Sofia Resnick, Author at New Jersey Monitor https://newjerseymonitor.com/author/sofia-resnick/ A Watchdog for the Garden State Mon, 17 Jun 2024 10:39:36 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.5 https://newjerseymonitor.com/wp-content/uploads/2021/07/cropped-NJ-Sq-2-32x32.png Sofia Resnick, Author at New Jersey Monitor https://newjerseymonitor.com/author/sofia-resnick/ 32 32 Anti-abortion groups say Supreme Court’s mifepristone ruling won’t deter them https://newjerseymonitor.com/2024/06/17/anti-abortion-groups-say-supreme-courts-mifepristone-ruling-wont-deter-them/ Mon, 17 Jun 2024 10:39:23 +0000 https://newjerseymonitor.com/?p=13535 An attorney for the plaintiffs said the ruling was disappointing, but that they will continue to “advocate for women’s health.”

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After justices rejected the legal standing of anti-abortion doctors, activists search for plaintiffs that say they were harmed by the drug Mifepristone, an FDA-approved for pregnancy terminations. (Photo by Chris Coduto/Getty Images)  

In the aftermath of the U.S. Supreme Court’s unanimous ruling Thursday to maintain current access to the abortion medication mifepristone, abortion-rights advocates and opponents vowed to continue their respective battles over the drug.

Mifepristone is one of two drugs used to treat miscarriages and terminate a pregnancy during the first trimester, and is the most common method of abortion in the U.S.

Anti-abortion groups, in conjunction with conservative religious law firm Alliance Defending Freedom, sought to revert the FDA guidelines to 2016, when the prescribed gestational time frame was three weeks shorter and there were more requirements around who could prescribe it and where and when provider visits had to take place.

The case made its way to the nation’s highest court after outspoken anti-abortion U.S. District Judge Matthew Kacsmaryk in Texas ruled that mifepristone’s approval should be revoked, followed by a Fifth Circuit Court of Appeals opinion that agreed in part, saying the restrictions should revert to pre-2016 rules.

In a unanimous decision rejecting the anti-abortion groups’ challenge to the U.S. Food and Drug Administration’s regulation of the drug, justices agreed that the case lacked standing, saying there was no clear injury to the plaintiffs to warrant reinstating the restrictions.

“The plaintiffs do not prescribe or use mifepristone. And FDA is not requiring them to do or refrain from doing anything. Rather, the plaintiffs want FDA to make mifepristone more difficult for other doctors to prescribe and for pregnant women to obtain,” Justice Brett Kavanaugh wrote in the opinion. “Under Article III of the Constitution, a plaintiff’s desire to make a drug less available for others does not establish standing to sue.”

Wendy Heipt, attorney for advocacy organization Legal Voice, said the fact that the unanimous ruling is focused on standing is helpful, because that’s an area of law that has been in question in many reproductive rights-related cases since the Dobbs decision in 2022.

“I’m not relaxing; it’s not over. But the fact that this one rogue judge in Texas opened the courthouse doors to people who had no right to be there was a real challenge to the way our judicial system works, so I am reassured that there are still rules,” Heipt told States Newsroom.

Many reproductive rights and medical organizations issued statements following the ruling, including the Guttmacher Institute, a reproductive rights research organization that has closely tracked abortion pill use in the two years since the Dobbs decision.

“We are relieved by this outcome, but we are not celebrating,” said Destiny Lopez, acting co-CEO of the Institute, in a statement. “From the start, this case was rooted in bad faith and lacking any basis in facts or science. This case never should have reached our nation’s top court in the first place and the Supreme Court made the only reasonable decision by leaving access to medication abortion using mifepristone unchanged.”

Nikki Madsen, co-executive director of the Abortion Care Network, said she wasn’t surprised by the ruling, but noted it only preserves the status quo.

“It’s just not enough,” Madsen told States Newsroom. “We know that the anti-abortion extremists are relentless, and their goal is to truly chip away at any abortion access. So today’s decision just preserves access, but it’s really not enough for the people across the country who are truly navigating a human rights crisis right now.”

Three intervenor states expected to continue fight at district court level

Alliance Defending Freedom, the conservative law firm that argued the case, is the same organization that argued in favor of the Dobbs decision that returned abortion regulation to the states. In a statement, ADF attorney Erin Hawley said the ruling was disappointing, but that they will continue to “advocate for women’s health.”

