Fragile anti-deventures studies cited in the event that mifepristone prohibits are retracted
A medical journal has retracted two studies examining the security of the mifepristone abortion pill after a federal judge in Texas cited them when they considered that the drug should be removed from the market.
Studies, both retracted due to methodology problems and conflicts of interest, have said that abortions involving mifepristone are associated with an increased risk of serious complications compared to procedural abortions. These conclusions contrast with hundreds of studies in the past two decades that have found that mifepristone – commonly approved by the United States Food and Drug Administration for abortion for 10 weeks of pregnancy – is safe and effective. Miffepristone is used in combination with drug misoprostol in almost all drug abortions in the United States, and drug abortions were more than half of the abortions nationwide in 2020.
A third study written by the same authors but not referenced by the judge was also retracted; These were doctors who prescribe mifepristone. The three articles were published in Search for health and management epidemiology services, which is published by Sage Journals. They appeared in the newspaper in 2019, 2021 and 2022.
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The documents drew attention after the Hippocratic Medicine Alliance, a group of doctors and anti-Ifo-organizations, continued the United States Food and Drug Administration in November 2022. The Alliance said that the FDA had not followed the appropriate procedures by approving the drug more than two decades and that it had minimized the risks of Mifepristone. When filing its prosecution, the alliance also requested a preliminary injunction to immediately withdraw mifepristone from the market.
In court documents, the United States Ministry of Justice (which represents the FDA in legal matters) described this request as “extraordinary and unprecedented”. The DoJ argued that “the complainants have not shown any cases, and the government has not been able to locate an example, when a court has the determination of the influence and efficiency of the FDA, and ordered a drug approved by the FDA largely available – a little less an example which includes a delay of two decades.”
The judge last April, Matthew Kacsmaryk, of the Northern Texas District, cited the newspapers 2021 and 2022 when he judged that the alliance had standing to continue, agree with the applicants of the request that mifepristone devotes a heavy burden to emergency doctors who deal with pregnant people who experience medical complications. Kacsmaryk rendered a preliminary decision invalidating the approval by the FDA of Miffepristone.
The Supreme Court interrupted the decision until the American Court of Appeal for the fifth circuit could make a decision. This court canceled part of Kacsmaryk’s decision a few days later, allowing Mifepristone to stay on the market with certain restrictions.
The decision of the Court of Appeal is suspended while the case is under study by the Supreme Court, which should hear arguments on this subject in March.
For the moment, mifepristone remains available for 10 weeks of pregnancy, with prescriptions authorized by telemedicine and by post in states where abortion is legal.
Safety of Mifepristone
Research shows that mifepristone, which has been used by more than five million pregnant people in the United States since its approved in 2000, has an excellent security file, explains Upadhyay, professor and scientist in public health at the University of California in San Francisco. “The decision of judge Kacsmaryk ignored science and relied on the few research articles selected by Cerise which supported its beliefs on abortion,” said Upadhyay, author of a new study, published last week in Nature Medicine,, Who has found mifepristone can be prescribed safely by telemedicine.
A coalition of medical groups – notably the American College of Obstetricians and Gynecologists and the American Medical Association – describe proofs of the safety of mifepristone as “overwhelming”.
Serious side effects occur in less than 1% of those who use the drug, according to a thesis that medical groups have deposited with the American district court for the North Texas District before Kacsmaryk’s decision. Major adverse events such as significant infection, blood loss or hospitalization occur in less than 0.3%.
Deaths are even rarer. According to the FDA, of the 3.7 million estimated women who used mifepristone to terminate pregnancy in the United States from 2000 to 2018, 24 died. This number includes those who had recently taken mifepristone and died of a cause which was not attributed to it, such as homicide, suicide or an overdose of another medication. This is equivalent to a mortality rate of 0,00065%.
“The risk of death is almost nonexistent,” said the brief. “Mifepristone is one of the most studied drugs prescribed in the United States and has a safety profile comparable to [that of] Ibuprofen. “
A study published in the journal Contraception Last year revealed that the risk of pregnancy death and childbirth is at least 35 times higher than that of a legal abortion.
Controversial studies
In a statement on his website, Sage Journés said that he had asked two independent experts to review the articles on mifepristone after a reader has expressed his concerns about the methodology of articles and unknown interest conflicts of the authors.
