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Roe v. Wade.

missy

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Yesterday's Supreme Court hearing on the abortion pill could decide the fate of a drug that millions rely on. It seemed like the justices were leaning toward preserving access to the drug.

States from California to New York have been stockpiling abortion pills.

Skeptical SCOTUS​

It’s been a rocky journey for the abortion pill mifepristone ever since it entered the US market over two decades ago, thanks to legal battles over its approval and restrictions imposed on its use.
The future for mifepristone, one drug of a two-pill regimen used to terminate a pregnancy, has been uncertain ever since a Texas federal judge moved to rescind the drug’s approval last year as part of a messy legal battle. A federal appeals court scaled back that order with a decision that would let mifepristone stay on the market but with more restrictions. Now, the Supreme Court will have its say.
Despite mounting evidence over the years that the medication is safe and effective, mifepristone has been subject to tight regulations. For years, doctors, medical bodies and researchers have argued that the rules are unnecessary and pressured the Food and Drug Administration to loosen them.
Since 2016, the FDA has revised its rules around the pill, allowing the drug to be used through 10 weeks of pregnancy instead of seven; the requirement that people go to a doctor’s office to pick up the pill was lifted; and last year, the FDA allowed the medication to be dispensed at retail pharmacies for the first time.
Tuesday’s Supreme Court hearing centered around the expansion of access to mifepristone since 2016 and the argument put forward by antiabortion groups that the FDA acted unlawfully when it relaxed the rules. Among other arguments, Erin Hawley, who represents the group of antiabortion doctors suing the FDA, said that the agency’s decisions forced doctors “to choose between helping a woman with a life-threatening condition and violating their conscience.”
The justices didn’t appear to buy the argument. They questioned why doctors faced with a moral or religious dilemma could not simply exercise their right to “conscientiously object” to performing an abortion instead of pursuing a nationwide ban on the pill.
“This case seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action,” said Justice Neil Gorsuch.
There were also a lot of questions about whether antiabortion doctors and organizations had legal standing to challenge the FDA’s decisions. Solicitor General Elizabeth B. Prelogar, who represents the Biden administration, said that rolling back the FDA’s changes would unnecessarily restrict access to mifepristone with no safety justification. Prelogar also said that there had been a “disturbing trend” of courts attempting to override the FDA’s expert judgment about what is necessary to ensure the safe use of medications.
“No matter which direction you come at it from, we, on behalf of the FDA, think that courts have no business making those judgments,” Prelogar said.
As the legal battle was first heating up last year, experts told me at the time that there was growing concern that the legal fight around mifepristone had opened the door for politically motivated plaintiffs to sue to remove medications they don’t like from the market. Drugs that have attracted controversy, like vaccines, could also be at risk.
And while the Supreme Court seems in favor of preserving access to mifepristone, we won’t know for sure until a final ruling is handed down, probably at the end of June. — Fiona Rutherford
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missy

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Two retracted studies at the Supreme Court this week


This week the Supreme Court heard a case about access to the first pill used in most medication abortions in the U.S.: mifepristone. Their decision should come down in June or July.
At the center of this case, the defendant argued that the FDA ignored safety concerns when it eased restrictions on the use of mifepristone. The defendants relied heavily on a few studies that claimed the abortion pill was unsafe.
However, in a stunning turn of events, the publisher of these scientific studies (SAGE) retracted them last month due to methodological and ethical concerns.
Why were these retracted? (What does that even mean?) And what are the implications?

Retractions are very rare

A retraction is the removal of a published article from a scientific journal. This is a big deal as it doesn’t happen because of some small error. A retraction can be done by the authors (realization of a huge error) or by the publisher (over ethical concerns, fraud, plagiarism, etc.).
It’s unusual for a scientific paper to be retracted (about 1 in 1000), but the rate is increasing. Misconduct accounts for the majority of retractions.
Number of retracted articles for specific causes by year of retraction. National Academies of Science Convening. Source here.

Behind the abortion study retractions

The two studies used in this week's Supreme Court case were peer-reviewed and published in 2021. After publication, though, other scientists started voicing major concerns about the statistical methods (and thus questioning the conclusions).
One external group took a deep dive and published their concerns in a pre-print in another journal. They found:
  • The codes used to define “abortion-related” emergency room visits were inaccurate. For example, the study used medical codes for ectopic pregnancies that naturally occurred, not caused by abortions.
  • Findings were presented in a deceiving way, like using dual y-axes on one graph. The left panel on the figure below is what was published. It shows abortions are leading to a lot of emergency room visits. However, when the y-axis is displayed properly on the same scale, abortions lead to a very small number of ED visits.
Figure Source: Upadhyay et al, 2024; Annotations by YLE
After these concerns were raised, SAGE asked for a review of the articles post-publication. They had two subject matter experts and one independent statistical reviewer take a look. Then SAGE retracted the paper based on three major factors:
  1. Methodological and statistical concerns. Specifically, “unjustified or incorrect factual assumptions,” “material errors,” and “misleading presentations” of data that “demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part.”
  2. Ethical considerations. The authors were members of three pro-life advocacy organizations, despite declaring no conflicts of interest in the study.
  3. More ethical considerations. The peer reviewer (who is supposed to be an unbiased third party) didn’t disclose their conflict of interest— that they know the authors personally.
SAGE did not publish the experts’ peer review, which is normal practice. However, given the stakes of this case, it could be coming.