“The FDA recklessly leaves women and girls to take these high-risk drugs all alone in their homes or dorm rooms, without requiring the ongoing, in-person care of a doctor,” Hawley said, adding that ADF is grateful to attorneys general in Idaho, Kansas and Missouri who successfully intervened in the case at the district court level with Kacsmaryk’s approval, because they intend to keep litigating the case there.

In a statement posted on X on Thursday, Missouri Attorney General Andrew Bailey wrote, “Today’s ruling only applies to standing; the court did not reach the merits. My case is still alive at the district court. We are moving forward undeterred with our litigation to protect both women and their unborn children.”

Bailey’s spokesperson did not give any further details about what that case would look like, and Idaho Attorney General Raúl Labrador’s office did not respond to a request for comment.

According to Susan B. Anthony Pro-Life America, a national anti-abortion organization, those attorneys general will move forward with the case “based on harms suffered by women in their states.”

Abortion opponents target abortion drugs from multiple angles 

Anti-abortion opponents have been fighting against the expansion of access to medication abortion since the FDA first approved the regimen in 2000, and they say they are not deterred by Thursday’s ruling.

“The Justices simply discussed the issue of legal standing and did not reach the merits of the case,” Carolyn McDonnell, litigation counsel at national anti-abortion policy shop Americans United for Life, told States Newsroom in a statement. “It’s still an open question whether the FDA unlawfully deregulated mifepristone.”

Longtime anti-abortion activist Rev. Pat Mahoney, chief strategy officer for the Stanton Public Policy Center, said the Supreme Court’s decision in this case was instructive, if not what abortion opponents wanted.

“There’s, I think, a misconception that a loss is a loss, and that isn’t always the case,” Mahoney told States Newsroom. “Sometimes a loss helps define the parameters for bringing the next case and next case, and believe me, there are going to be next cases on medical and chemical abortions. So now we know this isn’t a route to go.”

Mahoney said that like past legal defeats for the anti-abortion movement, this ruling offers at least a partial road map, such as the one abortion opponents followed after the Supreme Court ruled in 1992’s Planned Parenthood v. Casey that abortion until fetal viability was a federal right but that states could pass regulations that didn’t create an “undue burden” for people seeking abortions.

That ruling led to hundreds of restrictions and regulations around the country that kept nudging the viability and undue burden lines — limiting abortion access even before Roe v. Wade was overturned. Mahoney said his organization and others are pursuing various legislative proposals, such as regulating the disposal of embryonic and fetal remains following a medication abortion, which most people have at home or in private settings.

Americans United for Life said in a statement following the ruling that it “will continue to offer legal prescriptions for the strengthening of protections for unborn children from abortion pills through action on the federal and state levels in both executive and legislative branches of government, including through executive enforcement of the Comstock Act and RICO Act.”

Ever since Roe v. Wade was overturned, resurrecting the long-dormant Comstock Act to ban the mailing of abortion drugs and equipment (something legal scholars and historians say is an inaccurate interpretation of the law and how it was applied) has been the long-term focus of East Texas pastor Mark Lee Dickson and his partner Texas attorney Jonathan Mitchell.

They have been pushing various legal and legislative strategies to prevent people from obtaining abortions in states where it’s still legal. They have helped pass dozens of local ordinances in Texas and other states with restrictions that challenge current federal law, such as banning interstate travel to obtain an abortion. In New Mexico, where abortion is legal and largely unrestricted, a challenge to two local ordinances based on the Comstock Act await a ruling from the New Mexico Supreme Court.

The U.S. Supreme Court did not address the Comstock Act in its opinion, but Kascmaryk cited the old law in his initial ruling last year. Major conservative groups are pushing former President Donald Trump, if reelected this fall, to enforce the Comstock Act along with other federal abortion regulations. Trump has stayed silent about what he will do.

In the meantime, anti-abortion groups have not stopped pursuing other cases.

“I can confirm that there are several attorneys in the pro-life movement that are planning on bringing a number of different lawsuits relating to abortion-inducing drugs and the harm that they cause to mothers and their unborn children,” Dickson told States Newsroom.

Mahoney also said groups like his are working with attorneys on a potential class-action lawsuit against abortion-pill manufacturers. He said they are “actively gathering testimony and information from women who have been hurt through medical chemical abortions.”

“We’re working on it,” said Mahoney, adding, “It took us 50 years to overturn Roe.”

