Latest news with #Ethics&PublicPolicyCenter
New York Post
15-05-2025
- Health
- New York Post
HHS chief RFK Jr. says he's ordered a ‘complete review' of chemical abortion pill
Health and Human Services Secretary Robert F. Kennedy Jr. revealed Wednesday that he has ordered the Food and Drug Administration (FDA) to conduct a 'complete review' of a chemical abortion pill amid reports that the drug isn't as safe as advertised. 'It's alarming,' RFK Jr. said of a recent study conducted by the Ethics & Public Policy Center that found nearly 11% of women who used the popular abortion pill mifepristone experienced a 'serious adverse event.' 'I have asked Marty Makary, who is the director at FDA, to do a complete review and report back,' the HHS secretary revealed during a Senate Health, Labor, Education and Pensions Committee hearing. 3 The FDA will conduct a 'complete review' of mifepristone after reports that the drug isn't as safe as advertised. REUTERS The Ethics & Public Policy Center study – the 'largest-known' on the abortion pill – analyzed insurance claims data from 865,727 prescribed mifepristone abortions between 2017 and 2023. The study found 10.93% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion. Sen. Josh Hawley (R-Mo.) cited the group's research as he questioned RFK Jr. during the hearing and noted that the study showed the rate of serious adverse health effects 'is 22 times higher than the FDA's current label' for mifepristone, 'which says it's just 0.5%.' 'Clearly [the study] indicates, at the very least, that the label should be changed,' Kennedy Jr. told Hawley. Mifepristone was originally approved by the FDA in 2000. 3 Health and Human Services Secretary Robert F. Kennedy Jr. ordered the FDA to review mifepristone after reports of safety concerns. Jack Gruber-USA TODAY via Imagn Images 3 Demonstrators rallied in support of abortion rights at the US Supreme Court in Washington, DC, on April 15, 2023. AFP via Getty Images The Ethics & Public Policy Center, which released its findings last month, argued that the FDA should implement 'stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects,' in light of its study. 'The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether,' the group concluded. The FDA initially OK'd mifepristone for chemical abortions up to seven weeks into a pregnancy — a timeframe that was later extended to 10 weeks under former President Barack Obama. Former President Joe Biden opened the door to FDA approval of mifepristone prescriptions online or through the mail, which the Supreme Court upheld in a unanimous ruling last year. The Washington, DC-based Ethics and Public Policy Center is a conservative think tank and advocacy group that seeks 'to apply the riches of the Jewish and Christian traditions to contemporary questions of law, culture, and politics, in pursuit of America's continued civic and cultural renewal,' according to the group's website.
AFP
05-05-2025
- Health
- AFP
'Flawed' paper overstates health risks of abortion pills: experts
"The Abortion Pill Harms Women: Insurance Data Reveals One in Ten Patients Experience a Serious Adverse Event," says the title of a paper published April 28, 2025 by the Ethics & Public Policy Center (EPPC), a think tank that says its priorities include "pushing back against the extreme progressive agenda while building a consensus for conservatives." Image Screenshot of the Ethics & Public Policy Center website taken April 30, 2025 The findings quickly spread across platforms and were held up by conservative media, including Fox News. Politicians further amplified the claim. Republican Senator Steve Daines of Montana said in a statement: "This recent study is proof that pro-abortion advocates care more about promoting their radical agenda than they do about women's health." Since the US Supreme Court overturned the federal protection of the right to an abortion in 2022, Texas, Louisiana and other conservative states have adopted tough anti-abortion laws. The court ruled in 2024 that defendants in a case that could have restricted access to mifepristone lacked standing, but the medication remains at the center of efforts to limit abortion (archived here and here). The EPPC report came days after US Food and Drug Administration (FDA) Commissioner Marty Makary told PBS that while he was not planning to take action on mifepristone, he was looking at new data and would act if it "suggests something or tells us that there's a real signal" (archived here). But medical abortion has a proven safety record, the ACOG and independent reproductive health experts told AFP. "Decades of reputable, peer-reviewed, scientific evidence and use data prove that medication abortion is safe and effective," said Stella Dantas, president of ACOG (archived here). In an April 30 email, she said the EPPC paper is "seriously flawed" and "manipulates data to drive a myth that medication abortion isn't safe." Medication abortion Mifepristone, which prevents pregnancy progression, and misoprostol, which empties the uterus, are approved to terminate a pregnancy up to 70 days of gestation in the United States. In 2023, they accounted for 63 percent of US abortions. The FDA says on its website that Mifeprex, the brand name