The Supreme Court is slated to hear arguments against the safety of the chemical abortion drug mifepristone.
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Three medical research reports, which pieced together an alarming set of data showing the abortion pill mifepristone is very dangerous to girls and women, were retracted by the publisher, Sage, just weeks before the Supreme Court is slated to hear arguments against the safety of the drug. The publisher cited a conflict of interest but The Charlotte Lozier Institute (CLI), which funded the research, is fighting back.
"This case has been painted as a pro-life vs. pro-abortion case, but in its essence, it is about the FDA performing its job to protect the American public from dangerous drugs," Dr. Ingrid Skop, a 25-year veteran obstetrician-gynecologist who serves as vice president and director of medical affairs for the pro-life CLI, told Decision.
"When they approved the chemical abortion regimen, they did not follow their own rules," Skop said. "The FDA is required to study the pediatric population, which they never did. They approved mifepristone under a category called accelerated approval regulations, which is meant to be used for drugs that treat life-threatening illnesses. Over time, they've removed the safeguards. And many times, they point to studies that don't even replicate the conditions that they now allow the abortion pill to be used under."
The trouble started when, two years ago, a CLI study led by Dr. James Studnicki found an increase in the rate of post-abortion ER visits following chemical abortions based on Medicaid claims data. The study was widely cited and provided impetus for other studies seeking better information on the impacts of abortion on women. It was this study that, nearly two years later, caught the attention of a complainant whose letter, which remains unpublished to date, prompted the publisher, Sage, to issue an Expression of Concern (EOC) for the article.
The EOC did not refer to any finding of the study but claimed "potential issues regarding the representation of data in the article and author conflicts of interest." On November 13, Sage informed the CLI researchers that it was retracting the ER study and two additional studies (see here and here). Dr. Studnicki, of course, had no role whatsoever in reviewing and approving the articles that appeared under his lead authorship.
The three articles provided new data, sounding alarms that mifepristone, a drug used in chemical abortions to block oxygen and nutrients from getting to a developing fetus, was never assessed properly and that rather than being safe and effective, as the FDA and Big Abortion has been pushing for the last twenty years, it poses great health risks to females who take it.
The retraction notice indicates that an independent assessment of the studies was undertaken in response to a single reader's complaint that the studies contained misleading data and that the authors were linked with a pro-life organization, the Charlotte Lozier Institute, creating a conflict of interest.
The papers' authors claim the retractions are a politically motivated attempt to discredit data used in US District Judge Matthew Kacsmaryk's April 2023 ruling to freeze approval of mifepristone, which is now used in about half of all abortions in the United States. The Supreme Court is scheduled to hear arguments on March 26 on the constitutionality of banning abortion pills based on Kacsmaryk's decision, which will undoubtedly be influenced by the retractions.
Dr. James Studnicki, a listed author on all three papers in question, has stated that the retractions were "completely unjustified" and intended to undermine scientific research that challenged the pro-abortion bias ingrained in academia.
Studnicki, who studied at Johns Hopkins University and has spent decades conducting scientific research, told the Daily Wire that he and his colleagues were targeted "because of the visibility of our work, because of the fact that our work was having such an influence on the abortion debate that was taking place in the states and in the courts at the highest levels."
According to Medicaid claims data, one of the now-retracted studies, released on November 9, 2021, found that the rate of emergency room visits after chemical abortions increased by 500 percent between 2002 and 2015. Another study, published on May 20, 2022, examined the likelihood of recurring emergency room visits for women who did not tell clinicians they had a chemical abortion.
These two studies were used in Kacsmaryk's decision to halt FDA approval of mifepristone.
Furthermore, Dr. Ingrid Skop's testimony, who was an author on all three articles, was cited several times in an August decision by the Fifth Circuit Court of Appeals, which stated that the chemical abortion drug mifepristone should not be distributed by mail or prescribed via telemedicine.