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Hundreds protest outside the U.S. Supreme Court to keep abortion medication accessible https://newjerseymonitor.com/2024/03/27/hundreds-protest-outside-the-u-s-supreme-court-to-keep-abortion-medication-accessible/ Wed, 27 Mar 2024 10:16:21 +0000 https://newjerseymonitor.com/?p=12361 The justices heard oral arguments in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine Tuesday, their first major reproductive rights case since overturning Roe v. Wade almost two years ago.

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Protesters take to the streets outside the U.S. Supreme Court on Tuesday, March 26, 2024, where justices questioned attorneys about broad changes in access to mifepristone. (Sofia Resnick/States Newsroom)

WASHINGTON—As the enormous yellow banner unfurled in front of the steps of the U.S. Supreme Court Tuesday morning, Laura Clime-Coates turned to her 9-year-old daughter and said, “Those are the names of people who agree with us.”

On the sign, titled “We the People Support Medication Abortion,” were what activists estimated to be half-a-million signatures from people across the U.S. asking the Supreme Court not to restrict mifepristone, a commonly used drug for abortions and miscarriage management. And for Clime-Coates, who said she signed several petitions in support of medication abortion, mifepristone is the reason her oldest child was standing beside her, and the reason she has a little sister at home in Baltimore.

Back in 2009, Clime-Coates said she experienced what she referred to as a missed miscarriage.

“There was no heartbeat, and it was risking my future ability to have children, and I really wanted children,” she told States Newsroom. “The tissue was not developing and threatening my uterus. My choice was to wait around and damage my body or take mifepristone.”

Clime-Coates and her daughter were among hundreds of abortion rights supporters holding signs and chanting, while inside, the justices heard oral arguments in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, their first major reproductive rights case since overturning Roe v. Wade almost two years ago.

In the absence of a legal precedent protecting the right to terminate a pregnancy, the implications for abortion access in this case are as high as they have ever been. More than a dozen states have banned or heavily restricted abortion since 2022’s Dobbs v. Jackson Women’s Health Organization decision, but abortion rates have risen rather than fallen.

The Guttmacher Institute recently published data estimating more than 1 million abortions in 2023, of which about 63% were via medication, and that only includes abortions in the formal medical system. Many reproductive rights researchers and providers credit the rise in part to the FDA lifting certain restrictions on abortion medication after more than two decades of consistent safety and efficacy data. Beginning in 2016, the FDA increased the gestational window women could terminate pregnancies using medication, adjusted the dosages, removed in-clinic requirements, and made medication abortion available via telemedicine and directly at pharmacies.

Initially filed in 2022 by anti-abortion doctors and medical groups a few months after Roe was overturned, the case has incurred criticism from throughout the medical and scientific community because of its flawed scientific claims that mifepristone is dangerous and should not have been approved by the FDA. At issue now in the FDA’s appeal to the Supreme Court is whether to uphold the 5th U.S. Circuit Court of Appeals’ opinion that the FDA must reapply older restrictions against the agency’s own scientific determination. The coalition of anti-abortion medical groups have largely relied on anecdotes from longtime anti-abortion activists, as well as a handful of studies produced by some of the main medical groups connected to the lawsuits, two of which were recently retracted by academic publisher Sage for methodological flaws and undisclosed conflicts of interest.

Melanie Salazar, 25, of San Francisco, California, who heads the group Pro-Life San Francisco, demonstrated in front of the U.S. Supreme Court Tuesday, March 26, 2024, as the justices heard oral arguments over access to mifepristone, one of two pharmaceuticals used in medication abortion. (Ashley Murray/States Newsroom)

In anticipation of the oral arguments in this case, those in the pharmaceutical industry have expressed anxiety that a ruling against the FDA could stifle future drug development, by allowing anyone with an ideological opposition to a medication to try to force a drug-policy change.

“This case isn’t about mifepristone,” said Elizabeth Jeffords, the CEO of a small biotech company called Iolyx Therapeutics, on a webinar organized by reproductive health researchers last week. “This is about whether or not the FDA is allowed to be the scientific arbiter of what is good and safe for patients. …. It’s critical for our ecosystem that we continue to have investors, and investors will only come to our ecosystem if they have some certainty. If I had to believe that I would have to stand up to multiple litigations from parties without standing over the course of any drug that we’re working on developing, I wouldn’t have enough money to exist, and all of the little biotech companies would be out of existence as well.”

