Latest news with #EPPC
Yahoo
2 hours ago
- Business
- Yahoo
FDA To Review Safety Of Abortion Pill After Junk Science Report Paved The Way
Republican Sen. Josh Hawley's quest to legitimize a junk science report undermining the safety of a widely used abortion pill was fully realized this week. Food and Drug Administration Commissioner Martin Makary confirmed in a Monday letter to the Missouri senator that the agency will conduct a safety review of the abortion pill mifepristone. Makary's letter is in response to an April request from Hawley for the department to review mifepristone following a new report published by the Ethics and Public Policy Center, an anti-abortion conservative think tank and advisory board member of Project 2025. 'As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,' Makary wrote in his letter. 'As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the Agency who review this data.' The FDA and the Department of Health and Human Services did not immediately respond to HuffPost's request for comment. Although Makary does not mention the EPPC report, Hawley's entire argument for reviewing mifepristone relies on the junk science paper. The EPPC report claims it's the 'largest-known study of the abortion pill' and that nearly 11% of women 'experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.' But data scientists voiced serious concerns about the validity of the report, pointing out that it's not peer-reviewed and the report's recommendations do not line up with the data they analyzed. 'It is highly concerning that the FDA is committed to a new review of mifepristone, given the massive amount of evidence on its safety and efficacy,' said Dr. Angel Foster, co-founder of the Massachusetts Medication Abortion Access Project, a shield law practice that provides telehealth abortion care to people in all 50 states. 'This is purely politically motivated and not rooted in science,' Foster said. 'Rolling back access to mifepristone would be a disaster, especially for the patients that The MAP serves every day – patients living in states where abortion is banned, who can't afford to pay for a procedure, and for whom neither traveling to another state nor remaining pregnant are options.' Republicans have been laying the groundwork to undermine the safety of mifepristone for months. It makes sense that anti-abortion groups have set their sights on the pill: telehealth abortion care now accounts for 20% of all abortion care since the Supreme Court repealed Roe v. Wade. Democrats have repeatedlygrilled Makary and HHS Secretary Robert F. Kennedy Jr. about their plans for mifepristone. The FDA commissioner's promise to review the abortion pill stands in stark contrast to his past statements that he has 'no plans' to restrict mifepristone. But Makary has repeatedly left the door open, hinting that if there was reason to believe mifepristone was unsafe his agency would review it. Makary has not once stated mifepristone's proven safety record since the FDA approved it in 2000. The medication has been used safely by over 6 million people in the U.S., according to the agency. Major medical groups have repeatedly said mifepristone is safe, pointing to more than 100 studies that have corroborated its safety and effectiveness. During a recent Senate appropriations hearing, Sen. Patty Murray (D-Wash.) asked Makary about the EPPC report and whether he would use it in his approach to mifepristone. Makary said he would want to see the underlying data of the study, but took issue with Murray's characterization of the EPPC paper as a 'sham study.' 'I have not seen that study, senator, and you have not seen that study,' Makary responded. 'So how can you call it a sham, bogus study? Neither of us have seen the study, the underlying data, or the methodology.' The FDA did not respond to HuffPost when asked if Makary's decision to review mifepristone stemmed from the EPPC report or if he's seen its underlying data. 'Even apart from all the red flags with the data and supposed analysis, the fact where they land in the recommendations — that has nothing to do with the research itself — indicates this was driven more by ideology than by scientific rigor,' Rachel Jones, a principal research scientist at the Guttmacher Institute, said of the EPPC report in April. Jones told HuffPost that she would not call the paper a 'study' since it's impossible for other researchers to fully assess the methodology and integrity of its results without access to the underlying data. 'We've known this moment was coming, and we've been sounding the alarm on Martin Makary since his nomination,' Reproductive Freedom for All President and CEO Mini Timmaraju said in a Tuesday statement. 'After months of signals and dog whistles, it's now in black and white on official FDA letterhead,' she continued. 'This review is not grounded in new data or real safety concerns – it's driven by Project 2025-aligned groups and right-wing politicians who want to ban abortion nationwide. We are now one step closer to the Trump administration's ultimate goal of a national abortion ban.' GOP Lays Groundwork To Restrict Abortion Pill With New Junk Science Report Trump DOJ Just Sided With Biden On Abortion Pill Case – But It's Not What You Think Josh Hawley Introduces Law To Ban Mailing Of Abortion Pills, Citing Junk Science Report
ABC News
3 hours ago
- Business
- ABC News
A dubious report on medical abortion was cited in NSW Parliament. Where did it come from?