Studnicki went on to say that the retractions exemplified the politicization of science. He stated that proponents of abortion were greatly intimidated by the decision of Roe v. Wade and were now attempting to prohibit any study indicating risks associated with abortion from the academia.
"I think Dobbs really accelerated this, there's a sense of desperation among those in the abortion industry. They've always had the literature to themselves. All of the major health associations are pro-abortion, most of the journals are pro-abortion, all the academic departments in the universities are pro-abortion," he said.
In prior correspondence with the authors, Sage pushed back against charges of political bias, claiming that the faults identified in the publications were based on independent evaluation by "subject experts" and that the articles had methodological issues.
No problems were reported with any of the studies until April 2023, the same month as Kacsmaryk's decision, when pharmaceutical sciences professor and abortion supporter Chris Adkins complained to Sage about an article claiming that the study showing an increase in the rate of emergency room visits was full of "dishonest science" and "grossly misleading."
The researchers were unaware of any problems with the papers until June 28, 2023, when they received a complaint from a reader. They reacted to the complaints on July 13, and the Expression of Concern was added to the article on July 25.
After months of correspondence with the journal, Sage informed the researchers on November 13 that they would retract the three papers. The following day, Studnicki was removed from the editorial board of the Health Services Research and Managerial Epidemiology journal, months before the retractions occurred.
"In light of the decision to retract three research articles in which you are an author, I believe your term as an editorial board member has come to an end. As the Editor, I appreciate your contributions to the journal," Dr. Gregory Garrison said to Studnicki in an email obtained by The Post Millennial.
This remark occurred after Garrison had previously mentioned Studnicki's research in an editorial for Sage in March 2022.
On November 16, the researchers wrote to Sage, requesting more time to respond to the retraction notice, claiming that the retractions were "procedurally improper" and implying that the true reason for the retractions was to undermine their research ahead of the Supreme Court's consideration of mifepristone.
"Your decision also represents an unfortunate trend of utilizing scientific papers as a weapon against controversial conclusions, regardless of their objectivity. This further weakens the public's trust in scientific groups and undermines your objective to 'advance knowledge,'" the authors wrote.
Days after missing the initial retraction deadline, Sage responded to the researchers on November 21, giving them until November 29 to respond and denied that the retractions were politically driven.
"Sage rejects as baseless your allegation that the timing of the Retraction Notice was in any way related to a Supreme Court case," Sage stated in a letter obtained by The Post Millennial. "The retraction of the three publications is exclusively based on the findings of the investigation, which Sage was responsible for as a COPE [Committee on Publication Ethics] member and as the journal's publisher. Sage's principal purpose and commitment, as it has for over 50 years, is to ensure the highest level of academic publishing integrity. Any insinuation that politics plays a role in this mission is both unfounded and offensive."
Sage argued that one of the reasons for the retractions was that the researchers failed to disclose conflicts of interest. The journal said that the CLI researchers tricked them and failed to reveal "blatant conflicts."
Studnicki, on the other hand, stated that they had made it obvious that their work was supported by the Charlotte Lozier Institute and had repeatedly detailed their ties. The institute is the research arm of the Susan B. Anthony Pro-Life America organization. Kacsmaryk cites both pieces, which indicate at the bottom, "This work was supported by the Charlotte Lozier Institute."
Tessa Longbons, another author of the research, claimed that Sage was using a double standard with the conflict of interest claim, citing other papers published with Sage Journals in which writers linked with pro-abortion groups failed to disclose conflicts of interest.
For example, in one Sage article arguing for mifepristone access, no competing interests were mentioned, despite the fact that the lead author supports abortion and the other writers are members of a pro-abortion group. Similarly, no conflict of interest was declared by Sage when they published this research from the well-known Goliath of Big Abortion,The Guttmacher Institute.
Sage's response to the researchers stated that the claim that they held pro-life and pro-abortion authors to separate standards was "baseless and needlessly provocative."
The researchers responded by highlighting the apparent double standard.
