Medical journal Two studies retreated Study the integrity of the birth control pills, abortion, Mifterbriston, after a federal judge was martyred in Texas when they judge that drugs should be transmitted from the market.
Studies, which have declined due to methodology and conflicts of interests, are associated with the supported abortion that involves MEFIPresston increased the risk of serious complications compared to procedural abortion. Those conclusions in contrast to that with Hundreds of studies In the past two decades who have found that MifePristone – which has been approved by the US Food and Drug Administration for current use of miscarriage within 10 weeks of pregnancy – is safe and effective. MivePristone is Used in combination with mazoprostol drugs In almost all drug abortion in the United States, abortion for medicines formed more than half of the country’s abortion in 2020.
A third study was also deported by the same authors, but it was not referred to by the judge; It was about doctors who prescribe MivePristone. All three papers were published in Health services and administrative epidemics research, Posted by Sage Journals. They appeared in the magazine in 2019, 2021 and 2022.
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The papers drew attention after the Essential Medicine Alliance, a group of doctors and anti -mine organizations, Filed a lawsuit against the US Food and Drug Administration In November 2022. The coalition claimed that the Food and Drug Administration did not follow the appropriate procedures in approval of the drug for more than two decades and that he had it Reduce the risks of mivePristone. When filing her lawsuit, the alliance also Request a preliminary judicial order To immediately remove Mivipriston from the market.
In the court documents, the US Department of Justice (which represents the FDA in legal matters) described this request as “unusual and unprecedented.” the Doj “The prosecutors did not indicate to any case, and the government was unable to determine any example, as the court stored it in safety and effectiveness in the FDA, and ordered widespread large-scale drugs to remove it from the market-a less example of this, which includes a two-decade delay.”
Last April, Judge Matthew Kuxamerik from the northern region of Texas was killed in 2021 and 2022 leaves when he died that the coalition was to prosecute, and it was agreed with the prosecutors claiming that Mivipriston was putting a heavy burden on the emergency room doctors who treat pregnant people with medical complications. KacSmaryk issued a preliminary ruling that nullifies the approval of the Food and Drug Administration on MivePristone.
The Supreme Court suspended the ruling so that the American Appeal Court of the Fifth Circuit could issue a ruling. That court Hit a portion of Kacsmaryk’s Judgment a few days later, allowing Mivipriston to stay on the market with some restrictions.
The ruling of the Court of Appeal is suspended during the case under consideration by the Supreme Court, which is scheduled to hear arguments on this issue in March.
for now, MivePristone is still available Within 10 weeks of pregnancy, with the prescriptions that are allowed by remote medicine and by mail in the states where miscarriage is legal.
MifePristone safety
Research shows that MivePristone, which has been used by more than five million pregnant women in the United States since then It was approved in 2000Ushma Upadhyy, a professor and public health scientist at the University of California, San Francisco, says he has an excellent safety record. “Judge KacSmaryk’s decision ignored the flag and relied on a few of the few research papers that support his beliefs on abortion,” says Upadhyay, author of a new study. Posted last week in Nature Medicineand That found that MivePristone can be described safely through remote medical trees.
An alliance of medical groups – including The American College of Obstetricians and Gynecologists and American Medical Association– Description of the safety of MivePristone as “overwhelming”.
Dangerous side effects occur in less than 1 percent of those who use the drug, According to a summary Medical groups submitted to the American boycott court for the northern region of Texas before KacSmaryk’s decision. The main negative events such as big infection, blood loss or hospital occur in less than 0.3 percent.
The deaths are rare. According to FDA, of 3.7 million women estimated at MivePristone to end the pregnancy in the United States from 2000 to 2018, 24 died. This number includes those who recently taken MivePristone and Tofio for a reason not attributed to it, such as killing, suicide or an overdose of another drug. Which – which The death rate is equivalent From 0.00065 percent.
“The risk of death is almost no exist.” “MivePristone is one of the most studied medications described in the United States and has a similar safety image [that of] Epoprofen. “
A study published in the magazine contraception Last year I found that The risk of death from pregnancy and childbirth At least 35 times of legal abortion.
Controversial studies
In a statement on its website, Sage Journals said He asked two independent experts To review articles on MifePristone after the reader expressed his concerns about the methodology of papers and conflicts of interests, the authors have not been revealed.
