Latest news with #mifepristone
ABC News
40 minutes ago
- Health
- 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."
Forbes
5 hours ago
- General
- Forbes
Access To Abortion Pill Mifepristone Could Be Threatened, Again
In this photo illustration, packages of mifepristone tablets are displayed at a family planning ... More clinic. Mifepristone is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug misoprostol. (Photo illustration by) The abortion pill mifepristone is in the crosshairs of politics again, as plaintiffs in several high-profile court cases together with Republican lawmakers push for restrictions. More importantly perhaps, the Food and Drug Administration is reviewing the regulation and labeling of mifepristone, a drug with a well-established safety and effectiveness record. In an unusual move, Secretary of Health and Human Services, Robert F. Kennedy Jr., issued a statement last month to the Senate Health, Education, Labor and Pensions Committee directing the FDA to 'do a complete review' of its regulations on mifepristone, a medication used in conjunction with misoprostol in two-thirds of abortions in the United States– which has been used by more than eight million people since its approval more than two decades ago. The FDA approved mifepristone in 2000 for medication abortion. Mifepristone is a drug that blocks progesterone, which is needed for a pregnancy to continue. When taken in conjunction with misoprostol, mifepristone ends early pregnancies (up to ten weeks following conception). Mifepristone can be safely administered at home when prescribed by a provider, The FDA has allowed people to take the medication outside of a clinic setting since 2021. And that same year, the FDA further eased several conditions with respect to the prescribing and sale of mifepristone. Specifically, the regulatory authority allowed for prescriptions to be issued through telemedicine visits in addition to shipments of the product by mail, as MedPage Today reported. It appears that rising numbers of abortions using prescription drugs in the past four years may be linked to the changes instituted by the FDA. In addition, the use of medication to end pregnancies could have also been triggered by the Supreme Court decision to overturn Roe v. Wade in 2022, as a Journal of the American Medical Association study describes. But it appears that besides wanting to subject mifepristone to a new FDA review, Kennedy also wishes to reinstate the in-person dispensing requirement, which would mean women must go to a clinic to obtain mifepristone. The Supreme Court preserved convenient access to mifepristone last year, throwing out a lawsuit that sought to reinstate the previous requirements. The justices' argument, however, largely hinged on questioning the physician plaintiffs' right to sue the FDA to restore conditions rather than the substance of the case. But then, earlier this year, The Hill reported that a Texas federal judge, Matthew Kacsmaryk, is allowing three Republican-led states to move forward with a lawsuit to restrict access to mifepristone. It's noteworthy that in 2023, Kacsmaryk temporarily halted FDA's approval of mifepristone altogether. In brief, it's unclear what will happen to access as cases move through the court system and findings from the review which Kennedy ordered are revealed. Mifepristone has been in use in Europe for nearly three decades with a minimal number of reported adverse events. And the drug has had a similar safety record in the U.S since its approval in 2000. Between September 2000 and December 2018, only 24 of the more than 3.7 million women who had undergone medicated abortions have died, according to the FDA. Overall, the adverse events rate is less than 1% and the drug is considered safer than, say, over-the-counter non-steroidal anti-inflammatory drugs and anti-histamines. At least 100 studies from around the world have examined the effectiveness and safety of mifepristone and misoprostol. All peer-reviewed studies concluded that the pills are a safe method for terminating a pregnancy. Yet there seems to be a non-peer-reviewed study that's at the center of a request for the FDA to assess mifepristone. It's from the conservative think tank, the Ethics and Public Policy Center. This particular study makes claims about what it views as a high rate of serious adverse events following medication abortions. Yet, the evidence from the U.S. and around the globe suggests a highly safe and effective medication. The FDA's mandate is to review the safety and efficacy of drugs based on clinical evidence. As such, the FDA is the federal authority for all pharmaceuticals distributed throughout the U.S., including mifepristone and misoprostol. And so, a series of court cases and Secretary Kennedy's request for another look at mifepristone set a potentially unsettling precedent in which the FDA's regulatory authority from past decisions is undermined. And it's not just mifepristone that's currently under renewed scrutiny. Consider, for example, that HHS is revisiting debunked theories of links between the measles, mumps and rubella vaccine and autism. The department has also spearheaded changes in COVID-19 vaccine recommendations that are not necessarily evidence-based, and inconsistent with prior and even current guidance from the Centers for Disease Control and Prevention.
