What is the Truth about the Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration lawsuit?

This is Issue 14 of CLI’s On Science Series.

What is medical or chemical abortion?

The chemical abortion regimen approved by the U.S. Food and Drug Administration (FDA) is carried out with two drugs. Mifepristone (Mifeprex) blocks progesterone receptors to cut off hormonal support for the pregnancy, which results in disruption of the implantation site and embryonic or fetal death. Misoprostol (Cytotec) is consumed 24 to 48 hours later to induce contractions to expel the pregnancy tissue.[1] Misoprostol is widely available because it is used for other indications, such as peptic ulcer disease prevention, while mifepristone is more regulated and is only available under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) supervision.

What are the complaints in the Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration legal case?

The Alliance for Hippocratic Medicine (AHM), a consortium of medical organizations that seek to practice in accordance with Hippocratic principles by not electively ending human life, includes the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), American College of Pediatricians (ACPeds), Christian Medical & Dental Associations (CMDA), Catholic Medical Association (CMA), and Coptic Medical Association of North America (CMANA). AHM and four physicians who have cared for women suffering chemical abortion complications sued the Food and Drug Administration (FDA) and its key leaders on behalf of themselves, their members and their patients, alleging that the FDA failed to protect women and girls seeking abortion when it “chose politics over science and approved chemical abortion drugs for use in the United States.”[2]

Specific examples of the FDA’s politicization and malfeasance mentioned in the lawsuit include:

1. In an unprecedented action, President Clinton and his agency officials pressured the French manufacturer of mifepristone (RU-486) to donate for free the U.S. patent rights of the drug to the Population Council, and the FDA quickly approved Mifeprex in the U.S. just one month before the 2000 election.
2. In order to approve the drug quickly, the FDA used its accelerated drug approval authority reserved for drugs that treat “serious or life-threatening illnesses” and provide a “meaningful therapeutic benefit” over existing treatments. Pregnancy is hardly ever life-threatening, and surgical abortions, which have far fewer complications, were widely available at that time, constituting over a million abortions yearly.
3. The FDA is required by the Pediatric Research and Equity Act (PREA) to perform focused studies in a pediatric population to investigate the potential hormone-blocking impact of Mifeprex on a female’s developing body, but the FDA has never performed these studies.
4. The FDA is required by the Federal Food, Drug and Cosmetic Act (FFDCA) to study the safety under the labeled conditions that it approves, but on many occasions the studies the FDA referenced did not replicate the conditions of use that it approved.
5. A citizen’s complaint was filed by the plaintiffs in 2002 requesting the FDA to withdraw its approval of Mifeprex. The FDA is required by law to respond to such a complaint within 18 months, but instead it dragged its heels for fourteen years, and rejected the complaint in 2016.
6. On that same day in 2016, in the waning months of President Obama’s administration, the FDA made major changes to the approved chemical abortion regimen, eliminating crucial safeguards, including:
   1.  Extended use from seven to 10 weeks’ gestational age, despite studies documenting higher failure rates in the higher gestational ages.
   2. Changed the dosage and route of administration.
   3. Reduced the number of required in-person visits from three to one.
   4. Allowed medical professionals other than doctors to prescribe chemical abortion pills, even though only a physician will have the surgical skills to care for complications requiring surgery.
   5. Eliminated the prescriber’s mandatory complication reporting requirement, requiring reporting only if use of chemical abortion led to a woman’s death.
7. In 2019, the FDA approved a generic form of Mifeprex, mifepristone, without requiring any new clinical studies or safety data, in violation of FFDCA and PREA.
8. In April 2021, shortly after President Biden took office, citing the Covid-19 pandemic as the reason, the FDA issued a “Non-Enforcement Decision,” temporarily eliminating the in-person prescribing requirements, allowing the drugs to be prescribed by telemedicine and dispensed by mail.
9. In December 2021, the FDA permanently removed the in-person prescribing requirement, allowing mail-order abortions without in-person counseling, physical examination, ultrasound or laboratory evaluation.
10. On that same day, it rejected a citizen petition filed by the plaintiffs two and a half years earlier, asking the FDA to return to the pre-2016 prescribing requirements.
11. In January 2023, the FDA updated the mifepristone REMS to make official the removal of in-person dispensing and also allow the drug to be dispensed by certified pharmacies.

Although this lawsuit has been falsely portrayed as an attempt by pro-life organizations to eliminate chemical abortions through judicial activism, the truth is that the lawsuit is an attempt to provide necessary oversight of the FDA through the American tradition of checks and balances.  The FDA’s website states that it is “responsible for protecting the public health by assuring the safety, efficacy and security of human drugs.”[3]  This paper will look closely at the FDA’s actions to see if they have adhered to their mission in the case of chemical abortion drugs.

At the time of publication, Judge Kacsmaryk, a federal judge in an Amarillo court, has enjoined the use of mifepristone for chemical abortion nationwide.  This action was appealed to the 5^th Circuit Court of Appeals, where three justices recommended that chemical abortion provision return to the conditions of its initial approval in 2000.  An emergency appeal to the U.S. Supreme Court resulted in return of the issue to the lower court and allowing the current FDA conditions to continue pending the results of a trial, which began May 17, 2023.

Examination of The New York Times rebuttal:

In response to the AHM v. FDA lawsuit, The New York Times (NYT) published an article they said proves definitively that abortion pills are “safe and effective.”[4]  The article was peppered with eye-catching graphics representing the 101 studies they reviewed, which they claimed demonstrated this conclusion. Unfortunately, the icons were for visual effects only and did not provide or link to the studies for the public to review and independently verify the data, rather than merely accepting the NYT’s word. Thus, this paper will address the limitations of the NYT’s conclusions and provide a framework for a thorough examination of the entirety of the literature on this subject.

Problem #1: The NYT did not provide a standardized definition of “side effects” and “complications”

The NYT equated “side effects” with “complications” but did not provide a definition for these terms (or describe how the two might differ).  They labeled as “mild complications” patient experiences that are common and expected, such as nausea, diarrhea, vomiting, headache, dizziness, fever, and chills.  These symptoms, although unpleasant, are anticipated physiologic responses to the medications, so in actuality these were “side effects,” defined as “unwanted, undesirable effects that are possibly related to a drug,”[5] but not “complications,” defined as “an unanticipated problem that arises following, and is a result of, a procedure, treatment or illness.”[6]

It was not necessary for The NYT to invent its own definition of side effects and complications, as a better understanding and categorization of complications is available through the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAEv3).  The five levels of coding are:

1. Grade 1 “Mild”: asymptomatic or mild symptoms requiring clinical or diagnostic observations only; intervention not indicated; including expected bleeding, pain and gastrointestinal symptoms.
2. Grade 2 “Moderate”: minimal, local or noninvasive intervention indicated; including outpatient clinic or telemedicine management for bleeding, pain or low-grade infection.
3. Grade 3 “Severe or medically significant but not immediately life-threatening”: including emergency room evaluation, surgical aspiration procedure (clinic or hospital), or hospital admission for intravenous antibiotics.
4. Grade 4 “Life-threatening consequences”: urgent intervention indicated; including intensive care unit admission, blood transfusion, surgical laparoscopy or laparotomy, adjacent organ repair.
5. Grade 5 “Death related to AE.”[7]

These definitions were applied to an independent review of the adverse event reports for mifepristone used for a chemical abortion, as submitted to the FDA and obtained through a FOIA request, documenting that 20% of reported events were “life-threatening” and 74% were “severe.” Of note: 17% of the complication reports contained such limited data that a grade could not be assigned, demonstrating another common limitation of abortion complication data collection.[8] Standardization of terminology is critical when abortion complications are discussed.  Additionally, understanding what a woman seeking abortion would consider a complication is of utmost importance for accurate informed consent counseling.  It is her experience that is crucial, not the whitewashed experience the abortion industry misleadingly promotes.