Multiple members of NSW Parliament have cited a flawed US report on the safety of a medical abortion pill, during the parliamentary debate on a bill to expand abortion access in the state. The bill, which has passed both houses of parliament, allows nurse practitioners and endorsed midwives to prescribe abortion medication for early-stage pregnancies. The recent paper, which suggested the medical abortion pill mifepristone carried more risk for women than previously thought, was cited by MPs on both sides of the divide — including Liberals, Labor, and independents. ABC NEWS Verify contacted Australian experts for help interpreting the report. They variously labelled it "not scientific", "scaremongering" and "misinformation". The document was published by a US-based conservative think tank named the Ethics and Public Policy Center (EPPC). On its website it says "pushing back against the extreme progressive agenda, while building a consensus for conservatives" is one of its priorities. The report was authored by the EPPC's director of data analysis, Jamie Bryan Hall, and its president, Ryan T. Anderson. Both men formerly worked for one of Washington's most prominent right-wing think tanks, the Heritage Foundation — which controversially spearheaded Project 2025, sometimes labelled a "blueprint" for US President Donald Trump's second-term agenda. The report claimed that one in 10 patients experience at least one serious adverse event within 45 days following an abortion involving the drug mifepristone. Mifepristone is one of the drugs used in medical abortions in Australia, the US, and other countries. In Australia, the medication misoprostol is also prescribed as a second step. The EPPC report further claimed the rate of serious adverse events after mifepristone abortions was "at least 22 times as high as the summary figure of 'less than 0.5 per cent' in clinical trials reported on the drug label". University of Sydney gynaecology professor Kirsten Black said there were a number of issues with the report. "This study in America was not published in a reputable journal," she said "It's not really clear … where the data came from, how it was analysed. It hasn't been peer-reviewed. "It's misinformation and it's just propaganda," she said. On an FAQ page for the paper, the EPPC said the point of the study wasn't peer review, but replicability. "We have made our study fully replicable for anyone who wants to analyze the insurance claims data," it said, claiming the dataset was available for purchase and the methodology was public. A spokesman for the EPPC refused to disclose the source of the data to ABC NEWS Verify. "There's nothing unique about our dataset — it's effectively all the insurance claims data that exist from 2017 to early 2024, both public and private," he said. Asked about whether this contributed to what the FAQ page called a "replicability crisis" he said the data was clear and it was easy for anybody interested to replicate the study, but didn't address how those seeking to replicate the study would do so without knowing the exact source. Despite these transparency shortcomings, ABC NEWS Verify found at least eight Liberal MPs, a Labor MP, and two independents all cited the report in parliament during the debate. Independent MP Joe McGirr, who is medically trained, highlighted the report in parliament as an example of complication rates of mifepristone abortions, orally citing the report's authors, in a manner similar to how scientific studies are often referenced. "A paper released in April this year by Hall and Anderson cites an analysis of American insurance claims data," he said during his speech. In a statement to ABC NEWS Verify, Dr McGirr said he cited the study "in the context of showing a range of interpreted complication rates from the use of MS-2 Step, with other rates between 3 per cent and 6.6 per cent cited elsewhere." He didn't answer a question on whether he probed the report's methodology before referencing it in parliament. Labor's Greg Donnelly drew attention to the report under the guise of "medical, academic and other literature", without mentioning any of the academic literature, including systematic reviews, published in peer-reviewed journals. Mr Donnelly did not respond to questions from ABC NEWS Verify about why he chose to quote the study. Upper house Liberal MP Susan Carter used the report to suggest "the science is changing" and it "indicated a significantly higher serious adverse event rate from medical abortion than had previously been understood". In an interview, she told ABC NEWS Verify she quoted the study because she found it "really interesting" as it was "the biggest study of its kind". She said it was the first paper she had seen which relied on health insurance records to track a patient's progress after taking the pill. "So you could actually, instead of tracking the procedure, which is what we do in Australia, this was tracking the woman." Professor Black said that serious adverse events following mifepristone "happen in about one in 1,000 cases, two in 1,000, not 10 per cent". Monash University women's health professor Danielle Mazza