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ABC News
5 days 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
29-04-2025
- Health
- Yahoo
‘Abortion pill' found to have ‘severe adverse effects' for 1 in 10 women, study finds
A new study has exposed "serious adverse events" linked to mifepristone, also known as the "abortion pill." Mifepristone is a "pregnancy blocker" that is used in combination with another medication, misoprostol, to terminate pregnancies, according to Mayo Clinic. It is also used to manage early miscarriages, as it helps prepare the body to empty the uterus. Abortion Pill Use Has Spiked In Recent Years, New Report Reveals: 'Substantial Increase' Research by the Ethics & Public Policy Center in Washington, D.C., has revealed that the rate of serious side effects is 22 times higher than what is indicated on the FDA-approved drug label. After going through an abortion assisted by mifepristone, nearly 11% of women — more than one in 10 — reported experiencing "infection, hemorrhaging, or another serious or life-threatening adverse event," according to the study summary. Read On The Fox News App The study used insurance claims data that includes more than 865,000 medication abortions prescribed between 2017 and 2023, resulting in what is described as the largest-ever dataset on chemical abortion. Abortion On Demand: These 6 States Allow Women To Get Pregnancy-ending Drugs By Phone Or Online "By contrast, the current FDA-approved drug label is based on the results of 10 clinical trials with a total of 30,966 women, less than 0.5 percent of whom reportedly experienced severe adverse reactions," the study states. "Some of these trials were conducted as long as 42 years ago." The study authors — Jamie Bryan Hall, EPPC's director of data analysis, and Ryan T. Anderson, EPPC's president — called the results a "truly shocking and sad reality." "We weren't exactly surprised by these findings, as other studies of smaller datasets have found significant safety problems with chemical abortion drugs — particularly after the Obama and Biden administrations removed important FDA safety protections that were required when the chemical abortion drug was first approved," the authors said in a statement sent to Fox News Digital. "The largest limitation, which we're working to address, is that there is no insurance code for death — and sadly, we know that women die from complications resulting from the abortion pill." Based on the study, the researchers are calling on the FDA to reinstate the original safety protections that they required when they approved mifepristone, stating that "women deserve the truth." Christina Francis, M.D., CEO of the American Association of Pro Life OBGYNs, who is based in Ft. Wayne, Indiana, was not involved in the research but commented on the significance of the outcome. "The findings of this study, which analyzes nearly 900,000 drug-induced abortions, align with what I have seen in my two decades of practice as an OB-GYN, during which I have cared for many women who have been lied to about the safety of abortion drugs and suffered significant complications from them," she told Fox News Digital. Francis concluded that nearly 71,000 women likely suffered these types of severe complications in 2023, based on numbers from the Guttmacher Institute. "This should serve as a wake-up call for the FDA that the complication rate is over 20 times higher than what has previously stated — and is a public health crisis that should be investigated immediately," she said. "Women deserve informed consent about the potentially life-threatening dangers of these drugs." Professor Jessie Hill, a health law expert at Case Western Reserve University in Cleveland, Ohio, also reviewed the study findings. She stated that mifepristone has been one of the most-studied medications ever since its approval in the U.S. 25 years ago, claiming it is also "one of the safest." Click Here To Sign Up For Our Health Newsletter Hill pointed out that the EPPC's study is not peer-reviewed and questioned its "potential bias." "The study uses insurance claims data, but insurance claims are an imperfect proxy for causal medical outcomes," she told Fox News Digital. "They often lack context — a claim for hemorrhage, for instance, may not even be causally linked to mifepristone itself." Hill also objected to the comparison of modern claims data to the FDA's clinical trial data. "Clinical trials have rigorous standards for defining and reporting adverse events. Claims data are generated for billing purposes, not scientific analysis, and often overcount or misclassify events." Hill also noted that the legal standard for FDA drug regulation is not "no risk," and that all medications have adverse event rates. "Overstating risks without weighing benefits distorts the regulatory framework," she said. For more Health articles, visit Approximately 63% of all abortions in the U.S. in 2023 were medication abortions, according to the Guttmacher Institute. This was an increase from 53% in 2020. Fox News Digital reached out to the FDA and to the manufacturer of mifepristone for article source: 'Abortion pill' found to have 'severe adverse effects' for 1 in 10 women, study finds