Nonetheless, using these limited categories, The NYT defined “moderate complications” as when a procedure was needed after incomplete abortion, uterine infection requiring (oral) antibiotics, or emergency room visit.  They defined “severe complications” as when hospitalization was required for serious complications, blood transfusion, infection requiring hospitalization (for intravenous antibiotics), and death.

How significant is the complication of a follow-up surgery needed after failed chemical abortion?

Further discussion is warranted to address the situations when surgery is required following chemical abortion.  Abortion advocates prefer the terminology “procedural” rather than “surgical,” but this stems from their pattern of using euphemisms to discuss abortion.  “Surgery” can be defined as “a procedure that alters anatomy or removes tissue,” which certainly describes a “suction aspiration,” required to remove retained tissue, address hemorrhage, or treat an infected uterus.  The NYT defines the need for aspiration surgery to complete the abortion as a moderate, not serious, complication, but when a woman presents to an emergency room needing surgery, she is in a far different and more serious situation than if she had chosen surgical abortion, rather than chemical abortion, in the first place.   The NYT quotes Dr. Adam Jacobs, saying, “these [surgeries following failed chemical abortion] are no more risky than if you had a surgical procedure from the beginning,” but fails to acknowledge that Dr. Jacobs has served on the boards of Planned Parenthood of NYC and Physicians for Reproductive Choice,[9] so he is not exactly an impartial expert.

As a board-certified obstetrician-gynecologist practicing in Texas for over 30 years, I have cared for many women who suffered from abortion pill complications but did not receive the care they needed from the abortion provider, who promoted chemical over surgical abortion to them as a more “natural” abortion procedure, performed in the “comfort of her own home.”  These women have frequently told me that when they returned to the abortion provider suffering from incomplete abortions, they were given additional doses of misoprostol to induce more contractions, rather than being offered the surgical aspiration they needed.  Some women presented to emergency rooms with acute brisk bleeding, and one such woman required a blood transfusion due to excessive blood loss.  Other women have had prolonged bleeding for six to eight weeks due to retained dead tissue in the uterus.  All required emergent surgical aspiration to remove the tissue their uterus was unable to extrude.  This is not the same, emotionally or physically, as having a surgical procedure in the first place with an unwanted pregnancy.

These complications likely negatively impacted these women.  Clearly, the lack of resolution over a long time period would cause emotional distress, in addition to prolonged physical symptoms of bleeding and pain (which 40% of women surveyed described as “severe pain”).[10]  The retained tissue, especially if it becomes infected, increases the risk of intrauterine scar tissue development (Asherman’s Syndrome) which may cause future infertility or pregnancy complications.[11] It should be noted that the FDA maintains a “black box” warning on mifepristone because, rarely, infection can progress quickly to overwhelming sepsis, responsible for almost half of the deaths reported after mifepristone use.[12] The risk of early delivery of a subsequent pregnancy may also be increased.  A large Chinese study documented 69% increased risk of preterm birth (< 37 weeks gestation) and 261% increased risk of very preterm birth (< 32 weeks gestation) for women who required surgical completion of chemical abortions.[13]

These complications also negatively impact the health care system.  When a woman suffering from an incomplete chemical abortion presents for emergency room care, she will need to go to the operating room of that hospital for an unscheduled surgery. By definition, this becomes a hospitalization, upgrading to a “serious” complication, as defined by The NYT.  The hospital will code the admission as an “observation” because she will likely not stay more than 24 hours, and perhaps this is how The NYT is able to argue it is not a “hospitalization,” but this woman’s complication will clearly utilize the limited emergency resources of that hospital.

This emergency surgery may entail rescheduling or delaying other scheduled daytime cases or calling the on-call OR team into the hospital in the middle of the night.  It may also require the on-call obstetrician/gynecologist to neglect other patients (waiting in the office or laboring on L&D) in order to attend to the patient abandoned by the abortion provider, or possibly call in a backup physician to care for other patients while he is unavailable.  Also, an emergency room evaluation and urgent surgery will cost orders of magnitude more than a similar procedure in an abortion clinic would cost, and these costs are usually borne by insurance companies or the taxpayer through Medicaid. No U.S. study has analyzed the increased costs associated with a failed chemical abortion requiring follow-up surgical intervention, but a Chinese study comparing chemical to surgical abortions at less than seven weeks’ gestation documented 10% of the women who had chemical abortions required surgical removal of retained pregnancy tissue, doubling the cost compared to those with uncomplicated chemical abortions (664 v. 338 CNY = 1/8 USD).  Also, nearly one-third (62/192) of the women who had chemical abortions required additional medications due to continued bleeding at the two-week follow-up visit, increasing their costs by 62%.[14]

Perhaps this is one of the many reasons that studies document frequent miscoding of chemical abortion complications treated in emergency rooms as being caused by “miscarriage” rather than abortion.  One large records-linkage study documented that over 60% of known chemical abortion complications are miscoded in this way.[15]  Abortion centers can lower costs and avoid extra appointments and demands on staff time by shifting women to the emergency room for follow-up care. For telemedicine abortion centers, in-person follow-up treatment may not even be an option. Unsurprisingly, some abortion providers and abortion advocacy groups encourage women not to report a chemical abortion if they should seek emergency care, reassuring them that the ER staff will not be able to tell the difference and the care will be the same.[16]  But that is untrue. This study determined that the concealment negatively impacted the care the women received, causing delays in appropriate treatment, and increasing the risk of repetitive emergency room visits, hospitalization, and surgery. These important considerations are all ignored by The NYT and abortion providers when they assert that a primary surgical abortion procedure is equivalent to one performed emergently to care for complications.

Serious or long-term complications:

Additionally, there are many serious complications not mentioned in The NYT article.  Failure to perform ultrasound prior to providing chemical abortion, an increasingly common situation as women seek abortions on-line or by telemedicine, may lead to a missed diagnosis of ectopic pregnancy, which can progress to a ruptured Fallopian tube, catastrophic internal hemorrhage, and even maternal death, because mifepristone cannot work upon a pregnancy implanted outside the uterus.

