Abortions Before Fetal Viability Are Legal: Might Science and the Change on the Supreme Court Undermine That?
This article is part of the magazine, "The Future of Science In America: The Election Issue," co-published by LeapsMag, the Aspen Institute Science & Society Program, and GOOD.
Viability—the potential for a fetus to survive outside the womb—is a core dividing line in American law. For almost 50 years, the Supreme Court of the United States has struck down laws that ban all or most abortions, ruling that women's constitutional rights include choosing to end pregnancies before the point of viability. Once viability is reached, however, states have a "compelling interest" in protecting fetal life. At that point, states can choose to ban or significantly restrict later-term abortions provided states allow an exception to preserve the life or health of the mother.
This distinction between a fetus that could survive outside its mother's body, albeit with significant medical intervention, and one that could not, is at the heart of the court's landmark 1973 decision in Roe v. Wade. The framework of viability remains central to the country's abortion law today, even as some states have passed laws in the name of protecting women's health that significantly undermine Roe. Over the last 30 years, the Supreme Court has upheld these laws, which have the effect of restricting pre-viability abortion access, imposing mandatory waiting periods, requiring parental consent for minors, and placing restrictions on abortion providers.
Viability has always been a slippery notion on which to pin legal rights.
Today, the Guttmacher Institute reports that more than half of American women live in states whose laws are considered hostile to abortion, largely as a result of these intrusions on pre-viability abortion access. Nevertheless, the viability framework stands: while states can pass pre-viability abortion restrictions that (ostensibly) protect the health of the woman or that strike some kind a balance between women's rights and fetal life, it is only after viability that they can completely favor fetal life over the rights of the woman (with limited exceptions when the woman's life is threatened). As a result, judges have struck down certain states' so-called heartbeat laws, which tried to prohibit abortions after detection of a fetal heartbeat (as early as six weeks of pregnancy). Bans on abortion after 12 or 15 weeks' gestation have also been reversed.
Now, with a new Supreme Court Justice expected to be hostile to abortion rights, advances in the care of preterm babies and ongoing research on artificial wombs suggest that the point of viability is already sooner than many assume and could soon be moved radically earlier in gestation, potentially providing a legal basis for earlier and earlier abortion bans.
Viability has always been a slippery notion on which to pin legal rights. It represents an inherently variable and medically shifting moment in the pregnancy timeline that the Roe majority opinion declined to firmly define, noting instead that "[v]iability is usually placed at about seven months (28 weeks) but may occur earlier, even at 24 weeks." Even in 1977, this definition was an optimistic generalization. Every baby is different, and while some 28-week infants born the year Roe was decided did indeed live into adulthood, most died at or shortly after birth. The prognosis for infants born at 24 weeks was much worse.
Today, a baby born at 28 weeks' gestation can be expected to do much better, largely due to the development of surfactant treatment in the early 1990s to help ease the air into babies' lungs. Now, the majority of 24-week-old babies can survive, and several very premature babies, born just shy of 22 weeks' gestation, have lived into childhood. All this variability raises the question: Should the law take a very optimistic, if largely unrealistic, approach to defining viability and place it at 22 weeks, even though the overall survival rate for those preemies remains less than 10% today? Or should the law recognize that keeping a premature infant alive requires specialist care, meaning that actual viability differs not just pregnancy-to-pregnancy but also by healthcare facility and from country to country? A 24-week premature infant born in a rural area or in a developing nation may not be viable as a practical matter, while one born in a major U.S. city with access to state-of-the-art care has a greater than 70% chance of survival. Just as some extremely premature newborns survive, some full-term babies die before, during, or soon after birth, regardless of whether they have access to advanced medical care.
To be accurate, viability should be understood as pregnancy-specific and should take into account the healthcare resources available to that woman. But state laws can't capture this degree of variability by including gestation limits in their abortion laws. Instead, many draw a somewhat arbitrary line at 22, 24, or 28 weeks' gestation, regardless of the particulars of the pregnancy or the medical resources available in that state.