"[If] Sage now purports to have always required ideological disclosures, Sage itself has not maintained that standard it seeks now to impose on us," the authors of the paper stated. "Despite Sage's dismissal of this point as 'unsupported,' a cursory search clearly demonstrates that Sage journals have published dozens of articles on abortion access and safety by researchers affiliated with organizations with very public and open positions on abortion."
Another issue Sage had with the studies, according to correspondence with the authors, was that a reviewer on the manuscript was linked with the Charlotte Lozier Institute. Studnicki, on the other hand, stated that Sage picks reviewers and that the articles were reviewed in a double-blind manner, which means that the authors did not know who was examining the piece and the reviewers did not know whose work they were reviewing.
"We did not pick the reviewer in question, and the reviewer's identity is still unknown to us. In fact, this reviewer may not have been a CLI associate scholar when he or she wrote the review. Similarly, because Sage uses double-blind peer review, the reviewer was also unaware of our names when evaluating our work," the researchers informed Sage.
Sage questioned some of Studnicki and other researchers' methodological decisions. It faulted the November 2021 study because it measured abortion complications through emergency room visits. Using Medicaid data, the researchers tracked emergency room visits by women who had confirmed abortions within 30 days after the visit. The researchers classified the visits into categories, including abortion-related visits.
Some critics argue that an adverse reaction to abortion should only be counted if the visit requires surgery or hospitalization, but Studnicki disagrees.
"I think that if a woman has an abortion and she starts to bleed or she starts to have serious pain or she sees some sort of discharge that is indicative of an infection, she goes to an emergency room, I think that is a serious adverse event and a complication," the doctor added.
Despite the retractions, Studnicki stated that he and his colleagues will continue to create high-quality research, calling it a badge of pride to be targeted by pro-abortion supporters.
"This is the most powerful tribute to the strength of our science that anyone could hope for. We are doing all of the proper things. We aim to continue doing the right things, but it will be more difficult to have things published since they are attempting to ruin our reputation," he stated.
Meanwhile, the case against the FDA and the shadowy manufacturer of mifepristone, Danco Laboratories, is still set to be heard by the Supreme Court. The Charlotte Lozier Institute's Amicus Curiae can be read here.
"This case has been painted as a pro-life vs. pro-abortion case, but in its essence, it is about the FDA performing its job to protect the American public from dangerous drugs," Dr. Ingrid Skop, a 25-year veteran obstetrician-gynecologist who serves as vice president and director of medical affairs for the pro-life CLI, told Decision.
"When they approved the chemical abortion regimen, they did not follow their own rules," Skop said. "The FDA is required to study the pediatric population, which they never did. They approved mifepristone under a category called accelerated approval regulations, which is meant to be used for drugs that treat life-threatening illnesses. Over time, they've removed the safeguards. And many times, they point to studies that don't even replicate the conditions that they now allow the abortion pill to be used under."
The trouble started when, two years ago, a CLI study led by Dr. James Studnicki found an increase in the rate of post-abortion ER visits following chemical abortions based on Medicaid claims data. The study was widely cited and provided impetus for other studies seeking better information on the impacts of abortion on women. It was this study that, nearly two years later, caught the attention of a complainant whose letter, which remains unpublished to date, prompted the publisher, Sage, to issue an Expression of Concern (EOC) for the article.
The EOC did not refer to any finding of the study but claimed "potential issues regarding the representation of data in the article and author conflicts of interest." On November 13, Sage informed the CLI researchers that it was retracting the ER study and two additional studies (see here and here). Dr. Studnicki, of course, had no role whatsoever in reviewing and approving the articles that appeared under his lead authorship.
The three articles provided new data, sounding alarms that mifepristone, a drug used in chemical abortions to block oxygen and nutrients from getting to a developing fetus, was never assessed properly and that rather than being safe and effective, as the FDA and Big Abortion has been pushing for the last twenty years, it poses great health risks to females who take it.
