Medical magazine Removed two studies inspect the safety of mifepristone abortion tablets after The federal judge in Texas is quoted They are deciding to make the drug removed from the market.
Studies revoked from the methodological problems and conflicts of interests argue that abortions with the participation of mifeperon are associated with an increased risk of serious complications compared to procedural abortions. These conclusions, unlike Hundreds of research Over the past two decades, which have found that Mifepristone, which, approved by the US Products and Drugs control, is safe and effective in 10 weeks of pregnancy. There is mifepriston used in combination with medicinal mizstol In almost all drugs in the United States, abortion of drugs were more than half of abortion throughout the country in 2020.
The third study, which was written by the same authors, but not referring to the judge, was also withdrawn; It was about doctors who prescribe Mifepriston. All three articles were published in Health care studies and managerial epidemiology, Which is published by wise magazines. They appeared in the journal in 2019, 2021 and 2022.
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Documents attracted attention after the Hippocrates medicine alliance, groups of doctors and organizations to combat anti -abedation, filed a lawsuit against US products and medicines In November 2022. The alliance claimed that the FDA did not follow the appropriate procedures when approving the drug more than two decades ago and that it has The undermined risk of mifepristoneThe field when filing its claim is the alliance also I asked for a preliminary court prohibition Remove myfeperiston from the market immediately.
In court documents, the US Department of Justice (which presents FDA on legal issues) described this request as “extraordinary and unprecedented.” A The Ministry of Justice argued This “the plaintiffs did not point out a single thing, and the government could not find any example when the court has in the second case to be remote from the market, given from two decades approved by FDA.”
In April last year, judge Matthew Kachsmarik from the Northern District of Texas referred to the documents of 2021 and 2022, when he decided that the Alliance was supposed to sue gifts, agreeing with the approval of the plaintiffs that Mifepriston imposes a heavy burden Pregnant people who experience medical complications are treated on emergency doctors. Kacsmaryk released a preliminary solution Annulate the approval of FDA Mifepristone.
A The Supreme Court stopped the decision As long as the US Appeal Court in the Fifth District will not be able to make a decision. This court Part of Kacsmaryk's Management after a few days, allowing Mifepriston to stay on the market with certain restrictions.
The appeal decision has been suspended while the Supreme Court will consider the case that plans to hear arguments about this in March.
For now, Mifepristone remains affordable After 10 weeks of pregnancy, with recipes permitted by telemedicine and by mail in the states where abortion is legal.
Safety of Mifepristone
Studies show that mifepristone, which has been used by more than five million pregnant people in the United States since its was approved in 2000It has an excellent security record, says Ushma Podadhyai, a professor and healthcare scientist at the University of California at the San Francisco. “The decision of the judge of Kachsmarika ignored science and was relied by only a few research works, the chosen cherries that supported his beliefs about abortion,” says Podadhyai, the author of the new study, Published last week in Natural medicineIN This found that Mifepristone could be safely spelled out through telemedicine.
Coalition of medical groups, including American college of obstetricians and gynecologists And American Medical Association– Describe evidence of the safety of Mifepriston as a “stunning”.
Serious side effects are found in less than 1 percent of those who use the drug, In accordance with a brief that medical groups filed in the US district court in the northern district of Texas before the decision of the Kachsmarik. The main side effects, such as significant infection, blood loss or hospitalization, occur in less than 0.3 percent.
Death is even less common. According to FDA, of 3.7 million women who used Mifepriston to stop pregnancy in the United States from 2000 to 2018, 24 died. This number includes those who recently took Mifepriston and died of a reason that was not connected with him, such as murder, suicide or an overdose of another drug. What equates to the rate of mortality 0,00065 percent.
“The risk of death practically does not exist,” the brief presentation says. “Mifepriston is one of the most studied drugs prescribed in the United States and has a security profile comparable to [that of] Ibuprofen. “
Research published in the journal Contraception Last year I discovered that The risk of death from pregnancy and childbirth At least 35 times more than from legal abortion.
Controversial research
In a statement on your web, Sage Journals said this asked two independent experts In order to consider articles about Mifepriston after the reader expressed concern about the methodology of documents and unsolved conflicts of the interests of the authors.
In the study of 2021, in which patients about patients were studied from 1999 to 2015, the researchers found that visiting the emergency department associated with abortion were 50 percent more often after abortion using a mythiprodon than a procedural abortion. This led them to the conclusion that “the abortion of mifepristone is sequentially and is gradually associated with increased incidence” compared to procedural abortion.
