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Nearly two years after Texas’ six-week abortion ban, more infants are dying | CNN

CNN
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Texas’ abortion restrictions – some of the strictest in the country – may be fueling a sudden spike in infant mortality as women are forced to carry nonviable pregnancies to term.

Some 2,200 infants died in Texas in 2022 – an increase of 227 deaths, or 11.5%, over the previous year, according to preliminary infant mortality data CNN obtained through a public records request. Infant deaths caused by severe genetic and birth defects rose by 21.6%. That spike reversed a nearly decade-long decline. Between 2014 and 2021, infant deaths had fallen by nearly 15%.

In 2021, Texas banned abortions beyond six weeks of pregnancy. When the Supreme Court overturned federal abortion rights the following summer, a trigger law in the state banned all abortions other than those intended to protect the life of the mother.

The increase in deaths could partly be explained by the fact that more babies are being born in Texas. One recent report found that in the final nine months of 2022, the state saw nearly 10,000 more births than expected prior to its abortion ban – an estimated 3% increase.

But multiple obstetrician-gynecologists who focus on high-risk pregnancies told CNN that Texas’ strict abortion laws likely contributed to the uptick in infant deaths.

“We all knew the infant mortality rate would go up, because many of these terminations were for pregnancies that don’t turn into healthy normal kids,” said Dr. Erika Werner, the chair of obstetrics and gynecology at Tufts Medical Center. “It’s exactly what we all were concerned about.”

The issue of forcing women to carry out terminal and often high-risk pregnancies is at the core of a lawsuit filed by the Center for Reproductive Rights, with several women – who suffered difficult pregnancies or infant deaths shortly after giving birth – testifying in Travis County court this week.

Prior to the recent abortion restrictions, Texas banned the procedure after 20 weeks. This law gave parents more time to learn crucial information about a fetus’s brain formation and organ development, which doctors begin to test for at around 15 weeks.

Samantha Casiano, a plaintiff in the suit filed against Texas, wished she’d had more time to make the decision.

“If I was able to get the abortion with that time, I think it would have meant a lot to me because my daughter wouldn’t have suffered,” Casiano said.

When Casiano was 20 weeks pregnant, a routine scan came back with devastating news: Her baby would be stillborn or die shortly after birth.

The fetus had anencephaly, a rare birth defect that keeps the brain and skull from developing during pregnancy. Babies with this condition are often stillborn, though they sometimes live a few hours or days. Many women around the country who face the prospect choose abortion, two obstetrician-gynecologists told CNN.

But Casiano lived in Texas, where state legislators had recently banned most abortions after six weeks of pregnancy. She couldn’t afford to travel out of the state for the procedure.

“You have no options. You will have to go through with your pregnancy,” Casiano’s doctor told her, she claimed in the lawsuit.

In March, Casiano gave birth to her daughter Halo. After gasping for air for four hours, the baby died, Casiano said during her testimony on Wednesday.

“All she could do was fight to try to get air. I had to watch my daughter go from being pink to red to purple. From being warm to cold,” said Casiano. “I just kept telling myself and my baby that I’m so sorry that this had to happen to you.”

Casiano and 14 others – including two doctors – are plaintiffs in the lawsuit. They allege the abortion ban has denied them or their patients access to necessary obstetrical care. The plaintiffs are asking the courts to clarify when doctors can make medical exceptions to the state’s ban.

Casiano and two other plaintiffs testified Wednesday about hoping to deliver healthy babies but instead learning their lives or pregnancies were in danger.

Plaintiffs Anna Zargarian, Lauren Miller, Lauren Hall, and Amanda Zurawski at the Texas State Capitol after filing a lawsuit on behalf of Texans harmed by the state's abortion ban on March 7 in Austin, Texas.

“This was just supposed to be a scan day,” Casiano told the court. “It escalated to me finding out my daughter was going to die.”

Lawyers representing the state argued Wednesday that the plaintiffs’ doctors were to blame, saying they misinterpreted the law and failed to provide adequate care for such high-risk pregnancies.

“Plaintiffs will not and cannot provide any evidence of any medical provider in the state of Texas being prosecuted or otherwise penalized for performance of an abortion using the emergency medical exemption,” a lawyer said during the state’s opening statement.

Kylie Beaton, another plaintiff, also had to watch her baby die. Beaton, who didn’t testify this week, learned during a 20-week scan that something was wrong with her baby’s brain, according to the suit.

The doctor diagnosed the fetus with alobar holoprosencephaly, a condition where the two hemispheres of the brain don’t properly divide. Babies with this condition are often stillborn or die soon after birth.

Beaton’s doctor told her he couldn’t provide an abortion unless she was severely ill, or the fetus’s heart stopped. Beaton and her husband sought to obtain an abortion out of state. However, the fetus’s head was enlarged due to its condition, and the only clinic that would perform an abortion charged up to $15,000. Beaton and her husband couldn’t afford it.

Instead, Beaton gave birth to a son she named Grant. The baby cried constantly, wouldn’t eat, and couldn’t be held upright for fear it would put too much pressure on his head, according to the suit. Four days later, Grant died.

Amanda Zurawski of Austin, Texas, center, is the lead plaintiff in the lawsuit.

Experts say that abortion bans in states like Texas lead to increased risk for both babies and mothers.

Maternal mortality has long been a top concern for doctors and health-rights activists. Even before the Supreme Court decision, the United States had the highest maternal mortality rate among wealthy nations, one study found.

Amanda Zurawski, the lawsuit’s lead plaintiff, testified Wednesday that her water broke 18 weeks into her pregnancy, putting her at high risk for a life-threatening infection. Zurawski’s baby likely wouldn’t survive.

But the fetus still had a heartbeat, and so doctors said they were unable to terminate the pregnancy. She received an emergency abortion only after her condition worsened and she went into septic shock.

Zurawski described during Wednesday’s hearing how her family visited the hospital, fearing it would be the last time they would see her. Zurawski has argued that had she been able to obtain an abortion, her life wouldn’t have been in jeopardy in the same way.

“I blame the people who support these bans,” Zurawski said.

Zurawski previously said the language in Texas’ abortion laws is “incredibly vague, and it leaves doctors grappling with what they can and cannot do, what health care they can and cannot provide.”

Pregnancy is dangerous, and forcing a woman to carry a non-viable pregnancy to term is unnecessarily risky when it’s clear the baby will not survive, argued Dr. Mae-Lan Winchester, an Ohio maternal-fetal medicine specialist.

“Pregnancy is one of the most dangerous things a person will ever go through,” Winchester said. “Putting yourself through that risk without any benefit of taking a baby home at the end, it’s … risking maternal morbidity and mortality for nothing.”

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Black or ‘Other’? Doctors may be relying on race to make decisions about your health | CNN

Post By Health african americans, business, business and industry sectors, curricula, demographic groups, discrimination, diseases and disorders, economy and trade, education, football (american), health and health care (by demographic group), health and medical, Health Care, health care facilities, health care professionals, hospitals, kidney disease, law and legal system, lawsuits and claims, maternal and child health, medical education, medical fields and specialties, minority and ethnic groups, NFL, obstetrics and gynecology, pharmaceutical industry, pharmaceuticals, pharmaceuticals and prescription drugs, physicians and surgeons, population and demographics, pregnancy and childbirth, racism and racial discrimination, science, societal issues, society, sports and recreation, sports organizations and teams, students and student life, trial and procedure, urogenital disorders and injuries, womens health

Editor’s Note: CNN’s “History Refocused” series features surprising and personal stories from America’s past to bring depth to conflicts still raging today.

CNN
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When she first learned about race correction, Naomi Nkinsi was one of five Black medical students in her class at the University of Washington.

Nkinsi remembers the professor talking about an equation doctors use to measure kidney function. The professor said eGFR equations adjust for several variables, including the patient’s age, sex and race. When it comes to race, doctors have only two options: Black or “Other.”

Nkinsi was dumbfounded.

“It was really shocking to me,” says Nkinsi, now a third-year medical and masters of public health student, “to come into school and see that not only is there interpersonal racism between patients and physicians … there’s actually racism built into the very algorithms that we use.”

At the heart of a controversy brewing in America’s hospitals is a simple belief, medical students say: Math shouldn’t be racist.

The argument over race correction has raised questions about the scientific data doctors rely on to treat people of color. It’s attracted the attention of Congress and led to a big lawsuit against the NFL.

What happens next could affect how millions of Americans are treated.

Carolyn Roberts, a historian of medicine and science at Yale University, says slavery and the American medical system were in a codependent relationship for much of the 19th century and well into the 20th.

“They relied on one another to thrive,” Roberts says.

It was common to test experimental treatments first on Black people so they could be given to White people once proven safe. But when the goal was justifying slavery, doctors published articles alleging substantive physical differences between White and Black bodies — like Dr. Samuel Cartwright’s claim in 1851 that Black people have weaker lungs, which is why grueling work in the fields was essential (his words) to their progress.

The effects of Cartwright’s falsehood, and others like it, linger today.

In 2016, researchers asked White medical students and residents about 15 alleged differences between Black and White bodies. Forty percent of first-year medical students and 25% of residents said they believed Black people have thicker skin, and 7% of all students and residents surveyed said Black people have less sensitive nerve endings. The doctors-in-training who believed these myths — and they are myths — were less likely to prescribe adequate pain medication to Black patients.

To fight this kind of bias, hospitals urge doctors to rely on objective measures of health. Scientific equations tell physicians everything from how well your kidneys are working to whether or not you should have a natural birth after a C-section. They predict your risk of dying during heart surgery, evaluate brain damage and measure your lung capacity.

But what if these equations are also racially biased?

Race correction is the use of a patient’s race in a scientific equation that can influence how they are treated. In other words, some diagnostic algorithms and risk predictor tools adjust or “correct” their results based on a person’s race.

The New England Journal of Medicine article “Hidden in Plain Sight” includes a partial list of 13 medical equations that use race correction. Take the Vaginal Birth After Cesarean calculator, for example. Doctors use this calculator to predict the likelihood of a successful vaginal delivery after a prior C-section. If you are Black or Hispanic, your score is adjusted to show a lower chance of success. That means your doctor is more likely to encourage another C-section, which could put you at risk for blood loss, infection and a longer recovery period.

Cartwright, the racist doctor from the 1800s, also developed his own version of a tool called the spirometer to measure lung capacity. Doctors still use spirometers today, and most include a race correction for Black patients to account for their supposedly shallower breaths.

Turns out, second-year medical student Carina Seah wryly told CNN, math is as racist as the people who make it.

The biggest problem with using race in medicine? Race isn’t a biological category. It’s a social one.

“It’s based on this idea that human beings are naturally divided into these big groups called races,” says Dorothy Roberts, a professor of law and sociology at the University of Pennsylvania, who has made challenging race correction in medicine her life’s work. “But that’s not what race is. Race is a completely invented social category. The very idea that human beings are divided into races is a made-up idea.”

Ancestry is biological. Where we come from — or more accurately, who we come from — impacts our DNA. But a patient’s skin color isn’t always an accurate reflection of their ancestry.

Look at Tiger Woods, Roberts says. Woods coined the term “Cablinasian” to describe his mix of Caucasian, Black, American Indian and Asian ancestries. But to many Americans, he’s Black.

“You can be half Black and half White in this country and you are Black,” says Seah, who is getting her medical degree and a PhD in genetics and genomics at the Icahn School of Medicine at Mount Sinai in New York. “You can be a quarter Black in this country — if you have dark skin, you are Black.”

So it can be misleading, Seah says, even dangerous, for doctors to judge a patient’s ancestry by glancing at their skin. A patient with a White mother and Black father could have a genetic mutation that typically presents in patients of European ancestry, Seah says, but a doctor may not think to test for it if they only see Black skin.