The retraction notice indicates that an independent assessment of the studies was undertaken in response to a single reader's complaint that the studies contained misleading data and that the authors were linked with a pro-life organization, the Charlotte Lozier Institute, creating a conflict of interest.
The papers' authors claim the retractions are a politically motivated attempt to discredit data used in US District Judge Matthew Kacsmaryk's April 2023 ruling to freeze approval of mifepristone, which is now used in about half of all abortions in the United States. The Supreme Court is scheduled to hear arguments on March 26 on the constitutionality of banning abortion pills based on Kacsmaryk's decision, which will undoubtedly be influenced by the retractions.
Dr. James Studnicki, a listed author on all three papers in question, has stated that the retractions were "completely unjustified" and intended to undermine scientific research that challenged the pro-abortion bias ingrained in academia.
Studnicki, who studied at Johns Hopkins University and has spent decades conducting scientific research, told the Daily Wire that he and his colleagues were targeted "because of the visibility of our work, because of the fact that our work was having such an influence on the abortion debate that was taking place in the states and in the courts at the highest levels."
According to Medicaid claims data, one of the now-retracted studies, released on November 9, 2021, found that the rate of emergency room visits after chemical abortions increased by 500 percent between 2002 and 2015. Another study, published on May 20, 2022, examined the likelihood of recurring emergency room visits for women who did not tell clinicians they had a chemical abortion.
These two studies were used in Kacsmaryk's decision to halt FDA approval of mifepristone.
Furthermore, Dr. Ingrid Skop's testimony, who was an author on all three articles, was cited several times in an August decision by the Fifth Circuit Court of Appeals, which stated that the chemical abortion drug mifepristone should not be distributed by mail or prescribed via telemedicine.
Studnicki went on to say that the retractions exemplified the politicization of science. He stated that proponents of abortion were greatly intimidated by the decision of Roe v. Wade and were now attempting to prohibit any study indicating risks associated with abortion from the academia.
"I think Dobbs really accelerated this, there's a sense of desperation among those in the abortion industry. They've always had the literature to themselves. All of the major health associations are pro-abortion, most of the journals are pro-abortion, all the academic departments in the universities are pro-abortion," he said.
In prior correspondence with the authors, Sage pushed back against charges of political bias, claiming that the faults identified in the publications were based on independent evaluation by "subject experts" and that the articles had methodological issues.
No problems were reported with any of the studies until April 2023, the same month as Kacsmaryk's decision, when pharmaceutical sciences professor and abortion supporter Chris Adkins complained to Sage about an article claiming that the study showing an increase in the rate of emergency room visits was full of "dishonest science" and "grossly misleading."
The researchers were unaware of any problems with the papers until June 28, 2023, when they received a complaint from a reader. They reacted to the complaints on July 13, and the Expression of Concern was added to the article on July 25.
After months of correspondence with the journal, Sage informed the researchers on November 13 that they would retract the three papers. The following day, Studnicki was removed from the editorial board of the Health Services Research and Managerial Epidemiology journal, months before the retractions occurred.
"In light of the decision to retract three research articles in which you are an author, I believe your term as an editorial board member has come to an end. As the Editor, I appreciate your contributions to the journal," Dr. Gregory Garrison said to Studnicki in an email obtained by The Post Millennial.
This remark occurred after Garrison had previously mentioned Studnicki's research in an editorial for Sage in March 2022.
On November 16, the researchers wrote to Sage, requesting more time to respond to the retraction notice, claiming that the retractions were "procedurally improper" and implying that the true reason for the retractions was to undermine their research ahead of the Supreme Court's consideration of mifepristone.
"Your decision also represents an unfortunate trend of utilizing scientific papers as a weapon against controversial conclusions, regardless of their objectivity. This further weakens the public's trust in scientific groups and undermines your objective to 'advance knowledge,'" the authors wrote.
Days after missing the initial retraction deadline, Sage responded to the researchers on November 21, giving them until November 29 to respond and denied that the retractions were politically driven.
