The Case Against the Abortion Pill

Here is how I buried the body of my fifth child: I took myself to the emergency room because I was in labor and bleeding. The baby on the ultrasound screen lay still in the curve of my belly, its heart silent. Fetal demise resulting from spontaneous abortion, the medical term for miscarriage. The room was quiet as I delivered the baby. At first I was afraid to hold my child, who fit the length of my hand, its clavicles and ribs delicate as strands of hair. Then I saw the face, and the features were perfect. I marveled. My baby was soft, its bones not yet hardened, and still warm from the heat of my body. In my grief, I was granted a glimpse into secret places. I am made, and I make. I was no longer afraid.

The room went black as I lost consciousness, hemorrhaging. I awoke breathing through an oxygen mask, surrounded by concerned nurses. I avoided emergency surgery because my physician manually extracted the retained placenta lodged in my cervix, a common complication of late-term miscarriages, and gave me a shot to stop the bleeding.

When I left the hospital, I signed a form stating that I was transporting human remains in the small cardboard box they gave me. Inside, the baby rested on a pillow. Some older ladies had knitted hats and booties to remember miscarried babies, and I kept the gift for my other children, aged six, four, two, and ten months. Escorted in a wheelchair from the hospital’s antepartum unit, I was told to keep the form with me in case our vehicle was searched by police on our way home.

I opened the box one last time and looked at the child. Then my husband buried our baby in the corner of the garden. I sat, too weak to walk more than a few steps. Fetal demise as a result of spontaneous abortion—spontaneous as opposed to induced. I had been in the hospital, closely monitored for complications. The nurses made sure to call it a baby. They told me they were sorry.

My baby has a grave. Where are the babies dead from induced abortions? Do their mothers bury their bodies?

Abortion advocates tell us that abortion is safe. By becoming legal, so the story goes, hidden violence is made safe, and it must be protected because without abortion access, women will die. The majority of abortions in the United States are now medical as opposed to surgical, induced with the controversial medication mifepristone. The FDA claims this process is safe, with an extremely low complication rate.

But there is another story: one in which a child dies and a woman’s body becomes collateral damage in the culture war. This is a story in which a woman is nearly three times more likely to die in the year following an abortion than in the year following a live birth.

In this story, medical abortions induce an unnatural process, one in which up to 20 percent of women experience a complication—four times the complication rate of surgical abortion. The medical abortion process is designed to hide adverse events and discourage patient follow-up. Women seeking abortion receive lower standards of care than do women suffering miscarriage, despite advocates’ claims that miscarriage and chemical abortion are the same physiological processes with an identical treatment regimen. This story starts with mifepristone and the dubious history of its development and approval.

This story is being told before the Supreme Court in the case of U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine.

Medical abortion begins with a woman seeking a prescription for mifepristone and misoprostol, which together constitute the medical abortion regimen. Mifepristone blocks progesterone, the critical pregnancy hormone. Denied progesterone, which causes the nourishing uterine lining to grow, the baby dies. Misoprostol, taken after mifepristone has done its work, is a prostaglandin used off-label to produce uterine cramping and expel the fetal tissue.

Medical abortion occurs at home, with no oversight once the woman has received her prescription from an abortion provider. Mifepristone was developed to turn a public event, surgical abortion, into a private, self-administered one that could be confused with miscarriage. One young woman who participated in the original clinical trials for mifepristone told the Wall Street Journal, “At home it was just a private, personal thing . . . much better than waiting around in some doctor’s office.”

Originally called RU-486, mifepristone was developed in the 1980s by Étienne-Émile Baulieu, a French doctor working with the Swiss pharmaceutical company Roussel-Uclaf, a subsidiary of the German drug manufacturer Hoechst. The drug was controversial from the start. Hoechst was a member of the interwar pharmaceutical conglomerate IG Farben, infamous for developing Zyklon B, the gas used to exterminate prisoners in Nazi death camps. During a shareholders meeting, Baulieu recounts, anti-abortion protesters shouted, “You are turning the uterus into a crematory oven!”

In his 1991 book The “Abortion Pill”, Baulieu theorizes that “fertility control is at the heart of the human condition.” Baulieu saw mifepristone as a solution to “a demographic crisis that overwhelms us all.” He recounts that in the 1980s, the World Health Organization became enamored with his invention and offered “not only to endorse the pill but also pay for testing.” Roussel-Uclaf collaborated with WHO to perform trials in developing countries and provide mifepristone to “third-world public health services” at “a reduced price.” Today, these drugs flow into the developing world through a variety of NGOs. Baulieu saw mifepristone as a tool, not only for thinning the herd in the developing world, but also for culling “mutants,” the “deformed,” and the “diseased.” When mifepristone was approved for use in China in 1988, Baulieu writes that he was thrilled that his drug would be distributed “in a nation that constituted one quarter of humanity.”