told ABC NEWS Verify that adverse events following mifepristone in Australia were very rare. She said the EPPC report is "scaremongering by anti-abortionists". Professor Mazza pointed to two systematic reviews that analysed data from several different studies and concluded that mifepristone and misoprostol are highly safe and effective. Epidemiologist and science communicator Gideon Meyerowitz-Katz, who is a senior research fellow at the University of Wollongong, identified the lack of transparency around the source of the data used in the report as an issue, labelling the document as "very inadequate". He called the paper's definition of a serious adverse event "bizarre". The serious adverse event rate of "one in 10" (or 10.93 per cent, to be precise) includes some questionable categories. For example, repeated (surgical) abortion — where a woman might need a surgical abortion after an incomplete medical one — makes up 2.84 per cent. Dr Meyerowitz-Katz said this does not count as a serious adverse event. "[Surgical abortions] have an extremely low rate of severe adverse events themselves … these are usually considered failures of the pill, not adverse events per se," he said. Then there is the category of "ectopic pregnancy" (0.35 per cent) which occurs when a fertilised egg implants itself outside the uterus. Mifepristone does not cause this condition, but the EPPC included it because the FDA specifies patients with the condition should not take it. The EPPC later acknowledged to the Washington Post that not all ectopic pregnancy patients who are prescribed mifepristone, for example, while they're waiting for an ectopic pregnancy diagnosis, later took the drug. There are also contradictions in the EPPC's description of its methodology, which claims to have analysed procedure codes in the insurance data. For example, in the report, it states "other abortion-specific complications" includes codes "related to an abortion or miscarriage, as well as life-threatening mental health diagnoses". In the FAQ, published days later, it said it excluded mifepristone use for miscarriage care from the dataset. The EPPC spokesman asserted to ABC NEWS Verify that miscarriage was excluded from the report, without explaining the discrepancy. The FAQ also said the report only included mental health codes which "met the criteria for life-threatening, in order to not overestimate that category". But the spokesman conceded no patients were actually found under these codes. Beyond these classification issues is the broader issue of causation — that is, whether the adverse events following mifepristone can be causally linked to the pill. "The authors have assumed that every event following an abortion is related to that abortion, but they have no methodology that would allow them to make such an assessment," Dr Meyerowitz-Katz said. He said the EPPC's FAQ didn't adequately explain the paper's methodology. "How specifically did they define something that was 'life-threatening'? Which codes did they use?" Dr Meyerowitz-Katz said. "Had the authors attempted to get this published in a high-quality scientific journal, these questions would have been asked by peer-reviewers. "This [paper] is completely worthless as evidence and should be ignored by anyone who is interested in accurate health information." It is unclear how so many NSW politicians came to quote the report during debate in parliament. An adviser to Dr McGirr said, "it was provided by a parliamentary colleague" without giving additional context. But the debate, which took place in the first two weeks of May, occurred shortly after the report's release, and amidst a push in the US to review the use of mifepristone in abortions. Some US conservatives want tighter restrictions placed on the drug. On April 24, US Food and Drug Administration Commissioner Marty Makary told PBS News he had "no plans to take action on mifepristone". But that came with a caveat about "hypothetical" new data on the drug. "If the data suggests something or tells us that there's a real signal … we can't promise we're not going to act on that data that we have not yet seen," Mr Makary said. Days later, on April 28, the EPPC published its report, with insurance data questioning the safety of the drug. On the same day, it was seized upon by Republican senator Josh Hawley, who has a long history of anti-abortion positions. "It is time to revisit and restore the FDA's longstanding safety measures governing mifepristone," Senator Hawley said in a letter to Mr Makary. On May 14, Health and Human Services Secretary Robert F. Kennedy Jr told a congressional hearing — in answer to a question from Senator Hawley — that he had ordered a complete review of the drug. Dr Meyerowitz-Katz said the report was not a study, as it has been presented, but a "white paper", published by an "explicitly religious" organisation. "[The report] is filled with issues, and the authors have failed to include basic data to allow us to know what they actually did," he said. "All in all, this reads to me more like the political strategising of an explicitly anti-abortion group than any rational scientific analysis."