Failure to correctly diagnose gestational age by sonogram will lead to more failures if gestational age is underestimated, and one study documented that nearly four in 10 women will require surgical completion if they accidentally consume chemical abortion pills in the second trimester.[17]

Failure to perform in-person sexually transmitted infection testing, a standard test prior to abortion provision, leads to a missed opportunity to diagnose and treat conditions such as chlamydia that commonly lead to future infertility due to tubal damage.  Chlamydia is diagnosed at the time of chemical abortion in 5.7% of adolescent women and 3.7% of adult women.[18]

The NYT also ignored adverse events following chemical abortion which take some time to develop.  Failure to perform labs to screen for Rh-D negativity and provide RhoGAM prophylaxis, if indicated, may lead to alloimmunization, a maternal immune response directed against the woman’s future unborn children, which can lead to those children’s life-threatening complications of severe neonatal anemia, brain damage and stillbirth, or neonatal death.[19]

Extensive international research literature increasingly suggests that abortion has a devastating effect on women’s mental health (contributing to anxiety, depression, alcohol and substance abuse or overdose, accidents from high-risk taking behavior and even self-harm and suicide),[20] increased death rates from all causes,[21] and preterm birth in subsequent pregnancies.[22] By contrast, there is no meta-analysis of induced abortion research that provides evidence that it delivers any clinically defined favorable outcome in healthy women with healthy fetuses — 95% or more of all induced abortions.[23]

Obtaining abortion pills online ensures that a woman in crisis will not receive full informed consent counseling regarding options other than abortion.  Recent research indicates that 2/3 of women felt their abortion was “inconsistent with their values or preferences” with 1/4 of women describing their abortions as “unwanted” or “coerced.”  Sixty percent of these women would have preferred to give birth if they had received either more emotional support or had more financial security.[24]  These women attributed more negative mental health consequences to their abortions.[25]  Over 2,700 pregnancy centers across the country exist to provide emotional and material support such as this, and many states have “alternatives to abortion” funding available for women,[26] but obtaining abortion pills through on-line websites ensures that they will not be informed of the availability of these options, and may subsequently suffer from their abortion decision.

Despite the plethora of potential complications documented above, for seven years the FDA has only mandated reporting by prescribers of deaths following chemical abortion.  Because they are not asking for reports of complications, they are receiving few such reports. The paucity of complication reports is then presented as evidence that complications are few. This is not the way public health usually works or should work.  Health departments collect information on serious sexually transmitted infection rates, such as syphilis and HIV, in order to intervene early, to prevent serious illness and deaths. The FDA’s interest only in deaths from chemical abortion is scientific and regulatory malpractice.  The first step in preventing a death from a drug-related complication is to identify all complications, to address problems early to avoid progression to serious complications and deaths. Discouraging complications reporting does not make them go away, it just ensures they will remain unknown and unanalyzed.

Problem #2: The NYT made misleading and erroneous statements:

“Abortion providers often say that the pills are safer than many common drugs, such as Tylenol or Viagra.”  This statement is made by comparing the undercounted number of chemical abortion-related deaths recorded by the FDA (well documented to be dramatically incomplete)[27] to better-documented deaths from Tylenol overdoses and cardiac arrests following Viagra use.  Phrased in this way, it leads women to believe that chemical abortion is safer than normal use of Tylenol.  At any rate, deaths are not the only measure of safety, but the many other complications from chemical abortion pills are completely ignored by this statement.  Tylenol is available over the counter, whereas the FDA has regulated mifepristone distribution for use in abortion through its Risk Evaluation and Mitigation Strategy (REMS) drug safety program and also placed a black box warning (the highest safety-related warning that medications can have assigned)[28] on mifepristone: “Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifeprex use.”[29]

“More than 100 scientific studies…have examined the effectiveness and safety of mifepristone and misoprostol… All conclude that the pills are a safe method for terminating a pregnancy.”  “Safe” is not defined in the abortion industry studies that mindlessly report the mantra of “safe and effective,” but one medical definition of safety is “freedom from danger, risk or injury.”  Clearly there are many risks and injuries documented following chemical abortions, so it is not accurate to describe it as “safe.” One abortion industry study reported that chemical abortions were 99.6% effective while also documenting that 2.1% of women with known outcomes required surgical completion for retained tissue and other complications.[30] Abortion advocates consider “effective” to refer to successfully killing the unborn human, whereas women likely consider “effective” to mean completely evacuating the uterus of tissue without the need for additional treatment.

Problem #3: The NYT prioritizes study quantity over study quality.

The NYT remarked, “The plaintiffs cite a handful of studies, none of which contradict the body of research in the Times review. Instead, the cited studies point to patient experiences that are common and expected, such as bleeding and pain, or experiences that are not a clear measure of serious complications, such as visits to the emergency room after taking the pills.” The studies cited by the plaintiffs were large, high-quality records-linkage studies—three from Finland[31] and two from U.S. data in 17 states that used Medicaid state funds to pay for elective abortions.[32]  Although the number of records-linkage studies referenced by the plaintiffs was small (5), they were of higher quality than the abortion industry studies cited by The NYT because they studied large numbers of abortions and were able to avoid the limitation of retrospective studies, in which many women are lost to follow-up, meaning their abortion outcomes were unknown. The U.S. Medicaid study authors noted, “these findings are especially consequential because they are derived directly from all paid medical claims records, unlike most other studies of abortion complications which involve voluntary survey reporting and/or a more limited query of a select set of treatment codes.” These five high-quality studies studied over 87,074 chemical abortions drawn from 465,619 total abortions, comparable to the 124,000 abortions in the 101 poorer-quality studies cited by The NYT.[33]

The two U.S. Medicaid studies demonstrated that approximately 5% of women after chemical abortions and 2% after surgical abortions presented to an emergency room (ER) within a month with abortion-related complications in 2015.  If these ER visits are solely related to “common and expected patient experiences,” this is definitive proof that patients are not receiving adequate informed consent counseling to expect such symptoms.  Women are presenting to ERs because they are worried something is wrong.  Their concerns are warranted, as these ER studies document that frequently “something is wrong.” In these studies, over 60% of charts were inaccurately coded as complications following miscarriage, further demonstrating data deficiencies related to abortion complications in the U.S. Among women who visited the ER within 30 days of a chemical abortion and who were then admitted to the hospital, correctly coded women averaged 1.8 hospital admissions and incorrectly coded women 3.2 hospital admissions, with 86% of the admissions of incorrectly coded women resulting in surgery, demonstrating that these visits were related to more serious complications, not merely expected “experiences.”[34] The three Finnish studies demonstrated that hemorrhage occurred in 12.8-16.9%, infection in 2%, incomplete abortion in 6.7-10.2%, and surgery in 5.9-13% of women who had chemical abortions.[35]  Separated by trimester, it was documented that 7.9% in the first trimester and 38.5% in the second trimester required surgical completion; 17.2% (1^st trimester) and 14.4% (2^nd trimester) experienced hemorrhage; and 1.9% (first trimester) and 4% (second trimester) had infections.[36] These records-linkage studies, in which all abortions are known due to single-payer healthcare system funding, and all subsequent medical events are documented due to meticulous record-keeping, demonstrate conclusively that the poor-quality data documented by the U.S. abortion industry dramatically undercounts complications caused by chemical abortion.