“You have to ask, how Black is Black enough?” Nkinsi asks. And there’s another problem, she says, with using a social construct like race in medicine. “It also puts the blame on the patient, and it puts the blame on the race itself. Like being Black is inherently the cause of these diseases.”

Naomi Nkinsi is a third-year medical and masters of public health student at the University of Washington in Seattle. She has been advocating for the removal of race correction in medicine.

After she learned about the eGFR equation in 2018, Nkinsi began asking questions about race correction. She wasn’t alone — on social media she found other students struggling with the use of race in medicine. In the spring of 2020, following a first-year physiology lecture, Seah joined the conversation. But the medical profession is nothing if not hierarchical; Nkinsi and Seah say students are encouraged to defer to doctors who have been practicing for decades.

Then on May 25, 2020, George Floyd was killed by police in Minneapolis.

His death and the growing momentum around Black Lives Matter helped ignite what Dr. Darshali A. Vyas calls an “overdue reckoning” in the medical community around race and race correction. A few institutions had already taken steps to remove race from the eGFR equation. Students across the country demanded more, and hospitals began to listen.

Four days after Floyd’s death, the University of Washington announced it was removing race correction from the eGFR equation. In June, the Boston-based hospital system Mass General Brigham where Vyas is a second-year Internal Medicine resident followed suit. Seah and a fellow student at Mount Sinai, Paloma Orozco Scott, started an online petition and collected over 1600 signatures asking their hospital to do the same.

Studies show removing race from the eGFR equation will change how patients at those hospitals are treated. Researchers from Brigham and Women’s Hospital and Penn Medicine estimated up to one in every three Black patients with kidney disease would have been reclassified if the race multiplier wasn’t applied in earlier calculations, with a quarter going from stage 3 to stage 4 CKD (Chronic Kidney Disease).

That reclassification is good and bad, says Dr. Neil Powe, chief of medicine at Zuckerberg San Francisco General Hospital. Black patients newly diagnosed with kidney disease will be able to see specialists who can devise better treatment plans. And more patients will be placed on kidney transplant lists.

On the flip side, Powe says, more African Americans diagnosed with kidney disease means fewer who are eligible to donate kidneys, when there’s already a shortage. And a kidney disease diagnosis can change everything from a patient’s diabetes medication to their life insurance costs.

Dr. Neil Powe says by simply removing race from the eGFR equations,

Powe worries simply eliminating race from these equations is a knee-jerk response — one that may exacerbate health disparities instead of solve them. For too long, Powe says, doctors had to fight for diversity in medical studies.

The most recent eGFR equation, known as the CKD-EPI equation, was developed using data pooled from 26 studies, which included almost 3,000 patients who self-identified as Black. Researchers found the equation they were developing was more accurate for Black patients when it was adjusted by a factor of about 1.2. They didn’t determine exactly what was causing the difference in Black patients, but their conclusion is supported by other research that links Black race and African ancestry with higher levels of creatinine, a waste product filtered by the kidneys.

Put simply: In the eGFR equation, researchers used race as a substitute for an unknown factor because they think that factor is more common in people of African descent.

Last August, Vyas co-authored the “Hidden in Plain Sight” article about race correction. Vyas says most of the equations she wrote about were developed in a similar way to the eGFR formula: Researchers found Black people were more or less likely to have certain outcomes and decided race was worth including in the final equation, often without knowing the real cause of the link.

“When you go back to the original studies that validated (these equations), a lot of them did not provide any sort of rationale for why they include race, which I think is appalling.” That’s what’s most concerning, Vyas says – “how willing we are to believe that race is relevant in these ways.”

Vyas is clear she isn’t calling for race-blind medicine. Physicians cannot ignore structural racism, she says, and the impact it has on patients’ health.

Powe has been studying the racial disparities in kidney disease for more than 30 years. He can spout the statistics easily: Black people are three times more likely to suffer from kidney failure, and make up more than 35% of patients on dialysis in the US. The eGFR equation, he says, did not cause these disparities — they existed long before the formula.

“We want to cure disparities, let’s go after the things that really matter, some of which may be racist,” he says. “But to put all our stock and think that the equation is causing this is just wrong because it didn’t create those.”

In discussions about removing race correction, Powe likes to pose a question: Instead of normalizing to the “Other” group in the eGFR equation, as many of these hospitals are doing, why don’t we give everyone the value assigned to Black people? By ignoring the differences researchers saw, he says, “You’re taking the data on African Americans, and you’re throwing it in the trash.”

Powe is co-chair of a joint task force set up by the National Kidney Foundation and the American Society of Nephrology to look at the use of race in eGFR equations. The leaders of both organizations have publicly stated race should not be included in equations used to estimate kidney function. On April 9, the task force released an interim report that outlined the challenges in identifying and implementing a new equation that’s representative of all groups. The group is expected to issue its final recommendations for hospitals this summer.

Race correction is used to assess the kidneys and the lungs. What about the brain?

In 2013, the NFL settled a class-action lawsuit brought by thousands of former players and their families that accused the league of concealing what it knew about the dangers of concussions. The NFL agreed to pay $765 million, without admitting fault, to fund medical exams and compensate players for concussion-related health issues, among other things. Then in 2020, two retired players sued the NFL for allegedly discriminating against Black players who submitted claims in that settlement.

01 race correction Kevin Henry Najeh Davenport SPLIT

The players, Najeh Davenport and Kevin Henry, said the NFL race-corrected their neurological exams, which prevented them from being compensated.

According to court documents, former NFL players being evaluated for neurocognitive impairment were assumed to have started with worse cognitive function if they were Black. So if a Black player and a White player received the exact same scores on a battery of thinking and memory tests, the Black player would appear to have suffered less impairment. And therefore, the lawsuit stated, would be less likely to qualify for a payout.

Race correction is common in neuropsychology using something called Heaton norms, says Katherine Possin, an associate professor at the University of California San Francisco. Heaton norms are essentially benchmark average scores on cognitive tests.

Here’s how it works: To measure the impact of a concussion (or multiple concussions over time), doctors compare how well the patient’s brain works now to how well it worked before.

“The best way to get that baseline was to test you 10 years ago, but that’s not something we obviously have for many people,” Possin says. So doctors estimate your “before” abilities using an average score from a group of healthy individuals, and adjust that score for demographic factors known to affect brain function, like your age.

Heaton norms adjust for race, Possin says, because race has been linked in studies to lower cognitive scores. To be clear, that’s not because of any biological differences in Black and White brains, she says; it’s because of social factors like education and poverty that can impact cognitive development. And this is where the big problem lies.

In early March, a judge in Pennsylvania dismissed the players’ lawsuit and ordered a mediator to address concerns about how race correction was being used. In a statement to CNN, the NFL said there is no merit to the players’ claim of discrimination, but it is committed to helping find alternative testing techniques that do not employ race-based norms.

The NFL case, Possin wrote in JAMA, has “exposed a major weakness in the field of neuropsychology: the use of race-adjusted norms as a crude proxy for lifelong social experience.”

This happens in nearly every field of medicine. Race is not only used as a poor substitute for genetics and ancestry, it’s used as a substitute for access to health care, or lifestyle factors like diet and exercise, socioeconomic status and education. It’s no secret that racial disparities exist in all of these. But there’s a danger in using race to talk about them, Yale historian Carolyn Roberts says.

We know, for example, that Black Americans have been disproportionally affected by Covid-19. But it’s not because Black bodies respond differently to the virus. It’s because, as Dr. Anthony Fauci has noted, a disproportionate number of Black people have jobs that put them at higher risk and have less access to quality health care. “What are we making scientific and biological when it actually isn’t?” Roberts asks.

Vyas says using race as a proxy for these disparities in clinical algorithms can also create a vicious cycle.

“There’s a risk there, we argue, of simply building these into the system and almost accepting them as fact instead of focusing on really addressing the root causes,” Vyas says. “If we systematize these existing disparities … we risk ensuring that these trends will simply continue.”

Nearly everyone on both sides of the race correction controversy agrees that race isn’t an accurate, biological measure. Yet doctors and researchers continue to use it as a substitute. Math shouldn’t be racist, Nkinsi says, and it shouldn’t be lazy.

“We’re saying that we know that this race-based medicine is wrong, but we’re going to keep doing it because we simply don’t have the will or the imagination or the creativity to think of something better,” Nkinsi says. “That is a slap in the face.”

Shortly after Vyas’ article published in The New England Journal of Medicine, the House Ways and Means Committee sent letters to several professional medical societies requesting information on the misuse of race in clinical algorithms. In response to the lawmakers’ request, the Agency for Healthcare Research and Quality is also gathering information on the use of race-based algorithms in medicine. Recently, a note appeared on the Maternal Fetal Medicine Units Network’s website for the Vaginal Birth After Cesarean equation — a new calculator that doesn’t include race and ethnicity is being developed.

Dorothy Roberts is excited to see change on the horizon. But she’s also a bit frustrated. The harm caused by race correction is something she’s been trying to tell doctors about for years.

“I’ve taught so many audiences about the meaning of race and the history of racism in America and the audiences I get the most resistance from are doctors,” Roberts says. “They’re offended that there would be any suggestion that what they do is racist.”

Nkinsi and Seah both encountered opposition from colleagues in their fight to change the eGFR equation. Several doctors interviewed for this story argued the change in a race-corrected scores is so small, it wouldn’t change clinical decisions.

If that’s the case, Vyas wonders, why include race at all?

“It all comes from the desire for one to dominate another group and justify it,” says Roberts. “In the past, it was slavery, but the same kinds of justifications work today to explain away all the continued racial inequality that we see in America… It is mass incarceration. It’s huge gaps in health. It’s huge differences in income and wealth.”

It’s easier, she says, to believe these are innate biological differences than to address the structural racism that caused them.

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Stem Cells Fast Facts | CNN

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CNN
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Here is some background information about stem cells.

Scientists believe that stem cell research can be used to treat medical conditions including Parkinson’s disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis and rheumatoid arthritis.

Sources: National Institutes of Health, Mayo Clinic

Stem cell research focuses on embryonic stem cells and adult stem cells.

Stem cells have two characteristics that differentiate them from other types of cells:

– They are unspecialized cells that can replicate themselves through cell division over long periods of time.

– Stem cells can be manipulated, under certain conditions, to become mature cells with special functions, such as the beating cells of the heart muscle or insulin-producing cells of the pancreas.

There are many different types of stem cells, including: pluripotent stem cells and adult stem cells.
– Pluripotent stem cells (ex: embryonic stem cells) can give rise to any type of cell in the body. These cells are like blank slates, and they have the potential to turn into any type of cell.
– Adult stem cells can give rise to multiple types of cells, but are more limited compared with embryonic stem cells. They are more likely to generate within a particular tissue, organ or physiological system. (Ex: blood-forming stem cells/bone marrow cells, sometimes referred to as multipotent stem cells)

Embryonic stem cells are harvested from four to six-day-old embryos. These embryos are either leftover embryos in fertility clinics or embryos created specifically for harvesting stem cells by therapeutic cloning. Only South Korean scientists claim to have successfully created human embryos via therapeutic cloning and have harvested stem cells from them.

Adult stem cells are already designated for a certain organ or tissue. Some adult stem cells can be coaxed into or be reprogrammed into turning into a different type of specialized cell within the tissue type – for example, a heart stem cell can give rise to a functional heart muscle cell, but it is still unclear whether they can give rise to all different cell types of the body.

The primary role of adult stem cells is to maintain and repair the tissue in which they are found.

Regenerative medicine uses cell-based therapies to treat disease.

Scientists who research stem cells are trying to identify how undifferentiated stem cells become differentiated as serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation.