Yahoo
3 days ago
- General
- Yahoo
Abortion opponents are coming for mifepristone using what medical experts call ‘junk science'
Packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023, in Rockville, Maryland. (Photo illustration by) Using flawed studies and scientific journal publications, abortion opponents are building a body of research meant to question the safety of the abortion pill mifepristone, a key target for the movement. The effort comes as federal officials have expressed a willingness to revisit the drug's approval — and potentially impose new restrictions on a medication used in the vast majority of abortions. This report was originally published by The 19th. The Illuminator is a founding member of the 19th News Network. Mainstream medical researchers have criticized the studies, highlighting flaws in their methodology and — in the case of one paper published by the conservative think tank Ethics and Public Policy Center (EPPC) — lack of transparency about the data used to suggest mifepristone is unsafe. The vast body of research shows that the drugs used in medication abortion, mifepristone and misoprostol, are safe and effective in terminating a pregnancy. 'There's a proliferation of anti-abortion propaganda right now. I think it is a coordinated attack on mifepristone,' said Ushma Upadhyay, an associate professor at the University of California, San Francisco who studies medication abortion. Released in April, the EPPC paper suggests that mifepristone results in serious adverse events for 1 in 10 patients — substantially higher than the widely accepted figure of .3 percent complication rate most research has attributed to the pill. The paper appears to count what other researchers say are non-threatening events, such as requiring follow-up care to complete the abortion, or visiting an emergency room within 45 days of an abortion — even if the patient did not end up requiring emergency care — as serious adverse effects. That paper also did not go through peer review, a standard process for scientific research in which other scholars review a study's findings and methodology before it can be published. Another paper, a commentary piece published this week in the journal BioTech, challenges the commonly cited statistic that mifepristone has a lower complication rate than acetaminophen, or Tylenol, tracing the history of the comparison and arguing that it is mathematically flawed. The paper's author, Cameron Loutitt, is a biomedical engineer by training and director of life sciences at the Charlotte Lozier Institute, a research arm of the anti-abortion group SBA Pro-Life America. SUBSCRIBE: GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX 'My hope is that this paper sparks action in my peers in the research and medical community to more critically evaluate these unfounded claims regarding abortion drug safety,' Loutitt said in a statement. Days later, a group of researchers from the institute published another study, this one arguing that emergency rooms are likely to identify medication abortions as miscarriages, which they say increases the risk of needing hospital care. A miscarriage and a medication abortion are medically indistinguishable, and patients will sometimes visit an emergency room to ensure the drugs worked, or if they suspect possible complications. In places where abortion is illegal, patients may also tell health care providers they experienced a miscarriage to minimize their legal risk. Studies like the Lozier Institute paper suggest complications from medication abortions are being undercounted. That study was rejected by another journal on April 12 before being published this week, noted Upadhyay, who had served as a peer reviewer in that rejection process. A similar paper written by many of the same researchers behind the Lozier Institute's was retracted a year ago by the journal that published it, along with two others suggesting mifepristone was unsafe. 'They keep trying to publish the same junk science,' Upadhyay said. James Studnicki, the Charlotte Lozier Institute's director of data analytics, who led the second of its new anti-abortion papers and the study retracted last year, did not respond to a request for comment. But a spokesperson for the institute said the organization is challenging last year's retraction through an arbitration process. This March, Studnicki said in a statement that the retraction placed 'politics over publication ethics.' These studies and papers all fall outside the scientific consensus. More than 100 studies over decades of research have found that mifepristone — and the medication abortion regimen as a whole — has a low complication rate and is very safe to use for abortions. Papers like these aren't new, and their scientific accuracy has long been questioned. But the bevy of new reports and analyses comes at a moment when abortion opponents may have more influence in shaping public policy. Mifepristone restrictions are a top priority for the anti-abortion movement. About two-thirds of all abortions in the United States are now done using medication. Even in states with abortion bans, pregnant people have increasingly turned to abortion medication, which they receive from health providers in states with laws protecting abortion. Nationwide, about 1 in 5 abortions are now performed using telehealth; almost half of those are for people in states with bans or restrictions. Mifepristone is currently approved for use through 10 weeks of pregnancy. Health and Human Services Secretary Robert F. Kennedy Jr. testified before a Senate committee that he has directed the Food and Drug Administration to review the approval of mifepristone, citing the EPPC paper specifically. Jim O'Neill, who is nominated for a deputy secretary role, has also said he is in favor of a 'safety review' of the drug — a move that could result in new restrictions on how it is prescribed. Meanwhile, physicians and researchers are highlighting the rigor of the FDA approval process. 