Implications can be long-lasting

Clinical guidance and policy are (ideally) built on decades of research and consideration of the totality of evidence. In the case of mifepristone, more than 100 studies show it’s safe—in fact, safer than Tylenol—with only a few dissenting studies. Some dissenting studies have now been retracted due to methodological and ethical issues.
However, big mistakes can make it past the peer-review process, and, in some rare cases, “mistakes” are intentional and egregious. Even if studies are retracted, they can do a lot of harm (just look at the Wakefield study on autism and the MMR, for example).

Bottom line

A lot of emotion and opinions surround abortion. But I hope we can all agree that we need a solid foundation of data to make smart policy decisions. This bedrock is highly dependent on ethical scientists and a strong review process.
It’s shocking that these studies reached the Supreme Court and were used as a source for decision-making.


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Matata

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The two studies used in this week's Supreme Court case were peer-reviewed and published in 2021. After publication, though, other scientists started voicing major concerns about the statistical methods (and thus questioning the conclusions).

When reading studies to determine a course of action, it is imperative that one finds out who sponsors it, where the funding comes from, who the peer reviewers are and how they are chosen.

Sadly, there are experts in medical fields who take payment from groups to give misleading information about abortion and several other issues that are currently targeted by those trying to control which narratives reach the public.
 

PinkAndBlueBling

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When reading studies to determine a course of action, it is imperative that one finds out who sponsors it, where the funding comes from, who the peer reviewers are and how they are chosen.

This is exactly why I won't sign petitions for ballot initiatives here in CA. People ask "Will you sign this to ban/change xxx?" but you need to read the text and find out who the backers are before signing. These are often very misleading.

Regarding studies, if it can't be replicated and isn't peer-reviewed, then just stop with the biased pushing of an agenda.
 

Matata

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The Roe v Wade fallout continues. Pregnant women in need of emergency care are being refused care. Federal mandates for emergency care are being ignored. I hope we see an abundance of lawsuits stemming from the inhumane treatment of women.

"One woman miscarried in the lobby restroom of a Texas emergency room as front desk staff refused to check her in. Another woman learned that her fetus had no heartbeat at a Florida hospital, the day after a security guard turned her away from the facility. And in North Carolina, a woman gave birth in a car after an emergency room couldn't offer an ultrasound. The baby later died.

Complaints that pregnant women were turned away from U.S. emergency rooms spiked in 2022 after the U.S. Supreme Court overturned Roe v. Wade, federal documents obtained by The Associated Press reveal.

The cases raise alarms about the state of emergency pregnancy care in the U.S., especially in states that enacted strict abortion laws and sparked confusion around the treatment doctors can provide."

 

missy

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The Roe v Wade fallout continues. Pregnant women in need of emergency care are being refused care. Federal mandates for emergency care are being ignored. I hope we see an abundance of lawsuits stemming from the inhumane treatment of women.

"One woman miscarried in the lobby restroom of a Texas emergency room as front desk staff refused to check her in. Another woman learned that her fetus had no heartbeat at a Florida hospital, the day after a security guard turned her away from the facility. And in North Carolina, a woman gave birth in a car after an emergency room couldn't offer an ultrasound. The baby later died.

Complaints that pregnant women were turned away from U.S. emergency rooms spiked in 2022 after the U.S. Supreme Court overturned Roe v. Wade, federal documents obtained by The Associated Press reveal.

The cases raise alarms about the state of emergency pregnancy care in the U.S., especially in states that enacted strict abortion laws and sparked confusion around the treatment doctors can provide."


It feels like the end of civilization. Oh wait, too late.
What a mess. We are in the worst episode of "Black Mirror" ever...and have been for quite a while
 

Matata

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It feels like the end of civilization. Oh wait, too late.
What a mess. We are in the worst episode of "Black Mirror" ever...and have been for quite a while

We don't learn from history either which is probably why our civilization is in steep decline. There's been an increase in abortions since Roe v. Wade was overturned. Imagine that.
 

missy

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We don't learn from history either which is probably why our civilization is in steep decline. There's been an increase in abortions since Roe v. Wade was overturned. Imagine that.

Yes. That’s 100% true.

It’s amazing how ignorant (and evil) politicians and other humans can be.
 

Matata

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SCOTUS will determine today whether they value the lives of women, at least the lives of those residing in Idaho.
 
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