As variable and resource-dependent as viability is today, science may soon move that point even earlier. Ectogenesis is a term coined in 1923 for the growth of an organism outside the body. Long considered science fiction, this technology has made several key advances in the past few years, with scientists announcing in 2017 that they had successfully gestated premature lamb fetuses in an artificial womb for four weeks. Currently in development for use in human fetuses between 22 and 23 weeks' gestation, this technology will almost certainly seek to push viability earlier in pregnancy.
Ectogenesis and other improvements in managing preterm birth deserve to be celebrated, offering new hope to the parents of very premature infants. But in the U.S., and in other nations whose abortion laws are fixed to viability, these same advances also pose a threat to abortion access. Abortion opponents have long sought to move the cutoff for legal abortions, and it is not hard to imagine a state prohibiting all abortions after 18 or 20 weeks by arguing that medical advances render this stage "the new viability," regardless of whether that level of advanced care is available to women in that state. If ectogenesis advances further, the limit could be moved to keep pace.
The Centers for Disease Control and Prevention reports that over 90% of abortions in America are performed at or before 13 weeks, meaning that in the short term, only a small number women would be affected by shifting viability standards. Yet these women are in difficult situations and deserve care and consideration. Research has shown that women seeking later terminations often did not recognize that they were pregnant or had their dates quite wrong, while others report that they had trouble accessing a termination earlier in pregnancy, were afraid to tell their partner or parents, or only recently received a diagnosis of health problems with the fetus.
Shifts in viability over the past few decades have already affected these women, many of whom report struggling to find a provider willing to perform a termination at 18 or 20 weeks out of concern that the woman may have her dates wrong. Ever-earlier gestational limits would continue this chilling effect, making doctors leery of terminating a pregnancy that might be within 2–4 weeks of each new ban. Some states' existing gestational limits on abortion are also inconsistent with prenatal care, which includes genetic testing between 12 and 20 weeks' gestation, as well as an anatomy scan to check the fetus's organ development performed at approximately 20 weeks. If viability moves earlier, prenatal care will be further undermined.
Perhaps most importantly, earlier and earlier abortion bans are inconsistent with the rights and freedoms on which abortion access is based, including recognition of each woman's individual right to bodily integrity and decision-making authority over her own medical care. Those rights and freedoms become meaningless if abortion bans encroach into the weeks that women need to recognize they are pregnant, assess their options, seek medical advice, and access appropriate care. Fetal viability, with its shifting goalposts, isn't the best framework for abortion protection in light of advancing medical science.
Ideally, whether to have an abortion would be a decision that women make in consultation with their doctors, free of state interference. The vast majority of women already make this decision early in pregnancy; the few who come to the decision later do so because something has gone seriously wrong in their lives or with their pregnancies. If states insist on drawing lines based on historical measures of viability, at 24 or 26 or 28 weeks, they should stick with those gestational limits and admit that they no longer represent actual viability but correspond instead to some form of common morality about when the fetus has a protected, if not absolute, right to life. Women need a reasonable amount of time to make careful and informed decisions about whether to continue their pregnancies precisely because these decisions have a lasting impact on their bodies and their lives. To preserve that time, legislators and the courts should decouple abortion rights from ectogenesis and other advances in the care of extremely premature infants that move the point of viability ever earlier.
[Editor's Note: This article was updated after publication to reflect Amy Coney Barrett's confirmation. To read other articles in this special magazine issue, visit the e-reader version.]
Everyone Should Hear My COVID Vaccine Experience
On December 18th, 2020, I received my first dose of the Pfizer mRNA vaccine against SARS-CoV-2. On January 9th, 2021, I received my second. I am now a CDC-card-carrying, fully vaccinated person.
