In his ruling last week, US District Judge Matthew J. Kacsmaryk of Texas cited numerous statistics that suggest mifepristone, one of two drugs used in medical abortions, is unsafe and untested, even though it has been used for more than two decades.
Here are six statements from the decision, which attempts to invalidate the FDA’s approval of the drug, that medical experts said are either inflammatory, inaccurate, or both:
1. “Jurists often use the word ‘fetus’ to inaccurately identify unborn humans in unscientific ways,” Kacsmaryk wrote in a footnote. Throughout the decision, he uses the terms ‘unborn human’ or ‘unborn child’ instead.
Medical experts say “unborn human” and “unborn child” are terms used by antiabortion activists to minimize the role of the person carrying the pregnancy.
“No one in medicine is referring to a pregnancy as an unborn [child],” said Dr. Katherine Pocius, medical director of family planning at Massachusetts General Hospital.
2. “Mifepristone … blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death.”
Mifepristone does block the hormone progesterone, causing the uterine lining to shed. It separates the pregnancy sac — which contains the placenta, fetus, and fluid — from the wall of the uterus.
While abortion does cut off the fetus from the uterus, Dr. Katharine White, a complex family planning specialist at Boston Medical Center and an obstetrics and gynecology professor at the Boston University Chobanian & Avedisian School of Medicine, objects to Kacsmaryk’s use of terms that evoke starvation. They conjure images of a baby not getting enough milk. In reality, the pregnancy sac might be smaller than an inch in diameter, with an embryo mere millimeters long.
“It’s meant to evoke emotion, which distracts from the major point of a person not trying to be pregnant,” White said. “That pulls attention to the fetus and embryo and away from the actual pregnant person, which is inappropriate.”
3. “ ... adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications.”
“That’s simply not true,” White said.
White said the complication rate from medication abortion is incredibly low, with no evidence in the 20-plus years that it’s been used of patients ever overwhelming an emergency room.
One study put the risk of a major complication from abortion at 0.23 percent.
Comparatively, 1.4 percent of women experienced severe complications after delivery, according to CDC data.
Pocius said, in fact, the opposite would be true: that removing mifepristone as a tool to manage abortions and miscarriages would increase the use of surgical abortions, which use more resources and would overwhelm the system.
4. “The entire abortion process takes place within the mother’s home, without physician oversight, potentially leading to undetected ectopic pregnancies ... and misdiagnosis of gestational age — all leading to severe or even fatal consequences.”
“His statement is assuming you’re getting no care,” Pocius said “These patients are being highly screened, often still getting ultrasounds, often getting blood typing.”
She added that a majority of patients in Massachusetts who undergo medication abortion receive ultrasounds to determine gestational age and to check for ectopic pregnancies, which is when a fertilized egg implants and grows outside the uterus. They also have bloodwork performed.
Some providers, however, don’t feel that ultrasounds are necessary in medical abortion. Studies have shown that the risk of adverse outcomes among women who undergo medical abortions via telehealth are limited when providers follow certain protocols — including asking patients a series of questions about their medical history and the likely duration of pregnancy, and counseling women on how to take the medications and what complications to look out for.
“I’m a convert,” White said. “For years, I felt everyone had to have an ultrasound. But I’ve been very persuaded by the data, which shows clearly that people can do this very safely at home without ever seeing me.”
5. Surgical abortion is “a statistically far safer procedure” than medical abortion.
According to one study, medication abortion had a major complication rate of 0.31 percent, compared with 0.16 percent for first-trimester aspiration abortion, and 0.41 percent for second-trimester or later procedures.
In general, providers considered both methods of abortion to be very safe.
“In fact for some patients, medical termination is safer,” said Dr. Erika Werner, chair and chief of obstetrics and gynecology at Tufts Medical Center and Tufts Medical School. “It depends on the patient’s surgical history, their medical history.”
White noted that both methods are also significantly safer than staying pregnant.
The court decision also cited studies showing that women who had medical abortions were more likely to have side effects such as bleeding and cramping and to seek out care in the emergency room.
“We know the bleeding can be heavy, even when people are counseled. It can be nerve-wracking. Just because a person presented to the emergency room doesn’t mean they were having a complication,” White said.
6. In its 2000 approval, the “FDA ‘entirely failed to consider an important aspect of the problem’ by omitting any evaluation of the psychological effects of the drug or an evaluation of the long-term medical consequences of the drug.”
White said this description is patently false, pointing to the FDA’s extensive and lengthy review of mifepristone before it was approved, including the data from its widespread use in Europe.
White added that the lack of negative psychological effects from abortion have also been well-documented.
“A negative mental health issue comes from an unplanned pregnancy in the first place, not from choosing abortion,” she said.
The argument also ignores data showing the mental health effects of not getting an abortion when one is wanted. According to The Turnaway Study, a 10-year study that looked at the impact of unwanted pregnancies on women in 21 states, those who were denied an abortion and gave birth reported more life-threatening complications like eclampsia and postpartum hemorrhage compared with those who received wanted abortions.
Further, the study found that women who have an abortion are no more likely than those denied the procedure to have depression, anxiety, or suicidal ideation. In fact, 95 percent of women reported that having the abortion was the right decision for them more than five years after the procedure.
Areta Kupchyk, a partner and co-chair of the FDA practice group at law firm Foley Hoag, said the psychological impacts of a medication are typically not something considered when a drug is approved, unless there is evidence of psychological impact as an adverse event, or it is a psychiatric drug.
The FDA is concerned about long-term medical consequences, and like other drugs, undertook an analysis of reported adverse effects. An initial requirement that the effects be reported elicited so few reports that the requirement was discontinued, and further analysis of voluntarily reported adverse effects done in 2016 and again in 2019 showed no larger concern, Kupchyk said.
Jessica Bartlett can be reached at email@example.com. Follow her on Twitter @ByJessBartlett.