Changing the science

Changing the science (Hal Gatewood/Unslpash)

In November 2021, researchers with the Charlotte Lozier Institute (CLI) published a study on the incidents of chemical abortion-related emergency room visits. The paper was published in Sage, a global academic publisher. Related papers from CLI were published by Sage in 2019 and 2022. With litigation about the abortion pill ongoing, Sage retracted the papers in February 2024.

The 2021 study found that the incidence of emergency room visits following a chemical abortion (i.e., abortion pill) increased 500% from 2002 to 2015. Among other findings, the data also showed ER visits were more frequent for those undergoing a chemical abortion than surgical. 

The abortion pill mifepristone was fast-tracked for approval by the FDA in the year 2000. The Code of Federal Regulations Title 21 only permits “accelerated approval” of a drug if it is for “treating serious or life-threatening illnesses…” 

The Alliance for Hippocratic Medicine pointed out the error in the drug’s original approval. In their November 2022 case filing against the FDA, they stated: 

“But chemical abortion drugs do not treat serious or life-threatening illnesses. Indeed, pregnancy is a normal physiological state that many females experience one or more times during their childbearing years.”

[Click here to subscribe to Pregnancy Help News!]

In April 2023, Federal Judge Matthew Kacsmaryk, halted FDA approval of the abortion drug mifepristone. In his ruling, he cited the 2021 CLI study. That study was particularly relevant to the safety issue at hand. As the CLI authors have noted: “To our knowledge, there is no study that has reviewed actual hospital admissions by volume and type, by physicians who perform abortions, other than our own study.”

The case is before the U.S. Supreme Court with a hearing scheduled for March 26.

A Sage attorney said they received “concerns raised by a reader” about the study and potential conflicts of interest of the authors. This complaint came following the Kacsmaryk ruling. Media later revealed that the complainant was a pharmaceutical professor, Chad Adkins. In an interview, he openly advocated for abortion and espoused euphemisms that sanitize abortion as “reproductive health and bodily autonomy.” 

Sage accommodated the complaint and conducted an investigation. In the month prior to the upcoming Supreme Court hearing, on February 5, 2024, Sage issued a retraction of the three articles by CLI authors. 

Researchers at CLI have archived the documents and communications pertaining to Sage’s retraction at the website CLI’s rebuttal details why Sage’s concerns were unfounded and at times fabricated. Examples include:

• Sage claimed the article authors’ affiliation “to Charlotte Lozier Institute” “should have been declared in the article.” However, this allegation is false. As CLI responded, “In fact, the affiliations of all authors are documented in the paper. In addition, a bio sketch for each author is included with the paper.” The first 4 footnotes of the 2021 paper correspond to the authors’ affiliations, including to CLI. CLI also noted several examples of Sage having no issue publishing other authors’ studies when those authors were affiliated with abortion advocacy groups.

• In the retraction notice, Sage noted that one of the original peer reviewers was also affiliated with CLI. However, this criticism was also disingenuous because “Sage had and has entire and exclusive control of the review process including the selection of the reviewers.” Additionally, when the paper in question was originally reviewed, all other reviewers agreed with the quality of the work and approved it for publication. 

• Sage criticized the researchers for counting multiple ER visits following abortion as multiple visits. Sage suggested this “artificially” inflated the number of adverse events. However, CLI explained that the method is an “accurate count of the number of events” and that their method was clearly disclosed in the research. To use Sage’s methodology would have counted a woman experiencing multiple adverse events as equal to a woman who experienced one.

• Sage expressed concern that the researchers did not compare abortion-related ER visits against overall ER visits. But as CLI pointed out, the study did not purport to compare abortion-related to non-abortion-related ER visits. The study compared chemical abortion with surgical abortion. To have included what Sage suggested “would not have affected the chemical versus surgical abortion comparison. … [The] results would be exactly as reported.”

• Sage claimed the researchers “did not look at diagnoses or treatments received” in ER visits. This criticism was also false. CLI described in detail the three code categories of the ER visits, each broken into multiple codes pertaining to patient treatment.

• Sage claimed the researchers described miscoded abortions as the “cause” of serious adverse events. CLI responded to these concerns as “factually incorrect and nonsensical.” CLI’s research “concluded that abortions miscoded in the ER were more likely to result in hospitalization for any reason” and that “chemical abortions are significantly more likely…than surgical abortions to result in hospitalization for the surgical removal of retained products of conception.” CLI further responded: “We did not assert causal interpretations based upon our statistical associations, and it is a purposeful mischaracterization of our papers to suggest otherwise. We instead used words like ‘association,’ ‘correlation’ and ‘increased risk.’

Tweet This: CLI details why Sage’s concerns were unfounded and at times fabricated at the website

In their response to Sage’s retractions, the CLI authors also made clear they have not waived any rights to “seek compensation for the publication fees…and for any financial and irreparable damages these retractions have cause or may cause to our reputations and careers.” 

Commenters on the study retractions point to an anti-science, pro-abortion bias. Dr. James Studnicki, VP and director of data analytics at CLI and corresponding author of the studies, opined on the reason why their findings are under attack:

“These findings have been used in in legal action in many of the states. ... People are quoting us. And for that reason, we are dangerous. … What happened to us has little or nothing to do with real science and has everything to do with political assassination of real science.”

Tessa Longbons, senior research associate at CLI and study author similarly commented:

“Our study has been challenged, and our credibility has been challenged not because of our research, but simply because of who we are. And this is a double standard. Many different research organizations, on both sides of the spectrum when it comes to beliefs on abortion, publish, and they publish frequently, in multiple journals.” 

Jor-El Godsey, president of the pregnancy help organization Heartbeat International, stated:

“Every woman should have the opportunity to make an informed decision about her pregnancy. This is a hallmark of life-affirming pregnancy help's half-century of outreach. Information brings light to the darkness of ignorance. The best decision is an informed decision. Big Abortion and its lackeys are, again, obscuring the truth about abortion and its real effects. Now they brazenly deny the Supreme Court to keep women in darkness in this most difficult of decisions. This is deception at the highest levels.”

Erin Hawley, attorney with Alliance Defending Freedom, explained why she does not believe the Sage retractions will affect the upcoming March 26 Supreme Court hearing: 

“None of these studies will be at issue as the Supreme Court considers the case. … all we need to rely on are the data that the FDA itself cites and the concessions it makes about those data.”

Long after the abortion pill’s fast-track approval in 2000, changes were made to the FDA Adverse Event Reporting System (FAERS). The FDA reduced the adverse event reporting requirements even though there were no studies revealing new safety information about the drug. 

“[The FDA] must provide ‘satisfactory explanations’ for doing so,” Hawley wrote. “Flawed FAERS data and misused scientific literature are not satisfactory.”

In the April 2023 federal case, the FDA attempted to justify the reduction of safety standards by pointing to a low number of “adverse events” reported from the drug’s use. However, Judge Kacsmaryk noted the illogic of this reasoning:

“[I]t is circular and self-serving to practically eliminate an ‘adverse event’ reporting requirement and then point to a low number of ‘adverse events’ as justification for removing even more restrictions than were already omitted in 2000 and 2016. In other words, it is a predetermined conclusion in search of non-data.”

Those wishing to support CLI in the wake of the sage retraction or send a note of encouragement to the CLI authors can do so at the website.

Editor's note: Heartbeat International manages Pregnancy Help News.

To contact us regarding an article or send a tip, click here.

Related Articles