In the 2021 study, which examined the patient’s data from 1999 to 2015, the researchers found that the visuance department visits were 50 percent more likely after miscarriage using MivePristone than procedural abortion. This has led to the conclusion that “the abortion of the Movestone is constantly linked and graduated from the increase of the disease,” compared to procedural abortion.
Chris Adkins, associate professor of pharmaceutical sciences at South University in South in Savana, says Georgia, who has known himself as the reader who interrogated the eager magazines about materials.
Adkins says that pregnant people in the 2021 study could have gone to the emergency department for any number of reasons, from food poisoning to the effects of the ear, adding that he did not talk about his university. Research shows that half of the emergency room visits that were conducted after abortion It has nothing to do with abortion. And many people, often, including those who qualify for Medicaid, go to the emergency room with non -emergency needs because they cannot reach care anywhere else.
Adkins says that some people who aborted medicines visit emergency departments “simply to determine whether the amount of bleeding and cramping is normal.” “There are a large number of ER visits, these are just a monitoring care, not a real negative event related to miscarriage.”
The 2021 study also failed to provide an important context, including the significant increase in joining the microbes during the study period (between 1999 and 2015), partly as a result of the law of care at reasonable prices. The number of Americans registered in Medicaid It grew from 34.1 million in 2000 to 71.5 million in 2015.
Although the authors of the 2021 article announced that they had no conflict of interest when they presented this to publication, all of them belonged to the anti -advocacy groups, including the Charlotte Lawzie Institute, the Elliot Institute and the American Association of Obstetrics and Obstetrics supporting life. This paper was funded and a study declined from 2022 by the same authors by the Charlotte Lawzie Institute, and the Research and Education Institute in Susan B. Anthony Pro-Life America, an anti-cancellation group.
The peer references, who originally evaluated the articles, were affiliated with the Charlotte Lawzie Institute at the time, which later prompted the publisher that the auditor’s work was “unreliable”, according to the Sage Journals statement.
Independent experts who recommended the three decline found that articles from 2021 and 2022 contain “basic problems in the design and methodology of the study, unjustified or incorrect realistic assumptions, material errors in the authors analysis of data, and pure presentations in the statements they fully clarify.
James Stodenicky, the main author of all three studies, vice president and director of data analysis at the Charlotte Lawsie Institute, Publish the point after another From Sage Journals’ Criticism. He and his participants wrote did not try to hide their affiliations. The articles did not include a short biography that noticed the affiliations of the researchers. In an e -mail response to American scientific, “It relies on magazine editors to make individual decisions on the actions submitted. Magazine editors rely on peer auditors to assess the quality of an introductory article and determine whether it is strict and ultimately, if it is acceptable to publish. We are working together to take corrective measures when necessary.”
Studnicki and Tessa Longbons, one of the senior fellow researchers at the Charlotte Institute of a minister and co -author of the three papers, claims to be targeted by politics. In video Posted onlineStudnicki claimed that most medical magazines are “pro -abortion”.
“This incident indicates a larger and latest phenomenon, which is that many of our scientific institutions and publications are no longer defending the open investigation,” Stodenicky and Longbones wrote in an email comment on American scientific. “We are witnessing an elite group throughout the medical community with all the authority that tries to suppress any research that reduces the adopted and supportive narration of abortion. Scientific research and publishing must be based on science, and not driven by ideology.”
Critics of the papers that have been retracted say their fears are practical – not personal or political.
“This is not about ideology,” says Upadhyy. “The decline in these studies depends on its flawed scientific approach, which greatly distorts the safety classification of miscarriage.”
Impact on future legal decisions
Marie Ziegler, a professor at the University of California, Davis, the Faculty of Law, which is studying the date of abortion, says that the decline “is unlikely to make a big difference legally” in terms of court decisions or future legislation.
Ziegler says that legislators in the state who are trying to restrict or prohibit miscarriage in general seem more motivated by the desire to protect the fetus more than concerns about protecting pregnant people from possible negative events.
She says that the decision of the Court of Appeal in the Fifth Department regarding MEFPresson did not rely on the papers that were deported, but on another certificate.
The Supreme Court, which was voted in 2022 to capture it Ro against a valley (The historical issue that led to abortion in 1973) is unlikely to be affected by decline, says Ziegler. “Given the problems of the plaintiffs case to stand, the court may actually tend alongside the coalition for urban medicine,” she says. “If the judges are ready to overlook other cases with standing and weighing evidence on the MivePristone, then it is likely that the decline is not more than strengthening the current position.”