'FDA approval of mifepristone must reflect the rigorous clinical evidence that has proven unequivocally that it is safe and effective for use in medication,' 13 reproductive medical organizations, including the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, said in a statement after Kennedy indicated the drug may undergo a new FDA review. 'Mifepristone has been used for decades for abortion and miscarriage management by millions of patients, and complications are exceedingly rare, minor, and most often easily treatable.' The International Institute for Reproductive Loss, an anti-abortion nonprofit, has explicitly prioritized the publication of research that supports restrictions on medication abortion. Presenting at an anti-abortion conference last September, that organization's science director, Priscilla Coleman, highlighted strategies that she said could help result in the retraction of studies showing mifepristone's safety, such as finding 'agenda-driven, poorly developed and conducted studies published in peer-reviewed journals' and writing to journal editors. Coleman did not respond to a request for comment. Though no scientific consensus has changed, anti-abortion lawmakers have rallied around the suggestion that complications are common. In a private Zoom meeting reported on by Politico, abortion opponents cited the EPPC paper as a potential tool to justify further restrictions on mifepristone — even while acknowledging that the report is 'not a study in the traditional sense' and 'not conclusive proof of anything.' Sen. Josh Hawley, a Republican from Missouri, cited the EPPC paper in a letter to FDA Commissioner Marty Makary, who had only a day before the report's publication indicated openness to reviewing mifepristone's approval if new evidence emerged. 'The time to act is now. It is time to revisit and restore the FDA's longstanding safety measures governing mifepristone,' Hawley wrote. His office did not reply to a request for further comment. 'They're producing this terrible 'science' because they don't have any real science that backs them up. And all they've gotten from the administration is, 'Yeah, we'll study it,'' said David Cohen, a law professor at Drexel University who has advised state legislatures on crafting abortion-protetctive laws. Through the courts and Trump administration, abortion opponents have pushed to reverse a 2021 FDA decision allowing mifepristone to be distributed via telehealth. In addition to calling for the in-person requirement to be reinstated, abortion opponents are asking for restrictions such as the dispensation of the drug to require three in-person visits, and for mifepristone to only be approved for use only in the first seven weeks of pregnancy. Many have also argued the drug should be taken off the market entirely. The Trump administration said on the campaign trail that it would leave abortion policy up to the states. So far, there has been little indication from the federal government that such changes are imminent. 'Pills are kind of just spreading, as we predicted, without almost any restriction and so far the anti-abortion movement hasn't figured out what to do,' Cohen said. SUPPORT: YOU MAKE OUR WORK POSSIBLE This story was originally reported by Shefali Luthra of The 19th. Meet Shefali and read more of her reporting on gender, politics and policy.
Yahoo
4 days ago
- General
- Yahoo
Abortion opponents are coming for mifepristone using what medical experts call 'junk science'
Using flawed studies and scientific journal publications, abortion opponents are building a body of research meant to question the safety of the abortion pill mifepristone, a key target for the movement. The effort comes as federal officials have expressed a willingness to revisit the drug's approval — and potentially impose new restrictions on a medication used in the vast majority of abortions. Mainstream medical researchers have criticized the studies, highlighting flaws in their methodology and — in the case of one paper published by the conservative think tank Ethics and Public Policy Center (EPPC) — lack of transparency about the data used to suggest mifepristone is unsafe. The vast body of research shows that the drugs used in medication abortion, mifepristone and misoprostol, are safe and effective in terminating a pregnancy. 'There's a proliferation of anti-abortion propaganda right now. I think it is a coordinated attack on mifepristone,' said Ushma Upadhyay, an associate professor at the University of California, San Francisco who studies medication abortion. Released in April, the EPPC paper suggests that mifepristone results in serious adverse events for 1 in 10 patients — substantially higher than the widely accepted figure of .3 percent complication rate most research has attributed to the pill. The paper appears to count what other researchers say are non-threatening events, such as requiring follow-up care to complete the abortion, or visiting an emergency room within 45 days of an abortion — even if the patient did not end up requiring emergency care — as serious adverse effects. That paper also did not go through peer review, a standard process for scientific research in which other scholars review a study's findings and methodology before it can be published. Another paper, a commentary piece published this week in the journal BioTech, challenges the commonly cited statistic that mifepristone has a lower complication rate than acetaminophen, or Tylenol, tracing the history of the comparison and arguing that it is mathematically flawed. The paper's author, Cameron Loutitt, is a biomedical engineer by training and director of life sciences at the Charlotte Lozier Institute, a research arm of the anti-abortion group SBA Pro-Life America. 