Scientists believe stem cells can be used to generate cells and tissues that could be used for cell-based therapies as the need for donated organs and tissues outweighs the supply.

Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases, including Alzheimer’s diseases.

Cloning human embryos for stem cells is very controversial.

The goal of therapeutic cloning research is not to make babies, but to make embryonic stem cells, which can be harvested and used for cell-based therapies.

Using fertilized eggs left over at fertility clinics is also controversial because removing the stem cells destroys them.

Questions of ethics arise because embryos are destroyed as the cells are extracted, such as: When does human life begin? What is the moral status of the human embryo?

1998 – President Bill Clinton requests a National Bioethics Advisory Commission to study the question of stem cell research.

1999 – The National Bioethics Advisory Commission recommends that the government allow federal funds to be used to support research on human embryonic stem cells.

2000 – During his campaign, George W. Bush says he opposes any research that involves the destruction of embryos.

2000 – The National Institutes of Health (NIH) issues guidelines for the use of embryonic stem cells in research, specifying that scientists receiving federal funds can use only extra embryos that would otherwise be discarded. President Clinton approves federal funding for stem cell research but Congress does not fund it.

August 9, 2001 – President Bush announces he will allow federal funding for about 60 existing stem cell lines created before this date.

January 18, 2002 – A panel of experts at the National Academy of Sciences (NAS) recommends a complete ban on human reproductive cloning, but supports so-called therapeutic cloning for medical purposes.

February 27, 2002 – For the second time in two years, the House passes a ban on all cloning of human embryos.

July 11, 2002 – The President’s Council on Bioethics recommends a four-year ban on cloning for medical research to allow time for debate.

February 2005 – South Korean scientist Hwang Woo Suk publishes a study in Science announcing he has successfully created stem cell lines using therapeutic cloning.

December 2005 – Experts from Seoul National University accuse Hwang of faking some of his research. Hwang asks to have his paper withdrawn while his work is being investigated and resigns his post.

January 10, 2006 – An investigative panel from Seoul National University accuses Hwang of faking his research.

July 18, 2006 – The Senate votes 63-37 to loosen President Bush’s limits on federal funding for embryonic stem-cell research.

July 19, 2006 – President Bush vetoes the embryonic stem-cell research bill passed by the Senate (the Stem Cell Research Enhancement Act of 2005), his first veto since taking office.

June 20, 2007 – President Bush vetoes the Stem Cell Research Enhancement Act of 2007.

January 23, 2009 – The FDA approves a request from Geron Corp. to test embryonic stem cells on eight to 10 patients with severe spinal cord injuries. This will be the world’s first test in humans of a therapy derived from human embryonic stem cells. The tests will use stem cells cultured from embryos left over in fertility clinics.

March 9, 2009 – President Barack Obama signs an executive order overturning an order signed by President Bush in August 2001 that barred the NIH from funding research on embryonic stem cells beyond using 60 cell lines that existed at that time.

August 23, 2010 – US District Judge Royce C. Lamberth issues a preliminary injunction that prohibits the federal funding of embryonic stem cell research.

September 9, 2010 – A three-judge panel of the US Court of Appeals for the District of Columbia Circuit grants a request from the Justice Department to lift a temporary injunction that blocked federal funding of stem cell research.

September 28, 2010 – The US Court of Appeals for the DC Circuit lifts an injunction imposed by a federal judge, thereby allowing federally funded embryonic stem-cell research to continue while the Obama Administration appeals the judge’s original ruling against use of public funds in such research.

October 8, 2010 – The first human is injected with cells from human embryonic stem cells in a clinical trial sponsored by Geron Corp.

November 22, 2010 – William Caldwell, CEO of Advanced Cell Technology, tells CNN that the FDA has granted approval for his company to start a clinical trial using cells grown from human embryonic stem cells. The treatment will be for an inherited degenerative eye disease.

April 29, 2011 – The US Court of Appeals for the District of Columbia lifts an injunction, imposed last year, banning the Obama administration from funding embryonic stem-cell research.

May 11, 2011 – Stem cell therapy in sports medicine is spotlighted after New York Yankees pitcher Bartolo Colon is revealed to have had fat and bone marrow stem cells injected into his injured elbow and shoulder while in the Dominican Republic.

July 27, 2011 – Judge Lamberth dismisses a lawsuit that tried to block funding of stem cell research on human embryos.

February 13, 2012 – Early research published by scientists at Cedars-Sinai Medical Center and Johns Hopkins University shows that a patient’s own stem cells can be used to regenerate heart tissue and help undo damage caused by a heart attack. It is the first instance of therapeutic regeneration.

May 2013 – Scientists make the first embryonic stem cell from human skin cells by reprogramming human skin cells back to their embryonic state, according to a study published in the journal, Cell.

April 2014 – For the first time scientists are able to use cloning technologies to generate stem cells that are genetically matched to adult patients,according to a study published in the journal, Cell Stem Cell.

October 2014 – Researchers say that human embryonic stem cells have restored the sight of several nearly blind patients – and that their latest study shows the cells are safe to use long-term. According to a report published in The Lancet, the researchers transplanted stem cells into 18 patients with severe vision loss as a result of two types of macular degeneration.

May 2, 2018 – The science journal Nature reports that scientists have created a structure like a blastocyst – an early embryo – using mouse stem cells instead of the usual sperm and egg.

June 4, 2018 – The University of California reports that the first in utero stem cell transplant trial has led to the live birth of an infant that had been diagnosed in utero with alpha thalassemia, a blood disorder that is usually fatal for fetuses.

January 13, 2020 – In a study published in the Proceedings of the National Academy of Sciences, researchers announce they have created the world’s first living, self-healing robots using stem cells from frogs. Named xenobots after the African clawed frog (Xenopus laevis), the machines are less than a millimeter (0.04 inches) wide, small enough to travel inside human bodies. Less than two years later, scientists announce that these robots can now reproduce.

February 15, 2022 – A US woman becomes the third known person to go into HIV remission, and the first mixed-race woman, thanks to a transplant of stem cells from umbilical cord blood, according to research presented at a scientific conference on Retroviruses and Opportunistic Infections.

November 7, 2022 – Scientists announce they have transfused lab-made red blood cells grown from stem cells into a human volunteer in a world-first trial that experts say has major potential for people with hard-to-match blood types or conditions such as sickle cell disease.

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Opioid Crisis Fast Facts | CNN

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CNN
—

Here’s a look at the opioid crisis.

Experts say the United States is in the throes of an opioid epidemic. An estimated 9.2 million Americans aged 12 and older misused opioids in 2021, including 8.7 million prescription pain reliever abusers and 1.1 million heroin users.

Opioids are drugs formulated to replicate the pain-reducing properties of opium. Prescription painkillers like morphine, oxycodone and hydrocodone are opioids. Illegal drugs like heroin and illicitly made fentanyl are also opioids. The word “opioid” is derived from the word “opium.”

Nearly 110,000 people died of drug overdoses in 2022, and more than two-thirds of those deaths involved a synthetic opioid.

Overdose deaths have been on the rise for years in the United States, but surged amid the Covid-19 pandemic: Annual deaths were nearly 50% higher in 2021 than in 2019, CDC data shows.

Prescription opioid volumes peaked in 2011, with the equivalent of 240 billion milligrams of morphine prescribed, according to the market research firm, IQVIA Institute for Human Data Science.

Alabama, Arkansas, Louisiana and Tennessee had the highest opioid dispensing rates in 2020.

Opioids such as morphine and codeine are naturally derived from opium poppy plants more commonly grown in Asia, Central America and South America. Heroin is an illegal drug synthesized from morphine.

Hydrocodone and oxycodone are semi-synthetic opioids, manufactured in labs with natural and synthetic ingredients.

Fentanyl is a fully synthetic opioid, originally developed as a powerful anesthetic for surgery. It is also administered to alleviate severe pain associated with terminal illnesses like cancer. The drug is up to 100 times more powerful than morphine. Just a small dose can be deadly. Illicitly produced fentanyl has been a driving factor in the number of overdose deaths in recent years.

Methadone is another fully synthetic opioid. It is commonly dispensed to recovering heroin addicts to relieve the symptoms of withdrawal.

Opioids bind to receptors in the brain and spinal cord, disrupting pain signals. They also activate the reward areas of the brain by releasing the hormone dopamine, creating a feeling of euphoria or a “high.”

Opioid use disorder is the clinical term for opioid addiction or abuse.

People who become dependent on opioids may experience withdrawal symptoms when they stop using the medication. Dependence is often coupled with tolerance, meaning that users need to take increasingly larger doses for the same effect.

A drug called naloxone, available as an injection or a nasal spray, is used as a treatment for overdoses. It blocks or reverses the effects of opioids and is often carried by first responders.

More data on overdose deaths

The 21st Century Cures Act, passed in 2016, allocated $1 billion over two years in opioid crisis grants to states, providing funding for expanded treatment and prevention programs. In April 2017, Health and Human Services Secretary Tom Price announced the distribution of the first round of $485 million in grants to all 50 states and US territories.

In August 2017, Attorney General Jeff Sessions announced the launch of an Opioid Fraud and Abuse Detection Unit within the Department of Justice. The unit’s mission is to prosecute individuals who commit opioid-related health care fraud. The DOJ is also appointing US attorneys who will specialize in opioid health care fraud cases as part of a three-year pilot program in 12 jurisdictions nationwide.

On October 24, 2018, President Donald Trump signed opioid legislation into law. The SUPPORT for Patients and Communities Act includes provisions aimed at promoting research to find new drugs for pain management that will not be addictive. It also expands access to treatment for substance use disorders for Medicaid patients.

State legislatures have also introduced measures to regulate pain clinics and limit the quantity of opioids that doctors can dispense.

1861-1865 – During the Civil War, medics use morphine as a battlefield anesthetic. Many soldiers become dependent on the drug.

1898 – Heroin is first produced commercially by the Bayer Company. At the time, heroin is believed to be less habit-forming than morphine, so it is dispensed to individuals who are addicted to morphine.

1914 – Congress passes the Harrison Narcotics Act, which requires that doctors write prescriptions for narcotic drugs like opioids and cocaine. Importers, manufacturers and distributors of narcotics must register with the Treasury Department and pay taxes on products

1924 – The Anti-Heroin Act bans the production and sale of heroin in the United States.

1970 – The Controlled Substances Act becomes law. It creates groupings (or schedules) of drugs based on the potential for abuse. Heroin is a Schedule I drug while morphine, fentanyl, oxycodone (Percocet) and methadone are Schedule II. Hydrocodone (Vicodin) is originally a Schedule III medication. It is later recategorized as a Schedule II drug.

January 10, 1980 – A letter titled “Addiction Rare in Patients Treated with Narcotics” is published in the New England Journal of Medicine. It looks at incidences of painkiller addiction in a very specific population of hospitalized patients who were closely monitored. It becomes widely cited as proof that narcotics are a safe treatment for chronic pain.

1995 – OxyContin, a long-acting version of oxycodone that slowly releases the drug over 12 hours, is introduced and aggressively marketed as a safer pain pill by manufacturer, Purdue Pharma.

May 10, 2007 – Purdue Pharma pleads guilty for misleadingly advertising OxyContin as safer and less addictive than other opioids. The company and three executives are charged with “misleading and defrauding physicians and consumers.” Purdue and the executives agree to pay $634.5 million in criminal and civil fines.

2010 – FDA approves an “abuse-deterrent” formulation of OxyContin, to help curb abuse. However, people still find ways to abuse it.

May 20, 2015 – The DEA announces that it has arrested 280 people, including 22 doctors and pharmacists, after a 15-month sting operation centered on health care providers who dispense large amounts of opioids. The sting, dubbed Operation Pilluted, is the largest prescription drug bust in the history of the DEA.

