Noem’s Misleading Claim About Safety of Medication Abortion

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The Food and Drug Administration and numerous peer-reviewed academic studies have concluded that medication abortions are “safe and effective” and that serious adverse events from medication abortion are relatively rare. Recent research on women who receive abortion pills through the mail after a video conference with a clinician — rather than in-person from a medical clinic — does “not appear to show increases in serious safety concerns,” the FDA said.

Nonetheless, South Dakota Gov. Kristi Noem, who opposes abortion, defended her state’s ban on prescriptions via telemedicine (rather than in-person) appointments by calling medication abortions “very dangerous medical procedures” and claiming that “a woman is five times more likely to end up in an emergency room if they’re utilizing this kind of method for an abortion.”

Noem’s press office said Noem meant to say four times more likely, not five (a figure she has used in the past), and cited research on emergency room visits by women with Medicaid coverage who got medication abortions. She isn’t citing the study correctly, though. It found that women who got medication abortions were 53% more likely (not four times) to have a subsequent emergency room visit for an abortion-related reason than a woman who received a surgical abortion.

But other researchers warn not to assume that a higher rate of emergency room visits necessarily means it is a higher safety risk. They cite research that shows most women with Medicaid who visit an ER after a medication abortion are not treated for any serious complication.

Noem’s Case Against Medication Abortion

The U.S. Supreme Court on June 24 voted 5-4 to overturn Roe v. Wade, holding that the “Constitution does not confer a right to abortion” and returning the regulation of abortion to states. Thirteen states, including South Dakota, passed so-called trigger laws to ban abortion when Roe was overturned, and other states are expected to follow suit.

As states begin to implement abortion bans and restrictions, CBS News says medication abortions — which are done early in abortions and now account for more than half of abortions in the U.S. — “may be the next front in the fight to preserve abortion rights in states that are curtailing access.” Signaling a fight ahead between the White House and states that may seek to prohibit medication abortions, Attorney General Merrick Garland issued a statement on June 24 in which he said, “States may not ban [one of the abortion drugs] Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

South Dakota is one of 19 states that require a clinician to be physically present when abortion medication is taken, and it is one of 30 states that require clinicians who administer medication abortion to be physicians, according to the Guttmacher Institute.

On CBS’ “Face the Nation” on June 26, host Margaret Brennan asked Noem if South Dakota planned to try to stop women from receiving abortion-inducing medications by mail, even though the drugs are FDA-approved.

In this photo illustration, a person looks at an abortion pill displayed on a smartphone. Photo by Olivier Douliery/AFP via Getty Images.

“Well, we’ve already addressed this in many ways in the state of South Dakota,” Noem said. “I brought a bill that would ban telemedicine abortions, which means a doctor over  the internet or over the phone could prescribe an abortion for an individual, because these are very dangerous medical procedures. A woman is five times more likely to end up in an emergency room if they’re utilizing this kind of method for an abortion.”

Noem is not alone is criticizing abortion pills as dangerous.

In September 2020, 20 Republican senators wrote to the FDA claiming the pills are “highly dangerous” and “deadly” and calling for their removal from the U.S. market. The letter also claims “the abortion pill poses a fourtimes higher risk of complication than surgical abortion in the first trimester,” and cites a different study (which we’ll address shortly).

The lead author of the study cited by Noem, James Studnicki, is vice president and director of data analytics for Charlotte Lozier Institute, an anti-abortion organization. He told us via email that Noem’s larger point “is absolutely correct that the abortion pill carries greater risks for women than surgical abortion.” But he said, “Our peer-reviewed study, based on the largest universe of confirmed pregnancy outcomes available in the United States, shows that a woman who takes the abortion pill regimen is 53% more likely to have a subsequent emergency room visit for an abortion-related reason than a woman who received a surgical abortion.” (The study does conclude that “[m]iscoded spontaneous abortion visits as a percent of total visits are nearly 4 times as high for chemical abortions,” but that is a subset of the abortions.)

Other researchers say it is misleading to cite Studnicki’s study as evidence of a safety risk associated with medication abortions, because it only tracked ER visits, not whether those visits required medical intervention, or if they did, whether the intervention was for a serious adverse event, such as needing a blood transfusion.

Research published in Obstetrics & Gynecology in 2015 looked at women in the California Medicaid program who received medication and surgical abortions and tracked not only emergency room visits, but also diagnosis and treatment. The study found that major complications — meaning cases that required hospital admission, surgery or blood transfusion — were relatively rare in both types of abortion. For medication abortions, the rate of major complications was 0.31%, a bit higher than the 0.16% rate for surgical abortions. Two-thirds of abortion-related emergency room visits, the study found, “did not result in a diagnosis or treatment, representing visits primarily for symptoms, not complications.”

The source for the Republican senators’ claim — that “the abortion pill poses a fourtimes higher risk of complication than surgical abortion in the first trimester” — is this same 2015 study, which also found: “The total abortion-related complication rate including all sources of care including EDs and the original abortion facility” was 5.2% for medication abortions and 1.3% for first-trimester surgical abortion. Although they may sound similar, “complications” and “severe adverse events” are not interchangeable in the research. 

“For about 5% of patients who have medication abortions, an additional procedure will be required to complete the abortion,” Dr. Ushma Upadhyay, the lead author of the study, told us in an email. “This is not considered a severe adverse event, it just means that the abortion was not effective. This additional procedure can be done at a clinic or by an obgyn, but people who don’t have a primary care provider often go to emergency rooms. In our paper, we examined emergency department visits and complications that were treated at clinics, obgyns and primary care providers.