for mifepristone, was first approved in 2000 after a review of the scientific evidence "determined that it was safe and effective for its indicated use" (archived here). The FDA monitors postmarketing data for Mifeprex and its approved generic equivalent, and as of February 2025, it has not identified new safety concerns. Jack Resneck, former president of the American Medical Association, wrote in a 2024 message supporting access to the medication that mifepristone is "an exceedingly safe and effective prescription drug" (archived here). Mifeprex maker Danco says on its website that patients will experience cramping and bleeding as part of ending a pregnancy, and as with any prescription drug, there can be rare serious side effects (archived here). The FDA investigated reports of 36 patient deaths that followed taking mifepristone between September 2000 and December 2024. However, its review of these deaths found: "The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient" (archived here and here). Jennifer Lincoln, a board-certified obstetrics and gynecology physician in Oregon, said postmarketing studies show "thousands of people have used mifepristone in conjunction with misoprostol to have abortions that are without complication 99.7 percent of the time" (archived here and here). "It is safer to take than Tylenol and far safer than a full-term pregnancy and birth," Lincoln said, referencing the over-the-counter pain medication, which can lead to liver damage if the recommended dosage is ignored (archived here). Methodology flaws The EPPC paper is neither peer-reviewed nor published in a medical journal. It was written by the organization's president of public policy and director of data analysis. The paper's authors say they purchased insurance claim data from 2017 to 2023. From that information, they claim to have identified 865,726 mifepristone abortions by looking for specific procedure, diagnosis and billing codes or prescriptions. Lincoln pointed to flaws with this strategy, including that it counted "people who got mifepristone and may have taken that alone, without misoprostol -- which is not the evidence-based regimen." ACOG's Dantas said the methodology could be overestimating the number of people seeking abortion care by including patients who were prescribed mifepristone to deal with complications associated with miscarriages. Asked about the sample, Hunter Estes, the EPPC's director of communications, dismissed concerns that treatments for a miscarriage would have shown up in the database. "We would not count that as an abortion, even if she was given mifepristone on that visit," he said in a May 2 email. After selecting the patients to track, the paper then looked for medical codes for what it categorized as "serious adverse events that occurred within 45 days following the abortion." Lincoln took issue with the authors including ectopic pregnancy -- a condition where the fertilized egg implants and grows outside of the uterus -- among the negative outcomes. "Pills can't move your pregnancy out of your uterus and into your fallopian tubes," she said. Lauren Ralph, associate professor of obstetrics, gynecology and reproductive sciences at the University of California-San Francisco, agreed (archived here). "Ectopic pregnancy is not caused by a medication abortion, but rather is something that occurs in pregnancy. Abortion medications do not create harm if taken by someone with an ectopic pregnancy," she said in a May 2 email. The paper also recorded 40,960 visits to a hospital emergency department as serious adverse events following medical abortion. EPPC's Estes said the report included only visits deemed "likely to be related to the abortion, based on the diagnosis and procedure codes in the insurance records." But Ralph told AFP a visit to the emergency room alone is not evidence of a serious adverse event. "Prior research indicates that many people go to the emergency department for follow-up care post-abortion, but this care is often to ensure abortion completion or get reassurance about symptoms rather than for treatment of an adverse event," she said, referencing a 2018 study (archived here). She said research has consistently found that the rate of serious adverse events is 0.3 to 0.5 percent -- far lower than the figures pushed by EPPC. When medical abortion was first approved by the FDA in 2000, patients were required to visit a clinic in person to receive the pills (archived here). In December 2021, the policy was updated to allow certain providers to prescribe the medication via telehealth appointments (archived here). Further policy changes allowed pharmacies to be certified to dispense mifepristone directly to patients, and in March 2024, major US chains CVS and Walgreens announced plans to fill prescriptions in Massachusetts and other states where the medication is legal. The EPPC called on the FDA to "reinstate its earlier, stronger patient safety protocols." But a peer-reviewed study published in Nature Medicine in February 2024 found: "Telehealth medication abortion is effective, safe and comparable to published rates of in-person medication abortion care" (archived here). Read more of AFP's reporting on misinformation about abortion here.