The build-up to the first dose was momentous. I was scheduled for the first dose of the morning. Our vaccine clinic was abuzz with excitement and hope, and some media folks were there to capture the moment. A couple of fellow emergency physicians were in the same cohort of recipients as I; we exchanged virtual high-fives and took a picture of socially distanced hugs. It was, after all, the closest thing we'd had to a celebration in months.
I walked in the vaccine administration room with anticipation – it was tough to believe this moment was truly, finally here. I got a little video of my getting the shot, took my obligate vaccine selfie, waited in the observation area for 15 minutes to ensure I didn't have a reaction, and then proudly joined 1000s of fellow healthcare workers across the country in posting #ThisIsMyShot on social media. "Here we go, America!"
The first shot, though, didn't actually do all that much for me. It hurt less than a flu shot (which, by the way, doesn't hurt much). I had virtually no side effects. I also knew that it did not yet protect me. The Pfizer (and Moderna) data show very clearly that although the immune response starts to grow 10-12 days after the first shot, one doesn't reach full protection against COVID-19 until much later.
So when, two days after my first shot, I headed back to work in the emergency department, I kept wondering "Will this be the day that I get sick? Wouldn't that be ironic!" Although I never go without an N95 during patient care, it just takes one slip – scratching one's eyes, eating lunch in a break room that an infected colleague had just been in – to get ill. Ten months into this pandemic, it is so easy to get fatigued, to make a small error just one time.
Indeed, I had a few colleagues fall ill in between their first and second shots; one was hospitalized. This was not surprising, but still sad, given how close they had come to escaping infection.
Scientifically speaking, one doesn't need to feel bad to develop an immune response. Emotionally, though, I welcomed the symptoms as proof positive that I would be protected.
This time period felt a little like we had our learner's permit for driving: we were on our way to being safe, but not quite there yet.
I also watched, with dismay, our failures as a nation at timely distribution of the vaccine. On December 18th, despite the logistical snafus that many of us had started to highlight, it was still somewhat believable that we would at least distribute (if not actually administer) 20 million doses by the New Year. But by December 31, my worst fears about the feds' lack of planning had been realized. Only 14 million doses had gone to states, and fewer than 3 million had been administered. Within the public health and medical community, we began to debate how to handle the shortages and slow vaccination rates: should we change prioritization schemes? Get rid of the second dose, in contradiction to what our FDA had approved?
Let me be clear: I really, really, really wanted my second dose. It is what is supported by the data. After living this long at risk, it felt frankly unfair that I might not get fully protected. I waited with trepidation, afraid that policies would shift before I got it in my arm.
At last, my date for my second shot arrived.
This shot was a little less momentous on the outside. The vaccine clinic was much more crowded, as we were now administering first doses to more people, as well as providing the second dose to many. There were no high fives, no media, and I took no selfies. I finished my observation period without trouble (as did everyone else vaccinated the same day, as is typical for these vaccines). I walked out the door planning to spend a nice afternoon outdoors with my kids.
Within 15 minutes, though, the very common side effects – reported by 80% of people my age after the second dose – began to appear. First I got a headache (like 52% of people my age), then body aches (37%), fatigue (59%), and chills (35%). I felt "foggy", like I was fighting something. Like 45% of trial participants who had received the actual vaccine, I took acetaminophen and ibuprofen to stave off the symptoms. There is some minimal evidence from other vaccines that pre-treatment with these anti-inflammatories may reduce antibodies, but given that half of trial participants took these medications, there's no reason to make yourself suffer if you develop side effects. Forty-eight hours later, just in time for my next shift, the side effects magically cleared. Scientifically speaking, one doesn't need to feel bad to develop an immune response. Emotionally, though, I welcomed the symptoms as proof positive that I would be protected.
My reaction was truly typical. Although the media hype focuses on major negative reactions, they are – statistically speaking – tremendously rare: fewer than 11/million people who received the Pfizer vaccine, and 3/million who received the Moderna vaccine, developed anaphylaxis; of these, all were treated, and all are fine. Compare this with the fact that approximately 1200/million Americans have died of this virus. I'll choose the minor, temporary, utterly treatable side effects any day.