'My hope is that this paper sparks action in my peers in the research and medical community to more critically evaluate these unfounded claims regarding abortion drug safety,' Loutitt said in a statement. Days later, a group of researchers from the institute published another study, this one arguing that emergency rooms are likely to identify medication abortions as miscarriages, which they say increases the risk of needing hospital care. A miscarriage and a medication abortion are medically indistinguishable, and patients will sometimes visit an emergency room to ensure the drugs worked, or if they suspect possible complications. In places where abortion is illegal, patients may also tell health care providers they experienced a miscarriage to minimize their legal risk. Studies like the Lozier Institute paper suggest complications from medication abortions are being undercounted. That study was rejected by another journal on April 12 before being published this week, noted Upadhyay, who had served as a peer reviewer in that rejection process. A similar paper written by many of the same researchers behind the Lozier Institute's was retracted a year ago by the journal that published it, along with two others suggesting mifepristone was unsafe. 'They keep trying to publish the same junk science,' Upadhyay said. James Studnicki, the Charlotte Lozier Institute's director of data analytics, who led the second of its new anti-abortion papers and the study retracted last year, did not respond to a request for comment. But a spokesperson for the institute said the organization is challenging last year's retraction through an arbitration process. This March, Studnicki said in a statement that the retraction placed 'politics over publication ethics.' These studies and papers all fall outside the scientific consensus. More than 100 studies over decades of research have found that mifepristone — and the medication abortion regimen as a whole — has a low complication rate and is very safe to use for abortions. Papers like these aren't new, and their scientific accuracy has long been questioned. But the bevy of new reports and analyses comes at a moment when abortion opponents may have more influence in shaping public policy. Mifepristone restrictions are a top priority for the anti-abortion movement. About two-thirds of all abortions in the United States are now done using medication. Even in states with abortion bans, pregnant people have increasingly turned to abortion medication, which they receive from health providers in states with laws protecting abortion. Nationwide, about 1 in 5 abortions are now performed using telehealth; almost half of those are for people in states with bans or restrictions. Mifepristone is currently approved for use through 10 weeks of pregnancy. Health and Human Services Secretary Robert F. Kennedy Jr. testified before a Senate committee that he has directed the Food and Drug Administration to review the approval of mifepristone, citing the EPPC paper specifically. Jim O'Neill, who is nominated for a deputy secretary role, has also said he is in favor of a 'safety review' of the drug — a move that could result in new restrictions on how it is prescribed. Meanwhile, physicians and researchers are highlighting the rigor of the FDA approval process. 'FDA approval of mifepristone must reflect the rigorous clinical evidence that has proven unequivocally that it is safe and effective for use in medication,' 13 reproductive medical organizations, including the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, said in a statement after Kennedy indicated the drug may undergo a new FDA review. 'Mifepristone has been used for decades for abortion and miscarriage management by millions of patients, and complications are exceedingly rare, minor, and most often easily treatable.' The International Institute for Reproductive Loss, an anti-abortion nonprofit, has explicitly prioritized the publication of research that supports restrictions on medication abortion. Presenting at an anti-abortion conference last September, that organization's science director, Priscilla Coleman, highlighted strategies that she said could help result in the retraction of studies showing mifepristone's safety, such as finding 'agenda-driven, poorly developed and conducted studies published in peer-reviewed journals' and writing to journal editors. Coleman did not respond to a request for comment. Though no scientific consensus has changed, anti-abortion lawmakers have rallied around the suggestion that complications are common. In a private Zoom meeting reported on by Politico, abortion opponents cited the EPPC paper as a potential tool to justify further restrictions on mifepristone — even while acknowledging that the report is 'not a study in the traditional sense' and 'not conclusive proof of anything.' Sen. Josh Hawley, a Republican from Missouri, cited the EPPC paper in a letter to FDA Commissioner Marty Makary, who had only a day before the report's publication indicated openness to reviewing mifepristone's approval if new evidence emerged. 'The time to act is now. It is time to revisit and restore the FDA's longstanding safety measures governing mifepristone,' Hawley wrote. His office did not reply to a request for further comment. 'They're producing this terrible 'science' because they don't have any real science that backs them up. And all they've gotten from the administration is, 'Yeah, we'll study it,'' said David Cohen, a law professor at Drexel University who has advised state legislatures on crafting abortion-protetctive laws. Through the courts and Trump administration, abortion opponents have pushed to reverse a 2021 FDA decision allowing mifepristone to be distributed via telehealth. In addition to calling for the in-person requirement to be reinstated, abortion opponents are asking for restrictions such as the dispensation of the drug to require three in-person visits, and for mifepristone to only be approved for use only in the first seven weeks of pregnancy. Many have also argued the drug should be taken off the market entirely. The Trump administration said on the campaign trail that it would leave abortion policy up to the states. So far, there has been little indication from the federal government that such changes are imminent. 'Pills are kind of just spreading, as we predicted, without almost any restriction and so far the anti-abortion movement hasn't figured out what to do,' Cohen said. The post Abortion opponents are coming for mifepristone using what medical experts call 'junk science' appeared first on The 19th. News that represents you, in your inbox every weekday. Subscribe to our free, daily newsletter.