Yahoo
05-05-2025
- Health
- Yahoo
The Bad Data Backing Josh Hawley's Attack on Abortion Pills
The abortion pill mifepristone "is not safe and effective," argue the authors of a new study that uses insurance claim data to examine adverse reactions to the pill. They claim to have found a "serious adverse event" rate of 10.93 percent, and they say this finding justifies renewed restrictions on mifepristone. Sen. Josh Hawley (R–Mo.) seems to agree. The day the Ethics & Public Policy Center (EPPC) released its new mifepristone study, Hawley wrote to Food and Drug Administration (FDA) chief Marty Makary, urging the commissioner to "follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone." Makary said in late April that he has "no plans" to restrict access to abortion pills. But he added that "there is an ongoing set of data that is coming into FDA on mifepristone. So 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." Taken at face value, that's simply a reasonable statement of scientific uncertainty. But it seems a little odd considering we have decades of data on mifepristone already—this isn't some new or relatively unstudied drug. And things get even dicier when we consider that, a few days after Markary's April 24 comments at the Semafor World Economy Summit, a conservative group released new data that are being used by conservative politicians to suggest it is time for the FDA to act. Hall and Anderson base their arguments on their claim that "serious adverse events" are very common with mifepristone—occurring, they say, in slightly more than a tenth of patients. They based this conclusion on information gleaned from an insurance claim database. It contained "de-identified data for all U.S. patients during the years 2017 to 2023," and they identified 865,727 likely mifepristone-enabled abortions in this database. Of these cases, 10.93 percent ended in a "serious adverse event," they say. Clinical trial reports of a "less than 0.5 percent" adverse event rate are way off, they conclude—and therefore, they argue, mifepristone is neither safe nor effective. But the methods they used to reach these conclusions are highly questionable. First, they identified "mifepristone abortions" by flagging insurance codes indicating the prescription of mifepristone with or without misoprostol, a "medically induced abortion by oral ingestion of medication," or the "elective termination of pregnancy" in conjunction with billing codes that suggest mifepristone was given. Already there are problems. This study is supposed to concern the safety of people undergoing a drug-induced abortion, right? But people who have miscarried naturally are also prescribed mifepristone, and they seem to be lumped in here, despite the fact that they have different circumstances that could wind up producing more, fewer, or different sorts of adverse events than seen in patients prescribed the drug for elective abortion in the first 10 weeks. Furthermore, the authors do not seem to take into account whether patients followed up the mifepristone with misoprostol, as is the FDA's recommended practice. Taking mifepristone alone might lead to different outcomes than seen with the two-pill protocol. And then there's a much bigger issue—what the study considers a "serious adverse event." There's a clear pattern in the study, in which the very specific or clearly dire categories of adverse events occurred in a relatively small number of patients, while the categories that make up the bulk of adverse events flagged are vaguely defined and may represent minor or even benign situations. Just 0.10 percent of cases resulted in patients getting sepsis, 0.15 ended in patients needing blood transfusions, and 0.22 percent in what the study authors define as other life-threatening events. The rates of serious and well-defined complications here are all low and well within the parameters advertised by abortion pill manufacturers. The reason this study finds so much higher prevalence of adverse events comes down to the event categories they won't tell us much about. Of the 865,727 cases analyzed (some of which involved repeat patients), 94,605 were determined by the authors to have ended in serious adverse events, which they defined as any one of a broad range of outcomes happening within 45 days of taking the pill. Patients could be coded into multiple categories, so someone admitted to the hospital for an infection might be listed in both the infection and hospitalization categories. The largest category of adverse events is "other abortion-specific complications," reportedly experienced in 49,169 cases. But the authors give us little idea about what these "other" complications might be. By definition, they do not include sepsis, infection, transfusion, hemorrhage, an ectopic pregnancy, a need for a surgical abortion, or "other life-threatening events." The only explanation the authors give is that "other abortion complications include codes specifically related to an abortion or miscarriage, as well as life-threatening mental health diagnoses, etc." And this seems all the more questionable when they allude to an undefined category of "mental health" issues that occur within a month and a half after taking the pill. "Let's say you go see your doctor for anxiety or insomnia a month after having an abortion," writes Jessica Valenti in the Abortion, Every Day newsletter. "Because EPPC