Now, more than 14 days after my second dose, the data says that my chance of getting really sick is, truly, infinitesimally low. I don't have to worry that each shift will put me into the hospital. I feel emotionally lighter, and a little bit like I have a secret super-power.
But I also know that we are not yet home free.
I may have my personal equivalent of Harry Potter's invisibility cloak – but we don't yet know whether it protects those around me, at all. As Dr. Fauci himself has written, while community spread is high, there is still a chance that I could be a carrier of infection to others. So I still wear my N95 at work, I still mask in public, and I still shower as soon as I get home from a shift and put my scrubs right in the washing machine to protect my husband and children. I also won't see my parents indoors until they, too, have been vaccinated.
At the end of the day, these vaccines are both amazing and life-changing, and not. My colleagues are getting sick less often, now that many of us are a week or more out from our second dose. I can do things (albeit still masked) that would simply not have been safe a month ago. These are small miracles, for which I am thankful. But like so many things in life, they would be better if shared with others. Only when my community is mostly vaccinated, will I breathe easy again.
My deepest hope is that we all have – and take - the chance to get our shots, soon. Because although the symbolism and effect of the vaccine is high, the experience itself was … not that big a deal.
New Hope for Organ Transplantation: Life Without Anti-Rejection Drugs
Rob Waddell dreaded getting a kidney transplant. He suffers from a genetic condition called polycystic kidney disease that causes the uncontrolled growth of cysts that gradually choke off kidney function. The inherited defect has haunted his family for generations, killing his great grandmother, grandmother, and numerous cousins, aunts and uncles.
But he saw how difficult it was for his mother and sister, who also suffer from this condition, to live with the side effects of the drugs they needed to take to prevent organ rejection, which can cause diabetes, high blood pressure and cancer, and even kidney failure because of their toxicity. Many of his relatives followed the same course, says Waddell: "They were all on dialysis, then a transplant and ended up usually dying from cancers caused by the medications."
When the Louisville native and father of four hit 40, his kidneys barely functioned and the only alternative was either a transplant or the slow death of dialysis. But in 2009, when Waddell heard about an experimental procedure that could eliminate the need for taking antirejection drugs, he jumped at the chance to be their first patient. Devised by scientists at the University of Louisville and Northwestern University, the innovative approach entails mixing stem cells from the live kidney donor with that of the recipient to create a hybrid immune system, known as a chimera, that would trick the immune system and prevent it from attacking the implanted kidney.
The procedure itself was done at Northwestern Memorial Hospital in Chicago, using a live kidney donated by a neighbor of Waddell's, who camped out in Chicago during his recovery. Prior to surgery, Waddell underwent a conditioning treatment that consisted of low dose radiation and chemotherapy to weaken his own immune system and make room for the infusion of stem cells.
"The low intensity chemo and radiation conditioning regimen create just enough space for the donor stem cells to gain a foothold in the bone marrow and the donor's immune system takes over," says Dr. Joseph Levanthal, the transplant surgeon who performed the operation and director of kidney and pancreas transplantation at Northwestern University Feinberg School of Medicine. "That way the recipient develops an immune system that doesn't see the donor organ as foreign."
"As a surgeon, I saw what my patients had to go through—taking 25 pills a day, dying at an early age from heart disease, or having a 35% chance of dying every year on dialysis."
A week later, Waddell had the kidney transplant. The following day, he was infused with a complex cellular cocktail that included blood-forming stem cells derived from his donor's bone marrow mixed what are called tolerance inducing facilitator cells (FCs); these cells help the foreign stem cells get established in the recipient's bone marrow.
Over the course of the following year, he was slowly weaned off of antirejection medications—a precaution in case the procedure didn't work—and remarkably, hasn't needed them since. "I felt better than I had in decades because my kidneys [had been] degrading," recalls Waddell, now 54 and a CPA for a global beverage company. And what's even better is that this new approach offers hope for one of his sons who has also inherited the disorder.