March 18, 2016 – The CDC publishes guidelines for prescribing opioids for patients with chronic pain. Recommendations include prescribing over-the-counter pain relievers like acetaminophen and ibuprofen in lieu of opioids. Doctors are encouraged to promote exercise and behavioral treatments to help patients cope with pain.

March 29, 2017 – Trump signs an executive order calling for the establishment of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. New Jersey Governor Chris Christie is selected as the chairman of the group, with Trump’s son-in-law, Jared Kushner, as an adviser.

July 31, 2017 – After a delay, the White House panel examining the nation’s opioid epidemic releases its interim report, asking Trump to declare a national public health emergency to combat the ongoing crisis

September 22, 2017 – The pharmacy chain CVS announces that it will implement new restrictions on filling prescriptions for opioids, dispensing a limited seven-day supply to patients who are new to pain therapy.

November 1, 2017 – The opioid commission releases its final report. Its 56 recommendations include a proposal to establish nationwide drug courts that would place opioid addicts in treatment facilities rather than prison.

February 9, 2018 – A budget agreement signed by Trump authorizes $6 billion for opioid programs, with $3 billion allocated for 2018 and $3 billion allocated for 2019.

February 27, 2018 – Sessions announces a new opioid initiative: The Prescription Interdiction & Litigation (PIL) Task Force. The mission of the task force is to support local jurisdictions that have filed lawsuits against prescription drugmakers and distributors.

March 19, 2018 – The Trump administration outlines an initiative to stop opioid abuse. The three areas of concentration are law enforcement and interdiction; prevention and education via an ad campaign; and job-seeking assistance for individuals fighting addiction.

April 9, 2018 – The US surgeon general issues an advisory recommending that Americans carry the opioid overdose-reversing drug, naloxone. A surgeon general advisory is a rarely used tool to convey an urgent message. The last advisory issued by the surgeon general, more than a decade ago, focused on drinking during pregnancy.

May 1, 2018 – The Journal of the American Medical Association publishes a study that finds synthetic opioids like fentanyl caused about 46% of opioid deaths in 2016. That’s a three-fold increase compared with 2010, when synthetic opioids were involved in about 14% of opioid overdose deaths. It’s the first time that synthetic opioids surpassed prescription opioids and heroin as the primary cause of overdose fatalities.

May 30, 2018 – The journal Medical Care publishes a study that estimates the cost of medical care and substance abuse treatment for opioid addiction was $78.5 billion in 2013.

June 7, 2018 – The White House announces a new multimillion dollar public awareness advertising campaign to combat opioid addiction. The first four ads of the campaign are all based on true stories illustrating the extreme lengths young adults have gone to obtain the powerful drugs.

December 12, 2018 – According to the National Center for Health Statistics, fentanyl is now the most commonly used drug involved in drug overdoses. The rate of drug overdoses involving the synthetic opioid skyrocketed by about 113% each year from 2013 through 2016.

January 14, 2019 – The National Safety Council finds that, for the first time on record, the odds of dying from an opioid overdose in the United States are now greater than those of dying in a vehicle crash.

March 26, 2019 – Purdue Pharma agrees to pay a $270 million settlement to settle a historic lawsuit brought by the Oklahoma attorney general. The settlement will be used to fund addiction research and help cities and counties with the opioid crisis.

July 17, 2019 – The CDC releases preliminary data showing a 5.1% decline in drug overdoses during 2018. If the preliminary number is accurate, it would mark the first annual drop in overdose deaths in more than two decades.

August 26, 2019 – Oklahoma wins its case against Johnson & Johnson in the first major opioid lawsuit trial to be held in the United States. Cleveland County District Judge Thad Balkman orders Johnson & Johnson to pay $572 million for its role in the state’s opioid crisis. The penalty is later reduced to $465 million, due to a mathematical error made when calculating the judgment. In November 2021, the Oklahoma Supreme Court reverses the decision.

September 15, 2019 – Purdue files for bankruptcy as part of a $10 billion agreement to settle opioid lawsuits. According to a statement from the chair of Purdue’s board of directors, the money will be allocated to communities nationwide struggling to address the crisis.

September 30, 2019 – The FDA and DEA announce that they sent warnings to four online networks, operating a total of 10 websites, which the agencies said are illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol.

February 25, 2020 – Mallinckrodt, a large opioid manufacturer, reaches a settlement agreement in principle worth $1.6 billion. Mallinckrodt says the proposed deal will resolve all opioid-related claims against the company and its subsidiaries if it moves forward. Plaintiffs would receive payments over an eight-year period to cover the costs of opioid-addition treatments and other needs.

October 21, 2020 – The Justice Department announces that Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to three federal criminal charges for its role in creating the nation’s opioid crisis. They agree to pay more than $8 billion and close down the company. The money will go to opioid treatment and abatement programs. The Justice Department also reached a separate $225 million civil settlement with the former owners of Purdue Pharma, the Sackler family. In November 2020, Purdue Pharma board chairman Steve Miller formally pleads guilty on behalf of the company.

March 15, 2021 – According to court documents, Purdue files a restructuring plan to dissolve itself and establish a new company dedicated to programs designed to combat the opioid crisis. As part of the proposed plan, the Sackler family agrees to pay an additional $4.2 billion over the next nine years to resolve various civil claims.

September 1, 2021 – In federal bankruptcy court, Judge Robert Drain rules that Purdue Pharma will be dissolved. The settlement agreement resolves all civil litigation against the Sackler family members, Purdue Pharma and other related parties and entities, and awards them broad legal protection against future civil litigation. The Sacklers will relinquish control of family foundations with over $175 million in assets to the trustees of a National Opioid Abatement Trust. On December 16, 2021, a federal judge overturns the settlement.

February 25, 2022 – Johnson & Johnson and the three largest US drug distributors – McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp – finalize a $26 billion nationwide opioid settlement.

March 3, 2022 – The Sackler families reaches a settlement with a group of states the first week of March, according to court filings. The settlement, ordered through court-ordered mediation that began in January, requires the Sacklers to pay out as much as $6 billion to states, individual claimants and opioid crisis abatement, if approved by a federal bankruptcy court judge.

November 2, 2022 – CVS and Walgreens agree to pay a combined $10 billion, over 10 and 15 years, to settle lawsuits brought by states and local governments alleging the retailers mishandled prescriptions of opioid painkillers.

November 15, 2022 – Walmart agrees to the framework of a $3.1 billion settlement, which resolves allegations from multiple states’ attorneys general that the company failed to regulate opioid prescriptions contributing to the nationwide opioid crisis.

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Amid contradictory laws, hospitals in one state were unable to explain policies on emergency abortion care, study finds | CNN

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CNN
—

Oklahoma’s laws restricting abortions have created a confusing, contradictory environment that may have a chilling effect on health care, new research says.

After the US Supreme Court overturned the right to an abortion last year with the Dobbs v. Jackson Women’s Health Organization decision, several states quickly passed laws that restricted such procedures. A report released Tuesday and described in the medical journal the Lancet finds that the laws in at least one state left workers at many hospitals confused about how to proceed.

When the court made its decision, the Oklahoma law that criminalized abortion in 1910 went back into effect, according to the state’s attorney general. Lawmakers then created multiple overlapping laws that further criminalized abortion and increased penalties for those who performed or assisted in an abortion procedure, according to the new report from Physicians for Human Rights, Oklahoma Call for Reproductive Justice and the Center for Reproductive Rights.

The Oklahoma laws allow abortion in the case of a medical emergency, but one doesn’t define a medical emergency. Another says it allows for the “preservation of life in a medical emergency,” defined as causing “substantial and irreversible body of bodily impairment” – which is not a medical term, experts say.

To understand exactly how well Oklahoma hospitals understood the laws, the researchers used a “secret shopper method,” study co-author Dr. Michele Heisler said.

Researchers posed as prospective patients and called 34 hospitals to ask about the emergency pregnancy care they offered.

Heisler said that when the researchers designed the study, she expected the hospitals to tell the patients that they could get help in an emergency but that a second provider might have to sign off on an abortion or that a doctor would have to get the decision past an “onerous” hospital oversight committee.

“What we weren’t expecting is that there would be so much confusion and contradictory information and really not clear information,” said Heisler, who is medical director at Physicians for Human Rights and a professor of internal medicine and public health at the University of Michigan.

The researchers said that none of the hospitals they contacted in Oklahoma was totally able to articulate clear, consistent policies for emergency obstetric care to potential patients.

Specifically, 65% – 22 of the 34 hospitals – were unable to provide information about policies, procedures or the support provided to doctors when it is clinically necessary to terminate a pregnancy to save the life of a pregnant patient.

In 14 of the 22 cases, hospital representatives provided unclear and/or incomplete answers about whether doctors require approval to perform a medically necessary abortion.

Three of the hospitals said they do not provide abortions at all, even though it remains legal in the case of a medical emergency or to “preserve the life” of the pregnant person. Four others provided information that was factually wrong, the report says.

Four hospitals said they had formal approval processes that clinicians must go through if they have a situation in which it is medically necessary to terminate a pregnancy; they cannot make that decision on their own.

Three hospitals indicated that they have policies for these situations but refused to share any information about them.

“Unfortunately, it is being just left up to individual health systems and clinicians to try to make sense of these laws and provide guidance and support,” Heisler said.

The Oklahoma Hospital Association said it has been in conversations with Oklahoma’s medical licensure boards to seek clarity about the state’s conflicting abortion laws.

The association sent guidance to its members in September to explain what it interpreted as “saving the life of a pregnant woman” and what the laws would mean for a person made pregnant through rape or incest, among other issues. The guidance explains that the state’s criminal laws do not make an exception for these circumstances unless it is to save the life of someone who is pregnant in a medical emergency.

The guidance also warns that a person convicted of “administering, prescribing, advising, or procuring a woman to take any medicine drug or substance, or a person convicted of using or employing any instruction or ‘other means whatever,’ with the intent to procure an abortion, shall be guilty of a felony punishable by two (2) to (5) years imprisonment. From August 27, 2022, forward, a person convicted of performing or attempting to perform an abortion shall be guilty of a felony punishable by a fine not to exceed One Hundred Thousand ($100,000.00) and/or imprisonment not to exceed ten (10) years.”

The guidance says the “persons potentially liable” are the provider, not the pregnant person.

Study co-author Rabia Muqaddam, a senior staff attorney at the Center for Reproductive Rights who is working on multiple cases challenging the abortion bans in Oklahoma, called the overlapping laws a “bizarre” situation.

“Aside from the fact that there are so many of them is that they all conflict,” she said. “All of the laws have inconsistent definitions, which is where a lot of the confusion comes from for health care providers. What’s most dangerous for patients is the fact that the definitions of medical emergency and life-preserving abortions is unclear and inconsistent.”

“If I was the hospital general counsel and I was looking at these laws, I have absolutely no idea what my physician could or could not do in any particular circumstance,” she said.

When there is a lack of clarity and when penalties are involved, “what you get is massive chill.”

“Physicians are terrified. They’re terrified that if they make the wrong decision, they’re going to go to jail. They’re going to lose their license. And at the other end of that is that patients are being seriously harmed,” Muqaddam said.

Sonia M. Suter, a professor of law at George Washington University who was not involved in the new research, said recent abortion laws have created “such a mess.”

“You are telling physicians that they have two conflicting obligations,” said Suter, whose scholarship focuses on issues at the intersection of law, medicine and bioethics, with a particular focus on reproductive rights.

There is an obligation to stabilize patients in emergencies that may not always qualify as “life-threatening,” but doctors and hospitals could also risk being sued because the doctors are not following the standard of care, “which you can’t do with how some of these exceptions are worded.”