The NYT article acknowledged that “the pills are 95% effective with 3-5% of patients needing an additional procedure to remove remaining tissue or terminate the pregnancy.”  They failed to mention that only studies performed at less than nine weeks’ gestation documented complication rates this low.  Elsewhere they wrote, “the drugs are typically used through the first twelve weeks of pregnancy.” As noted above, records linkage studies document even more failures requiring surgery than The NYT reports,[37] but nonetheless even 5% is not a number to be ignored.  In 2020, there were nearly 500,000 chemical abortions in the U.S. If five percent resulted in complications requiring surgery, this means that approximately 25,000 women were harmed by chemical abortion.  That is clearly not “safe and effective” and instead indicates a public health crisis.

Even Planned Parenthood’s website acknowledges that complications and failures are more common than The NYT alleges. It documents, “At 8 weeks pregnant or less, it works about 94-98% of the time.  At 8-9 weeks pregnant, it works about 94-96% of the time.  At 9-10 weeks pregnant, it works about 91-93% of the time… At 10-11 weeks pregnant, it works about 87% of the time…”[38]  Although the FDA has approved chemical abortion only until 10 weeks’ gestation, Planned Parenthood and other providers brazenly provide chemical abortions past this gestational age, even though they acknowledge that more than one in 10 women will have a failed abortion, requiring surgery, at the higher gestational ages, with all of the horrendous experiences documented above.

Discussion about how study quality is determined may benefit The NYT’s readers and journalists.  The highest-quality, “gold standard” study is prospective, double-blinded, placebo controlled.  Yet virtually everyone agrees it is inappropriate to randomize women seeking abortion to a placebo group, so the next highest quality study would link medical records of known abortions to records of medical events following the abortion to document accurately how many women sought medical care.  The three Finnish studies and two U.S. Medicaid studies were performed in this way.  Next in accuracy would be a systematic review of all available studies.  Such a review might suffer from deficiencies in those studies (such as high loss to follow-up), but the large number of studies might help to average out those deficiencies.  Two systematic reviews document 3.3-4.8% failures requiring surgery,[39] and these are probably the source of The NYT’s statistic of 3-5% failures requiring surgery.  Finally, the lowest-quality studies would be retrospective chart reviews in which not all outcomes could be known, particularly if small numbers of abortions were studied.  These types of studies, by abortion industry researchers with known biases, constitute the bulk of the dozens of studies reported by The NYT, leading to the least reliable data.

Problem #4:  The studies the FDA relied upon to justify its chemical abortion drug approval had many flaws (e.g., high loss-to-follow-up, misleading terminology, undercount of complications due to miscoding, and study protocols that do not use the protocols being considered by the agency).       

It should be noted that the papers referenced by The NYT do not represent the entirety of the data on this topic.  It appears they “cherry-picked” the articles, favoring those that support their chosen narrative, while ignoring, marginalizing, or misrepresenting those that do not.  In this regard, it resembles the methods of the tobacco industry, which successfully delayed attention to the smoking–lung cancer connection for more than 50 years through selective literature citing.[40]

The NYT ignored the biggest problem for abortion science in the U.S.: Our data is so incredibly limited that official national reports acknowledge they are missing a substantial percentage of abortions occurring in the country, and independent estimates of abortion numbers produced by the Guttmacher Institute are 50 percent greater than the totals reported by the CDC.[41]  The growth of chemical abortion is an existential threat to valid data about the incidence and adverse outcomes of abortion because it is often provided outside of medical supervision leaving complications even less likely to be detected. Researchers in the U.S. literally do not know how many abortions or abortion complications are occurring—and we know less every day. We cannot do good science or practice good medicine without good data.  There is nearly zero informed consent for most abortions in the U.S. now—in the future, informed consent will be impossible in the absence of information.[42]

Most of The NYT’s chosen “experts” are from California—the state in the U.S. with the largest number of abortions and one of three states that fail to report abortion incidence to the CDC. Other nations, such as Finland, have comprehensive national registries of pregnancy outcomes which can be linked to health care and death registries to detect all complications and deaths following abortion.  If the abortion industry were really interested in the safety of abortion, it would demand such a system in the U.S.  The fact that abortion providers and advocates have not prominently called for more reliable data emphasizes the reality that the industry benefits from the true complication incidence remaining unknown. Without a reliable system for collecting complications, they can continue to advertise the drug to women, using the narrative that “abortion is safer than childbirth and Tylenol.”

Incomplete data is referenced in many abortion studies (loss to follow-up):  Abortion providers document the number of complications they know about, but they often report large numbers of women lost to follow-up (15-35%[43]).  It is inappropriate to assume these are uncomplicated abortions.  I have cared for many women who did not return to the abortion provider who told them chemical abortion was safer than Tylenol because they felt misled, instead presenting to other gynecologists and emergency rooms for care.

Misleading terminology used by abortion advocacy researchers often do not reflect patients’ understanding, such as defining “effective” in relation to embryonic death rather than complete extrusion of pregnancy tissue without need for further interventions.  Inconsistent definitions of terms such as “side effect,” “complication,” and “adverse event” further confuse the discussion.

Frequent miscoding of abortion complications has been documented in emergency rooms. There are many reasons for this.  Women are being told to lie about the preceding abortion.  Most abortions are paid for privately. A woman may assume she will receive additional financial charges from the abortion provider if follow-up surgery is needed. If she goes to an ER and reports that she had a miscarriage, her insurance will cover the cost.  Many women are ashamed of their abortions and will fail to report them to healthcare providers.  ICD-10 search engines in electronic medical record systems often fail to produce accurate codes documenting prior induced abortion, as the system only includes a dozen codes that do not encompass the full spectrum of complications that may follow abortion. They may default to miscarriage codes or nonspecific codes (such as “hemorrhage, not otherwise specified” which fails to identify the type of preceding pregnancy event). Doctors may assume the complication resulted from a miscarriage or document falsely for ideologic reasons.  Only records-linkage, as performed in U.S. Medicaid and Finnish studies, will identify these miscoded complications as abortion-related.

One final but immensely important flaw is that the study protocols relied upon by the FDA were often not replicated in the FDA’s recommendations for chemical abortion use.  For example, many studies supposedly demonstrating that telemedicine abortion is as safe as in-person abortions utilized standard pre-abortion testing—importantly requiring ultrasound (or a hybrid model where ultrasound was available if there was uncertainty about pregnancy location or gestational age) to confirm intrauterine pregnancy and accurate gestational age, whereas the FDA’s protocol does not require an ultrasound.  The malfeasance of this approach would be similar to a governmental agency referencing studies of automobile safety which utilized seat belts, then not requiring seat belts but stating that safety should remain the same in an unbuckled passenger.