In 1994, Roussel-Uclaf donated the U.S. rights to mifepristone to the Population Council, a group committed to limiting births in both the developing and the industrialized world. The single U.S. study on mifepristone prior to FDA approval was funded by the Population Council. Though the study found that mifepristone successfully terminated pregnancies 92 percent of the time when combined with misoprostol at less than forty-nine days gestation, it also found that failure rates increased with gestational age. For example, by a gestational age of fifty-seven days, the failure rate rose to 27 percent, necessitating further interventions to complete the abortion. The Population Council sponsored the New Drug Application for mifepristone before transferring the license to Danco Laboratories, a notoriously secretive company created by the Population Council to produce and distribute the drug. Danco received early funding from Warren Buffett and George Soros, among other population control enthusiasts.

In 2000, the FDA approved mifepristone for use in the United States, relying on Subpart H of the Code of Federal Regulations, created during the AIDS epidemic to accelerate approval of drugs that treat “serious or life-threatening illnesses.” In order to fast-track approval, the FDA classified pregnancy as a life-threatening illness, with abortion as a cure. It should come as no surprise that a majority of the Reproductive Health Drugs Advisory Committee, responsible for vetting mifepristone, had public pro-abortion affiliations, including the committee’s chair, Ezra Davidson, a member of Planned Parenthood’s advisory board.

A 2008 report by the Government Accountability Office (GAO) explains that approving mifepristone under Subpart H allowed the FDA to circumvent standard safeguards, moving the drug to market before “measures of effectiveness” from clinical trials were available. The Charlotte Lozier Institute reports that the FDA typically requires “two randomized, blinded, placebo-controlled trials demonstrating significant efficacy and minimal risks” to approve a pharmaceutical; mifepristone, however, was approved on the basis of a “single published trial that was non-blinded, non-randomized, and utilized only a historical, non-concurrent control.” The FDA also waived the requirement that mifepristone undergo a separate pediatric approval process in order to be used in women and girls under eighteen.

According to the GAO report, Danco and the Population Council promised the FDA they would perform two safety studies post-market. When they later reneged on their commitment, the FDA decided that post-market studies were unnecessary, despite their being required for drugs approved under Subpart H.

The FDA paid unusual deference to mifepristone’s sponsor, accepting the Population Council’s argument that requiring prescribers to perform follow-up procedures, such as surgery to resolve incomplete abortions, was unnecessary because “incomplete miscarriages were routinely handled by referring patients to outside providers with specialized surgical or emergency care training.” But an induced abortion is not a miscarriage.

Medical abortion needed to masquerade as miscarriage in order to bury complications that would threaten confidence in mifepristone’s safety. This cover-up was only possible if the breakdown of the patient–provider relationship—enacted through the requirement that nonprescriber physicians manage abortion complications—was baked into the drug’s approval.

According to the FDA, a woman need not confirm the date of her last menstrual period in order receive a prescription for mifepristone and misoprostol. Nor is an ultrasound required to determine the baby’s gestational age or to rule out an ectopic pregnancy. The woman does not need an in-office visit to ingest mifepristone, nor must she take misoprostol under supervision. No final ultrasound exam is performed to confirm that all the tissue has passed, which is the only way to ensure that retained tissue doesn’t cause a life-threatening septic infection. A woman can obtain these drugs out of state and carry them back to her state, where abortion may be illegal. She can obtain a prescription through a telehealth appointment and have the drugs mailed to her, regardless of the legality of abortion in her state.

The system encourages women obtaining medical abortions to seek emergency care rather than follow up with their prescribers if they experience complications. (The name-brand version of mifepristone, Mifeprex, has a patient agreement form that presumes women are unlikely to be treated for complications by their prescribers and vaguely instructs women seeking care to head to the ER rather than the clinic.) Abortion providers are not required to have admitting privileges at local hospitals. Some women are encouraged to hide the fact that they’ve taken drugs to induce an abortion. Franz Theard, one of the most prolific abortionists in the U.S., admitted to the Washington Post that he instructs women “to go to your favorite hospital and blame the cramps on—tell them you’re having a miscarriage . . . just don’t tell them about the pill. I recommend that you don’t. They’ll treat you like you killed Jesus or something.”

