Undisclosed conflicts of interest and unreliable findings led to the retraction of three studies by pro-life researchers
Three studies that were used as evidence to challenge the safety and efficacy of mifepristone, a drug used for medication abortion and miscarriage management, have been retracted by the academic publisher Sage due to undisclosed conflicts of interest and unreliable findings. The studies were funded and produced by the Charlotte Lozier Institute, the research arm of the influential Susan B. Anthony Pro-Life America, which works to elect federal and state anti-abortion lawmakers.
The retraction comes as the U.S. Supreme Court is set to hear an appeal next month on a case that centers on mifepristone, which is part of a two-drug regimen used to terminate pregnancies and to manage miscarriages. The case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, was filed by a group of anti-abortion doctors and medical groups who want the FDA to recall mifepristone or impose stricter regulations on its use. They claim that the drug poses serious health risks to women and that the FDA has ignored relevant safety data.
The retracted studies were cited by a Texas judge who invalidated the FDA approval of mifepristone
One of the retracted studies, titled “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015”, was cited by U.S. District Judge Matthew Kacsmaryk, a Trump judicial appointee, in his decision last week to invalidate the FDA approval of mifepristone. Kacsmaryk wrote that “the lack of restrictions resulted in many deaths and many more severe or life-threatening adverse reactions” and accused the FDA of acquiescing to “the pressure to increase access to chemical abortion at the expense of women’s safety.”
However, the study, which looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion, was found to have several flaws that undermined its validity and reliability. According to Sage, the study “demonstrate[d] a lack of scientific rigor that invalidates or renders unreliable the authors’ conclusions.” For example, the study did not account for the differences in the characteristics and health status of the women who had medication or surgical abortions, nor did it verify the cause of the emergency room visits. The study also used a misleading definition of “chemical abortion” that included other drugs besides mifepristone.
The other retracted studies also had methodological and ethical problems
The other two retracted studies also had methodological and ethical problems that cast doubt on their findings and implications. One of them, titled “A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization”, claimed that women who had complications from medication abortion were more likely to be hospitalized than women who had miscarriages. However, the study used a small and unrepresentative sample of women and did not control for confounding factors that could affect the outcomes. The study also violated the privacy and consent of the women whose medical records were used without their knowledge.
The third retracted study, titled “Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges”, purported to show that abortion providers were less qualified and less likely to have hospital privileges than other doctors. However, the study used outdated and incomplete data and did not account for the differences in the types and locations of the medical practices. The study also had a political agenda to support the anti-abortion laws that require abortion providers to have hospital admitting privileges, which have been shown to have no medical benefit and to create barriers to access.
The retraction exposes the bias and agenda of the pro-life researchers and organizations
The retraction of the three studies by Sage was based on the guidelines of the Committee on Publication Ethics (COPE), which advises journals on how to handle cases of research misconduct and ethical breaches. One of the main reasons for the retraction was the undeclared conflicts of interest of the authors, who all had affiliations with one or more of the Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists – all pro-life advocacy organizations that explicitly support judicial action to restrict access to mifepristone. One of the authors, James Studnicki, was also on the editorial board of the journal that published the studies.
The retraction exposes the bias and agenda of the pro-life researchers and organizations, who have been trying to undermine the scientific evidence and consensus on the safety and efficacy of mifepristone. The drug, which has been approved by the FDA since 2000, has a record of safety and efficacy in more than two decades of use. According to the FDA, the drug has been used by more than 5.6 million women in the U.S. and has been associated with 28 deaths, none of which could be directly attributed to the drug. The FDA also says that the rate of serious complications from medication abortion is rare and comparable to that of surgical abortion and other common medical procedures.
The retraction has implications for the upcoming Supreme Court case and the future of abortion access
The retraction of the three studies by Sage has implications for the upcoming Supreme Court case and the future of abortion access in the U.S. The case, which is scheduled for oral arguments on March 2, will decide whether the FDA can suspend the in-person dispensing requirement for mifepristone during the COVID-19 pandemic. The requirement, which was imposed by the Trump administration and blocked by a lower court, forces women to travel to a health-care facility to obtain the drug, even though they can take it at home. The requirement poses unnecessary health risks and logistical challenges for women, especially those who live in rural areas or states with few abortion providers.
The case could also have broader implications for the FDA’s authority and the regulation of other drugs and medical devices. The plaintiffs in the case argue that the FDA did not consider certain relevant safety data when it approved mifepristone, and that the agency should be compelled to review and revoke its approval. However, this argument could open the door for legal challenges to any previously approved drug or device, based on selective or flawed evidence. This could undermine the FDA’s role as the leading regulator of human drugs and medical devices, and jeopardize the public health and safety.
The retraction of the three studies by Sage shows that the scientific evidence and consensus on the safety and efficacy of mifepristone is strong and reliable, and that the legal and political attempts to restrict access to the drug are based on biased and unreliable sources. Mifepristone is a safe and effective option for women who need or want to end a pregnancy or manage a miscarriage, and it should be available without unnecessary barriers or burdens.