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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
"
 

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.


"
 

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.
 

Lookinagain

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

I'm listening to reporting of the arguments right now.
 

monarch64

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Even married women are becoming afraid to get pregnant now. I predict they will come for marital rape laws next.

This Moyle v United States stuff is nightmarish!
 

missy

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"
US Supreme Court faces fight over emergency abortions after toppling Roe

Published April 24, 2024 | Originally published on Health News Online Report
The idea of a doctor in the United States having to consider the risk of imprisonment before performing an emergency abortion might have been difficult to imagine just two years ago.
But after the U.S. Supreme Court in June 2022 overturned the 1973 Roe v. Wade ruling that had legalized abortion nationwide, such dilemmas are a reality in several states that have since adopted Republican-backed near-total bans that include the threat of criminal penalties and loss of medical licensure.

[COLOR=rgb(32 37 41/var(--tw-text-opacity))]CME Activity: [COLOR=rgb(0 126 115/var(--tw-text-opacity))]Oncology Innovations: Liquid Biopsy in Lung Cancer Management[/COLOR][COLOR=rgba(32, 37, 41, 0.4)] RealCME[/COLOR]
The court on Wednesday is set to hear arguments in a case pitting Idaho's strict abortion ban against a federal law that ensures that patients can receive emergency care. It forces the court, which has a 6-3 conservative majority, to revisit the fraught legal landscape that it created with its 2022 Dobbs v. Jackson Women's Health Organization ruling that scuttled Roe.
Idaho is appealing a judge's decision, made in a 2022 lawsuit by President Joe Biden's administration, that found that the 1986 federal law at issue, the Emergency Medical Treatment and Labor Act (EMTALA), takes precedence over the state's law.
EMTALA requires hospitals that receive funding under the federal Medicare program to "stabilize" patients with emergency medical conditions. At issue now is whether Idaho's ban must yield to EMTALA when a doctor determines an abortion is the necessary "stabilizing care."
"The Supreme Court is having to reckon with, yet again, litigating abortion rights in an era that the majority opinion in Dobbs suggested would return it to the states and out of the courts," said Rachel Rebouché, dean of the law school at Temple University in Philadelphia.
"In the cross-hairs here are providers," Rebouché added, "many of whom just want to deliver care and know it's legal."
In Idaho, a so-called abortion "trigger" law automatically took effect upon Roe's reversal. Passed by the Republican-led state legislature and signed by Republican Governor Brad Little in 2020, Idaho's law bans all abortions unless needed to prevent a mother's death.
Idaho is one of seven states with no exception to protect the health of pregnant patients, according to a U.S. Justice Department filing.
Among the critics of Idaho's near-total abortion ban are some of the state's doctors, who would face two to five years in prison and suspension or revocation of their medical license if convicted of performing what the law calls a "criminal abortion."
"Criminalization of doctors providing healthcare is dangerous for patients, for doctors and for our communities," Amelia Huntsberger, an obstetrician-gynecologist who practiced medicine in Idaho for a decade before relocating to Oregon due to Idaho's abortion law, wrote this month in an open letter to Idaho's legislature.
The number of obstetricians in Idaho dropped from 268 to 210 in the first 15 months after its abortion ban took effect, according to the Idaho Physician Well-Being Action Collaborative, a group founded by doctors in the state.
National groups representing obstetricians, gynecologists and emergency physicians have told the Supreme Court that many emergency conditions that could threaten the woman's life and health - from gestational hypertension to excessive bleeding - could require an abortion to stabilize her or avoid seizures, vital organ damage and failure, or the loss of the uterus.
But Idaho's law allows for abortion only to prevent the woman's death, which makes it impossible to comply with both EMTALA and Idaho law, the providers said.
Clinicians are expected to make high-stakes judgments under the threat of criminal penalty, they added.
"At what point," they asked in their filing, "does the condition of a pregnant woman with a uterine hemorrhage deteriorate from health-threatening to the point that an abortion is 'necessary' to prevent death? When is it certain she will die but for medical intervention? How many blood units does she have to lose?"
When two laws collide
Following Roe's demise, Biden's administration issued federal guidance stating that EMTALA takes precedence over state abortion bans when the two conflict.
Idaho's Republican attorney general and top Republican state lawmakers in court papers told the Supreme Court that the state's law and EMTALA are not actually at odds.
"Whatever emergency medical treatment EMTALA could require is consistent with the balance struck in Idaho law," the state officials wrote.
Boise-based U.S. District Judge B. Lynn Winmill in 2022 blocked enforcement of Idaho's law in cases of abortions that are needed to avoid putting the woman's health in "serious jeopardy" or risking "serious impairment to bodily functions."
"Where federal law requires the provision of care and state law criminalizes that very care, it is impossible to comply with both laws," the judge wrote.
The Supreme Court in January let Idaho enforce its law while also agreeing to decide its legality. A ruling is expected by the end of June.
(Reporting by John Kruzel; Additional reporting by Andrew Chung; Editing by Will Dunham)
—John Kruzel
"

 

missy

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"

New Reporting Requirements for Life-Saving Abortions Worry Some Texas Doctors​

— "How can a physician feel protected enough to provide good medical care?" says Houston ob/gyn​

by Eleanor Klibanoff, The Texas Tribune April 26, 2024


An abortion chair in a hospital clinic.