Pharmaceutical sciences professor Chris Adkins – who sparked the investigation into those studies and has co-authored a new academic paper in the journal Contraception breaking down what he says are significant methodological flaws – said it has been difficult to watch this case advance all the way to the Supreme Court.

“I just hope moving forward that we’ve got more public awareness that our federal courts have not always been the best evaluators of scientific evidence,” Adkins told States Newsroom. “I really hope that the public can really put some pressure on the courts to do a better job at evaluating the scientific and the medical literature, because I think this all impacts each one of us, our families, our futures. … This type of case could threaten regulatory approval or the processes they’re involved with, not just for mifepristone, but for others.”

But for both abortion opponents and supporters outside the Supreme Court Tuesday, the issue is personal.

“I was really glad I had that choice,” Clime-Coates said. “It’s health care! And I would hate for any of my children or any woman or anyone who’s capable of reproduction to not have that choice in the future.”

Alethea Shapiro, a protester from Florida, told States Newsroom she needed mifepristone years ago to terminate a pregnancy for medical reasons. “Hands off our mifepristone!” she yelled in a small circle of activists organized by the Women’s March and the Center for Popular Democracy. Some of the activists had prepared for arrests, but they eventually dispersed while law enforcement officers surveilled the crowd.

Robin Ross, an anti-abortion activist from Amarillo, Texas – home of the conservative federal district court where the case was originally filed, told States Newsroom she had secretly attended abortion rights demonstrators’ planning session the night before but said she learned little beyond logistics. The 57-year-old Navy veteran said she recently became an activist after learning that her teenage mother had attempted to abort her in the 1960s, before abortion was legal throughout the country. Ross said that she has had many health problems, including the inability to have children, because of the abortion attempt (she did not give specifics, but she said it was not the medication abortion method authorized by the FDA, at issue in this lawsuit). She is currently working to make Amarillo a so-called sanctuary city for the unborn.

“As soon as I heard about the ability to put my faith into action and me as an abortion survivor, I instantly wanted to start [anti-abortion activism].

Some anti-abortion activists proudly displayed their pregnant bellies in protest of medication abortion.

“I’m here because I’m 34 weeks’ pregnant. I’m advocating for the rights of my child, my baby in the womb,” said Savannah Evans from Tampa, Florida, who does marketing for the national anti-abortion group Live Action. “ I don’t want her to grow up in a world that sees an abortion as an acceptable option for women.”

At 22, Evans said her pregnancy was unplanned and that she was initially “terrified,” but she and her now-husband chose to parent.

Among the speakers in the largely outnumbered anti-abortion crowd, messages focused heavily on alleged high risks of medication abortion and called on the Supreme Court to order the FDA to reapply the since-lifted restrictions that have made it possible for women to have medication abortions via telemedicine and in their homes.

“FDA, do your job!” shouted Marjorie Dannefelser, the president of Susan B. Anthony Pro Life America. “We certainly do not have complete agreement upon the fact that there are two patients in every pregnancy, but we can at least pledge ourselves to one patient: the woman receiving abortion drugs in the mail in her home alone. … She has become her own abortionist in an unsafe home abortion.”

Recent research on telemedicine abortions, co-authored by University of California San Francisco epidemiologist Ushma Upadhyay, finds a low rate of serious adverse risks. And reproductive rights activists working to expand medication access around the nation said in interviews that abortion drugs are here to stay, even if the Supreme Court sides with the anti-abortion activists, which as States Newsroom reported Tuesday, is far from a sure thing.

“We know that people, no matter what happens with this case, are going to continue to access pills outside of the formal health care system,” said Bethany Van Kampen Saravia, senior legal and policy advisor at Ipas, which for decades has worked in countries with restrictive laws to train providers and help expand access to abortion care. Since the overturning of Roe, she said Ipas has refocused their efforts throughout the U.S., where at least half the states have near-total bans or heavy restrictions. As States Newsroom recently reported, new data shows a rise in self-managed abortions since the Dobbs decision.

“People will continue to get medication abortion through online access, through telehealth service, through online pharmacies, through your community network,” Van Kampen Saravia said. “Self-managed abortion is a WHO-recommended method of care. What Ipas knows from decades of working outside of the U.S. is that abortion with medication is safe and effective. And that’s not going to stop no matter what happens.”

Abortion providers who work in and outside of the formal medical system told States Newsroom they should be able to prescribe the current medication abortion regimen off label, if the FDA is ordered to change its protocol.