Kidney transplants are the most frequent organ transplants in the world and more than 23,000 of these procedures were done in the United States in 2019, according to the United Network for Organ Sharing. Of this, about 7,000 operations are done annually using live organ donors; the remainder use organs from people who are deceased. Right now, this revolutionary new approach—as well as a similar strategy formulated by Stanford University scientists--is in the final phase of clinical trials. Ultimately, this research may pave the way towards realizing the holy grail of organ transplantation: preventing organ rejection by creating a tolerant state in which the recipient's immune system is compatible with the donor, which would eliminate the need for a lifetime of medications.
"As a surgeon, I saw what my patients had to go through—taking 25 pills a day, dying at an early age from heart disease, or having a 35% chance of dying every year on dialysis," says Dr. Suzanne Ildstad, a transplant surgeon and director of the Institute for Cellular Therapeutics at the University of Louisville, whose discovery of facilitator cells were the basis for this therapeutic platform. Ildstad, who has spent more than two decades searching for a better way, says, "This is something I have worked for my entire life."
The Louisville group uses a combination of chemo and radiation to replace the recipient's immune and blood forming cells with that of the donor. In contrast, the Stanford protocol involves harvesting the donor's blood stem cells and T-cells, which are the foot soldiers of the immune system that fight off infections and would normally orchestrate the rejection of the transplanted organ. Their transplant recipients undergo a milder form of "conditioning" that only radiates discrete parts of the body and selectively targets the recipient's T-cells, creating room for both sets of T-cells, a strategy these researchers believe has a better safety profile and less of a chance of rejection.
"We try to achieve immune tolerance by a true chimerism," says Dr. Samuel Strober, a professor of medicine for immunology and rheumatology at Stanford University and a leader of this research team. "The recipients immune system cells are maintained but mixed in the blood with that of the donor."
Studies suggest both approaches work. In a 2018 clinical trial conducted by Talaris Therapeutics, a Louisville-based biotech founded by Ildstad, 26 of 37 (70%) of the live donor kidney transplant recipients no longer need immunosuppressants. Last fall, Talaris began the final phase of clinical tests that will eventually encompass more than 120 such patients.
The Stanford group's cell-based immunotherapy, which is called MDR-101 and is sponsored by the South San Francisco biotech, Medeor Therapeutics, has had similar results in patients who received organs from live donors who were either well matched, such as one from siblings, meaning they were immunologically identical, or partially matched; Talaris uses unrelated donors where there is only a partial match.
In their 2020 clinical trial of 51 patients, 29 were fully matched and 22 were a partial match; 22 of the fully matched recipients didn't need antirejection drugs and ten of the partial matches were able to stop taking some of these medications without rejection. "With our fully matched, roughly 80% have been completely off drugs up to 14 years later," says Strober, "and reducing the number of drugs from three to one [in the partial matches] means you have far fewer side effects. The goal is to get them off of all drugs."
But these protocols are limited to a small number of patients—living donor kidney recipients. As a consequence, both teams are experimenting with ways to broaden their approach so they can use cadaver organs from deceased donors, with human tests planned in the coming year. Here's how that would work: after the other organs are removed from a deceased donor, stem cells are harvested from the donor's vertebrae in the spinal column and then frozen for storage.
"We do the transplant and give the patient a chance to recover and maintain them on drugs," says Ildstad. "Then we do the tolerance conditioning at a later stage."
If this strategy is successful, it would be a genuine game changer, and open the door to using these protocols for transplanting other cadaver organs, including the heart, lungs and liver. While the overall procedure is complex and costly, in the long run it's less expensive than repeated transplant surgeries, the cost of medications and hospitalizations for complications caused by the drugs, or thrice weekly dialysis treatments, says Ildstad.
And she adds, you can't put a price tag on the vast improvement in quality of life.