The Food and Drug Administration has convened a Pediatric Advisory Committee this week to determine whether artificial womb technology is ready to try on premature infants as well as to address regulatory and ethical considerations. Although the technology is promising, this development poses numerous ethical challenges.
Artificial wombs have been a dream of neonatologists for decades. While current ICU technology has saved or aided innumerable premature infants in the United States and many other nations, there are limits to what can be done to save preemie fetuses.
Fetuses don’t develop lungs mature enough to breathe outside a mother’s body before 23 or 24 weeks of gestation, though some hospitals are equipped to treat them. Indeed, the old standard for fetal viability used in Roe v. Wade, before the Supreme Court overruled the decision last year, linked viability to this biological development, at about 28 weeks.
Artificial wombs for animals are used in many versions. They can attempt to save younger preemies. The most advanced use of artificial wombs in animals is at the Children’s Hospital of Philadelphia. Research with lambs, whose gestational development is similar to humans, has been ongoing for many years, and now the hospital’s neonatal researchers are seeking approval for the first human use of what they call the Extra-uterine Environment for Newborn Development, or EXTEND.
EXTEND is not yet able to support human fetal development from conception to birth. And it requires a caesarean section delivery in order to use the technology.
The researchers have told the FDA that simulating some aspects of a natural womb environment will increase survival and improve outcomes for extremely premature babies — 28 weeks or less and perhaps as early as 22. If the fetus does well attached to the synthetic womb, the fetus would be moved to a neonatal ICU when its lung function stabilizes to grow further.
There are numerous ethical challenges that this kind of technology poses. First and most important: Has enough animal research been done to create confidence among the neonatal medical community that human fetuses are reasonably likely to survive? Those offering to attempt it on preemies have financial interests in EXTEND; their opinions need to be confirmed by independent experts. In addition, success requires sending a healthy baby home, not simply keeping a preemie alive for a few days or weeks.
If there seems to be enough animal data to justify a human experiment, then which fetuses and families ought be eligible to be subjects and why? Should only pregnant people at high risk of prematurity but not carrying multiple fetuses be approached? Or those who have a fetus with an inherited disease that has potential for high risk of death or severe disability? And will only the insured be approached for their consent or those who have stable families and strong emotional support to get them through a grueling, tense experiment? What about a first-time pregnancy or those parents who already have a family? Or only legally married couples who have a full genetic relationship to the at-risk fetus — this would exclude surrogate mothers or those who donated eggs or sperm?
There are more considerations. A desperate parent, knowing they are likely to lose a much-wanted baby to prematurity, may agree to anything doctors might offer. So local research ethics committees can’t rely solely on parental consent. They will need to convince themselves, no matter what approval the FDA gives, that this is the appropriate situation for a high-risk tech gamble.
And down the road, what about the reverse, when parents do not wish to attempt to use the artificial womb but their clinicians feel it’s life-saving and appeal to the state for the right to force treatment? Will parents lose the right to refuse?
The artificial womb will also add more fuel to the raging debate over abortion. Is the goal to rescue fetuses or babies? What quality of fetal life would make it reasonable to change the definition of viability? Would artificial womb technology soon be mandatory in any pro-life state regardless of the odds or the cost?
Twenty-seven years ago, one of us predicted that society would have to struggle with the ethical challenges posed by the creation of the first artificial wombs for human use. The technology is now very close, but the moral answers are no easier.
Arthur Caplan is a professor at the New York University Grossman School of Medicine. Gwendolyn P. Quinn is a professor of Obstetrics and Gynecology at the NYU Grossman School of Medicine.