Following are the specific studies relied upon by FDA and cited by The NYT[44]:

2000 FDA approval of chemical abortion:

• U.S. Spitz Trial: 1998. 2,121 women < 9 weeks. Mifepristone 600 mg orally, Misoprostol 400 mcg orally 48 hours later. Failures requiring surgery: 8% < 7 weeks, 17% 7-8 weeks, 23% 8-9 weeks. Ongoing pregnancy (failure to kill the embryo or fetus): 1% < 7 weeks, 4% 7-8 weeks, 9% 8-9 weeks. Loss to follow-up (LTFU) 5%.[45]
• French trials #1: (FFR/91/486/14) 1,286 women < 7 weeks. Surgery 4.5%. LTFU not available.
• French trial #2 (FF/92/486/24) 1,194 women < 9 weeks. Surgeries 7.2%.[46] LTFU not available.
• It should be noted that in their review of the French data the FDA raised concerns about potential falsification due to failure to maintain complete and accurate records (missing lab and ultrasound reports, unreported surgeries, consents dated incorrectly, underreported side effects).[47] The FDA based their initial approval of chemical abortion on trials of only 4,601 women, over half of which they acknowledged contained significant data deficiencies. The U.S. data demonstrated unacceptably high rates of failures requiring surgery of 8-23%.  Compared to surgical abortion failure rates (requiring repeat surgery) of less than 1%,[48] this regimen is clearly inferior and should not have been approved.

2016 FDA changes to approved regimen:

• At that time, the FDA extended use from seven to 10 weeks’ gestational age; changed dosage, timing and route of delivery; removed the requirement for a follow-up visit; removed the requirement for the prescriber to be a physician, and removed the mandatory complication reporting by prescribers unless the complication resulted in death:
• To support these new protocols, the FDA evaluated 30 studies, 22 of which used the new dosage protocol of mifepristone 200 mg orally and misoprostol 800 mcg buccally (dissolved in cheek pouch), with failures requiring surgery ranging from 2-9%.
• The FDA relied primarily upon Chen & Creinin’s 2015 systematic review (SR) which summarized 20 studies comprising 33,846 women through 10 weeks’ gestation. The SR documented overall failures requiring surgery of 3.3%: 1.9% < 7 weeks, 3.3% 7-8 weeks, 4.8% 8-9 weeks, and 6.9% 9-10 weeks. Overall ongoing pregnancies 0.8%: 0.4% < 7 weeks, 0.8% 7-8 weeks, 1.8% 8-9 weeks, 2.9% 9-10 weeks.  For the higher gestational age range of 63-70 days, the systematic review relied on outcomes of slightly more than 300 women.[49]  Three-quarters of the data in the Chen & Creinin SR came from only two studies:
  • Gatter: 13,373 women < 9 weeks, 2.3% overall failures requiring surgery, but 4.5% failures 8-9 weeks. LTFU 16%.[50]
  • Goldstone: 13,345 women < 9 weeks, 2.9% requiring surgery, and 0.6% ongoing pregnancies. LTFU 17%.[51]
• Limited studies were cited by the FDA for abortions in the 9–10-week gestational age range. It should be noted that most research on chemical abortion studies women < 9 weeks gestational age, perhaps not wanting to dilute the data with the dramatically increased failure rate that is known to occur after 9 weeks’ gestation. Yet, the FDA foolishly expanded chemical abortion’s use beyond gestational ages where it has been adequately studied.
  • U.S. (Winikoff): 57-63 days (325 women): 6.5% had surgery, including 3.1% for ongoing pregnancy, 5.2% failed and the majority had to repeat misoprostol, 3.7% seen in ER for complications; 64-70 days (n=304): 7.2% had surgery, including 3% ongoing pregnancy, 5.3% failed and the majority had to repeat misoprostol, 4.6% seen in ER. LTFU 13.1-14.2%.[52]
  • Mexico: 884 women < 10 weeks. Did not list failures by gestational age, reported overall failures of 1.6-2.1%.[53]
  • Mexico City: 1,001 women. Failure requiring surgery at 9-10 weeks: 9.5%.[54]
  • Curacao: 307 women. Documented failures of 2.3% overall with “similar results” in the 9–10-week gestational age range.[55]
  • Two other studies evaluated the efficacy rates from 64 to 70 days’ gestation, but used different dosing regimens than the proposed regimen, with failure rates of 5% and 8%.[56]
  • Abbas’ 2015 systematic review of the studies noted above, covering various dosing regimens for 9-10 weeks gestation, documented an overall 7.4% failure rate (ranging from 4-8%), ongoing pregnancy rate 3.1%, LTFU 5.4%.[57]
• The FDA referenced the Raymond 2013 systematic review to justify decreasing required visits with the abortion provider from three to one. This SR comprised 87 studies with 45,528 women that used mifepristone 200 mg with varying doses of misoprostol < 9 weeks. Overall failures requiring surgery were 4.8% (range 0 to 40%). Ongoing pregnancy 1.1% (range 0 to 25%). 3.7% (with some studies >10%) LTFU. The SR noted that the risk of failure was higher in groups in which at least 25% > 8 weeks, the interval between the two medications was < 24 hours, or misoprostol was administered orally. The SR also noted that for the group for which ultrasounds were not provided, ongoing pregnancy was twice as common.[58]
• The FDA referenced an article by Daniel Grossman to support their recommendation to require only the reporting of deaths following chemical abortion and no other complications. They studied 223 telemedicine chemical abortions compared to 226 face-to-face chemical abortions and documented 1 vs. 3% failures requiring surgery.  Both had 1.3% adverse events.  LTFU not mentioned in abstract.[59]

2021 FDA changes to approved regimen:

The FDA used the following studies to justify its 2021 decision to remove mandatory, in-person prescribing requirements without requiring ultrasound and labs.  It should be noted that all of these studies utilized standard pre-abortion testing with ultrasound and labs, or a hybrid model which allowed the prescriber to order these tests if clinically indicated (noted in blue text).  This decision by the FDA allowed women to obtain chemical abortion without any pre-abortion testing, even though chemical abortion has not been studied in that setting.  These studies were relatively small, with the exception of the Aiken study in the UK.  Unfortunately, the UK study only examined abortion center records and complications reported to the government’s database, but failed to examine ER records, and thus the true complication incidence in this large population is unknown.

• Chong. 1,390 chemical abortion packages were mailed to women in 13 states. Any needed pre-abortion tests were done locally (half of the women had an ultrasound) and then the women had a videoconference with a study clinician. 5% failed requiring surgery. 6% had ER visits. 1% serious adverse events. LTFU 17%.[60]
• Reynolds-Wright. 663 Scottish women < 12 weeks (97% < 10 weeks). One quarter had an ultrasound. 2% failed requiring surgery based on review of hospital data only. LTFU <1%.[61]
• Aiken. 52,142 UK women. Compared in-person with ultrasound vs. hybrid (telemedicine or in-person without ultrasound). Failures 1.2% v 1.8%. Follow-up not required due to Covid-19 emergency, assessed abortion provider records and national reporting system for complications but not ER records, thus LTFU unknown.[62]
• Kerestes. 334 Hawaiian women < 11 weeks. Three study groups: telemedicine in-person pickup, telemedicine mailed vs. traditional in-person chemical abortion provision. 2/3 of women had ultrasound. Failures requiring surgery: Overall 4.2%: 3.2% v 2.9% v 6.4% but failures were not broken down by gestational age. LTFU 12%.[63]
• Grossman. 224 telemedicine abortions < 9 weeks, standard assessment in clinic and if eligible, medications shipped by mail, 3.1% failures requiring surgery, 4.9% adverse events. LTFU 5.4%.[64]