Fox News
28-04-2025
- Health
- Fox News
‘Abortion pill' found to have ‘severe adverse effects' for 1 in 10 women, study finds
A new study has exposed "serious adverse events" linked to mifepristone, also known as the "abortion pill." Mifepristone is a "pregnancy blocker" that is used in combination with another medication, misoprostol, to terminate pregnancies, according to Mayo Clinic. It is also used to manage early miscarriages, as it helps prepare the body to empty the uterus. Research by the Ethics & Public Policy Center in Washington, D.C., has revealed that the rate of serious side effects is 22 times higher than what is indicated on the FDA-approved drug label. After going through an abortion assisted by mifepristone, nearly 11% of women — more than one in 10 — reported experiencing "infection, hemorrhaging, or another serious or life-threatening adverse event," according to the study summary. The study used insurance claims data that includes more than 865,000 medication abortions prescribed between 2017 and 2023, resulting in what is described as the largest-ever dataset on chemical abortion. "By contrast, the current FDA-approved drug label is based on the results of 10 clinical trials with a total of 30,966 women, less than 0.5 percent of whom reportedly experienced severe adverse reactions," the study states. "Some of these trials were conducted as long as 42 years ago." The study authors — Jamie Bryan Hall, EPPC's director of data analysis, and Ryan T. Anderson, EPPC's president — called the results a "truly shocking and sad reality." The study used insurance claims data for more than 865,000 medication abortions prescribed between 2017 and 2023. "We weren't exactly surprised by these findings, as other studies of smaller datasets have found significant safety problems with chemical abortion drugs — particularly after the Obama and Biden administrations removed important FDA safety protections that were required when the chemical abortion drug was first approved," the authors said in a statement sent to Fox News Digital. "The largest limitation, which we're working to address, is that there is no insurance code for death — and sadly, we know that women die from complications resulting from the abortion pill." Based on the study, the researchers are calling on the FDA to reinstate the original safety protections that they required when they approved mifepristone, stating that "women deserve the truth." Christina Francis, M.D., CEO of the American Association of Pro Life OBGYNs, who is based in Ft. Wayne, Indiana, was not involved in the research but commented on the significance of the outcome. "The findings of this study, which analyzes nearly 900,000 drug-induced abortions, align with what I have seen in my two decades of practice as an OB-GYN, during which I have cared for many women who have been lied to about the safety of abortion drugs and suffered significant complications from them," she told Fox News Digital. Francis concluded that nearly 71,000 women likely suffered these types of severe complications in 2023, based on numbers from the Guttmacher Institute. "This should serve as a wake-up call for the FDA that the complication rate is over 20 times higher than what has previously stated — and is a public health crisis that should be investigated immediately," she said. "Women deserve informed consent about the potentially life-threatening dangers of these drugs." Professor Jessie Hill, a health law expert at Case Western Reserve University in Cleveland, Ohio, also reviewed the study findings. She stated that mifepristone has been one of the most-studied medications ever since its approval in the U.S. 25 years ago, claiming it is also "one of the safest." Hill pointed out that the EPPC's study is not peer-reviewed and questioned its "potential bias." "The study uses insurance claims data, but insurance claims are an imperfect proxy for causal medical outcomes," she told Fox News Digital. "They often lack context — a claim for hemorrhage, for instance, may not even be causally linked to mifepristone itself." Hill also objected to the comparison of modern claims data to the FDA's clinical trial data. "Clinical trials have rigorous standards for defining and reporting adverse events. Claims data are generated for billing purposes, not scientific analysis, and often overcount or misclassify events." "Insurance claims are an imperfect proxy for causal medical outcomes." Hill also noted that the legal standard for FDA drug regulation is not "no risk," and that all medications have adverse event rates. "Overstating risks without weighing benefits distorts the regulatory framework," she said. Approximately 63% of all abortions in the U.S. in 2023 were medication abortions, according to the Guttmacher Institute. This was an increase from 53% in 2020. Fox News Digital reached out to the FDA and to the manufacturer of mifepristone for comment.