In most cases, a woman’s abortion complications will be miscoded as miscarriage complications, a consequence of either ignorance or intentional concealment on the part of the ER. Miscoding has resulted in a “large underrepresentation” of the true complication rate, according to a study by the Charlotte Lozier Institute (now retracted by Sage Journals in a bid to manipulate SCOTUS’s deliberations). A woman who hides her use of mifepristone significantly increases her risk for hospitalization.

Emergency rooms are not required to record the identity of the provider who prescribed the drug regimen, or even the fact that the patient took the drugs. Women suffering complications from medical abortion average three ER visits before getting the care they need: surgery to remove retained tissue. Their abortions are recorded as miscarriages, and the women are lost to follow-up. The system is designed to disrupt continuity of care in order to conceal the dangers of taking mifepristone.

Miscarriage itself can be far from safe, as I discovered firsthand. The likelihood of adverse events such as hemorrhaging, tissue retainment, and infection increases with gestational age. Around 20 percent of miscarriages require surgical intervention to remove retained tissue. This is comparable to the adverse event rate for medical abortion we see in data from Europe, long considered more reliable than U.S. abortion data. If abortion advocates took seriously their claim that miscarriage and medical abortion are essentially interchangeable, they would acknowledge the potentially high rate of adverse events with the use of chemical abortion drugs. Yet the FDA’s actions surrounding the approval of mifepristone and the continuous, systematic erosion of safety protocols around medical abortion demonstrate an intent to manufacture a low adverse event rate.

U.S. studies that conclude that medical abortion is safe are “frequently subject to design limitations such as the exclusion of an incomplete abortion as a complication.” You read that correctly: The most common complication from medical abortion procedures, incomplete abortion, is often excluded from studies purporting to determine complication rates of medical abortion. Such bald manipulation of data occurs in popular reporting as well. For example, in an analysis of abortion data, the New York Times does not count needing surgery to complete a medical abortion as an adverse event.

Abortion advocates manufacture an extremely low complication rate by defining away the problem: They tell women that pain and bleeding severe enough to warrant a visit to the ER are normal, or that needing surgery to complete a failed abortion is typical. The FDA does not require providers to report mifepristone complications unless the patient dies—burying evidence of complications as a matter of policy. Reporting of all other adverse events related to chemical abortion is completely voluntary. The FDA regulations conceal from women the true risks of medical abortion.

I spoke to an attending physician at an emergency room to learn how medical abortion complications are triaged. He told me that he was trained to treat medical abortion and miscarriage as interchangeable. Even if a woman tells him she has ingested medical abortion drugs, he does not chart it. He was taught that the genesis of the event is irrelevant to the care he provides.

Another physician explained that it is common practice not to record medical abortion drugs on patients’ charts, lest the patients face stigma. Another physician seconded this, telling me that when treating a woman for complications of an abortion, he doesn’t record her use of chemical abortion drugs because he wasn’t the prescriber and, he insisted, the fact has no impact on his triage care. But according to Mike Seibel, a malpractice attorney who represents women harmed by abortion complications, failure to record a patient’s medication use is not protected by HIPAA and can even be grounds for revoking a medical license. And for good reason.

Ingrid Skop, an ob-gyn and physician-researcher at the Charlotte Lozier Institute, explained to me why it is critical for providers to distinguish between miscarriage and abortion, and to record an accurate medical history. “If a woman presents to the ER with pain and bleeding, and acts like she’s miscarrying,” Dr. Skop told me, “the doctor assumes expectant management, treats her for pain, and sends her home to pass tissue naturally, telling her to follow up with her ob-gyn.” If the woman has attempted an abortion, however, “she is seeking emergency care because she most likely hasn’t passed the tissue, and she should be evaluated for surgical intervention. She’s already experiencing a complication.” Failure to distinguish between medical abortion and miscarriage puts women’s lives at risk.

Since the original approval of mifepristone in 2000, the FDA has made the chemical abortion regimen increasingly available. In 2016 it degraded Risk Evaluation and Mitigation Strategy (REMS) protocols, and it reaffirmed this decision in 2021. Mifepristone became available by telehealth, the prescriber pool was expanded to include non-physicians, and the gestational age cutoff was lengthened from seven weeks to ten. Prescribers are no longer required to maintain admitting privileges at local hospitals or “to report infections, hemorrhages, ectopic pregnancies, or hospitalizations.” 