Additional studies mentioned by The NYT are summarized here:

• Hamoda. 149 women < 9 weeks. Mifepristone plus misoprostol given sublingually 1.1% failures. Mifepristone plus misoprostol given vaginally 3.8% failures.[65]
• Guest. 450 women < 9 weeks. Mifepristone plus misoprostol vaginally comparing two dosing intervals. Misoprostol used after 6 hours 11% failures requiring surgery or repeat misoprostol. Misoprostol used after 36-48 hours 4% failures.[66]
• Hyland. 965 telemedicine abortions. Obtained screening tests locally. 5% of packages were sent 15 days or more after the request – this much of a delay is inappropriate. 4% failed requiring surgery. LTFU 22%.[67]
• Ireland. 30,146 women < 9 weeks comparing chemical vs. surgical abortions. Reported efficacy of chemical abortion 99.6% but documented failure requiring surgery 2.1%. Surgical abortion efficacy 99.8% but 0.6% failed requiring repeat surgery. LTFU 15.9%.[68]
• Upadhyay. 54,911 California Medicaid-paid abortions, records-linkage, covering claims paid which assures few lost to follow-up. 6.4% women had an ER visit within 6 weeks, but only 0.87% were classified by the researchers as abortion-related complications. This analysis examined only induced-abortion-specific codes but ignored miscarriage or unspecified pregnancy complication codes.  Total overall complications detected by abortion center chart review were 2.1%: 5.2% following chemical abortion and 1.3% following first-trimester surgical abortions.[69]  For comparison, the records-linkage study of 17 states’ Medicaid-paid abortions demonstrated that 5.2% of women presented with a complication related to chemical abortion within 30 days.  The significant difference between the two studies is that the Upadhyay study limited inclusion to only codes specific for induced abortion complications.  The Studnicki study group looked at all pregnancy-related complication codes (after determining that all these pregnancies were chemical abortions), identifying previously undetected chemical abortion complications that had been miscoded.[70]
• Chong. 400 women < 9 weeks. 1/3 took mifepristone at home with failures requiring surgery of 4%. 2/3 took mifepristone in the abortion center with failures at 3%. Standard pre-abortion screening.[71]
• Karki. 400 women < 8 weeks. 8.7% failures requiring surgery, LTFU 8%. Standard pre-abortion testing.[72]

Problem #5: The NYT describes the study authors in their review as “neutral” researchers, though they can be demonstrated to have a pro-abortion bias based on their funding sources, official affiliations, and public abortion advocacy. 

• The peer-reviewed literature sometimes allows funding sources for articles to remain anonymous, but when a journal requires disclosure, the funders are often documented to be ideologic pro-abortion organizations such as the Buffett, Grove, Hewlett, and Packard Foundations[73].
• “Incestuous funding” can also be demonstrated, as Buffett invests in Danco which manufactures the brand name Mifeprex, and Packard invests in GenBioPro which manufactures the generic mifepristone. These funders also contribute heavily toward Planned Parenthood, the Population Council, and Gynuity Health Projects—demonstrating a pro-abortion ideology typically motivated by population control.
• Many of the articles cited by The NYT originated at Advancing New Standards in Reproductive Health (ANSIRH), the Bixby Center for Global Reproductive Health, and the Department of Obstetrics, Gynecology and Reproductive Services, University of California, San Francisco (UCSF) – all related organizations funded by the pro-abortion Packard, Hewlett, and Buffett Foundations.[74]
• It may be useful to point out the conflicts of interest of many of the cited study authors and contributors[75]:
  • Daniel Grossman, consultant for Planned Parenthood and the Center for Reproductive Rights, and also Principal Investigator for a clinical trial studying pharmacy dispensation of mifepristone for abortion.[76]
  • Mitchell Creinin, consultant for Danco, former Medical Director of Planned Parenthood of Western Pennsylvania, member of Planned Parenthood Medical Directors Council,[77] member of Society of Family Planning.[78]
  • Sallie Rafie, consultant for GenBioPro. Received grants from the Society of Family Planning,[79] a group sponsored by Danco and GenBioPro.[80]
  • Beverly Winikoff, president of Gynuity Health Projects[81] (worldwide abortion advocacy and research organization) and former Director for Reproductive Health with the Population Council while that organization was working to bring mifepristone to the U.S.[82]
  • DeShawn Taylor, consultant for GenBioPro and abortion center owner.[83]
  • Courtney Schreiber, consultant for Danco. Submitted a declaration in support of the FDA in the Fifth Circuit case AHM v. FDA.[84]
  • Melissa J. Chen, associate professor of obstetrics and gynecology at the University of California, Davis who works closely with Daniel Grossman.
  • Oskari Heikinheimo, professor of obstetrics and gynecology at the University of Helsinki, who has worked as an abortion provider and authored a paper condemning conscientious objection to providing abortion.
  • Leah Koenig, data analyst at Advancing New Standards in Reproductive Health (ANSIRH) at the University of California, San Francisco, who previously worked for Gates Foundation, Population Council and Guttmacher Institute
  • Nathalie Kapp, chief medical officer of International Planned Parenthood Federation,[85] member of NARAL, ACOG, Society of Family Planning, and the National Abortion Federation[86]
  • Sarah Raifman, project director, Advancing New Standards in Reproductive Health (ANSIRH) at the University of California, San Francisco, who also advocates for advanced provision and over-the-counter abortion pills
  • Maria I. Rodriguez, professor of obstetrics and gynecology at Oregon Health & Science University, who is also an abortion provider
  • Ushma Upadhyay, professor with Advancing New Standards in Reproductive Health (ANSIRH) at the University of California, San Francisco, who oversaw the California Home Abortion by Telehealth (CHAT) study and advocates for “no test/no touch” protocols and “late period pills.”
  • Caleb Alexander, professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health and co-director of the Center for Drug Safety and Effectiveness, was the only contributor to The NYT article who cannot be demonstrated to be directly connected to the abortion industry.

Problem #6: The NYT ignores the scientific reality that a human death occurs with each abortion.

Most importantly, The NYT ignores the science that induced abortion involves two distinct and separate human lives, and one life is ended in every successful abortion. Ending embryonic or fetal life is the very definition and objective of the procedure.  So, there really is no safe abortion.

Conclusion

Hopefully, this extensive discussion will open the American public’s eyes to the facts about chemical abortion, in contrast to deceptive messaging by the pro-abortion media, and the failure of the FDA, which has not adequately protected women from these dangerous abortion drugs.  Political pressure and ideology have captured the FDA’s resources, diverting them from their mission of protecting American women.  It is imperative that governmental organizations that fail to serve the public good be held accountable to the people they have been created to serve.  We must all ask questions, dig deeper, and approach with skepticism what we are told regarding highly politicized issues like abortion.  A recent Washington Examiner poll demonstrated that two-thirds of Americans wanted chemical abortion pills to remain legal, and only one-quarter wanted them to be removed from the market.[87]  One wonders if this response would be the same if they knew the truth.