In the 2021 study, which examined patients from patients from 1999 to 2015, researchers found that visits to emergency services related to abortion were 50% more likely after an abortion using mifepristone than procedural abortion. This led them to conclude that “abortion to mifepristone is coherently associated with increased morbidity” compared to procedural abortions.
But the study, which focused on people covered by Medicaid, provides little evidence that people have experienced an adverse event linked to abortion, explains Chris Adkins, an associate professor of pharmaceutical sciences at South University in Savannah, in Georgia, who identified as the reader who questioned the wise newspapers.
The speakers of the retracted study in 2021 could have surrendered to the emergency room for a certain number of reasons, from food poisoning to ear ailments, says Adkins, adding that he is not talking about his university. Research shows that half of the emergency visits made after an abortion are not linked to abortion. And many people, including often those that are eligible for Medicaid, go to the emergency room with non -urgent needs because they cannot access care anywhere else.
Some people who have drug abortions visit emergency services “simply to determine if the quantity of bleeding and cramps is normal,” said Adkins. “A significant number of these visits are only observation care and not a real adverse event linked to abortion.”
The 2021 study also did not provide an important context, in particular the substantial increase in registration in Medicaid during the study period (between 1999 and 2015), partly following the affordable care law, explains Adkins. The number of Americans registered in Medicaid went from 34.1 million in 2000 to 71.5 million in 2015.
Although the authors of the 2021 article said they had no conflict of interests when they submitted it for publication, all except one were affiliated with anti-bortive defense groups, including the Charlotte Lozier Institute, the Elliot Institute and the American Association of Obostetrician and Gynecologists. This article and a retracted study of 2022 by the same authors were funded by the Charlotte Lozier Institute, the Research and Education Institute of Susan B. Anthony Pro-Life America, a group of anti-abortive influences.
An examiner who initially evaluated the articles was also affiliated with the Charlotte Lozier Institute at the time, which led the publisher to conclude later that the work of the reviewer was “unreliable”, according to the declaration of Sage’s journals.
The independent experts who recommended the three retractions found that the articles of 2021 and 2022 contained “fundamental problems with the design and methodology of the study, unjustified or incorrect factual hypotheses, important errors in the analysis by data of the data and invalidate the authors of the conclusion of the authors in hope.
James Studnicki, principal author of the three studies and vice-president and director of data analysis at the Charlotte Lozier Institute, published a point refutation by point of the Critique of Sage journals. He and his co-authors had not tried to hide their affiliations, he wrote. The articles included a brief biography which noted the affiliations of researchers. In an e-mail response to Scientific American, A spokesperson for Sage journals said that he “relies on editors to make individual decisions on submitted works.
Studnicki and Tessa Longbons, main research partner at the Charlotte Lozier Institute and co-author of the three articles, claim that their studies are targeted due to politics. In a video published online, Studnicki allegedly alleged that most medical journals are “proabortal virulently”.
“This incident indicates a more important and more American scientist. “We see a biased elite faction through the medical community with all the power that attempts to remove any research that reduces their approved and pro-abortion story. Scientific research and publication should be based on science, not motivated by ideology. ”
Critics of retracted articles say that their concerns are practical – not personal or political.
“This is not an ideology,” says Upadhyay. “The retraction of these studies is based on their imperfect scientific approach which roughly deforms the security rating for abortion.”
Effect on future legal decisions
The retractions are “unlikely to make a lot of legally difference” in terms of future decisions or legislation, explains Mary Ziegler, professor at the University of California, Davis, School of Law, who studies the history of abortion.
State legislators trying to restrict or prohibit abortion generally seem more motivated by the desire to protect the fetus than by concerns concerning the protection of pregnant persons against potential adverse events, says Ziegler.
The decision of the short Circuit Court of Appeals on Mifepristone did not rely on the retracted documents but on other testimonies, she said.
The Supreme Court, which voted in 2022 to overthrow Roe c. Wade (The historical affair which legalized abortion in 1973) is unlikely to be influenced by retractions, known as Ziegler. “Given the problems with the file of the position complainants, the court can already be inclined to store against the Alliance for Hippocratic Medicine,” she says. “And if judges are ready to ignore other positions of position of position and weight of evidence on mifepristone, the retractions will probably do more than strengthen an existing position.”