She said hospitals also don’t know how the laws will be applied. Lawyers typically will instruct institutions to interpret the law as conservatively as possible, and physicians may be equally conservative because they don’t want to risk their licenses or face stiff penalties.

“It’s just devastating for everybody,” Suter said. “It’s just cruel.”

Molly Meegan, general counsel for the American College of Obstetricians and Gynecologists, said state laws to restrict abortion with emergency exceptions are not comprehensive.

“They can’t be applied in a medical situation. They just aren’t practical,” she said. “They have an ethical and personal duty to their patients to do what is best for their patients. It can at times be in direct conflict with whatever the laws are, especially if they’re vague, and most of the ob/gyns throughout the country, including in Oklahoma, are in an impossible situation.”

Meegan and Suter both believe the confusion will lead to the deaths of more women. Those who survive may be left with dire health problems, including losing the ability to have children in the future.

“They already have horrific maternal mortality and infant mortality rates,” Suter said. “It feels like the end of evidence-based medicine.”

According to the US Centers for Disease Control and Prevention, Oklahoma persistently ranks among the states with the worst rates of maternal deaths, even before the new abortion laws went into effect. The state had a maternal mortality rate of 25.2 deaths per 100,000 live births for 2018-20, well above the national average.

For communities of color, the rate is significantly worse, according to the Oklahoma Health Department.

White women had 23.2 maternal deaths per 100,000 live births for 2018-20, the lowest rate overall in Oklahoma. The rates for Black women and Native American women were about twice as high: 49.4 and 44.4, respectively.

Oklahoma is not alone. The 13 states where most abortions are banned generally have some of the highest infant and maternal mortality rates in the country, Heisler said. Even more states could be restricting abortion access soon, the experts believe, with potentially more problems to come.

“The hostile climate many states are creating for the health care field by enacting criminal and other penalties for abortion care is an outcome whose reverberations we are only just beginning to see,” said Kelly Baden, vice president for public policy at the reproductive health nonprofit Guttmacher Institute.

Heisler noted that the researchers don’t blame the hospitals or the doctors for this confusion. Overall, she said, the staffers who talked to the researchers “were wonderful,” despite the circumstances.

“They were empathetic. They said, ‘I completely understand.’ They tried to give answers. They acted in good faith. But really, none of the hospitals were really able to say what we were hoping for, which is to unequivocally state that they would stand behind their clinicians and that clinicians at their facilities would be able to use their best clinical judgment for the individual case and that it would be made as medical decisions should be in collaboration with the patient, taking into account to their needs, their preferences and their values,” she said.

“We are recognizing that hospitals and clinicians are in an untenable situation,” Heisler added.

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These women ran an underground abortion network in the 1960s. Here’s what they fear might happen today | CNN

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CNN
—

The voice on the phone in 1966 was gruff and abrupt: “Do you want the Chevy, the Cadillac or the Rolls Royce?”

A Chevy abortion would cost about $200, cash in hand, the voice explained. A Cadillac was around $500, and the Rolls Royce was $1,000.

“You can’t afford more than the Chevy? Fine,” the voice growled. “Go to this address at this time. Don’t be late and don’t forget the cash.” The voice disappeared.

Dorie Barron told CNN she recalls staring blankly at the phone in her hand, startled by the sudden empty tone. Then it hit her: She had just arranged an illegal abortion with the Chicago Mafia.

The motel Barron was sent to was in an unfamiliar part of Chicago, a scary “middle of nowhere,” she said. She was told to go to a specific room, sit on the bed and wait. Suddenly three men and a woman came in the door.

“I was petrified. They spoke all of three sentences to me the entire time: ‘Where’s the money?’ ‘Lie back and do as I tell you.’ And finally ‘Get in the bathroom,’” when the abortion was over, Barron said. “Then all of a sudden they were gone.”

Bleeding profusely, Barron managed to find a cab to take her home. When the bleeding didn’t stop, her bed-ridden mother made her go to the hospital.

At 24, Barron was taking care of her ailing mother and her 2-year-old daughter when she discovered she was pregnant. Her boyfriend, who had no job and lived with his parents, “freaked,” said Barron, who appears in a recent HBO documentary. The boyfriend suggested she get an abortion. She had never considered that option.

“But what was I to do? My mom was taking care of my daughter from her bed while I worked — they would read and play games until I got home,” Barron said.”How was either of us going to cope with a baby?

“Looking back, I realize I was taking my life in my hands,” said Barron, now an 81-year-old grandmother. “To this day it gives me chills. If I had died, what in God’s green earth would have happened to my mom and daughter?”

Women in the 1960s endured restrictions relatively unknown to women today. The so-called “fairer sex” could not serve on juries and often could not get an Ivy League education. Women earned about half as much as a man doing the same job and were seldom promoted.

Women could not get a credit card unless they were married — and then only if their husband co-signed. The same applied to birth control — only the married need apply. More experienced women shared a workaround with the uninitiated: “Go to Woolworth, buy a cheap wedding-type ring and wear it to your doctor’s appointment. And don’t forget to smile.”

Marital rape wasn’t legally considered rape. And, of course, women had no legal right to terminate a pregnancy until four states — Alaska, Hawaii, New York and Washington — legalized abortion in 1970, three years before Roe v. Wade became the law of the land.

Illinois had no such protection, said Heather Booth, a lifelong feminist activist and political strategist: “Three people discussing having an abortion in Chicago in 1965 was a conspiracy to commit felony murder.”

Despite that danger, a courageous band of young women — most in their 20’s, some in college, some married with children — banded together in Chicago to create an underground abortion network. The group was officially created in 1969 as the “Abortion Counseling Service of Women’s Liberation.”

But after running ads in an underground newspaper: “Pregnant? Don’t want to be? Call Jane,” each member of the group answered the phone as “Jane.”

Despite their youth, members of Jane managed to run an illegal abortion service dedicated to each woman's needs.
From left: Martha Scott, Jeanne Galatzer-Levy, Abby Pariser, Sheila Smith and Madeline Schwenk.

“We were co-conspirators with the women who called us,” said 75-year-old Laura Kaplan, who published a book about the service in 1997 entitled “The Story of Jane: The Legendary Underground Feminist Abortion Service.”

“We’ll protect you; we hope you’ll protect us,” Kaplan said. “We’ll take care of you; we hope you’ll take care of us.”

What started as referrals to legitimate abortion providers changed to personalized service when some members of Jane learned to safely do the abortions themselves. Between the late 1960s and 1973, the year that the Supreme Court decided Roe v. Wade, Jane had arranged or performed over 11,000 abortions.

“Our culture is always searching for heroes,” said Kaplan. “But you don’t have to be a hero to do extraordinary things. Jane was just ordinary people working together — and look what we could accomplish, which is amazing, right?”

Even after several members were caught and arrested, the group continued to provide abortions for women too poor to travel to states where abortion had been legalized.

“I prayed a lot. I didn’t want to go to jail,” said 80-year-old Marie Learner, who allowed the Janes to perform abortions at her apartment.

“Some of us had little children. Some were the sole breadwinners in their home,” Learner said. “It was fearlessness in the face of overwhelming odds.”

Marie Learner opened her home to women undergoing abortions. Her neighbors knew, she said, but did not tell police.

The story of Jane has been immortalized in Kaplan’s book, numerous print articles, a 2022 movie, “Call Jane,” starring Elizabeth Banks and Sigourney Weaver, and a documentary on HBO (which, like CNN, is owned by Warner Bros. Discovery).

Today the historical tale of Jane has taken on a new significance. After the 2022 Supreme Court reversal of Roe v. Wade and the mid-term takeover of the US House of Representatives by Republicans, emboldened conservative lawmakers and judges have acted on their anti-abortion beliefs.

Currently more than a dozen states have banned or imposed severe restrictions on abortion. Georgia has banned abortions after six weeks, even though women are typically unaware they are pregnant at that stage. In mid-April, Florida Governor Ron DeSantis signed a bill that would ban most abortions after six weeks. It won’t go into effect until the state Supreme Court overturns its previous precedent on abortion. Several other states are considering similar legislation. In other states, judicial battles are underway to protect abortion access.

“It’s a horrific situation right now. People will be harmed, some may even die,” said Booth, who helped birth the Jane movement while in college.

“Women without family support, without the information they need, may be isolated and either harm themselves looking to end an unwanted pregnancy or will be harmed because they went to an unscrupulous and illegal provider,” said Booth, now 77.

A key difference between the 60s and today is medication abortion, which 54% of people in the United States used to end a pregnancy in 2022. Available via prescription and through the mail, use of the drugs is two-fold: A person takes a first pill, mifepristone, to block the hormone needed for a pregnancy to continue.  A day or two later, the patient takes a second drug, misoprostol, which causes the uterus to contract, creating the cramping and bleeding of labor.

In early April a Texas judge, US District Judge Matthew Kacsmaryk – a Trump appointee who has been vocal about his anti-abortion stance — suspended the US Food and Drug Administration’s approval of mifepristone despite 23 years of data showing the drug is safe to use, safer even than penicillin or Viagra.

On Friday, the Supreme Court froze the ruling and a subsequent decision by the Fifth US Circuit Court of Appeals at the request of the Justice Department and the drug manufacturer. The action allows access to mifepristone in states where it’s legal until appeals play out over the months to come.

However, 15 states currently restrict access to medication abortion, even by mail.

The actions of anti-abortion activists, who have been accused of “judge shopping” to get the decisions they want, is “an unprecedented attack on democracy meant to undermine the will of the vast majority of Americans who want this pill — mifepristone — to remain legal and available,” Heather Booth told CNN.

“This is a further weaponization of the courts to brazenly advance the end goal of banning abortion entirely,” she added.

If women in her day could have had access to medications that could be used safely in their homes, they would not have been forced to risk their lives, said Dorie Barron, thinking back to her own terrifying abortion in a sketchy Chicago motel.

“I’m depressed as hell, watching stupid, indifferent men control and destroy women’s lives all over again,” she said. “I really fear getting an abortion could soon be like 1965.”

Chicago college student Heather Booth had just finished a summer working with civil rights activists in Mississippi when she was asked to help with a different kind of injustice.

Heather Booth, 18, with civil rights heroine Fannie Lou Hamer during

A girl in another dorm was considering suicide because she was pregnant. Booth, who excelled at both organization and chutzpah, found a local doctor and negotiated an abortion for the girl. Word spread quickly.

“There were about 100 women a week calling for help, much more than one person could handle,” Booth said. “I recruited about 12 other people and began training them how to do the counseling.”

Counseling was a key part of the new service. This was a time when people “barely spoke about sex, how women’s bodies functioned or even how people got pregnant,” Booth said. To help each woman understand what was going to happen to them, Booth quizzed the abortion provider about every aspect of the procedure.

“What do you do in advance? Will it be painful? How painful? Can you walk afterwards? Do you need someone to be with you to take you home?” The questions continued: “What amount of bleeding is expected, and can a woman handle it on their own? If there’s a problem is there an urgent number they can call?”

Armed with details few if any physicians provided, the counselors at Jane could fully inform each caller about the abortion experience. The group even published a flyer describing the procedure, long before the groundbreaking 1970 book “Our Bodies, Ourselves” began to educate women about their sexuality and health.

“I don’t particularly like doctors because I always feel dissatisfied with the experience,” said Marie Learner, who spoke to many of the women who underwent an abortion at her home.

“But after their abortion at Jane, women told me, ‘Wow, that was the best experience I’ve ever had with people helping me with a medical issue.’”

Eileen Smith, now 73, was one of those women. “Jane made you feel like you were part of this bigger picture, like we were all in this together,” she said. “They helped me do this illegal thing and then they’re calling to make sure I’m OK? Wow!