“We’re continuing to work because the pills are still on the market, they’re still registered, so they will be available and the doctors have the freedom to prescribe them off label,” said Dutch physician Dr. Rebecca Gomperts, founder of the online clinic Aid Access, which she said has been working with states with shield laws to ship abortion drugs to women in states with abortion bans. She was in front of the court handing out, for free, a small amount of boxes of the abortion-medication regimen. She said Aid Access will continue helping women self-manage their abortions.

“No matter what the Supreme Court is going to do, we’ll be there,” Gomperts said.

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Telehealth abortions on the rise since Dobbs, new report shows  https://newjerseymonitor.com/2024/02/28/telehealth-abortions-on-the-rise-since-dobbs-new-report-shows/ Wed, 28 Feb 2024 21:32:34 +0000 https://newjerseymonitor.com/?p=11973 Before Dobbs, about 4% of total recorded abortions were via telehealth abortion; that rose to 16%, as of September 2023.

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Photo for Sofia's tele heath abortion story: Telehealth abortions rose to 16% as of September 2023 following the end of the federal right to abortion in 2022, according to Society of Family Planning’s #WeCount. (Getty Images)

Researchers studying national abortion trends found that in the 15 months since Roe v. Wade fell, abortion rates remained elevated despite more limited access throughout the U.S., according to the Society of Family Planning’s latest #WeCount report published Wednesday.

Partially explaining this is a rise in people having abortions via telemedicine, Ushma Upadhyay, co-chair of #WeCount, told States Newsroom. Before Dobbs, about 4% of total recorded abortions were via telehealth abortion; that rose to 16%, as of September 2023.

“Telehealth abortion has really had a huge impact,” said Upadhyay, a professor at the University of California, San Francisco’s Advancing New Standards in Reproductive Health. “We’re addressing unmet need that existed in those states, even before Dobbs. I think that a lot of the unmet need in the blue states is being met, as well as people traveling from states with abortion bans.”

In the nation overall between July and September 2023, there were between 81,000 and 89,000 abortions monthly, numbers that are slightly smaller than in the previous report covering April through June 2023, but higher than in the months leading up to the Dobbs v. Jackson Women’s Health Organization decision.

“Some of the volume may also be due to reductions of barriers to abortion care, including increased financial support for low-income abortion seekers, reduced burden of cost and travel by use of telehealth, and improved access via care navigation from practical support groups and public health departments,” the report reads.

However, researchers estimate that in the 14 states with total abortion bans, there were approximately 120,000 fewer abortions compared to before Dobbs.

“People in states with abortion bans or severe restrictions were forced to delay their abortions, to travel to another state, to obtain care from a provider in a shield law state, to self-manage their

abortions, or to continue a pregnancy they did not want,” the report reads.

Upadhyay said the recent small increases over the months does not compensate for the declines in banned states.

“Whenever we publish these numbers, we have to publish whatever we find,” she said. “But it is one of our worries that people will think, ‘Oh, there’s no longer a problem.’ We know that there are thousands of people living in states with abortion bans that continue to not be able to access abortion.”

States with the largest declines in 15 months were Texas (46,200), Georgia (24,640), Tennessee (17,545), Louisiana (11,465), and Alabama (9,525). Researchers saw the largest surges in Illinois (28,665), Florida (15,155), and California (12,515). Numbers in Wisconsin have fluctuated dramatically with its fluctuating abortion legality. Before Dobbs the state saw approximately 600 abortions per month, which dropped to fewer than 10 per month after Dobbs. Researchers recorded 50 abortions in Wisconsin in September 2023, shortly after providers resumed providing abortions following a court decision.

Though the majority were in-clinic abortions, Upadhyay believes the rate of telehealth abortions is likely to rise. There were a reported 14,110 telehealth abortions in July 2023, 14,060 in August, and 13,770 in September, according to the report, which includes in this tally abortions via telehealth provided by brick-and-mortar clinics and virtual-only providers, including those operating in the five states (Colorado, Massachusetts, New York, Vermont, and Washington) that in 2023 started providing abortion care under shield laws to patients from states with abortion restrictions.

The #WeCount team plans to finish collecting state-by-state data as part of this project through December 2024. Among the data’s limitations, it doesn’t not include self-managed abortions.