Free Malaysia Today
4 days ago
- Health
- Free Malaysia Today
French scientist behind abortion pill dies aged 98
Etienne-Emile Baulieu was awarded the prestigious Lasker prize in 1989. (AFP pic) PARIS : French scientist Etienne-Emile Baulieu, the inventor of the abortion pill, died at the age of 98 at his home in Paris today, his wife told AFP. The doctor and researcher, who achieved worldwide renown for his work that led to the pill, had an eventful life that included fighting in the French resistance and becoming friends with artists such as Andy Warhol. 'His research was guided by his commitment to the progress made possible by science, his dedication to women's freedom, and his desire to enable everyone to live better, longer lives,' Baulieu's wife Simone Harari Baulieu said in a statement. French President Emmanuel Macron paid tribute to his life, calling him 'a beacon of courage' and 'a progressive mind who enabled women to win their freedom'. 'Few French people have changed the world to such an extent,' he added in a post on X. Baulieu's most famous discovery helped create the oral drug RU-486, also known as mifepristone, which provided a safe and inexpensive alternative to surgical abortion to millions of women across the world. For decades, he pushed governments to authorise the drug, facing fierce criticism and sometimes threats from opponents of abortion. When Wyoming became the first US state to outlaw the abortion pill in 2023, Baulieu told AFP it was 'scandalous'. Then aged 96, Baulieu said he had dedicated a large part of his life to 'increasing the freedom of women', and such bans were a step in the wrong direction. On news of his death, French equality minister Aurore Berge passed on her condolences to Baulieu's family, saying on X he was 'guided throughout his life by one requirement: human dignity'. 'Fascinated by artists' Born on Dec 12, 1926 in Strasbourg to Jewish parents, Etienne Blum was raised by his feminist mother after his father, a doctor, died. He changed his name to Emile Baulieu when he joined the French resistance against Nazi occupation at the age of 15, then later adding Etienne. After the war, he became a self-described 'doctor who does science', specialising in the field of steroid hormones. Invited to work in the US, Baulieu was noticed in 1961 by Gregory Pincus, known as the father of the contraceptive pill, who convinced him to focus on sex hormones. Back in France, Baulieu designed a way to block the effect of the hormone progesterone, which is essential for the egg to implant in the uterus after fertilisation. This led to the development of mifepristone in 1982. Dragged before the courts and demonised by US anti-abortion groups who accused him of inventing a 'death pill', Baulieu refused to back down. 'Adversity slides off him like water off a duck's back,' Simone Harari Baulieu told AFP. 'You, a Jew and a resistance fighter, you were overwhelmed with the most atrocious insults and even compared to Nazi scientists,' Macron said as he presented Baulieu with France's top honour in 2023. 'But you held on, for the love of freedom and science.' In the 1960s, literature fan Baulieu became friends with artists such as Andy Warhol. He said he was 'fascinated by artists who claim to have access to the human soul, something that will forever remain beyond the reach of scientists'. Alzheimer's, depression research Baulieu kept going into his Parisian office well into his mid-90s. 'I would be bored if I did not work anymore,' he said in 2023. His recent research has included trying to find a way to prevent the development of Alzheimer's disease, as well as a treatment for severe depression, for which clinical trials are currently underway across the world. 'There is no reason we cannot find treatments' for both illnesses, he said. Baulieu was also the first to describe how the hormone DHEA secreted from adrenal glands in 1963. He was convinced of the hormone's anti-ageing abilities, but drugs using it only had limited effects, such as in skin-firming creams. In the US, Baulieu was also awarded the prestigious Lasker prize in 1989. After his wife Yolande Compagnon died, Baulieu married Simone Harari in 2016. He leaves behind three children, eight grandchildren and nine great-grandchildren, according to the statement released by his family.