Yahoo
24-05-2025
- Health
- Yahoo
A Convenient Piece of Junk Science
Robert F. Kennedy Jr. has had a long love affair with junk science, and as secretary of Health and Human Services, he has embraced it once more, most brazenly to justify his false claims that vaccines cause autism. Last week, he brought yet another shoddily designed study to a different fight. In a Senate Committee hearing, he cited a report that few scientists would recognize as science in order to justify an FDA safety review of the drug mifepristone, which is used in the majority of abortions in the United States. President Donald Trump had previously asked HHS to study the drug's safety, and Kennedy emphasized at the hearing that a review of the drug would be a top FDA priority. The unusually high rate of adverse events identified in the report, he noted, 'indicates that at very least, the label should be changed.' In other words, the top U.S. health official is prepared to rework—based at least in part on a poorly designed report that has not undergone scientific review—the government's official guidance on a widely used drug. The report that Kennedy cited was posted late last month to the website of the Ethics and Public Policy Center, a Washington, D.C.–based think tank focused on 'pushing back against the extreme progressive agenda while building a consensus for conservatives,' according to its website. The study's authors, Jamie Bryan Hall, EPPC's director of data analysis, and Ryan Anderson, the organization's president, are not health experts, and neither seems to have a record of publishing scientific research through peer review. Their methods deviated wildly from what is standard in the world of health research, and so, predictably, did their conclusions: In sharp contrast to dozens of trials conducted around the globe over decades, the EPPC report determined that mifepristone is a danger to women. The EPPC has written that its report 'presents a careful and conservative assessment of abortion pill safety.' However, the study lacks basic transparency about how that assessment was made. The authors relied on data from an insurance database that, according to the report, included more than 800,000 mifepristone abortions from 2017 to 2023. But the authors don't actually say which database they used, so 'there's no way for anybody to try to re-create their analysis to see if they receive the same results,' Sara Redd, of the Center for Reproductive Health Research in the Southeast at Emory University's Rollins School of Public Health, told me. (In an email, Hunter Estes, EPPC's communications director, told me that the center's contract with their data vendor prevents EPPC from sharing the name of the database or even of the vendor. But, he added, 'this insurance data is available from approximately a dozen data brokers and is widely used by researchers and health professionals.') [Read: The other abortion pill] The report also took some peculiar methodological steps to arrive at its conclusions. One of its key findings is that more than 10 percent of people who take mifepristone experience what the study refers to as 'serious adverse events.' (A variety of studies put the rate of significant adverse events from medical abortions involving mifepristone at less than 0.3 percent, which makes the drug safer than Tylenol and Viagra.) But the EPPC study's unusually wide-ranging criteria for defining those events raise a lot of questions. The researchers counted ectopic pregnancy as an adverse event, arguing that doctors should have ruled it out before prescribing mifepristone. (The American College of Obstetricians and Gynecologists acknowledges that mifepristone can be dangerous in cases of ectopic pregnancy but says that ruling out the rare condition—a process that involves an ultrasound—is unnecessary for most women taking the drug.) The authors counted episodes in which a surgical procedure was required to complete the abortion after mifepristone—patients require additional treatment in about one in 20 cases, so the FDA considers this a recognized outcome rather than an adverse effect. They counted 'other life-threatening adverse events,' including heart problems and mental-health concerns, that women in the study experienced in the weeks after the abortion—which may have had nothing to do with mifepristone. They also counted 'serious' events documented during emergency-room visits made within 45 days of a patient taking mifepristone. However, the report doesn't fully explain how they knew that those events were connected with mifepristone, and to judge which ones counted as 'serious,' they used a scale designed for cancer research, which has not been validated for use in studies of abortion care. Loosely counting emergency-room visits could artificially inflate the estimate of risk associated with getting an abortion, Ushma Upadhyay, an epidemiologist and a reproductive-health researcher at UC San Francisco, told me: In a study she led of abortion-related emergency-room visits from 2009 to 2013, half of patients had such mild symptoms that they did not need any treatment. She also said that the authors did not effectively distinguish between the outcomes of abortions and of miscarriages