Project, an ambitious research effort to track the aging process of tens of thousands of companion dogs across the US. He is one of a handful of scientists on a mission to improve, delay, and possibly reverse that process to help them live longer, healthier lives.
And dogs are just the beginning. One day, this research could help to prolong the lives of humans. Read the full story.
—Jessica Hamzelou
We can still have nice things
A place for comfort, fun and distraction in these weird times. (Got any ideas? Drop me a line or tweet ’em at me.)
+ All hail the unsung women of indie sleaze. + It’s officially October! + This list of sartorial advice has been entertaining us at MIT Technology Review—how many points do you agree with? + Put down the expired milk, it’s got a whole lot more to give. 🥛 + Some top tips for remembering your dreams more fully: should you want to, that is.
The technology would likely be used first on infants born at 22 or 23 weeks who don’t have many other options. “You don’t want to put an infant on this device who would otherwise do well with conventional therapy,” Mychaliska says. At 22 weeks gestation, babies are tiny, often weighing less than a pound. And their lungs are still developing. When researchers looked at babies born between 2013 and 2018, survival among those who were resuscitated at 22 weeks was 30%. That number rose to nearly 56% at 23 weeks. And babies born at that stage who do survive have an increased risk of neurodevelopmental problems, cerebral palsy, mobility problems, hearing impairments, and other disabilities.
Selecting the right participants will be tricky. Some experts argue that gestational age shouldn’t be the only criteria. One complicating factor is that prognosis varies widely from center to center, and it’s improving as hospitals learn how best to treat these preemies. At the University of Iowa Stead Family Children’s Hospital, for example, survival rates are much higher than average: 64% for babies born at 22 weeks. They’ve even managed to keep a handful of infants born at 21 weeks alive. “These babies are not a hopeless case. They very much can survive. They very much can thrive if you are managing them appropriately,” says Brady Thomas, a neonatologist at Stead. “Are you really going to make that much of a bigger impact by adding in this technology, and what risks might exist to those patients as you’re starting to trial it?”
Prognosis also varies widely from baby to baby depending on a variety of factors. “The girls do better than the boys. The bigger ones do better than the smaller ones,” says Mark Mercurio, a neonatologist and pediatric bioethicist at the Yale School of Medicine. So “how bad does the prognosis with current therapy need to be to justify use of an artificial womb?” That’s a question Mercurio would like to see answered.
What are the risks?
One ever-present concern in the tiniest babies is brain bleeds. “That’s due to a number of factors—a combination of their brain immaturity, and in part associated with the treatment that we provide,” Mychaliska says. Babies in an artificial womb would need to be on a blood thinner to prevent clots from forming where the tubes enter the body. “I believe that places a premature infant at very high risk for brain bleeding,” he says.
And it’s not just about the baby. To be eligible for EXTEND, infants must be delivered via cesarean section, which puts the pregnant person at higher risk for infection and bleeding. Delivery via a C-section can also have an impact on future pregnancies.
So if it works, could babies be grown entirely outside the womb?
Not anytime soon. Maybe not ever. In a paper published in 2022, Flake and his colleagues called this scenario “a technically and developmentally naive, yet sensationally speculative, pipe dream.” The problem is twofold. First, fetal development is a carefully choreographed process that relies on chemical communication between the pregnant parent’s body and the fetus. Even if researchers understood all the factors that contribute to fetal development—and they don’t—there’s no guarantee they could recreate those conditions.
The second issue is size. The artificial womb systems being developed require doctors to insert a small tube into the infant’s umbilical cord to deliver oxygenated blood. The smaller the umbilical cord, the more difficult this becomes.
What are the ethical concerns?
In the near term, there are concerns about how to ensure that researchers are obtaining proper informed consent from parents who may be desperate to save their babies. “This is an issue that comes up with lots of last-chance therapies,” says Vardit Ravitsky, a bioethicist and president of the Hastings Center, a bioethics research institute.
Last week, Elon Musk made the bold assertion that sticking electrodes in people’s heads is going to lead to a huge increase in the rate of data transfer out of, and into, human brains.
The occasion of Musk’s post was the announcement by Neuralink, his brain-computer interface company, that it was officially seeking the first volunteer to receive an implant that contains more than twice the number of electrodes than previous versions to collect more data from more nerve cells.
The entrepreneur mentioned a long-term goal of vastly increasing “bandwidth” between people, or people and machines, by a factor of 1,000 or more. But what does he mean, and is it even possible? Read the full story.
—Antonio Regalado
This story is from The Checkup, MIT Technology Review’s weekly biotech newsletter. Sign up to receive it in your inbox every Thursday.
Everything you need to know about artificial wombs
Earlier this month, US Food and Drug Administration advisors met to discuss how to move research on artificial wombs from animals into humans.
These medical devices are designed to give extremely premature infants a bit more time to develop in a womb-like environment before entering the outside world. They have been tested with hundreds of lambs (and some piglets), but animal models can’t fully predict how the technology will work for humans.
