Judge in Abortion Pill Case Cited Study So Bogus It Was Just Retracted
An academic publisher has retracted three studies about the adverse effects of the abortion pill mifepristone, two of which are central to the ongoing lawsuit to ban the medication nationwide.Sage Publishing announced its decision Monday to pull the studies after they were revealed to have been funded and produced by the Charlotte Lozier Institute, the research arm of the powerful anti-abortion group Susan B. Anthony Pro-Life America. The studies were published in 2019, 2021, and 2022. Sage began reviewing the 2021 study last year after a pharmaceutical sciences professor raised concerns about how it was cited in the mifepristone case.Ultraconservative Judge Matthew Kacsmaryk, who presided over the initial mifepristone trial in Texas, used the 2021 study to justify his ruling invalidating the Food and Drug Administration’s approval of mifepristone. Another one of the studies, also since retracted, was used by the anti-abortion plaintiffs in the case.The Sage investigation found that all but one of the study authors, including the lead author on each study, were affiliated with at least one of the anti-abortion associations Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists. The AAPLOG is listed as a plaintiff in the mifepristone lawsuit. One of the peer reviewers was also associated with Charlotte Lozier. None of the authors or the reviewer disclosed these affiliations.Since all three studies had the same lead author, Sage carried out an independent post-publication peer review of the data in all three studies. Two subject matter experts determined that the 2021 and 2022 articles, which use the same dataset, had “fundamental problems with the study design and methodology, unjustified or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data.”These issues “demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part,” according to the experts.Similarly, the 2019 study, which used a different dataset, included “unsupported assumptions and misleading presentations of the findings that … demonstrate a lack of scientific rigor and render the authors’ conclusion unreliable.”Kacsmaryk ruled in April that mifepristone had been improperly approved and should be yanked from the U.S. market. The Department of Justice appealed the decision, first to the Fifth Circuit Court, which only partially stayed the ruling. The Justice Department then appealed the case to the Supreme Court, which issued a temporary stay while the lawsuit plays out. The Supreme Court will hear arguments in the case next month.Kacsmaryk’s initial ruling hinged on several heavily biased “studies.” In addition to the faulty Charlotte Lozier article, he cited another study that claimed to find most people who had medication abortions reported negative effects. The sample size was 98 blog posts from an anti-abortion website. The study authors only analyzed 54 posts and then just cherry-picked quotes from the rest.Medication abortions make up more than half of all abortions performed in the United States. These drugs can be ordered online and delivered via mail, making them a key resource for people who live in states that have cracked down on abortion access since Roe v. Wade was overturned.A bigger issue at play, in this case, is that nonelected judges who do not have medical backgrounds are now making decisions about medication. When the lawsuit first began to play out, Rachel Rebouché, the dean of Temple University’s law school, told The New Republic, “The question for appellate courts is not just about abortion but about deference to a federal agency’s expertise.”The Texas case “undermined” the FDA’s authority, she said. “To take seriously that it ignored risks, risks unsupported by any credible evidence, suggests questions as to what federal courts might decide about other federal agencies’ decisions.”
An academic publisher has retracted three studies about the adverse effects of the abortion pill mifepristone, two of which are central to the ongoing lawsuit to ban the medication nationwide.
Sage Publishing announced its decision Monday to pull the studies after they were revealed to have been funded and produced by the Charlotte Lozier Institute, the research arm of the powerful anti-abortion group Susan B. Anthony Pro-Life America. The studies were published in 2019, 2021, and 2022. Sage began reviewing the 2021 study last year after a pharmaceutical sciences professor raised concerns about how it was cited in the mifepristone case.
Ultraconservative Judge Matthew Kacsmaryk, who presided over the initial mifepristone trial in Texas, used the 2021 study to justify his ruling invalidating the Food and Drug Administration’s approval of mifepristone. Another one of the studies, also since retracted, was used by the anti-abortion plaintiffs in the case.
The Sage investigation found that all but one of the study authors, including the lead author on each study, were affiliated with at least one of the anti-abortion associations Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists. The AAPLOG is listed as a plaintiff in the mifepristone lawsuit. One of the peer reviewers was also associated with Charlotte Lozier. None of the authors or the reviewer disclosed these affiliations.
Since all three studies had the same lead author, Sage carried out an independent post-publication peer review of the data in all three studies. Two subject matter experts determined that the 2021 and 2022 articles, which use the same dataset, had “fundamental problems with the study design and methodology, unjustified or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data.”
These issues “demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part,” according to the experts.
Similarly, the 2019 study, which used a different dataset, included “unsupported assumptions and misleading presentations of the findings that … demonstrate a lack of scientific rigor and render the authors’ conclusion unreliable.”
Kacsmaryk ruled in April that mifepristone had been improperly approved and should be yanked from the U.S. market. The Department of Justice appealed the decision, first to the Fifth Circuit Court, which only partially stayed the ruling. The Justice Department then appealed the case to the Supreme Court, which issued a temporary stay while the lawsuit plays out. The Supreme Court will hear arguments in the case next month.
Kacsmaryk’s initial ruling hinged on several heavily biased “studies.” In addition to the faulty Charlotte Lozier article, he cited another study that claimed to find most people who had medication abortions reported negative effects. The sample size was 98 blog posts from an anti-abortion website. The study authors only analyzed 54 posts and then just cherry-picked quotes from the rest.
Medication abortions make up more than half of all abortions performed in the United States. These drugs can be ordered online and delivered via mail, making them a key resource for people who live in states that have cracked down on abortion access since Roe v. Wade was overturned.
A bigger issue at play, in this case, is that nonelected judges who do not have medical backgrounds are now making decisions about medication. When the lawsuit first began to play out, Rachel Rebouché, the dean of Temple University’s law school, told The New Republic, “The question for appellate courts is not just about abortion but about deference to a federal agency’s expertise.”
The Texas case “undermined” the FDA’s authority, she said. “To take seriously that it ignored risks, risks unsupported by any credible evidence, suggests questions as to what federal courts might decide about other federal agencies’ decisions.”