Neither the FDA nor mifepristone manufacturer Danco felt they were “legally bound” to conduct trials to ensure the safety of these new standards. In an interview with the Wall Street Journal, a Danco spokeswoman claimed that the company “doesn’t have the resources to do the clinical trials.” The FDA and Danco had relied on trials conducted by activist-researchers to justify their sweeping changes to the drug’s use in 2016.

The FDA flouted basic medical ethics in order to secure a political end. Guidelines for mifepristone use establish a standard of care well below what obtains for women receiving any other form of medical treatment. This is unconscionable, and the gravity is compounded by the risks associated with abortion more broadly. Compared to women who deliver their children, women who abort are more than twice as likely to die of any cause within two years, according to a systematic review of record linkage studies of pregnancy-related mortality. The same review found that women who abort are at significantly elevated risk of suicide and substance abuse, and that a woman’s risk of premature death rises with each abortion she procures.

Danco stipulates use of mifepristone only until ten weeks of gestation and has distanced itself from off-label use of the drug. “Physicians are free to prescribe FDA-approved drugs as they wish,” a representative told the Los Angeles Times. “Danco uses only the FDA-approved regimen in its labeling and promotional materials and does not promote any other regimens.”

Yet abortion providers act without fear of repercussion, knowing that they have political cover, and they prescribe untested drug regimens that amount to “medical experimentation,” according to malpractice attorney Seibel. He frequently sees cases in which women have been prescribed mifepristone near the end of the second trimester, well after the FDA’s ten-week gestational age limit. The Atlantic reports that “women are using these pills even later in pregnancy” and encourages the United States to imitate the developing world, where mifepristone is routinely administered even in the third trimester in countries where abortion is illegal. According to data from Finland, the risk of requiring surgery to complete a medical abortion rises to 39 percent in the second trimester.

Seibel represented the family of Keisha Atkins, a young woman who died after a botched abortion turned septic. “Keisha was prescribed mifepristone along with a lethal injection to end the life of her second-trimester fetus,” he told me. Her death certificate states her death was “natural”—pulmonary embolism from pregnancy. But death from an abortion complication is not natural. Seibel suspects that the University of New Mexico Health Sciences Center’s medical examiner falsified the manner of death in order to protect the university hospital, which had referred Atkins to a late-term abortion provider. The University of New Mexico Health Sciences Center and the abortion provider settled with the family.

Holly Patterson died in 2003, also from a septic abortion complication. Holly is one of four California women who the FDA admits died as a result of mifepristone use between 2003 and 2005. The Planned Parenthood facility that administered mifepristone and misoprostol to Peterson did so off-label, instructing her to insert the drugs vaginally instead of orally, and at a lower dose than the FDA recommended at the time.

In 2022, Alyona Dixon arrived at a Nevada emergency room with pain and bleeding, having obtained a medical abortion at Planned Parenthood days earlier. According to the lawsuit her family filed, Alyona was released from the emergency room without a pelvic exam or consultation with an ob-gyn, despite the ER physician’s noting that she had a high white blood cell count and that an ultrasound had revealed retained products of conception. The next night, she returned to the ER with a septic infection. Her heart stopped while she was being intubated.

A complication need not be fatal to warrant evaluation of a drug’s safety. But accurate safety evaluations of mifepristone cannot be made if triage care for complications is systematically cordoned off from the originating event and prescriber, or if the reporting of complications from mifepristone use is voluntary, or if there is no patient follow-up.

I asked the emergency room physician whether he would consider filling out an adverse drug event report for mifepristone if a woman came in with a complication from a medical abortion. He laughed. “I have never filled out an adverse drug event report, for any drug, ever,” he said. “I don’t know a single physician who’s ever reported an event from a drug.”

The physician plaintiffs in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine allege that the use of mifepristone combined with misoprostol is not a safe means of inducing self-managed abortions and has harmed not only their practices—by diverting time and resources to the treatment of dangerous complications, degrading their care of other patients—but also their consciences. They claim that the FDA should never have approved mifepristone and was wrong to relax standards for its use without the support of safety data. The FDA has consistently refused to review contradicting safety claims on mifepristone since the initial approval, the plaintiffs allege, and even delayed a response to petitions filed by plaintiffs for six thousand days, thereby “stonewalling judicial review.”