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Fear and confusion over abortion access persists as SCOTUS takes its first post-Dobbs case https://newjerseymonitor.com/2023/12/14/fear-and-confusion-over-abortion-access-persists-as-scotus-takes-its-first-post-dobbs-case/ Thu, 14 Dec 2023 11:32:50 +0000 https://newjerseymonitor.com/?p=10970 Experts have said that a U.S. Supreme Court ruling on the use of mifepristone, a key abortion medication, could have implications for drug approval by the U.S. Food and Drug Administration.

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Anti-abortion and abortion rights activists protest during the 50th annual March for Life rally in front of the U.S. Supreme Court on January 20, 2023, in Washington, DC. Anti-abortion activists attended the annual march to mark the first to occur in a “post-Roe nation” since the Supreme Court's Dobbs vs Jackson Women's Health ruling which overturned 50 years of federal protections for abortion healthcare. (Photo by Chip Somodevilla/Getty Images)

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Abortion-rights victories cement 2024 playbook while opponents scramble for new strategy https://newjerseymonitor.com/2023/11/09/abortion-rights-victories-cement-2024-playbook-while-opponents-scramble-for-new-strategy/ Thu, 09 Nov 2023 16:42:22 +0000 https://newjerseymonitor.com/?p=10534 Anti-abortion leaders woke up Wednesday to the sobering reality that abortion rights remain the nation’s predominant political issue.

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COLUMBUS, Ohio — OCTOBER 08: People gather for the Ohioans for Reproductive Freedom Bans OFF Columbus rally for Issue 1, October 8, 2023, outside the Statehouse in Columbus, Ohio. (Photo by Graham Stokes for Ohio Capital Journal)

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Doctor suing FDA recruited to scientific advisory board to ‘repurpose’ abortion pill https://newjerseymonitor.com/2023/10/25/doctor-suing-fda-recruited-to-scientific-advisory-board-to-repurpose-abortion-pill/ Wed, 25 Oct 2023 10:43:42 +0000 https://newjerseymonitor.com/?p=10300 Dr. George Delgado is joining the scientific advisory board of Res Nova Biologics, Inc., which is developing a breast cancer treatment using mifepristone.

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ROCKVILLE, MARYLAND - APRIL 13: In this photo illustration, packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023 in Rockville, Maryland. A Massachusetts appeals court temporarily blocked a Texas-based federal judge’s ruling that suspended the FDA’s approval of the abortion drug Mifepristone, which is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug Misoprostol. (Photo illustration by Anna Moneymaker/Getty Images)

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A men’s movement takes reins in a nationwide quest to end abortion https://newjerseymonitor.com/2023/09/13/a-mens-movement-takes-reins-in-a-nationwide-quest-to-end-abortion/ Wed, 13 Sep 2023 10:36:20 +0000 https://newjerseymonitor.com/?p=9751 A male-dominated network of militants, academics, attorneys, judges and activists lead the drive to restrict and remove reproductive rights.

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The men of Operation Save America close out the group’s weeklong anti-abortion protest in front of the Nathan Deal Judicial Center in Atlanta, Georgia, on July 22, 2023. (John McCosh/Georgia Recorder)

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Study cited by Texas judge in abortion-pill case under investigation https://newjerseymonitor.com/2023/08/02/study-cited-by-texas-judge-in-abortion-pill-case-under-investigation/ Wed, 02 Aug 2023 10:45:18 +0000 https://newjerseymonitor.com/?p=9171 The authors of the study exaggerated their findings and visually misrepresented them in ways that are “grossly misleading," one expert says.

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Pharmaceutical sciences professor Chris Adkins, who has questioned the accuracy and data used in a 2021 study authored by anti-abortion doctors about the key abortion drug mifepristone, says U.S.-based academic publisher Sage Publishing is reviewing the paper. (Courtesy Chris Adkins)

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After Dobbs, abortion access in U.S. is harder, comes later and with a higher risk https://newjerseymonitor.com/2023/06/21/after-dobbs-abortion-access-is-harder-comes-later-and-with-a-higher-risk/ Wed, 21 Jun 2023 10:50:31 +0000 https://newjerseymonitor.com/?p=8661 State laws restricting abortion have caused more women to travel to seek the procedure, overwhelming clinics and leading to astronomical patient costs and major care delays.