AUSTIN, Texas -- Doctors who perform life-saving abortions may soon be required to document whether they first tried to transfer the patient to another facility to avoid terminating the pregnancy, a move some say goes beyond the language of the law.
Health lawyers and doctors worry this proposed requirement further disincentivizes doctors from performing medically necessary -- but legally risky -- abortions.
"This creates even more uncertainty for doctors who were already concerned," said Rachael Gearing, a Dallas healthcare lawyer who represents ob/gyn clinics. "It's basically saying, 'Well, you should have passed your patient off to someone else who would have held out longer and wouldn't have done the abortion.'"

Texas' laws allow abortions to save a patient's life, but doctors have struggled to apply that exception in practice, especially when faced with up to life in prison, fines, and the loss of their medical license.
After pressure from the Texas Supreme Court and an official petition, the Texas Medical Board issued guidance in Marchopens in a new tab or window laying out how the licensing agency would investigate complaints of prohibited abortions. The agency is currently considering public comment and will finalize the proposal at or after its June meeting.
In addition to requiring doctors to document how they diagnosed the patient as needing an abortion, the board's proposal requires them to note whether there was "adequate time to transfer the patient, by any means available to a facility or physician with a higher level of care or expertise to avoid performing an abortion."
Texas Medical Board President Sherif Zaafran, MD, said this was no different than what doctors are typically expected to do when a patient requires a higher level of care. He said the agency was not trying to "second guess" doctors, but rather laying out what they might expect to see in documentation if they are called on to investigate a complaint.

"All we're asking for is, you've made a determination, you've made a diagnosis, you've prescribed a treatment plan," he told the Texas Tribune. "Help us understand what led you to come up with that diagnosis."
But doctors -- and the lawyers who represent them -- say the law's crushing penalties mean treating complicated pregnancies is vastly different than any other type of medical treatment in Texas.
"How can a physician feel protected enough to provide good medical care when the ultimate decision is going to be made by the court, and they may not support the physician?" said Todd Ivey, MD, a Houston ob/gyn and officer with the Texas chapter of the American College of Obstetricians and Gynecologists. "And then suddenly, you're subject to criminal and civil liabilities?"
Since Texas banned nearly all abortions in summer 2022, dozens of women have come forward with stories of being unable to access medically necessary abortions because their doctors were unclear on when it was legally safe to intervene.

Amanda Zurawski, the lead plaintiff in a lawsuitopens in a new tab or window challenging Texas' abortion bans, was forced to wait until she was in sepsis before her doctors were willing to terminate her pregnancy. She spent 3 days in the intensive care unit and may be unable to conceive again as a result of the infection.
Doctors have reported providing alternative, and in some cases, substandard, care to avoid performing an abortion, or waiting to act until patients are "on death's door," according to one paper about the impacts of Texas' 2021 abortion lawopens in a new tab or window.
"You sometimes feel like you're damned if you do, damned if you don't," said Ivey. "Patients are in very difficult situations ... and then you have the threat from the other side of civil penalties in addition to criminal penalties, along with the loss of your license and prison time. It's incredibly frightening."
In December, Kate Cox, a 31-year-old Dallas mother, sued to terminate her non-viable pregnancy. The Texas Supreme Court ruled that Cox did not qualify under the medical exception, and called on the Texas Medical Board to "assess various hypothetical circumstances, provide best practices, identify red lines, and the like," to clarify the laws.

A month later, Texas lobbyists Steve and Amy Bresnen filed an official petition with the medical board and in March, the agency issued its proposed guidance. The long-awaited proposal mostly pulled together different definitions from across statutes, and reiterated that doctors should rely on their "reasonable medical judgment" to decide when an abortion is necessary.
The main new detail was a list of seven items that must be documented in a patient's medical record, including how the doctor decided to proceed with an abortion, what diagnostic testing was done, what second opinions were sought, what alternative treatments were attempted and failed, and whether there was time to transfer the patient to another facility to avoid an abortion.
Doctors, health lawyers, and women denied medical care for complicated pregnancies decried the guidance as both insufficiently clarifying and additionally burdensome on providers.
"Physicians are already on top of medical documentation, and know what they need to do," said Gearing, the Dallas lawyer. "This documentation test lists additional things that they should be doing that they may not typically consider as necessary. ... It shows the reasonable medical judgment standard isn't just your typical standard."