“For me, it helped battle the feeling that I was a bad person, that ‘What’s wrong with me? Why did I get pregnant? I should know better’ voice in my head,” said Smith. “It was priceless.”

Like many young women in the 60s, Heather Booth often protested for civil and women's rights.

Many of the women who joined Jane had never experienced an abortion. Some viewed the work as political, a part of the burgeoning feminist movement. Others considered the service as simply humanitarian health care. All saw the work as an opportunity to respect each woman’s choice.

“I was a stay-at-home mom with four kids,” said Martha Scott, who is now in her 80s. “We knew the woman needed to feel as though she was in control of what was happening to her. We were making it happen for her, but it was not about us. It was about her.”

Some volunteers, like Dorie Barron, experienced the Jane difference firsthand when she found herself pregnant a few years after her abortion at the hands of the Mafia.

“It was a 100% total reversal — I had never experienced such kindness,” Barron said. Not only did a Jane hold each woman’s hand and explain every step of the process, “they gave each of us a giant supply of maternity sanitary pads, and a nice big handful of antibiotics,” she said. “And for the next week, I got a phone call every other day to see how I was.”

Barron soon began volunteering for Jane by providing pregnancy testing for women in the back of a church in Chicago’s Hyde Park.

“It wasn’t just abortion,” Barron explained. “We also said, ‘You could consider adoption,’ and gave adoption referrals. And if the woman wanted to continue with her pregnancy, we said, ‘Fine, please by all that is holy make sure you get prenatal care, take your vitamins, and eat as best you can.’ It was women helping women with whatever they needed.”

Most of the women who contacted Jane were unable to support themselves, in unhealthy relationships, or already had children at home, so the service was a way of “helping them get back on track,” said Smith, who, like Barron, had begun working for Jane after her abortion.

“We were telling them ‘This isn’t the end of the world. You can continue to leave your boyfriend or your husband or continue to just take care of those kids you have.’ We were there to help them get through this,” said Smith, who later became a homecare nurse.

From left: Eileen Smith, Diane Stevens and Benita Greenfield were three of the dozens of women who volunteered for Jane.

Diane Stevens says she came to work for Jane after experiencing an abortion in 1968 at the age of 19. She was living in California at the time, which provided “therapeutic abortions” if approved in advance by physicians.

“I’d had a birth control failure, and I was coached by Planned Parenthood on how to do this,” said Stevens, now 74. “I had to see two psychiatrists and one doctor and tell them I was not able to go through with the pregnancy because it would a danger to both my physical and mental health.

“I was admitted to the psychiatric ward, although I didn’t really know that — I thought I was just in a hospital bed. But oh no, ‘I was mentally ill,’ so that’s where they put me,” said Stevens, who later went to nursing school with Smith. “Then they wheeled me off for the abortion. I had general anesthesia, was there for two days, and then I was discharged. Isn’t that crazy?”

Sakinah Ahad Shannon, now 75, was one of the few Black women who volunteered as a counselor at Jane. She joined after accompanying a friend who was charged a mere $50 for her abortion. At that time, Jane’s fee was between $1 and $100, based on what the woman could afford to pay, Shannon said.

“When I walked in, I said, ‘Oh my God, here we go again. It’s a room of White women, archangels who are going to save the world,’” said Shannon, a social worker and member of the Congress of Racial Equality, an interracial group of non-violent activists who pioneered “Freedom Rides” and helped organize the March on Washington in 1963.

What she heard and saw at her friend’s counseling session was so impressive it “changed my life,” Shannon said. She and her family later opened and operated three Chicago abortion clinics for over 25 years, all using the Jane philosophy of communication and respect.

“It was a profoundly amazing experience for me,” she said. “I call the Janes my sisters. The color line didn’t matter. We were all taking the same risk.”

Sakinah Ahad Shannon and her daughters went on to open and run three abortion clinics in Chicago.

It wasn’t long before the women discovered a “doctor” performing abortions for Jane had been lying about his credentials. There was no medical degree — in the HBO documentary, he admitted he had honed his skills by assisting an abortion provider.

The group imploded. A number of members quit in horror and dismay. For the women who stayed, it was an epiphany, said Martha Scott. Like her, several of the Janes had been assisting this fake doctor for years, learning the procedures step by step.

“You’d learn how to insert a speculum, then how to swap out the vagina with an antiseptic, then how to give numbing shots around the cervix and then how to dilate the cervix. You learned and mastered each step before you moved on to the next,” said Laura Kaplan, who chronicled the procedure in her book.

By now, several of the Janes were quite experienced and willing to do the work. Why not perform the abortions themselves?

“Clearly, this was an intense responsibility,” said Judith Acana, a 27-year-old high school teacher who joined Jane in 1970. She started her training by helping “long terms,” women who were four or five months along in the pregnancy.

“Remember, abortion was illegal (in Illinois) so it could take weeks for a woman to find help,” said Arcana, now 80. “Frequently women who wanted an abortion at 8 or 10 weeks wound up being 16 or 18 weeks or more by the time they found Jane.”

The miscarriage could happen quickly, but it rarely did, she said. It usually took anywhere from one to two days.

“Women who had no one to help them would come back when contractions started,” Arcana said. “One of my strongest memories is of a teenage girl who had an appointment to have her miscarriage on my living room floor.”

The group also paid two Janes to live in an apartment and be on call 24/7 to assist women who had no one to help them miscarry at home, said Arcana, a lifelong educator, author and poet. “But many women took care of it on their own, in very amazing and impressive and powerful ways,” she said.

Judith Arcana learned how to do abortions herself and wrote about the Jane experience in poems, stories, essays and books.

Any woman who had concerns or questions while miscarrying alone could always call Jane for advice any time of the day or night.

“People would call in a panic: ‘The bleeding won’t stop,’” Smith recalled. “I would tell them, ‘Get some ice, put it on your stomach, elevate your legs, relax.’ And they would say ‘Oh my gosh, thank you!’ because they were so scared.”

For women who were in their first trimester, Jane offered traditional D&C abortions — the same dilation and curettage used by hospitals then and today, said Scott, who performed many of the abortions for Jane. Later the group used vacuum aspiration, which was over in a mere five to 10 minutes.

“Vacuum aspiration was much easier to do, and I think it’s less difficult for the woman,” Scott said. “Abortion is exactly like any other medical procedure. It’s the decision that’s an issue — the doing is very straightforward. This was something a competent, trained person could do.”

It was May 3, 1972. Judith Arcana was the driver that day, responsible for relocating women waiting at what was called “the front” to a separate apartment or house where the abortions were done, known as “the place.”

On this day, a Wednesday, the “place” was a South Shore high-rise apartment. Arcana was escorting a woman who had completed her abortion when they were stopped by police at the elevator.

“They asked us, ‘Which apartment did you come out of?’ And the poor woman burst into tears and blurted out the apartment number,” Arcana said. “They took me downstairs, put cuffs on me and hooked me to a steel hook inside of the police van.”

Inside the apartment on the 11th floor, Martha Scott said she was setting up the bedroom for the next abortion when she heard a knock at the door, followed by screaming: “You can’t come in!”

“I shut the bedroom door and locked it,” Scott said, then hid the instruments and sat on the bed to wait. It wasn’t long until a cop kicked the door in and made her join the other women in the living room.

“We tell this joke about how the cops came in, saw all these women and said, ‘Where’s the abortionist?’ You know, assuming that it would be a man,” Scott said.

By day’s end, seven members of Jane were behind bars: Martha Scott, Diane Stevens, Judy Arcana, Jeanne Galatzer-Levy, Abby Pariser, Sheila Smith and Madeleine Schwenk. Suddenly what had been an underground effort for years was front page headlines.

“Had we not gotten arrested, I think no one would ever have known about Jane other than the women we served,” Scott said.

Top: Sheila Smith and Martha Scott.
Bottom: Diane Stevens and Judith Arcana.

An emergency meeting of Jane was called. The turnout was massive — even women who had not been active in months showed up, anxious to know the extent of the police probe, according to the women with whom CNN spoke.

Despite widespread fear and worry, the group immediately began making alternate plans for women scheduled for abortions at Jane in the next few days to weeks. The group even paid for transportation to other cities where abortion had already been legalized, they said.

News reports over the next few days gave further details of the bust: There was no widespread investigation by the police. It was a single incident, triggered by a call from a sister-in-law who was upset with her relative’s decision to have an abortion, they said.

“It wasn’t long after I was arrested that I came back and worked for quite a few months,” said Scott, one of the few fully trained to do abortions.

“I like to think I was a good soldier,” Scott said. “I like to think what did made a difference not only to a whole bunch of people, but also to ourselves. It gave us a sense of empowerment that comes when you do something that is hard to do and also right.”

As paranoia eased, women began to come back to work at Jane, determined to carry on.

“After the bust, we had a meeting and were told ‘Everybody needs to start assisting and learn how to do abortions.’ I was like, ‘Whoa, whoa, whoa!’” said Eileen Smith, who had not been arrested. “But you felt like you really didn’t have much of a choice. We had to keep the service running.”

Laura Kaplan volunteered for the Janes, later immortalizing the group in her book,

The preliminary hearing for the arrested seven was in August. Several of the women in the apartment waiting for abortions the day of the arrest suddenly developed amnesia and refused to testify. According to Kaplan’s book, one of the women later said, “The cops tried to push me around, but f**k them. I wasn’t going to tell on you.”

It didn’t matter. Each Jane was charged with 11 counts of abortion and conspiracy to commit abortion, with a possible sentence of up to 110 years in prison.

As they waited for trial, the lawyer for the seven, Jo-Anne Wolfson, adopted delaying tactics, Kaplan said. A case representing a Texas woman, cited as “Jane Roe” to protect her privacy, was being considered by the US Supreme Court. If the Court ruled in Roe’s favor, the case against the Jane’s might be thrown out.

That’s exactly what happened. On March 9, 1973, three months after the Supreme Court had legalized abortion in the US, the case against the seven women was dropped and their arrest records were expunged.

Later that spring, a majority of Janes, burned out by the intensity of the work over the last few years, voted to close shop. An end of Jane party was held on May 20. According to Kaplan’s book, the invitation read:

“You are cordially invited to attend The First, Last and Only Curette Caper; the Grand Finale of the Abortion Counseling Service. RSVP: Call Jane.”

Today, most of the surviving members of Jane are in their 70s and 80s, shocked but somehow not surprised by the actions of abortion opponents.

“This is a country of ill-educated politicos who know nothing about women’s bodies, nor do they care,” said Dorie Barron. “It will take generations to even begin to undo the devastating harm to women’s rights.”

In the meantime, women should research all available options, keep that information confidential, seek support from groups working for abortion rights, and “share your education with as many women as you can,” Barron added.

As more and more reproductive freedoms have been rolled back over the past year, many of the Janes are angry and fearful for the future.

Abortion rights demonstrators walk across the Brooklyn Bridge in New York nearly two weeks after the leak of a draft Supreme Court opinion that would overturn Roe v. Wade.

“This is about the most intimate decision of our lives — when, whether and with whom we have a child. Everyone should have the ability to make decisions about our own lives, bodies, and futures without political interference,” said Heather Booth, who has spent her life after leaving Jane fighting for civil and women’s rights.

“We need to organize, raise our voices and our votes, and overturn this attack on our freedom and our lives. I have seen that when we take action and organize we can change the world.”

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On ‘weed day,’ our medical analyst urges caution on recreational marijuana use | CNN

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CNN
—

As some people mark 4/20 as “weed day,” a day of celebration of marijuana use, I don’t want to bum you out — but I might.

Over the past decade, there has been a trend toward legalizing marijuana in the United States. Currently, at least 37 states, plus Washington, DC, have a comprehensive medical cannabis program. A growing number of states, currently at 21, have legalized recreational marijuana use.