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Latin American obstetrician doing an ultrasound on a pregnant woman at the hospital - healthcare and medicine

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Appeals court judges embrace anti-abortion speculation https://newjerseymonitor.com/2023/05/18/appeals-court-judges-embrace-anti-abortion-speculation/ Fri, 19 May 2023 00:37:36 +0000 https://newjerseymonitor.com/?p=8283 The judges who heard arguments in the abortion pill case Wednesday appeared to be persuaded by evidence that consists largely of anecdotes, speculation, and cherry-picked studies brought by a handful of anti-abortion medical groups and doctors.

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ROCKVILLE, MARYLAND - APRIL 13: In this photo illustration, packages of Mifepristone tablets are displayed at a family planning clinic on April 13, 2023 in Rockville, Maryland. A Massachusetts appeals court temporarily blocked a Texas-based federal judge’s ruling that suspended the FDA’s approval of the abortion drug Mifepristone, which is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug Misoprostol. (Photo illustration by Anna Moneymaker/Getty Images)

America’s major medical institutions and drug policy scholars have roundly denounced as “pseudoscience” many of the claims brought by anti-abortion groups in a high-profile federal lawsuit asking the Food and Drug Administration to revoke its 23-year-old approval of mifepristone, one half of a two-drug regimen that has become the most common form of pregnancy termination post-Roe v. Wade.

But the appeals court’s three-judge panel that heard oral arguments Wednesday appeared to be persuaded not by the medical consensus in this case, but by some of the evidence brought forward by plaintiffs that consists largely of anecdotes, speculation, and cherry-picked studies brought by a handful of anti-abortion medical groups and doctors.

Medical and public health societies led by the American Medical Association submitted a “friend of the court” briefbefore the 5th U.S. Circuit Court of Appeals, stating that the lower court’s ruling “relies on pseudoscience and on speculation, and adopts wholesale and without appropriate judicial inquiry the assertions of a small group of declarants who are ideologically opposed to abortion care and at odds with the overwhelming majority of the medical community and the FDA.”

While asking a question of U.S. Deputy Assistant Attorney General Sarah Harrington, Judge Jennifer Walker Elrod referred to mifepristone cutting off “nutrition” to the fetus, which is a false claim cited in the initial ruling written by Texas federal Judge Matthew Kacsmaryk in April. Kacsmaryk referred to mifepristone as a “synthetic steroid that blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death.”

According to Johns Hopkins Medicine, the progesterone hormone is produced in early pregnancy to help thicken the lining of the uterus to support implantation of a fertilized egg. Without that hormone stimulation, which mifepristone blocks, the lining breaks down and the pregnancy cannot continue. It is then followed by doses of misoprostol to induce contractions and expel the pregnancy.

Former President George W. Bush appointee Elrod – like her fellow Donald Trump appointee Judges James C. Ho and Cory T. Wilson – shares ideological views on abortion with the plaintiffs’ anti-abortion coalition, which is represented by the Alliance Defending Freedom. So does Kacsmaryk, whose since-blocked decision to suspend FDA approval of mifepristone cites anecdotal evidence from plaintiffs.

Mifepristone remains legal and on the market as the case winds its way through the legal system, and data from the FDA since the drug’s initial approval in 2000 shows it is overwhelmingly safe to use. Out of an estimated 5.6 million people in 23 years, 28 deaths have been associated with the FDA’s abortion medication regimen, which is a markedly lower rate than many common FDA-approved drugs, like Tylenol and Viagra. And as the FDA has noted, that number includes fatal cases “regardless of causal attribution to mifepristone,” such as people who died from homicide, suicide, and pulmonary emphysema.

If the plaintiffs prevail, health care providers, medical institutions and pharmaceutical industry organizations have warned of its potentially catastrophic consequences. In addition to radically reducing access to abortion nationwide, removing mifepristone from the market would reduce access for miscarriage treatment, public health experts say, and have far-reaching consequences beyond abortion.

“The implications of this case are extraordinary, and they include the potential termination of access to mifepristone, a precedent for court interference in the FDA’s rigorous and science-based testing and approval process not just for mifepristone, but for any drug,” said Joanne Rosen, a senior lecturer in the departments of Health Policy and Management and Population, Family and Reproductive Health at the Johns Hopkins Bloomberg School of Public Health, during a media briefing hosted by the university Thursday. “This would be the first time in history that a court has abrogated the FDA’s approval of a drug over the objections of the FDA.”