Malay Mail
4 days ago
- Health
- Malay Mail
Abortion pill inventor Etienne-Emile Baulieu dies aged 98
PARIS, May 31 — French scientist Etienne-Emile Baulieu, the inventor of the abortion pill, died at the age of 98 at his home in Paris yesterday, his wife told AFP. The doctor and researcher, who achieved worldwide renown for his work that led to the pill, had an eventful life that included fighting in the French resistance and becoming friends with artists such as Andy Warhol. 'His research was guided by his commitment to the progress made possible by science, his dedication to women's freedom, and his desire to enable everyone to live better, longer lives,' Baulieu's wife Simone Harari Baulieu said in a statement. French President Emmanuel Macron paid tribute to his life, calling him 'a beacon of courage' and 'a progressive mind who enabled women to win their freedom'. 'Few French people have changed the world to such an extent,' he added in a post on X. Baulieu's most famous discovery helped create the oral drug RU-486, also known as mifepristone, which provided a safe and inexpensive alternative to surgical abortion to millions of women across the world. For decades, he pushed governments to authorise the drug, facing fierce criticism and sometimes threats from opponents of abortion. When Wyoming became the first US state to outlaw the abortion pill in 2023, Baulieu told AFP it was 'scandalous'. Then aged 96, Baulieu said he had dedicated a large part of his life to 'increasing the freedom of women,' and such bans were a step in the wrong direction. On news of his death, French Equality Minister Aurore Berge passed on her condolences to Baulieu's family, saying on X he was 'guided throughout his life by one requirement: human dignity.' 'Fascinated by artists' Born on December 12, 1926 in Strasbourg to Jewish parents, Etienne Blum was raised by his feminist mother after his father, a doctor, died. He changed his name to Emile Baulieu when he joined the French resistance against Nazi occupation at the age of 15, then later adding Etienne. After the war, he became a self-described 'doctor who does science,' specialising in the field of steroid hormones. Invited to work in the United States, Baulieu was noticed in 1961 by Gregory Pincus, known as the father of the contraceptive pill, who convinced him to focus on sex hormones. Back in France, Baulieu designed a way to block the effect of the hormone progesterone, which is essential for the egg to implant in the uterus after fertilisation. This led to the development of mifepristone in 1982. Dragged before the courts and demonised by US anti-abortion groups who accused him of inventing a 'death pill', Baulieu refused to back down. 'Adversity slides off him like water off a duck's back,' Simone Harari Baulieu told AFP. 'You, a Jew and a resistance fighter, you were overwhelmed with the most atrocious insults and even compared to Nazi scientists,' Macron said as he presented Baulieu with France's top honour in 2023. 'But you held on, for the love of freedom and science.' In the 1960s, literature fan Baulieu became friends with artists such as Andy Warhol. He said he was 'fascinated by artists who claim to have access to the human soul, something that will forever remain beyond the reach of scientists.' Alzheimer's, depression research Baulieu kept going into his Parisian office well into his mid-90s. 'I would be bored if I did not work anymore,' he said in 2023. His recent research has included trying to find a way to prevent the development of Alzheimer's disease, as well as a treatment for severe depression, for which clinical trials are currently underway across the world. 'There is no reason we cannot find treatments' for both illnesses, he said. Baulieu was also the first to describe how the hormone DHEA secreted from adrenal glands in 1963. He was convinced of the hormone's anti-ageing abilities, but drugs using it only had limited effects, such as in skin-firming creams. In the United States, Baulieu was also awarded the prestigious Lasker prize in 1989. After his wife Yolande Compagnon died, Baulieu married Simone Harari in 2016. He leaves behind three children, eight grandchildren and nine great-grandchildren, according to the statement released by his family. — AFP
RNZ News
4 days ago
- Health
- RNZ News
