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everyendeavor · 26 minutes
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Daria Hlazatova, Ukraine
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everyendeavor · 4 hours
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Jessica Glenza at The Guardian:
A supreme court case about one little pill – mifepristone – has the medical and pharmaceutical world on edge. The pill, at the heart of a case that will be argued on Tuesday, is part of a two-drug regimen used to treat miscarriage and end early pregnancies.
Despite a more than 20-year track record of safe real-world use, backed up by more than 100 peer-reviewed studies, a group of anti-abortion doctors is seeking to roll back US Food and Drug Administration (FDA) decisions that changed and relaxed some prescribing rules. If the doctors succeed, despite contested and in some cases now-retracted evidence of harm, the case could reshape abortion access in the US and have enormous and unpredictable consequences for how drugs are prescribed, regulated and developed. A ruling in favor of anti-abortion doctors could threaten everything from trust in medicine to specific drugs to the US’s position as the world’s foremost drug innovator.
“I am terrified,” said Juan Hincapie-Castillo, a drug policy researcher, licensed pharmacist and assistant professor of epidemiology at the University of North Carolina. “This case is shifting the whole paradigm of how things could go moving forward”. Mifepristone was approved by the FDA in 2000 with stringent requirements for how it should be prescribed: only up to seven weeks gestation, dispensed in-person with mandatory follow-up appointments, and with enhanced risk-reporting requirements for doctors. Along with misoprostol, the second drug in the regimen, it is, in effect, designed to induce the equivalent of a miscarriage at home.
After more than 20 years and scientific articles spanning 26 countries, the scientific consensus is that the “abortion pill” has a remarkable track record of safety and effectiveness that, in the media, is often compared to that of Tylenol or Viagra. But following the fall of Roe v Wade in 2022, anti-abortion doctors initiated a lawsuit against the FDA in Amarillo, Texas, arguing that the drug’s approval should be withdrawn. The Trump-appointed judge Matthew Kacsmaryk ruled in favor of the doctors. Were his decision not appealed, it would have resulted in a de facto nationwide ban on medication abortion.
The government appealed to the fifth circuit appeals court in New Orleans, with a long history of law that deferred to expert federal agencies and the FDA. Although the fifth circuit struck down part of Kacsmaryk’s decision, which would have in effect banned the drug nationally, the appeals court ruled in favor of the doctors’ arguments against two FDA decisions in 2016 and 2021. At both of those times, the FDA relaxed prescribing rules. The agency allowed doctors to see patients for one visit, approved the drug for up to 10 weeks gestation, reduced risk reporting, allowed dispensing through the mail and retail pharmacies, and even reduced the dose of mifepristone from 600 to 200mg. It may sound like a wonky distinction – but the case is viewed with fear and trepidation by nearly the entire medical industry. And hundreds of pharmaceutical executives, doctors associations and even companies regulated by the FDA have lined up in the agency’s defense.
That’s for two reasons. First, the anti-abortion doctors don’t show a typical case of harm. They argue in briefs that a fraction of their doctors might have been forced to treat women who needed follow-up care from medication abortions, even though no specific party is named. Second, their arguments undermine the deference courts have long had for expert federal agencies, and in particular for the FDA, which is both the global gold standard for rigorous scientific review, and is directly involved in high-stakes decisions about the trade-offs of particular medicines in ways that have immediate impact on American health.
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It could also dramatically alter the FDA’s authority. If the agency’s decisions can be undone by a judge or it can be sued by any group who outlines theoretical harm, it opens the doors for judges to make medical decisions and for nearly anyone opposed to a drug to sue. “What you don’t want is for patients to have science unwound, so they end up faced – not only with fewer drugs or less innovation – but with outdated regimens and unnecessary burdens,” said Eva Temkin, an attorney who worked at the FDA for nearly a decade, and now advises pharmaceutical companies, medical device manufacturers and biotechnology companies at the law firm Paul Hastings.
Contraception, hormone blockers to treat gender dysphoria, vaccines and even some chemotherapy drugs all have detractors who could target the drugs in court, experts said. Commercial rivals may also have a new avenue to limit a drug’s availability. A decision in favor of anti-abortion drugs would also dramatically alter the drug development landscape, which relies heavily on a stable body of law for investment. Bringing a new drug to market can cost anywhere from less than $1bn to more than $2bn, and may take 10 to 15 years.
Tomorrow is the oral arguments at SCOTUS for a big mifepristone case called FDA v. Alliance For Hippocratic Medicine. The case could have disastrous consequences for not just abortion access, but also pharmaceutical inventions and the authority of the FDA.
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everyendeavor · 5 hours
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Thierrynuchanant
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everyendeavor · 7 hours
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“Nature has planted in our minds an insatiable longing to see the truth.”
— Cicero, Tusculan Disputations
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everyendeavor · 20 hours
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😂🤣
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everyendeavor · 21 hours
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everyendeavor · 23 hours
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everyendeavor · 1 day
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Villa No. 12 in Iporanga, São Paulo
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everyendeavor · 1 day
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Self-compassion supports personal evolution.
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everyendeavor · 1 day
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everyendeavor · 1 day
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One time a friend told me that if she wanted to have a chill night she would come to me and ask for tea and a book to read. I didn’t like tea at the time, but I always made sure my cupboards had them in case she needed a quiet night. One time I told my boss that I loved oranges, but couldn’t peel them because of my nails. For a year he made sure to peel me one at least once a week. Once my friends gave me a made up superlative of “most likely to have a pen they could borrow” and ever since I’ve made sure I always carry a pen with me. A long time ago, my high school librarian told me that no one would care what my grade in my sophomore chemistry class was if I’m bringing them doughnuts and asking them about their day.
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everyendeavor · 1 day
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everyendeavor · 2 days
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by majara__
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Autumn Mushroom Mix… from Lithuania 🍄🍁🍂🥰🍄 by Jurgita Kvas
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everyendeavor · 2 days
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There was a homeless man who 'camped' in the covered garage where my office was located. You'd see him huddle down for the night, along with his little dog, a small scruffy little terrier mix. When I walked thru the garage on my way to lunch, I would often check to see where he was and then bring him a burger and drink. He always tore the sandwich in half, ate one half and gave the other to his dog. I started bringing him a bag of dry dog food every month and he took great pains to keep it dry. His little dog rode in the child's seat in the grocery cart wherever he went. One especially cold winter morning, I noticed his dog was missing and he seemed utterly forlorn. I bought him some coffee and he explained how the city rounded up the homeless and took them to the shelter because it was bitterly cold and they took his dog away from him. They took her to the local shelter (no license, no tags, no rabies vaccination). I was appalled. I took the morning off, picked him up from the garage & drove him to the shelter where we asked to look for his 'lost' dog. When we found her, she put up such a racket of pure joy upon seeing him: yipping, yelping, wiggling uncontrollably. Paws squeezed between chain link trying to touch her master and his fingers stroking her little face. I paid for her license, basic shots and retrieval fee and he rode back in silence hugging her so tight, I thought he would break her. When we got out, I told him to keep her safe. He hugged me, made Sasha give me a smooch of thanks, and hurried off to where he'd hidden his cart. I understand the need to keep these souls safe but taking his one undeniable friend -- while legally founded -- was gut wrenchingly wrong on so many other levels. Any act of kindness can change lives….no matter how great or small.
Such a heartbreaking story
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everyendeavor · 2 days
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Dębki / Poland / 2010 - Installation by NeSpoon
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