I wanted to learn about the research around marijuana use, including the effects it has on the user and the medicinal uses for cannabis. I turned to CNN Medical Analyst Dr. Leana Wen, who has many concerns about recreational cannabis use, especially for certain populations such as young people and pregnant people.

Wen, who urged users and would-be users to be cautious, is an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She previously served as Baltimore’s health commissioner and as chair of Behavioral Health System Baltimore, where she oversaw policy and services around substances that can cause addiction, including marijuana.

CNN: What are the physiological effects of marijuana?

Dr. Leana Wen: Marijuana is a plant that has many active ingredients. One of the principal ones is a psychoactive compound called tetrahydrocannabinol. Often called THC, it’s similar to compounds that are naturally occurring in the body called cannabinoids and can mimic their function by attaching to cannabinoid receptors in the brain. In so doing, THC can disrupt normal mental and physical functions, including memory, concentration, movement and coordination.

Using marijuana can cause impaired thinking and interfere with someone’s ability to learn, according to the National Institute on Drug Abuse. Smoking cannabis can also impair the function of the parts of the brain that regulate balance, posture and reaction time. And THC stimulates the neurons involved in the reward system that release dopamine, or the “feel-good” brain chemical, which contributes to its addictive potential.

CNN: Marijuana is thought to have some positive and medicinal benefits. How can it be used for therapeutic purposes?

Wen: Short-term, many users report pleasant feelings, including happiness and relaxation. As a result, some people use marijuana to self-treat anxiety or depression. This is not a recommended use. What often ends up happening is that the person develops tolerance, requiring more and more of the drug to get the same effect.

There are some approved medicinal uses of marijuana for very specific indications. The US Food and Drug Administration has approved THC-based medications that are prescribed in pill form for treatment of nausea in patients with cancer undergoing chemotherapy and to stimulate appetite in patients with AIDS. There are several marijuana-based medications that are undergoing clinical trials for conditions like neuropathic pain, overactive bladder and muscle stiffness.

I think it’s really important for these and many more studies to continue. Researchers should continue to look not just at marijuana itself but its specific chemical components, since botanicals in their natural form can contain hundreds of active chemicals and obtaining the correct dosages may be challenging. In the meantime, users should use caution in evaluating supposed medicinal claims and clearly understand the risks of cannabis use.

CNN: What are the risks of marijuana use, and who may be particularly vulnerable to them?

Wen: The main concern about marijuana use is its impact on the developing brain. As the US Centers for Disease Control and Prevention states on its website, “Marijuana affects brain development. Developing brains, such as those in babies, children, and teenagers, are particularly susceptible to the harmful effects of marijuana and tetrahydrocannabinol.”

Numerous studies have linked marijuana use in women during pregnancy to a variety of cognitive and behavioral problems in their children. The CDC even warns against secondhand marijuana smoke exposure, and it also encourages breastfeeding individuals to avoid marijuana use.

Marijuana affects young people throughout adolescence and young adulthood. Much research has shown how marijuana use in childhood impacts memory, attention, learning and motivation. Regular cannabis use in adolescence is associated with higher likelihood of not completing high school and even lower IQ later in life. The negative impacts persist beyond the teen years. Some studies of university students have found that the regularity of marijuana use is correlated with lower grade point average in college.

I want to emphasize here that there is still a lot that we don’t know about the effects of marijuana, in particular long-term consequences. A recent study found that in adults, daily use of regular marijuana can increase the risk of coronary artery disease by as much as one-third. That’s the point, though; all the unknowns are exactly why I and many other clinicians and scientists urge caution.

To be clear, there are many reasons to support policy changes of decriminalizing marijuana, including to rectify the decades-long injustices of disproportionately incarcerating minority individuals for marijuana possession. However, supporting decriminalization should not be equated with believing that marijuana is totally safe. It’s not. Marijuana has the potential to cause real and lasting harm, especially to young people.

CNN: Could someone become addicted to marijuana?

Wen: Yes. There is a condition known as marijuana use disorder. Signs of this disorder include trying but failing to quit using marijuana;, continuing to use it even though it is causing problems at home, school or work;, and using marijuana in high-risk situations, including while driving. Some individuals, especially those who use large amounts, experience withdrawal symptoms when they try to stop.

As many as 3 in 10 people who use marijuana have marijuana use disorder, according to the CDC. The risk of developing marijuana use disorder is greater among those who use it more frequently and for those who started earlier in life.

CNN: Some people say that marijuana is no big deal, especially in comparison with other substances like alcohol and opioids. Would you agree that cannabis use is at least better than using those substances?

Wen: I wouldn’t frame it that way. It is true that marijuana doesn’t cause liver damage the way that high amounts of alcohol does, and it doesn’t have the lethality of opioids. If an adult is using marijuana once in a while, and not while driving, it’s probably not going to have lasting consequences.

However, there are harms associated with more frequent use of marijuana and in particular its use in children. In my opinion, the legalization movement has shifted the conversation so much towards acceptance of cannabis that we are neglecting the fact that it is a drug and, I believe, should be regulated just like alcohol, tobacco and opioids.

There should also be much more messaging and education so that people, including young people and their parents or guardians, can be aware of the harms of marijuana — just as they are aware of the harms of other drugs.

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Texas abortion drug ruling could create ‘slippery slope’ for FDA approvals, drug research and patients, experts say | CNN

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CNN
—

What happened in one judge’s courtroom in Texas could have drastic effects for the United States’ entire drug approval process, experts warn.

US District Judge Matthew Kacsmaryk’s ruling that suspended the US Food and Drug Administration’s approval of the medication abortion drug mifepristone was an unprecedented one, the first time a court has bypassed the federal system set up to determine what drugs should be allowed on the market.

Regardless of whether the ruling – or a part of it – is ultimately allowed to stand, legal scholars, scientists and drugmakers are concerned that the decision could start a trend of drugs being targeted in courts, creating a chilling effect on drug development in the US and hurting patients in the process.

Vaccines, including the Covid-19 shots, antidepressants and psychotropic medicines could be at risk, some said.

“Well, one does not want to be Chicken Little,” former FDA Commissioner Dr. Jane Henney said Wednesday, but “I can’t imagine that it wouldn’t have implications for other products.

“The approval process will be at risk, and it’s not just an approval process that patients rely on and providers rely on, it’s one that has been considered the gold standard, really, for the world,” said Henney, who was the head of the FDA when mifepristone was approved.

Since the dawn of the 20th century, the FDA has had the sole authority in the United States to regulate drugs. In 1906, the federal government created the agency to enforce the Pure Food and Drug Act, which was instituted to ensure that medicine, food and cosmetics were safe.

Over the years, that authority became more defined.

After elixir of sulfanilamide, a drug used to treat streptococcal infections, killed 107 people in 1937, Congress created the Food, Drug, and Cosmetic Act. Signed into law in 1938 by President Franklin D. Roosevelt, it required manufacturers to conduct pharmacological studies to prove that their drugs were safe before they could be sold or advertised. In 1962, drug manufacturers were also required to prove to the FDA that their products were effective.

Modern drug approval in the US is a careful and conscientious process. Before any drug goes to market, there are countless hours of research, the work and expertise of multiple scientists, and several layers of oversight for approval.

Until now, the courts have been deferential to the FDA’s process and have never overturned an FDA decision on the grounds that the agency misjudged the science, said William Schultz, a former deputy commissioner at the FDA and former general counsel for the Department of Health and Human Services.

“Any FDA drug approval involves hundreds of judgments by the agency. And if a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those FDA judgments wrong,” Schultz said in an online discussion Monday about the impact of the Texas court’s ruling that was hosted by Protect Our Care, an organization that advocates for equitable and affordable health care.

Hundreds of well-known biotech and pharmaceutical company leaders, concerned about the effects of Kacsmaryk’s ruling on other drug approvals, signed an open letter Monday in support of the FDA’s authority “to approve and regulate safe, effective medicines for every American.”

The letter also advocated a reversal of the mifepristone decision from a judge with “no scientific training,” saying it “set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”

In a separate statement, the biotech industry group BIO’s interim president and CEO, Rachel King, emphasized the “dangerous precedent” the decision sets.

“The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations,” King said.

The main lobbying group for the pharmaceutical industry, PhRMA, criticized Kacsmaryk’s ruling as undermining the regulatory process.

“PhRMA has serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making,” said James C. Stansel, the association’s executive vice president, general counsel and corporate secretary. Stansel added that such a decision could have a “chilling effect on the research and development ecosystem.”

The pharmacutical sector is a huge part of the American economy. Of the world’s 25 largest phamacutical companies, 10 are based in the US, and most of the others have a large base of operations in the country.

Often, the US market is the first to get access to new drugs, but that could change if lawsuits undermine the regulatory integrity of the FDA process, said Susan Lee, partner in the law firm Goodwin’s Life Sciences group and Life Sciences Regulatory & Compliance practice, who works with companies to get drugs approved by the FDA.

“If there do tend to be more lawsuits like this, I wonder if there might be a little bit of a tendency to not always look at the US as the first market,” Lee said. “Some manufacturers may say ‘we’d rather go to Europe, where we’re not going to be sued on a jurisdiction-by-jurisdiction basis.’ “

Lee also wonders whether manufacturers will abandon efforts to develop drugs that could be considered unappealing to some, such as those that help women’s health or work to prevent HIV.

“I think there are just certain sectors that are already kind of thinking about whether they might also have a target on their back. I’ve definitely heard that discussed,” Lee said.

The groups at the heart of the Texas case have not disclosed any further plans regarding lawsuits over medications, but experts say they are already hearing concern.

“I’ve already been getting questions from lawmakers and other people about ‘could the Covid vaccine be next?’ or other things that may have stigma around it,” said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

The Covid-19 vaccines have been thoroughly tested and found to be safe and effective, but they’re the subject of conspiracy theories and misunderstanding about how mRNA vaccines were tested. Beliefs that the vaccines were tested on recently harvested aborted fetal cells made some people decidedly anti-vaccine.

Dr. Lynn R. Goldman, professor and dean of the Milken Institute School of Public Health at George Washington University, is also concerned that mRNA vaccines could be targeted soon.

“There might be people who disagree with some of the technologies that are used by vaccine makers, like the mRNA vaccines, but feeling uncomfortable about a technology is not the same thing as identifying that there is risk,” she said in the Protect Our Care conversation.

Members of the LGBTQ+ community may also be vulnerable, experts say, as activists could target puberty blockers or hormones used in gender-affirming therapy.

“I don’t like to do slippery slope, but I’m also very worried about things like gender-affirming care, since there’s already been so many laws about that recently in other states,” Brandi said.

There is political pressure against other vaccines, antidepressants and psychotropic medicines, among others, former FDA Commissioner Margaret Hamburg and former Principal Deputy Commissioner Joshua Sharfstein wrote in an editorial published Thursday in the journal Science.

“If judges begin to dictate the terms of medication access, then others will seek to use ideology and influence to advance their agendas,” they warn.

Goldman said that any legal decision that could undermine the FDA drug approval process would ultimately hurt the doctors who prescribe them and the people who use them.

Doctors don’t have time to vet all the studies used to prove that a drug is safe and effective, so they rely on the FDA for this work, she said. Court interference could confuse this process.

“I think that this is, for doctors, an incredibly serious moment, because up to now, we have been able to trust that an approval by the FDA is a science-based decision and that we can say that if the FDA has approved a drug, that it is safe for us to use,” Goldman said.

A lack of confidence in the drug approval process will ultimately hurt people far beyond the most recent decision, Protect Our Care Chair Leslie Dach says.