Abortion pill inventor Etienne-Emile Baulieu dies, aged 98
By Benedicte Rey and Isabelle Tourne, AFP The inventor of the abortion pill Etienne-Emile Baulieu died at home in Paris on Friday. Photo: Joel Saget French scientist Etienne-Emile Baulieu, the inventor of the abortion pill, has died at the age of 98 at his home in Paris, according to his wife. The doctor and researcher, who achieved worldwide renown for his work that led to the pill, had an eventful life that included fighting in the French Resistance and becoming friends with artists such as Andy Warhol. "His research was guided by his commitment to the progress made possible by science, his dedication to women's freedom, and his desire to enable everyone to live better, longer lives," Baulieu's wife Simone Harari Baulieu said in a statement on Friday. French President Emmanuel Macron paid tribute to Baulieu's life, calling him "a beacon of courage" and "a progressive mind who enabled women to win their freedom". "Few French people have changed the world to such an extent," he added in a post on X. Baulieu's most famous discovery helped create the oral drug RU-486, also known as mifepristone, which provided a safe and inexpensive alternative to surgical abortion to millions of women across the world. For decades, he pushed governments to authorise the drug, facing fierce criticism and sometimes threats from opponents of abortion. When Wyoming became the first US state to outlaw the abortion pill in 2023, Baulieu told AFP it was "scandalous". Then aged 96, Baulieu said he had dedicated a large part of his life to "increasing the freedom of women", and such bans were a step in the wrong direction. On news of his death, French Equality Minister Aurore Berge passed on her condolences to Baulieu's family, saying on X he was "guided throughout his life by one requirement: human dignity". Born on 12 December, 1926 in Strasbourg to Jewish parents, Etienne Blum was raised by his feminist mother after his father, a doctor, died. He changed his name to Emile Baulieu when he joined the French Resistance against Nazi occupation at the age of 15, then later adding Etienne. After the war, he became a self-described "doctor who does science," specialising in the field of steroid hormones. Invited to work in the United States, Baulieu was noticed in 1961 by Gregory Pincus, known as the father of the contraceptive pill, who convinced him to focus on sex hormones. Back in France, Baulieu designed a way to block the effect of the hormone progesterone, which is essential for the egg to implant in the uterus after fertilisation. This led to the development of mifepristone in 1982. Dragged before the courts and demonised by US anti-abortion groups who accused him of inventing a "death pill", Baulieu refused to back down. "Adversity slides off him like water off a duck's back," Simone Harari Baulieu told AFP. "You, a Jew and a Resistance fighter, you were overwhelmed with the most atrocious insults and even compared to Nazi scientists," Macron said as he presented Baulieu with France's top honour in 2023. "But you held on, for the love of freedom and science." In the 1960s, literature fan Baulieu became friends with artists such as Andy Warhol. He said he was "fascinated by artists who claim to have access to the human soul, something that will forever remain beyond the reach of scientists". Baulieu kept going into his Parisian office well into his mid-90s. "I would be bored if I did not work anymore," he said in 2023. His recent research has included trying to find a way to prevent the development of Alzheimer's disease, as well as a treatment for severe depression, for which clinical trials are currently underway across the world. "There is no reason we cannot find treatments" for both illnesses, he said. Baulieu was also the first to describe how the hormone DHEA secreted from adrenal glands in 1963. He was convinced of the hormone's anti-ageing abilities, but drugs using it only had limited effects, such as in skin-firming creams. In the United States, Baulieu was also awarded the prestigious Lasker prize in 1989. After his wife Yolande Compagnon died, Baulieu married Simone Harari in 2016. He leaves behind three children, eight grandchildren and nine great-grandchildren, according to the statement released by his family. - AFP