is counting any event that happens within 45 days of taking mifepristone—and they're not defining 'life-threatening'—your sleep problem or anxiety could be counted as a 'serious adverse event' of abortion pills." It also seems possible that some situations—sexual assault, relationship troubles, a wanted pregnancy with fetal anomalies, health problems, money problems—could trigger both a desire for an abortion and some mental health problems. In those cases, it would hardly be the pill itself that is to blame. And even if the mental health issues flagged were directly related to feelings about the abortion, it still hardly seems fair to describe them as serious complications stemming from the pill itself. The study's second biggest category of adverse events is listed as emergency room visits, experienced in 40,960 cases. This category also suffers from some lack of information, as an emergency room visit alone does not actually tell us whether a serious complication took place. Women who take mifepristone often start experiencing the pill's effects outside of the normal business hours of an doctor's office or health clinic. Some might go to the emergency room to check on levels of pain or bleeding that turn out to be normal. Without actually knowing the nature and outcome of the emergency room visits in this study, we can't conclude much of anything. The fact that there were more than 40,000 trips to the emergency room but far fewer hospitalizations—5,699—suggests that many of these visits did not result in serious risks or harms. For what it's worth, the FDA has said that emergency room visits in themselves are not enough to count as serious adverse events. The agency defines serious adverse event as death, hospitalization, anything life-threatening, anything resulting in disability or permanent damage, anything requiring medical or surgical "intervention to prevent permanent impairment or damage," and anything that "may require medical or surgical intervention…to prevent one of the other outcomes." The third largest category of adverse events in the EPPC study is "hemorrhage," which occurred in 28,658 cases. Hemorrhages can be quite serious, of course. But "even that [hemorrhage] data is suspect because the EPPC doesn't define what it means!" writes Valenti. "Doctors I spoke with say bleeding is expected during medication abortion, and it's only considered a serious complication if a blood transfusion is needed." Transfusions were needed in far fewer cases (1,257) than there were cases of hemorrhage. The discrepancy in numbers here draws into question whether all of the events counted in the hemorrhages category should really be deemed serious adverse events. (Again, we could be looking at women who sought medical attention for what turned out to be normal amounts of bleeding.) The fourth largest category of adverse events was needing a surgical abortion after taking the pill, happening in 24,593 of the cases. But it's a well-advertised fact that the two-pill regimen is successful in only about 87 to 98 percent of cases, depending on when in pregnancy the mifepristone and misoprostol are taken. If fewer than three percent of people in the study needed surgical abortions after taking mifepristone, that is well within the expected range and not necessarily a sign of anything unusual. It simply means these drugs, like many drugs, are not 100 perfect effective. The smallest category of adverse events in the EPPC analysis was sepsis, a life-threatening infection that occurred in 824 cases. Far more people suffered from some sort of infection—11,707 cases, or 1.34 percent. Again, with infections, we have a category where it's hard to know what exactly is meant. Infections here may include yeast infections, urinary tract infections, or minor vaginal bacterial infections—things that may be unpleasant but aren't generally serious unless left untreated and aren't necessarily the fault of taking the pill per se. Having sex, using tampons, or engaging in other not-recommended behaviors too soon after an abortion or miscarriage can result in infections. The remaining categories were ectopic pregnancy (something not caused by abortion pills but a situation in which abortion pills will not work and would not be recommended), in 3,062 cases; and "other life-threatening adverse events," in 1,956 cases. Perhaps aware that total revocation of FDA approval isn't in the cards (yet), Hawley told Makary it "is time to revisit and restore the FDA's longstanding safety measures governing mifepristone." Over the past decade, the FDA has relaxed its rules around mifepristone prescribing, now allowing it to be prescribed up to 10 weeks into a pregnancy (instead of the former seven weeks), to be prescribed remotely, and to be shipped by mail. Those last two changes seem especially to anger anti-abortion advocates, since they help women in states where abortion pills are illegal in obtain them from doctors and pharmacies in states where they are not. Advocates previously tried to get the courts to change those requirements. The matter went all the way to the U.S. Supreme Court, but it rejected the challenge, holding that those who brought the case didn't have standing to do so. And while the same issues could be raised by a different group of plaintiffs, the standing problem could prove difficult to overcome. That means that changing the national rules regarding