But the study, which was focused on people covered by Medicaid, provides little evidence that these people have experienced an unfavorable event associated with abortion, says Chris Adkins, an associate professor of pharmaceutical sciences at the Southern University in Savannah, Georgia, who defined himself as a reader who questioned the wise magazines about articles.
According to Adkins, pregnant people in the study in 2021 could go to the emergency care department for any number of reasons, from food poisoning to the ears, adding that he does not speak for his university. Studies show that half of visits to the emergency department made after an abortion Not related to abortionThe field and many people who often include those who have the right to Medicaid go to the emergency department with non -detention, because they cannot access care anywhere.
Some people who have drug abortion visit emergency care departments, “just to determine whether the amount of bleeding and spasms is normal,” says Adkins. “A significant number of these ER visits is simply observant help, and not a true unfavorable event associated with abortion.”
The study of 2021 also could not ensure an important context, including a significant increase in the number of registration of Medicaid during the study (from 1999 to 2015), partly as a result of the law on affordable medical care, says Adkins. The number of Americans enrolled in Medicaid In 2015, it grew from 34.1 million in 2000 to 71.5 million.
Although the authors of the article 2021 stated that they had no conflict of interests when they presented it for publication, everyone except one was associated with the Anti -Aborian advocacy group, including the Charlotte Lozier Institute, the Elliot Institute and the American Association of Obstetroly Specialists in Life and Gynecologists. This article and the recalled study since 2022 were financed by the Charlotte Lozier Institute, the Susan B. Anthony Research and Educational Institute, and an influential anti -abortion group for the life of America.
The reviewer, who initially appreciated the articles, was also associated with the Charlotte Lozier Institute at that time that led to the fact that the publisher later came to the conclusion that the reviewer's work was “unreliable”, according to the Sage Journals statement.
Independent experts who recommended three involvements found that articles from 2021 and 2022 contained “fundamental problems with the design and research methodology, unjustified or incorrect actual assumptions, material errors in the analysis of the authors and misleading the ideas of data that, in their opinion, demonstrate the absence of scientific strictness and put into effect the authors for purposes, which is that this For the statement, in general, that this is the statement, in accordance with the part, that for purposes, in general, for purposes, as a whole, in Sovol with the authors, in the fact that they can be for purposes, in general, that they can be for the purpose of the authors, in general, that they can be for purposes, that they can be for purposes, in purposes, in purposes. That they can be for purposes.
James Studniki, the leading author of all three research and vice -President and Director of Data Analystation at the Charlotte Lozier Institute, Published a point refutation Critics of wise magazines. He and his co -authors did not try to hide his belonging, he wrote. The articles really included a brief biography, which noted the ownership of researchers. In response by e -mail Scientific American, The representative of Sage Journals said that “it is entitled to editors of magazines to make individual decisions on the presented work. These editors of the magazine rely on reviewers to assess the quality of the presented article and determine whether it is strict and ultimately, if it is acceptable for publication. We work together to accept the right action when necessary. ”
The student and Tessa Longbons, senior researcher at the Charlotte Lozier Institute and the co -author of these three works, argue that their research is aimed at politics. In the video Published onlineStudniki claimed that most medical journals are “branchingly proportional.”
“This incident indicates a newer, new phenomenon, which consists in the fact that many of our scientific institutions and publications no longer support the defense of an open research,” wrote students and Longbons in an electronic letter. Scientific AmericanThe field “We see a biased elite fraction throughout the medical community, and all power is trying to suppress any studies that overcome their approved, protracted.
Critics of withdrawn documents say that their fears are practical – not personal or political.
“It's not about ideology,” says Podadhyai. “The return of these studies is based on their erroneous scientific approach, which largely distorts the security rating for abortion.”
Impact on future legal decisions
According to Mary Tsigler, a professor at the University of California at the University of California at the University of California at the University of California at the University of California University at the University of California University, Davis, a law school that studies the history of abortion.
State lawmakers trying to limit or violate abortion, as a rule, seems to be a more motivated desire to protect the fetus than fears about the protection of pregnant women from potential side effects, Siegler says.
The decision of the fifth district of the Court of Appeal on Mifeperon was not supposed to be withdrawn documents, but for other testimonies, she says.
The Supreme Court, which voted in 2022 to turn over Row against Wade (According to Tsigler, it is unlikely that the case, which legitimized abortion in 1973). “Given the problems with the case of the plaintiffs about standing, the court may already be inclined to fight against the Hippocratic Alliance on Medicine,” she says. “And if the judges are ready to lose sight of other problems with the standing and weight of evidence in Mifeperiston, refusal, most likely, will not be more than strengthening the existing position.”