Ingrid Skop, M.D., F.A.C.O.G. is vice president and director of medical affairs at Charlotte Lozier Institute.

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[13] Hua Liao, Qiang Wei, Lijun Duan, et al., “Repeated Medical Abortions and the Risk of Preterm Birth in the Subsequent Pregnancy,” Archives of Gynecology and Obstetrics 284, (September 2011): 579–586, doi: 10.1007/s00404-010-1723-7.

[14] Wei Xia, Shouzhang She, Tai Hing Lam, “Medical Versus Surgical Abortion Methods for Pregnancy in China: a Cost-Minimization Analysis,” Gynecologic and Obstetric Investigation 72, no. 4 (December 2011): 257–263, doi: 10.1159/000328313.

[15] James Studnicki, Donna J. Harrison, Tessa Longbons, et al., “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999-2015,” Health Services Research and Managerial Epidemiology 8, (2021) doi: 10.1177/23333928211053965; James Studnicki, Tessa Longbons, Donna J. Harrison, et al., “A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization,” Health Services Research and Managerial Epidemiology 9, (2022) doi: 10.1177/23333928221103107.

[16] Zawn Villines, “A Guide to Surviving in a Post-Roe World: Advice from Doctors, Midwives, & Experts on Abortion,” Daily Kos, 19 May 2022, https://www.dailykos.com/stories/2022/5/19/2098906/-A-Guide-to-Surviving-in-a-Post-Roe-World-Advice-from-Doctors-Midwives-Experts-on-Abortion; “Will Medical Staff be Able to Notice That I am Having an Abortion?,” Safe2Choose, accessed 6 June 2023, https://safe2choose.org/faq/medical-abortion-faq/during-abortion-with-pills/will-medical-staff-be-able-to-notice-that-i-am-having-an-abortion; “How Do You Know If You Have Abortion Complications?,” AidAccess, accessed 6 June 2023, https://aidaccess.org/en/page/459/how-do-you-know-if-you-have-complications-and-what-should-you-do.; “Warning Letter: AidAccess.org,” U.S. Food & Drug Administration, 8 March 2019, accessed 6 June 2023, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aidaccessorg-575658-03082019; “Abortion Pill Online: Get a Prescription and Receive the Abortion Pills by Mail,” AidAccess, accessed 6 June 2023, https://aidaccess.org/en/i-need-an-abortion; “How to do an Abortion with Pills,” Women on Web, accessed 6 June 2023, https://www.womenonweb.org/en/page/11873/how-to-do-an-abortion-with-pills; “Frequently Asked Questions: Can I get in trouble for using abortion pills?,” Plan C, accessed 6 June 2023, https://www.plancpills.org/guide-how-to-get-abortion-pills#faq; “Consumer Health Info: Medication Abortion and Miscarriage,” National Women’s Health Network, 15 August 2019, accessed 6 June 2023, https://nwhn.org/abortion-pills-vs-miscarriage-demystifying-experience/; Renee Bracey Sherman, Twitter Post, 1 September 2021, 8:10 a.m., https://twitter.com/RBraceySherman/status/1433039656715755521?s=20.

[17] Mentula MJ, Niinimaki M, Suhonen S, et al. Immediate adverse events after second trimester termination of pregnancy. Hum Reprod 2011;26(4):927- 932. doi: 10.1093/humrep/der016; See also Ingrid Skop, “Chemical Abortion: Risks Posed by Changes in Supervision,” Journal of American Physicians and Surgeons 27, no. 2 (Summer 2022): 56-61.

[18] Maarit Niinimäki, Satu Suhonen, Maarit Mentula, et al., “Comparison of Rates of Adverse Events in Adolescent and Adult Women Undergoing Medical Abortion: Population Register Based Study,” BMJ 342, no. 7804 (2011) doi: 10.1136/bmj.d2111.

[19] “Practice Bulletin No. 181: Prevention of Rh D Alloimmunization,” Obstetrics & Gynecology 130, no. 2 (August 2017): 481-483. doi: 10.1097/AOG.0000000000002232.

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[21]  David C. Reardon, Thomas W. Strahan, John M. Thorp, et al., “Deaths Associated with Abortion Compared to Childbirth – A Review of New and Old Data and the Medical and Legal Implications,” Journal of Contemporary Health Law and Policy 20, no. 2 (2004): 279-327; David C. Reardon, Phillip G. Ney, Fritz Scheuren, et al., “Deaths Associated with Pregnancy Outcome: A Record Linkage Study of Low-Income Women,” Southern Medical Journal 95, no. 8 (2002): 834-841; David C. Reardon and Priscilla K. Coleman, “Short and Long Term Mortality Rates Associated With First Pregnancy Outcome: Population Register Based Study for Denmark 1980–2004,” Medical Science Monitor 18, no. 9 (2012): 71-76, doi: 10.12659/MSM.883338; Priscilla K. Coleman, David C. Reardon, Byron C. Calhoun, “Reproductive History Patterns and Long-term Mortality Rates: a Danish, Population-based Record Linkage Study,” European Journal of Public Health 23, no. 4 (August 2013): 569-574, doi:10.1093/eurpub/cks107.

[22] “Abortion and Risks of Preterm Birth,” American Association of Pro-Life Obstetricians and Gynecologists, November 2019, accessed 17 June 2022, https://aaplog.org/wp-content/uploads/2019/12/FINAL-PRACTICE-BULLETIN-5-Abortion-Preterm-Birth.pdf; “Practice Guideline 11: A Detailed Examination of the Data on Surgical Abortion and Preterm Birth,” Issues in Law and Medicine 37, no. 2 (2022): 189-220.

[23] David C. Reardon and John M. Thorp, “Pregnancy associated death in record linkage studies relative to delivery, termination of pregnancy, and natural losses: A systematic review with a narrative synthesis and meta-analysis,” SAGE Open Medicine 5 (November 2017):1-17, doi: 10.1177/2050312117740490; David M. Ferguson, L. John Harwood, and Joseph M. Boden, “Does Abortion Reduce the Mental Health Risks of Unwanted or Unintended Pregnancy? A Re-Appraisal of the Evidence,” The Australian and New Zealand Journal of Psychiatry 47, no. 9 (September 2013): 819-827, doi: 10.1177/0004867413484597.

[24] David C. Reardon, Katherine A. Rafferty, Tessa Longbons, “The Effects of Abortion Decision Rightness and Decision Type on Women’s Satisfaction and Mental Health,” Cureus 15, no. 5 (11 May 2023) doi: 10.7759/cureus.38882.

[25] David C. Reardon and Tessa Longbons, “Effects of Pressure to Abort on Women’s Emotional Responses and Mental Health,” Cureus 15, no. 1 (31 January 2023) doi: 10.7759/cureus.34456.

[26] “Pregnancy Centers Stand the Test of Time,” Charlotte Lozier Institute, 21 October 2020; Charles A. Donovan, “Expanding State and Federal Support for Decisions for Life,” Charlotte Lozier Institute, 21 May 2023, accessed 6 June 2023; Jeanneane Maxon, “Fact Sheet: Alternatives to Abortion Funding,” 28 March 2023, accessed 6 June 2023.