treated with mifepristone, or between normal amounts of post-abortion bleeding and severe hemorrhage. In the weeks following the report's publication, EPPC published two follow-up documents with more details about the study's methodology, which experts told me are still not convincing. As the documents explained, the authors relied on diagnostic codes to separate miscarriages, which are often also treated with mifepristone, from abortions—a practice that may yield imprecise results. The report included only suicidal and homicidal ideation among mental-health diagnoses categorized as serious adverse events—but that still does not prove that those diagnoses were connected to an abortion, Redd told me. It used 'only codes related to hemorrhage or serious bleeding (according to the FDA definition)'—which would still not be enough to distinguish between the normal amount of post-mifepristone bleeding and something more serious, Upadhyay said. [Read: A possible substitute for mifepristone is already on pharmacy shelves] According to EPPC, peer review of the report was not possible due to 'extensive pro-abortion bias in the peer-review process,' but a group of data scientists, analysts, and engineers 'conducted and validated' the project, with assistance from doctors. None of their names appears on the report. When I asked about that decision, the EPPC representative wrote, 'It is routine for individuals with controversial opinions to be subjected to a range of personal and professional attacks, including threats of violence in their own homes.' So far, the most prevalent attacks on the study have been about its substance. Alice Mark, an ob-gyn and the medical director of the National Abortion Federation, told me that 'to call it a study dignifies it too much.' Some anti-abortion advocates, too, have cautioned against overstating the study's rigor: Earlier this month, Politico reported that Christina Francis, the CEO of the American Association of Pro-Life OBGYNs, said on a private Zoom call with anti-abortion leaders that although the report contains credible data and should inspire further research, it is 'not a study in the traditional sense' and 'not conclusive proof of anything.' Anti-abortion activists have long seen mifepristone as a problem. In the years since the Supreme Court's 2022 decision to overturn the national right to abortion, abortions have increased in part due to a 2021 FDA decision that allowed mifepristone and misoprostol (a drug often used in parallel for abortion) to be prescribed via telehealth and mailed. According to reporting by Politico, questioning mifepristone's safety is part of a larger strategy called 'Rolling Thunder' that aims to cut off that access. High-quality data have failed to validate those questions, so second-rate research has often been used to make the case against mifepristone. In 2023, for example, a federal judge ruled that mifepristone should be taken off the market by citing low-quality studies that reported adverse effects from mifepristone. (The Supreme Court later threw out the lawsuit on procedural grounds.) Due to their 'lack of scientific rigor,' two of the studies cited were ultimately retracted by the journal that had published them. [Read: Anti-abortion conservatives' first target if Trump returns] When, in the past, the FDA has evaluated mifepristone's safety—which it's done several times since mifepristone's initial approval, in 2000—it has expanded access to mifepristone rather than curtailed it. If the agency evaluates mifepristone again, and its staff are allowed to independently assess the science, the FDA could loosen its rules for mifepristone even more, Elizabeth Raymond, an ob-gyn and a researcher who specializes in mifepristone safety, told me. Plenty of data support using mifepristone later in pregnancy than is currently approved, for instance. But Upadhyay told me she worries that FDA Chief Marty Makary—who has previously claimed that fetuses can 'resist' the tools of abortion by 20 weeks of gestation—or Kennedy could put their thumb on the scale to restrict mifepristone access, regardless of what FDA staff recommend. 'I don't want them to do a review, because I don't trust them to base any decisions they make on science,' Upadhyay said. (HHS and the FDA did not answer my questions about the FDA's plans to review mifepristone safety on the basis of the EPPC report. In an email, an HHS spokesperson told me of the FDA, 'The agency rigorously evaluates the latest scientific data, leveraging gold standard science to make informed decisions.') Although Kennedy has said that he reads scientific papers critically for a living, his approach to the medical literature most resembles 'an extreme version of what lawyers do to defend a client: create a narrative and then find supporting evidence,' Robert Califf, who led the FDA under Presidents Joe Biden and Barack Obama, told me an email. The scientific method involves the opposite: constructing a hypothesis and trying to disprove it with an open mind. When different people conducting the same experiment come to the same conclusion, it's not a sign of a shared ideology; it's a sign of a shared reality. Article originally published at The Atlantic