the prescription of mifepristone and misoprostol may have to rely on persuading the FDA to change its policy. So that's what the EPPC is trying to do. "The FDA should reinstate the original patient safety protocols that were required when mifepristone was first approved," write the study's authors, Jamie Bryan Hall and Ryan T. Anderson. "Doing so will likely reduce the harms to women and permit better monitoring to determine whether this drug should remain on the market." They argue that getting mifepristone "should require at least three in-person office visits by the patient," that it should be prescribed only by physicians (some states allow prescription by nurse practitioners, physician's assistants, or certified midwives), that it should have to be taken in a medical facility, that it should be allowed only through the first seven weeks of pregnancy, and that prescribing physicians "must be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary." Rule changes such as these would make it highly difficult for women in states where abortion is illegal to access abortion-inducing drugs outside of the black market. The fact that so much of this study was worded so vaguely should give everyone pause. If all of the serious adverse events cited here were undeniably serious, the researchers should have no problem defining them concretely or making their datasets public. That's the only way to reassure readers that they aren't inflating their count with less serious health problems. It would be silly to argue that medication abortion is 100 percent safe. But to put the serious complications in perspective, we should also look to complication rates in pregnancy and in miscarriages. No matter how a pregnancy ends, a pregnant woman incurs some risk. (For the record, "maternal sepsis occurred in 0.04% of deliveries in the United States," according to research published in the Journal of the American Medical Association in 2019.) It's also silly to contrast mifepristone's current complication rates with some mythical future in which far fewer of these abortions would take place. The alternative to legal and accessible mifepristone isn't necessarily "no abortion" and "no complications." It's also abortion with black market mifepristone or misoprostol pills, abortion attempts through more dangerous means, and abortions in which women feel afraid to seek care if they experience complications. Jury selection starts today in the OneTaste trial. Nicole Daedone, founder of the orgasmic meditation company OneTaste, and Rachel Cherwitz, the company's former head of sales, are charged with one count of conspiracy to commit forced labor and no underlying forced labor charge. Read more about the weak, weird case against them here. More nuanced findings about teens and tech. Politicians and anti-tech activists like to pretend that research overwhelmingly shows negative findings when it comes to young people and social media. But more and more we've been seeing studies that challenge this conventional wisdom, aloing with mixed messages and nuanced feelings from young people themselves. So it goes in a recent survey from the Pew Research Center. "Our latest survey of U.S. teens ages 13 to 17 and their parents finds that parents are generally more worried than their children about the mental health of teenagers today," Pew reports. Moreover, kids are more worried about the way social media might effect other kids' health than their own—a sign while they might buy into the dire warnings about teens and tech that are all around them, they don't necessarily find this concern validated by their own experiences: Roughly half of teens (48%) say these sites have a mostly negative effect on people their age, up from 32% in 2022. But fewer (14%) think they negatively affect them personally. Meanwhile, 28 percent of the teens surveyed said social media has a mostly positive effect on their own lives, and the majority—58 percent—said it's neither negative nor positive. And while teens see some ways social media affects them negatively, most notably in terms of sleep and productivity, they also cite it as a source for socialization, creativity, and learning about mental health. The return of the App Store Accountability Act. This newsletter covered a previous version of this bill last year. Like last year's iteration, this one would make digital marketplaces, such as Google Play and Apple's App Store, verify user agers and require parental consent before minors can download apps. Several social media companies, including Meta, Snap, and X, "have endorsed the idea of making app stores a sort of central clearinghouse for age verification," reports CNN. Apple and Google are opposed. NetChoice sues over Georgia's social media age-check mandate. Georgia's Senate Bill 351 would require social media platforms to "make commercially reasonable efforts to verify the age of account holders," require parental consent before anyone under age 16 can have an account, and ban targeted advertising to minors. In a new lawsuit, the tech trade group NetChoice argues that the law is unconstitutional. "NetChoice has already permanently blocked similar laws in Arkansas and Ohio because these heavy-handed government mandates violate the First Amendment," the group explains. "Georgia's law is no different." The post The Bad Data Backing Josh Hawley's Attack on Abortion Pills appeared first on