“A medication abortion may result in more ED [Emergency Department] visits than a procedural abortion,” Upadhyay said. “Unlike an in-clinic procedural abortion but similar to a natural pregnancy loss (miscarriage), much of the process of a medication abortion occurs while a patient is at home without medical supervision. This may contribute to increased concern about the symptoms which may then lead people to visit an ED for a consultation. This consultation does not necessarily mean an adverse event has occurred.”

“Studnicki’s analysis finds much higher rates of complications because they consider any ED visit to be a complication,” Upadhyay said. “It is important to note … that ED visits are not an indicator of abortion safety. ED visits do not represent a concerning outcome in and of themselves. Many people who have obtained abortions visit EDs afterwards because they have no other primary care provider. This is particularly true of Medicaid patients.”

Upadhyay points to a national study she led in 2018 that, she said, found “over 50% of ED visits after abortion receive no treatment or diagnosis. They receive observation care only. Looking at ED visits alone without attention to the treatments they received is not scientifically sound because those visits may not involve a problem that requires intervention.”

Safety of Medication Abortions

The FDA first approved Mifeprex (mifepristone) for use in 2000. Medication abortions in the U.S. are taken in a two-drug combination: mifepristone followed by misoprostol a day or two later. It is currently approved to end a pregnancy through 10 weeks gestation.

Dr. Nisha Verma, an OB-GYN and abortion care provider and fellow at the American College of Obstetricians and Gynecologists, said there are stronger studies than Studnicki’s that demonstrate the safety of medication abortions.

“Over the past 20 years, multiple studies have demonstrated that medication abortion is safe and effective,” Verma said.

She pointed to a review of studies published by Obstetrics & Gynecology in 2015 that followed 33,846 women through 70 days of gestation who underwent medication abortions. The review found that “severe adverse events like blood transfusion (0.03–0.6%) and hospitalization (0.04–0.9%) are very rare,” Verma said. “Many of these studies utilized much stronger scientific methodology than the Studnicki paper, which is entirely dependent on Medicaid claims data.” (One of the authors of the review cited by Verma reported he was a consultant for Danco, a major producer of the abortion pill in the U.S.)

The letter from 20 Republican senators we referenced above refers to abortion pills as “deadly” and “lethal,” and cites the FDA as the source for its claim that among 3.7 million women who had taken the pills by the end of 2018, those pills “caused 24 maternal deaths.” But the FDA report on adverse events suffered by women who had taken the pills explicitly states, “These events cannot with certainty be causally attributed to mifepristone because of information gaps about patient health status, clinical management of the patient, concurrent drug use, and other possible medical or surgical treatments and conditions.” In fact, the report notes that some were due to homicide, suicide or drug overdose.

A Government Accountability Office report in March 2018 found: “The mortality rate associated with Mifeprex is extremely low—about one fourteenth the mortality rate associated with live birth.”

A comprehensive review assessing the science related to the safety and quality of abortion care in the U.S. conducted by the National Academies of Sciences, Engineering, and Medicine in 2018 found that “clinical evidence clearly shows” that all methods of legal abortion in the U.S., including medication abortions, “are safe and effective” and that “[s]erious complications are rare.”

“Complications after medication abortion, such as hemorrhage, hospitalization, persistent pain, infection, or prolonged heavy bleeding, are rare—occurring in no more than a fraction of a percent of patients,” the National Academies wrote, citing two studies published in 2015, one in 2011 and two in 2016.

Access to Abortion Pills

In 2011, the FDA said that Mifeprex (mifepristone) could only be administered in-person in a clinic, medical office or hospital and under the supervision of a certified medical provider. When the COVID-19 pandemic hit, however, the FDA — at the urging of the American College of Obstetricians and Gynecologists — halted its enforcement of the in-person dispensing requirement, allowing some states to provide mifepristone to patients via telemedicine and mail.

Research published in Contraception in March 2021 followed 1,157 women who were mailed abortion pills between 2016 and 2020 after consulting via videoconference with a study clinician (which was allowed for the purposes of the study). The study found that 95% of the abortions were completed without the need for a follow-up procedure. The researchers said 70 women made “70 unplanned visits to emergency rooms or urgent care centers for reasons related to the abortion (6%), and 10 serious adverse events occurred, including 5 transfusions (0.4%).”

In September 2021, the Biden administration announced that the FDA would allow women to receive abortion pills by mail instead of in-person at a medical clinic or hospital for the duration of the pandemic.

In a letter to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, Dr. Janet Woodcock, then the acting FDA commissioner, wrote that a review of studies of women receiving abortion pills without the “in-person dispensing requirement” during the pandemic “do not appear to show increases in serious safety concerns,” such as hemorrhage, ectopic pregnancy or surgical interventions.

“Medication abortions are extremely safe and all of the available medical evidence we have finds an over 99% safety rate,” Upadhyay told us. “Across several studies, the severe adverse event rate has been less than .5% (less than half of one percent).”

Studnicki says Upadhyay’s research and other studies undercount ER visits because, he says, many medication-induced abortions are miscoded as post-miscarriage complications.

Studnicki cited a study from Finland that found the incidence of adverse events was four times higher for medication compared with surgical abortions. The study, published in 2009, looked at women who took “mifepristone alone or in combination with misoprostol or other prostaglandins.” In the U.S., medication abortions include both mifepristone and misoprostol.

But even that study concludes medication abortions are relatively safe, even if they carry slightly higher risk than surgical abortions.

“Both methods of abortion are generally safe, but medical termination is associated with a higher incidence of adverse events,” the authors wrote. “Termination of pregnancy by means of either medical or surgical methods is associated with a low level of serious complications.”

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