“Confidence that the FDA can do its work is essential for clinicians and patients who depend on it in its decision-making for matters of life and death,” Dach said.

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Clinics and doctors brace for more restrictions on women’s health care after court ruling on abortion drug | CNN

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CNN
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Less than a year after the US Supreme Court ended legal protection for abortions nationwide, clinics that provide reproductive health care across the United States are bracing for more restrictions on the care they provide to women.

If a judge’s ruling takes effect Friday, it may soon be illegal for doctors to prescribe mifepristone, the first in a two-drug regimen that can help women terminate a pregnancy at home – and that has other uses.

At Northeast Ohio Women’s Center, staffers are calling patients who expected to get medication abortions next week, telling them to change their plans.

“They’re scrambling to change their schedules to get in to see us earlier,” said Dr. David Burkons, the physician who runs the clinics.

About half of abortions in the US use mifepristone, which is sold under the brand name Mifeprex.

Mifeprex blocks the hormone progesterone, which effectively stops a pregnancy from continuing. For an abortion, women take mifepristone first, followed one or two days later by misoprostol, a drug that causes the uterus to contract, cramp and bleed, similar to a heavy period. It empties out the uterus, ending the pregnancy. It can be used up to 10 weeks of pregnancy.

But the uses of mifepristone go beyond abortion.

The drug helps soften and open the cervix, the neck of the uterus, and doctors depend on it to help when women are having a miscarriage and when a pregnancy needs to be terminated quickly if the life of the mother is at stake.

In certain situations, when a pregnancy has become too risky, time is of the essence, says Dr. Alison Edelman, who directs the division of Complex Family Planning at Oregon Health and Sciences University.

“The more expediently that we can have somebody not be pregnant, the better, and mifepristone helps us speed that process up and make it safer for patients,” she said.

Doctors also use mifepristone before procedures in which they need to go into the uterus, such as to remove bleeding polyps. Studies have shown that the drug helps reduce the amount of force needed to open the cervix and reduces the amount of blood loss associated with the procedure.

Studies also show that mifepristone has moderate to strong benefits for inducing labor and treating uterine fibroids and endometriosis, sometimes helping avoid surgery, according to the American Society of Health Systems Pharmacists.

It can be used to prevent bleeding between periods and to control hyperstimulation of the ovaries during in-vitro fertilization, the society said in a statement.

Doctors say they still have other ways to treat those problems, but when considering the needs of individual patients, they will be missing a valuable tool.

“We have our gold standard of what we provide – the safest, most effective regimen – and then if it’s not available, we use the next best one. And that’s what we would be left with,” Edelman said.

Mifepristone has been approved by the US Food and Drug Administration for 23 years, and it has been used by over 5 million women in the United States. FDA data shows that less than 1% of women who take it have significant adverse events. A CNN analysis of FDA data found that mifepristone was even less risky than some other common medications, including Viagra and penicillin.

Medication abortions have become an increasingly important option for women in states that restricted abortion access after the Supreme Court’s ruling last year that ended legal protections for abortions in every state. They are also sometimes the only kind of abortion many women can get in rural areas that have lost abortion providers.

This ease of access has also made the medication regimen a target for abortion opponents.

“They want to see a national ban, and this is in fact what they are going for in this case,” said Kristen Moore, director of the EMAA Project, a nonprofit that is seeking to make it easier to get abortion medications in the US.

What will happen next is far from settled. Appeals have been filed to stop the ruling in Texas from taking hold, and higher courts will have to weigh in.

Even if the court does take mifepristone off the market in the US, doctors say, they will still be able to provide medication abortions using misoprostol alone.

In fact, some abortion providers have been planning on using misoprostol by itself in case mifepristone is isn’t available.

Carafem, which provides telehealth abortion care, has been offering a misoprostol-only regimen since the Covid-19 pandemic began, Chief Operating Officer Melissa Grant says.

“In 2020, we started to use misoprostol alone as an option,” she said. Workers have since been tweaking the regimen and gathering data.

“We now feel confident that, even though we would much prefer to use both, that we can use misoprostol alone effectively and are ready to switch gears to have a higher percentage of our clients or even 100% of our colleagues use that option if necessary,” Grant said.

Still, some providers said it’s not ideal.

The misoprostol-only regimen is slightly less effective than the one that uses both drugs, and it causes more cramping and bleeding, which can mean more complications.

“We’re more likely to see failures and therefore more likely to need surgical intervention after misoprostol alone,” said Dr. Erika Werner, chair of the Department of Obstetrics and Gynecology at Tufts Medical Center.

Still, doctors want women to know that medication abortions and miscarriage care will still be available even if mifepristone isn’t. And they hope that higher courts will intervene to keep this medication on pharmacy shelves.

“The clinicians would have to use these other options instead of choosing based on their own expertise, knowledge and judgment when rendering such care,” Dr. Iffath Hoskins, president of the American Congress of Obstetricians and Gynecologists, said Monday. “Frankly, as a clinician, I do not want to be in that position.”

Correction: This story has been updated to include the correct name of Tufts Medical Center.

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EPA proposes new regulations on toxic gas used to sterilize spices and medical equipment | CNN

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The US Environmental Protection Agency on Tuesday proposed a set of new restrictions on facilities that use the cancer-causing chemical ethylene oxide, a colorless, odorless gas that is used to sterilize medical devices and spices.

The agency said the new rules, which have not been finalized, would help to reduce ethylene oxide gas that these facilities release by 80%, bringing emissions below a Clean Air Act standard for elevated cancer risk.

Communities exposed to ethylene oxide gas have been pushing the EPA to put tighter controls on plants that use ethylene oxide gas.

In 2018, an EPA report found that dozens of communities across the nation faced elevated cancer risks because of trace of amounts of ethylene oxide released into air as part of the sterilization process.

The EPA issued the report on the new risks without issuing a news release, as it had done for the same report in years past. Some affected communities learned of the risk through a health assessment conducted by the Agency for Toxic Substances and Disease Registry, a division of the US Centers for Disease Control and Prevention, and media reports. A report from the EPA’s Office of the Inspector General found that some communities weren’t alerted to their risk by EPA at all.

The elevated risk became apparent after a two-decade long review of the toxicity of ethylene oxide by scientists in EPA’s Integrated Risk Information System (IRIS) program.

While the EPA acknowledged that ethylene oxide was more dangerous that had been previously understood, it continued to use an older set of rules to regulate facilities that released ethylene oxide as well as companies that manufacture it.

The proposed rules aim to better align regulations on the producers and users of ethylene oxide with the cancer risk posed by the chemical. They follow a set of proposed rules issued by EPA last week that would put new controls on facilities that manufacture ethylene oxide.

Taken together, the two sets of rules would remove 77 tons of ethylene oxide emissions a year, an 84% reduction compared with 2020 levels, EPA Deputy Administrator Janet McCabe said in a call with reporters on Tuesday.

Environmental watchdog groups applauded the proposed restrictions, but noted that they don’t go far enough to protect vulnerable communities, where residents are often low-income and disproportionately people of color.

“These regulations are long overdue, by almost a decade. I’m relieved and pleased that the EPA has finally issued proposed standards that are based on their own scientists’ recommendations on an updated, higher cancer risk value. If enacted, these updated regulations would reduce emissions in fenceline communities,” said Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists.

“When the EPA issues the final rule, they should throw the net wider. The standard should cover a larger range of facilities to include off-site warehouses that often store recently sterilized equipment that continue to release ethylene oxide, but aren’t regulated for their air emissions.”

Minovi also said the EPA should require fenceline monitors – devices that constantly read the air outside of facilities to make sure that toxic gas isn’t drifting into neighborhoods.

Jaime Rukstales, a member of the Illinois grassroots advocacy group Stop EtO in Lake County – one of the communities impacted by ethylene oxide pollution – says the EPA needs to impose tougher restrictions on “all types of facilities that impact the health of our communities … including sterilizers, manufacturers and warehouses near our homes, schools and businesses.”

Some off-site warehouses used to store newly sterilized products have registered high levels of ethylene oxide due to off-gassing of the products.

Meanwhile, chemical manufacturers sued the EPA in February over its updated hazard assessment for ethylene oxide. The industry wants the agency to use a less protective standard developed by the Texas Commission on Environmental Quality.

AdvaMed, a group that lobbies for the interests of medical device manufacturers, warned that more regulations could pose problems for patients.

“If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short,” Scott Whitaker, president and CEO of AdvaMed, said in a comment posted on the group’s website.

The EPA said some commercial sterilizers have already made the planned changes.

“Many sterilization and health care facilities are already taking the steps outlined in the proposal and have seen emissions drop significantly,” McCabe said.

Most facilities have taken action to control ethylene oxide blown out of sterilization chambers through exhaust vents known as “back vents” but only 25% to 33% of sterilizers are controlling so-called fugitive emissions, ethylene oxide that escapes or leaks into room air, said Jonathan Witt, an environmental engineer and technical lead on EPA’s review of the National Emissions Standards for Hazardous Air Pollutants.

“So we think it’s a good sizable chunk of the industry, but still a little ways to go,” Witt said on a call with reporters.

If the rules go into effect, sterilizers would have 18 months to make the changes, which the EPA said is an accelerated time frame under the Clean Air Act.

AdvaMed’s Whitaker says that’s not enough time.

“It could take many months for abatement equipment to arrive. Supply chains and manufacturing are still recovering from the pandemic,” he noted in the statement.

In issuing the proposed rules, the EPA said it aimed to strike a balance between lowing cancer risks for impacted communities and workers who use ethylene oxide while preserving “critical sterilization capabilities.”

The proposed rules would apply to 86 commercial sterilization facilities in the United States that use ethylene oxide gas to fumigate spices and medical devices.

The EPA says 20 billion medical devices – mostly single-use, disposable items used in health care such as catheters, gloves and surgical gowns – are sterilized using ethylene oxide.

The US Food and Drug Administration is actively exploring alternatives to the use of the gas, the EPA said on Tuesday, but some devices still can’t be sterilized any other way.

In proposing the new rules, EPA said its new analysis found that exposure to ethylene oxide, or EtO, on the job significantly increased cancer risks for workers in sterilization facilities and those who apply ethylene oxide in health care facilities.

“Now, a new EPA analysis shows that there may also be significant risks to workers who handle [ethylene oxide] and people who live, work or go to school near places where EtO is used in sterilization. And failing to take action to address these risks is simply unacceptable,” EPA Administrator Janet McCabe said on a call with reporters.

The additional lifetime cancer risk for a worker exposed to ethylene oxide for eight hours a day, 240 days a year for 35 years was between 1 in 10 and 1 in 36 for workers in sterilization facilities; and between 1 in 12 and 1 in 25 for workers exposed to ethylene oxide in health care facilities.

To help lower those risks, the proposed rules require greater use of personal protective equipment for workers and new controls to decrease the amount of ethylene oxide in indoor air.

Whitaker from AdvaMed, the medical device industry group, said the cancer risk for employees exposed to ethylene oxide on the job is overstated and disregards “the strong employee protections already in practice.”

Companies will also be required to use new real-time monitoring methods to confirm that these pollution controls are working inside facilities. These controls can measure ethylene oxide in indoor air down to 10 parts per billion. If ethylene oxide levels climb above this threshold, everyone in the workplace would be required to wear protective equipment.

They will also lower the amount of ethylene oxide that can be used for each sterilization cycle. The EPA is proposing to limit the application rate for ethylene oxide to no more than 500 milligrams per liter of air.

The rules would eliminate some niche uses of ethylene oxide where alternatives exist, including its use in museums, archival settings, beekeeping, some cosmetics, and in musical instruments.

The EPA will take public comment on the new rules for 60 days. The agency will also host a virtual public webinar on May 1 to discuss its proposed rules and new risk assessment.

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