Lawyers and doctors told the Tribune they were particularly concerned about the requirement that doctors document whether there was time to transfer the patient to another facility to prevent an abortion. In a statement, the Bresnens, the lawyers who filed the initial petition for board guidance, said this would delay care and harm pregnant patients.
"Nothing in Texas law requires a female whose pregnancy threatens her life or major bodily functions to be transferred," they said in a statement to the Tribune this week. "At any time she meets those criteria, a physician is authorized to perform an abortion and it's up to her to decide whether the risks of delay outweigh any other consideration."
In big Texas cities with multiple hospitals in close proximity, Gearing worries it will always be possible to argue the patient should have been transferred rather than treated.
"If you're at Baylor, and there's a physician at (another Dallas hospital) who says they would have tried a different treatment, or taken a more invasive approach ... are they going to be under heightened scrutiny that they should have transferred?"

Ivey, the Houston ob/gyn, said he worries this may encourage overly cautious hospitals or doctors in isolated areas to transfer patients rather than take on the legal risk of terminating the pregnancy.
"If I were a practitioner in a rural area, and I had very little support, and I had a situation like this, it may be so overwhelming that you may just want to send (the patient) to somewhere where they have more resources," he said. "But that may not be the best thing for the patient."
Zaafran said this aspect of the guidance doesn't mean doctors shouldn't treat patients experiencing life-threatening emergencies.
"If I've got a patient dying in front of me, I'm not going to sit there and start talking about why I didn't transfer the patient," he said. "The patient is unstable, and I had to act quickly to save the patient's life ... You don't have to say anything else."

As for transfers after a patient is stabilized, Zaafran said this was no different than other situations that may require a higher level of care than a hospital is able to provide. He said the board didn't intend to "sit here and second guess" doctors' decision making, as long as they use their reasonable medical judgment to reach their conclusions.
"You can go to two different doctors and get two different treatments, and neither one would be wrong," he said. "The medical board, that's how we're going to view it." But, he noted, the medical board has "no control over whether a district attorney somewhere decides to take on the case and push in a little bit of a different manner."
Adding these additional documentation requirements opens the door for greater scrutiny from outside the medical field, Gearing said. Even if the medical board doesn't see an issue with their choices, doctors found to have violated the state's abortion laws can face up to 100 years in prison and a fine of $100,000.

"I think there's concern that ... even if they do everything right, this is a political battle versus a medical one," Gearing said. "If an official wants to make an example, some of my clients don't feel very confident that their choices would be viewed in a medical context, rather than a more political context."
As this guidance is being debated, Texas is in court arguing against a federal law that requires hospitals to screen and stabilize any patient experiencing a medical emergency.
The federal Emergency Medical Treatment and Labor Act (EMTALA) requires stabilizing care, including abortions, if necessary, when the health of a patient is at risk, but Texas law only allows abortions when the patient's life is at risk.
The 5th U.S. Circuit Court of Appeals in New Orleans has ruled that Texas' law supersedes EMTALA, and the Biden administration cannot require hospitals to offer abortions before a patient's life is at risk. This weekopens in a new tab or window, the U.S. Supreme Court heard a similar case out of Idahoopens in a new tab or window, where Elizabeth Prelogar, the U.S. solicitor general, argued that carving abortion out of the law is "entirely inconsistent" with federal law.

"One of the primary motivators here was to prevent patient dumping," she told the justices Wednesday. "The idea was, we do not want people to have to go somewhere else to get their care. You go to the first emergency room in your state, and they have to stabilize you."
Zaafran said the medical board's guidance is in line with hospitals' EMTALA obligations, as doctors would be expected to stabilize a patient before they try to transfer them.
But Sara Rosenbaum, an EMTALA legal expert at the Milken School of Public Health at the George Washington University, said the guidance to try to transfer a patient "by any means available," as the proposal says, has the potential to further confuse doctors about their obligations under state and federal laws.
"It's like you gave a roomful of law students a test, and said, think of all the ways to interfere with EMTALA and still look like you're trying to comply," she said. "It's a complete perversion."

The medical board is taking public comment on the proposed guidance and is considering holding stakeholder meetings to hear directly from impacted parties. At the board's next meeting in June, it will either introduce changes to the proposal or adopt the guidelines as they exist.
Ivey, the Houston ob/gyn, said he appreciates the tough spot the board is in trying to address this extremely fraught issue, but he is disappointed they didn't do more to address doctors' fears of being criminalized.
"We need some way we could allow physicians to practice good medicine without worrying about being criminally prosecuted or having some huge civil action against them," he said. "We want to practice good medicine and take care of people within the confines of the law. We need the law to help us, not hinder us."
Gearing said she was hoping for more of the "red lines" recommended by the Texas Supreme Court, like saying doctors that got two concurring opinions from fellow physicians could safely proceed.

Zaafran acknowledged the frustration with what the board has put out so far, saying they were being asked to give a "black and white answer" that doesn't exist.
"The law is black and white -- you cannot perform an abortion unless there is potential for major bodily injury or permanent organ damage, or death," Zaafran said. "The part that is not black and white is determining what is a threat to somebody's life, or a threat of permanent bodily organ damage or injury ... That's where the judgment is."
"
 
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