"Sage rejects as baseless your allegation that the timing of the Retraction Notice was in any way related to a Supreme Court case," Sage stated in a letter obtained by The Post Millennial. "The retraction of the three publications is exclusively based on the findings of the investigation, which Sage was responsible for as a COPE [Committee on Publication Ethics] member and as the journal's publisher. Sage's principal purpose and commitment, as it has for over 50 years, is to ensure the highest level of academic publishing integrity. Any insinuation that politics plays a role in this mission is both unfounded and offensive."
Sage argued that one of the reasons for the retractions was that the researchers failed to disclose conflicts of interest. The journal said that the CLI researchers tricked them and failed to reveal "blatant conflicts."
Studnicki, on the other hand, stated that they had made it obvious that their work was supported by the Charlotte Lozier Institute and had repeatedly detailed their ties. The institute is the research arm of the Susan B. Anthony Pro-Life America organization. Kacsmaryk cites both pieces, which indicate at the bottom, "This work was supported by the Charlotte Lozier Institute."
Tessa Longbons, another author of the research, claimed that Sage was using a double standard with the conflict of interest claim, citing other papers published with Sage Journals in which writers linked with pro-abortion groups failed to disclose conflicts of interest.
For example, in one Sage article arguing for mifepristone access, no competing interests were mentioned, despite the fact that the lead author supports abortion and the other writers are members of a pro-abortion group. Similarly, no conflict of interest was declared by Sage when they published this research from the well-known Goliath of Big Abortion,The Guttmacher Institute.
Sage's response to the researchers stated that the claim that they held pro-life and pro-abortion authors to separate standards was "baseless and needlessly provocative."
The researchers responded by highlighting the apparent double standard.
"[If] Sage now purports to have always required ideological disclosures, Sage itself has not maintained that standard it seeks now to impose on us," the authors of the paper stated. "Despite Sage's dismissal of this point as 'unsupported,' a cursory search clearly demonstrates that Sage journals have published dozens of articles on abortion access and safety by researchers affiliated with organizations with very public and open positions on abortion."
Another issue Sage had with the studies, according to correspondence with the authors, was that a reviewer on the manuscript was linked with the Charlotte Lozier Institute. Studnicki, on the other hand, stated that Sage picks reviewers and that the articles were reviewed in a double-blind manner, which means that the authors did not know who was examining the piece and the reviewers did not know whose work they were reviewing.
"We did not pick the reviewer in question, and the reviewer's identity is still unknown to us. In fact, this reviewer may not have been a CLI associate scholar when he or she wrote the review. Similarly, because Sage uses double-blind peer review, the reviewer was also unaware of our names when evaluating our work," the researchers informed Sage.
Sage questioned some of Studnicki and other researchers' methodological decisions. It faulted the November 2021 study because it measured abortion complications through emergency room visits. Using Medicaid data, the researchers tracked emergency room visits by women who had confirmed abortions within 30 days after the visit. The researchers classified the visits into categories, including abortion-related visits.
Some critics argue that an adverse reaction to abortion should only be counted if the visit requires surgery or hospitalization, but Studnicki disagrees.
"I think that if a woman has an abortion and she starts to bleed or she starts to have serious pain or she sees some sort of discharge that is indicative of an infection, she goes to an emergency room, I think that is a serious adverse event and a complication," the doctor added.
Despite the retractions, Studnicki stated that he and his colleagues will continue to create high-quality research, calling it a badge of pride to be targeted by pro-abortion supporters.
"This is the most powerful tribute to the strength of our science that anyone could hope for. We are doing all of the proper things. We aim to continue doing the right things, but it will be more difficult to have things published since they are attempting to ruin our reputation," he stated.
Meanwhile, the case against the FDA and the shadowy manufacturer of mifepristone, Danco Laboratories, is still set to be heard by the Supreme Court. The Charlotte Lozier Institute's Amicus Curiae can be read here.
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