Sympathetic, cynical and combative exchanges

The appeals court judges seemed sympathetic to the narrative brought by the plaintiffs that mifepristone is a dangerous drug, as they were in their previous opinion blocked by the Supreme Court, which would have restricted the use of mifepristone. A big question in this case has been whether the coalition of anti-abortion medical groups and four doctors, including Indiana state Sen. Dr. Tyler Johnson, have standing to sue. Plaintiffs have argued their doctors would suffer direct harm if mifepristone remains on the market.

Like medical and legal scholars following this case, Rosen said plaintiffs’ arguments for standing are weak, and if accepted would open the door to any group that wants to challenge the FDA’s approval of a drug for any reason.

Plaintiff groups argue that their member doctors could be overwhelmed with a potential future influx of emergency room visits from mifepristone patients, or forced to treat an abortion patient against their will. These claims are based not on robust data but largely on the testimony of handful of plaintiff doctors, three of whom give mostly non-specific anecdotes about treatment they performed for women who allegedly had taken some form of medication abortion, but it’s not clear when the procedures took place and whether it was the FDA’s regimen.

Harrington argued on behalf of the federal government that plaintiffs had not made claims of being forced to treat abortion patients against their will.

“They claim injury from speculative downstream effects of choices made by a chain of other people who are not parties to this lawsuit,” Harrington said.

But Wilson pushed back.

“The declarants here said they’ve seen these patients, they’ve cared for them,” he said. “I take that to mean that they treated them and that they expect to see more in the future. How’s that not enough for standing if the doctor also has a conscience objection to doing so?”

The judges made a series of sometimes snarky and combative comments and questions aimed at the attorneys for the U.S. Department of Justice, representing the FDA, and the mifepristone manufacturer Danco Laboratories, and called into question trust in the FDA’s expertise and judgment.

Echoing plaintiffs’ criticism of the FDA approving mifepristone as part of a particular category of drugs for serious illnesses, Ho said pregnancy is not a serious illness, quipping, “When we celebrated Mother’s Day, were we celebrating illness?”

A question of evidence

And they misstated non-scientific assertions by plaintiffs, such as claiming that non-fatal adverse reporting is no longer required by the FDA. Mifepristone manufacturers (but no longer medical providers) are still required to report non-fatal adverse reactions.

Much of the anti-abortion evidence submitted in this case was authored by researchers who work for the anti-abortion Charlotte Lozier Institute, whose role is to defend abortion bans and restrictions with research. Regarding mifepristone, Charlotte Lozier’s researchers have published articles that mostly speculate large amounts of under-reporting when it comes to abortion complications, and argue the true risk of mifepristone is unknown.

Another anti-abortion organization, the Family Research Council, also submitted a 125-page amicus brief with false claims that the drug approval was expedited by former President Bill Clinton. It also cites research from the Charlotte Lozier Institute to back claims that the drug is unsafe.

Judges echoed this sentiment and speculated on the safety of telemedicine abortion and questioned the FDA’s process of loosening restrictions over time. Elrod asked Harrington if a medical provider could examine someone via email rather than video, and if people could use telemedicine as an “intermediary” to send the medication to a state with an abortion ban. Elrod referenced amicus briefs that alleged individuals were engaging in those tactics to skirt state laws.

Harrington said the statements referenced by Elrod in the briefs are unsupported and irrelevant to the central issue.

“None of that is dictated by the FDA, and none of that is relevant to whether the FDA’s determination that this drug is safe and effective with these conditions in place,” Harrington said.

Elrod pushed back, asking if it was a relevant factor to consider in issuing an injunction that would limit access to the drug.

“If it’s violating other law, which we have to determine, perhaps, then we have to decide whether or not it’s appropriate to enter an injunction or not and that’s one of the factors we would consider,” Elrod said.

Public health experts say the appeals court’s attitudes toward the science in this case are deeply concerning.

“Judges and lawmakers should not be substituting their own opinion for the experience, expertise, and authority of the U.S. Food and Drug Administration. Nor should they ignore the substantial weight of scientific evidence from hundreds of studies and millions of patients confirming the safety and effectiveness of mifepristone, which has been used for decades in both medication abortion and miscarriage management,” said AMA President Dr. Jack Resneck Jr. in a recent statement.

Even if the appeals court rules to restrict or revoke approval of mifepristone, the federal government will most likely appeal the case to the U.S. Supreme Court. Regardless, the 5th Circuit Court judges’ reasoning could prove influential to the Supreme Court’s eventual decision.

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