[27] Ingrid Skop, “Handbook of Maternal Mortality: Addressing the U.S. Maternal Mortality Crisis, Looking Beyond Ideology,” Charlotte Lozier Institute, 6 January 2023, https://lozierinstitute.org/handbook-of-maternal-mortality-addressing-the-u-s-maternal-mortality-crisis-looking-beyond-ideology/; James Studnicki, David C. Reardon, Donna J. Harrison, et al., “Improving the Metrics and Data Reporting for Maternal Mortality: A Challenge to Public Health Surveillance and Effective Prevention,” Online Journal of Public Health Informatics 11, no. 2 (2019) doi: 10.5210/ojphi.v11i2.10012; Patrick J. Marmion and Ingrid Skop, “Induced Abortion and the Increased Risk of Maternal Mortality,” The Linacre Quarterly 87, no. 3 (2020): 302-310, doi: 10.1177/0024363920922687; Christina A. Cirucci, Kathi A. Aultman, and Donna J. Harrison, “Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act,” Health Services Research and Managerial Epidemiology 8 (December 2021) doi: 10.1177/23333928211068919.

[28] Claire Delong and Charles V. Preuss, “Black Box Warning,” Stat Pearls, February 2023, accessed 11 May 2023, https://www.ncbi.nlm.nih.gov/books/NBK538521/.

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[30] Luu Doan Ireland, Mary Gatter, Angela Y. Chen, “Medical Compared With Surgical Abortion for Effective Pregnancy Termination in the First Trimester,” Obstetrics & Gynecology 126, no. 1 (July 2015): 22-28, doi: 10.1097/AOG.0000000000000910.

[31] Maarit Niinimäki, Anneli Pouta, Aini Bloigu, et al., “Immediate Complications After Medical Compared with Surgical Termination of Pregnancy,” Obstetrics & Gynecology 114, no. 4 (October 2009): 795-804, doi: 10.1097/AOG.0b013e3181b5ccf9; Niinimäki, Suhonen, Mentula, et al., “Adverse Events in Adolescent and Adult Women Undergoing Medical Abortion”; Maarit J Mentula, Maarit Niinimäki, Satu Suhonen, et al., “Immediate Adverse Events After Second Trimester Medical Termination of Pregnancy: Results of a Nationwide Registry Study,” Human Reproduction 26, no. 4 (2011): 927-932, doi: 10.1093/humrep/der016.

[32] Studnicki, Harrison, Longbons, et al., “Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions”; “Studnicki, Longbons, Harrison, et al., “Induced Abortion Complications Mistaken for Miscarriage.”

[33] Niinimäki, Pouta, Bloigu, et al., “Immediate Complications After Medical Compared with Surgical,” 795-804; Niinimäki, Suhonen, Mentula, et al., “Adverse Events in Adolescent and Adult Women Undergoing Medical Abortion”; Mentula, Niinimäki, Suhonen, et al., “Immediate Adverse Events after Second Trimester Medical Termination of Pregnancy,” 927-932; Studnicki, Harrison, Longbons, et al., “Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions”; “Studnicki, Longbons, Harrison, et al., “Induced Abortion Complications Mistaken for Miscarriage.”

[34] Studnicki, Harrison, Longbons, et al., “Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions”; “Studnicki, Longbons, Harrison, et al., “Induced Abortion Complications Mistaken for Miscarriage.”

[35] Niinimäki, Pouta, Bloigu, et al., “Immediate Complications After Medical Compared with Surgical,” 795-804; Niinimäki, Suhonen, Mentula, et al., “Adverse Events in Adolescent and Adult Women Undergoing Medical Abortion.”

[36] Mentula, Niinimäki, Suhonen, et al., “Immediate Adverse Events after Second Trimester Medical Termination of Pregnancy,” 927-932.

[37] Niinimäki, Pouta, Bloigu, et al., “Immediate Complications After Medical Compared with Surgical,” 795-804; Mentula, Niinimäki, Suhonen, et al., “Immediate Adverse Events after Second Trimester Medical Termination of Pregnancy,” 927-932.

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[40] Allan M Brandt, “Inventing Conflicts of Interest: A History of Tobacco Industry Tactics,” American Journal of Public Health 102, no. 1 (January 2012): 63-71, doi: 10.2105/AJPH.2011.300292.

[41] Katherine Kortsmit, Antoinette T Nguyen Michele G. Mandel, et al., “Abortion Surveillance – United States, 2020,” Morbidity and Mortality Weekly Report: Surveillance Summaries 71, no. 10 (November 2022): 1–27, doi: 10.15585/mmwr.ss7110a1; Tessa Longbons and Mia Steupert, “Five Things We Don’t Know about Abortion in the U.S. (but Could with Better Reporting),” Charlotte Lozier Institute, 30 March 2023, https://lozierinstitute.org/five-things-we-dont-know-about-abortion-in-the-u-s-but-could-with-better-reporting/.

[42] Bryan Murray, “Informed Consent: What Must a Physician Disclose to a Patient,” Virtual Mentor 14, no. 7 (July 2012): 563-566, doi: 10.1001/virtualmentor.2012.14.7.hlaw1-1207.

[43] Danielle Young, Kelly Fitzgerald, Laura Laursen, et al., “Comparison of Vaginal and Buccal Misoprostol After Mifepristone for Medication Abortion Through 70 Days of Gestation,” Contraception 115 (November 2022): 62-66, doi: 10.1016/j.contraception.2022.06.012.

[44] In the below sections, numbers displayed in red indicate percent of chemical abortions requiring a follow-up surgery, and green numbers indicate percent of women lost to follow-up with unknown abortion outcomes.

[45] Spitz, “Early Pregnancy Termination,” 1241-1247.

[46] “Statistical Review and Evaluation of the Drug Mifepristone,” 21 May 1996, accessed 18 October 2003, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20687_Mifepristone_statr.pdf.

[47] Summary of Findings, Memorandum Accompanying FDA Form 483 Issued to Dr. Elizabeth Aubeny (28 June 1996): at 1[FDA FOIA Release: MIF 004135-45]; Bryan C Calhoun and Donna J Harrison, “Challenges to the FDA Approval of Mifepristone,” Annals of Pharmacotherapy 38, no. 1 (January 2004): 163-168, doi: 10.1345/aph.1D448.

[48] Luu Doan Ireland, Mary Gatter, Angela Y. Chen, “Medical Compared With Surgical Abortion for Effective Pregnancy Termination in the First Trimester,” Obstetrics & Gynecology 126, no. 1 (July 2015): 22-28, doi: 10.1097/AOG.0000000000000910.

[49] Chen and Creinin, “Mifepristone with Buccal Misoprostol,” 12-21.

[50] Mary Gatter, Kelly Cleland, Deborah L. Nucatola, “Efficacy and Safety of Medical Abortion Using Mifepristone and Buccal Misoprostol Through 63 Days,” Contraception 91, no. 4 (April 2015): 269-273, doi: 10.1016/j.contraception.2015.01.005.

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