In the spring of 2023, a federal judge in Texas ruled to invalidate the FDA’s original approval of mifepristone in 2000, a ruling the FDA appealed. The appeal transferred the case to the Fifth Circuit Court, which ruled to keep mifepristone on the market but reinstate safety protocols that existed prior to 2016. The FDA then petitioned the Supreme Court to intervene. The Court’s decision on this case is expected in June, marking the first time it will rule on abortion since the Dobbs decision.

The FDA contends in its petition that the physician plaintiffs do not have standing to bring this suit, arguing that the physicians cannot claim that “being presented with a patient in need of care” qualifies as an injury, since a physician’s “chosen profession is treating patients in an emergency setting.” The FDA claims that instances of the treatment of abortion complications by nonprescriber physicians are “isolated examples.” But this is false. The FDA’s mifepristone regulations assumed from the outset that nonprescriber physicians would bear the burden of treating complications. Just in the past few weeks, my own ob-gyn and the emergency room physician I interviewed have treated women for complications of incomplete chemical abortions—managing adverse effects from a pharmaceutical they did not prescribe, to complete a process they believe violates the Hippocratic Oath.

Those determined to make medical abortion readily available have intensified their pressure on the normal process of scientific review. During the writing of this essay, three peer-reviewed studies on the dangers of medical abortion published by physician researchers at the Charlotte Lozier Institute were retracted by Sage Journals. (Evidence from these studies has been included in this article.) Sage raised objections to the studies, which the authors refuted. Most concerning is Sage’s assertion that the authors’ “affiliations with pro-life institutes” present irreconcilable “conflicts of interest.” Whereas Charlotte Lozier scholars are excluded for their political, moral, or religious commitments, pro-abortion researchers are allowed to promote or even perform abortions, often for professional and financial gain, without challenge.

Pro-life advocates should hope that the Supreme Court at minimum rules to reinstate the safety constraints for mifepristone that were removed in 2016. Those constraints required, among other things: a physician visit to rule out ectopic pregnancy and confirm that gestational age does not exceed forty-nine days, a second physician’s visit for the administration of misoprostol, and a third visit to confirm passage of tissue. Mifepristone should not be made available through telehealth or mailed across state lines.

If the Supreme Court fails to hold the FDA accountable for first approving mifepristone and then eroding safety protocols as a matter of policy, abortion providers should be sued across the nation for continuing to prescribe the drug in ways that flout what few FDA guidelines exist.

Women should be encouraged to sue prescribers for malpractice over complications from mifepristone use. As Seibel reminded me, abortion has to be fought on the street: “It would be nice to head right through the front door on this issue and win, but there is an option to hit abortion providers where it hurts now.” His suit against Curtis Boyd, the notorious late-term abortionist who performed the abortion that killed Keisha Atkins, did just that. Boyd no longer performs abortions past twenty-four weeks in New Mexico. Seibel suspects that Boyd’s insurance has threatened to drop him if he performs third-trimester abortions.

States should introduce legislation requiring that “informed consent” specify that women have the right to sue abortion providers for complications related to mifepristone. This measure would lay the groundwork for women to sue not only abortion providers, but also the drug’s manufacturer. State legislators should also ensure that triaging physicians face serious consequences for failing to record a patient’s use of chemical abortion pills, up to and including the loss of their licenses.

It can be challenging to convince women to sue abortion providers who have caused them pain and suffering. Seibel told me that for a typical medical malpractice suit, a client meets with him just once and then decides to file. But for women harmed by abortion, “they typically talk to me seven to eight times before deciding to file.” Skop explained their reluctance: “I’ve asked women why they won’t pursue a lawsuit or complaint against the abortion provider who harmed them. They will usually respond by saying, ‘This is what I deserve for the choice I made.’”

I started to bleed over Christmas. I was newly pregnant, and I was miscarrying for the second time in three months. This pregnancy had never developed. There was no fetus, just tissue in the trophoblastic stage and an empty gestational sac—an abembryonic pregnancy.

I delivered the gestational sac alone at home. My pain and bleeding were manageable. I could make out the chorionic villi, hundreds of tiny, featherlike fingers that reached from the gestational sac to embed in the uterine lining and receive nourishment. I witnessed what had been knit together in my womb. My body produces remarkable things. The gestational sac was beautiful. I was devastated.

Though I avoided hospitalization, I had four separate physician visits, three with ultrasound. I have the personal cell number of my ob-gyn, and he checked in with me frequently during the process. Someone cared, not only about the baby I lost, but about me.

Rachel Roth Aldhizer writes from North Carolina. 

Image by Michelle Leman, public domain. Image cropped.