Wednesday’s hearing on a lawsuit seeking to revoke federal approval of a widely used abortion pill will provide the first opportunity to hear arguments from anti-abortion groups that have filed the lawsuit and the Food and Drug Administration, which is fighting to keep the abortion pill legal. .
A lawsuit to end more than 20 years of legal use of abortion drugs could have wide-ranging repercussions in states where abortion is legal, not just where it is illegal. Medical abortion is used in over half of abortions in the United States, and 40 percent of abortion clinics only offer abortion pills, not a surgical procedure.
Wednesday’s hearing will revolve around the plaintiffs’ request that Judge Matthew J. Kachsmarik of the Northern District of Texas issue a preliminary injunction ordering the FDA to withdraw its longstanding approval of mifepristone, the first pill in a two-drug abortion scheme. while the case is under litigation.
Judge Kaczmarik, appointed by Trump, who wrote critically about Row vs Calf and previously worked for a Christian conservative legal organization, took several unusual steps leading up to a hearing. In a meeting last Friday with lawyers for the parties to the case, he asked them to remain silent about the fact that a hearing had been scheduled and told them that he planned to delay public disclosure of it and would only publish it. court record the night before.
In a transcript of Friday’s meeting, obtained by The New York Times, Judge Kaczmarik said that other aspects of the case had “produced a flurry of death threats, protesters and whatnot” and that he wanted to avoid “an unnecessary circus atmosphere.” This may interfere with the appearance of lawyers in court.
Despite the judge’s request, news organizations learned of the hearing and reported on it. Members of pro-abortion rights groups plan to hold demonstrations outside the courthouse during hearings, including wearing kangaroo and judge costumes to protest what they see as a “kangaroo court” and driving around the city streets in a truck. with a billboard that reads “Most Americans Support Access to Abortion.”
The lawsuit alleges that the Food and Drug Administration (FDA) did not properly review the scientific evidence and did not follow proper protocols when it approved mifepristone in 2000, and that it has ignored the safety risks since then. drug.
Read more about the problems of abortion in America
The FDA and the Department of Justice, which the FDA represents, have strongly disputed these claims, saying that the FDA’s rigorous reviews of mifepristone over the years have repeatedly confirmed its decision to approve mifepristone, which blocks a pregnancy-promoting hormone.
It is unclear whether the judge will make a decision at the end of Wednesday’s session. Most legal experts expect him to make his decision at a later date.
Here are some of the questions the judge asked the lawyers to be ready to discuss at the hearing:
Do the plaintiffs have legal capacity to file a claim
Plaintiffs leads the Hippocratic Medicine Alliance, organization which lists five anti-abortion groups. Shortly after the Supreme Court overturned Roe v. Wade, the alliance was registered in August in Amarillo, where Judge Kaczmarik is the sole federal judge.
Five of the groups are not based in Amarillo, but Eric Baptist, senior counsel for the Freedom Defense Alliance, a conservative Christian advocacy group that represents the plaintiffs, said some of the group members are in the Amarillo area, as is one of them. of the four doctors who are plaintiffs in the case.
The plaintiffs allege that they have a legal right to sue as parties who were harmed by the FDA approval because they treated women they said were harmed by abortion pills. Legal experts, including some conservative legal scholars, have said it can be difficult to uphold a claim that plaintiffs have to justice because the harms they allege can be considered a few steps away from FDA approval of the drug. Intermediate stages include patients who decide to take the drug and then seek medical help.
If the judge had decided that the plaintiffs had no standing to sue, the case could not have been heard.
Is this lawsuit an appropriate legal challenge to the authority of the FDA?
The judge indicated that he expected the parties to discuss issues related to the FDA’s authority to approve and regulate drugs. Some legal experts have pointed to constitutional provisions and congressional actions that suggest the FDA has overarching power that the court cannot review. Legal experts say that if the judge had ruled in favor of the plaintiffs, it would likely be the first time that a court has taken a decision to remove a drug from the market over objections from the FDA.
The FDA also indicated in its statement in the case that there is a six-year statute of limitations for challenging the agency’s actions and that plaintiffs are filing this lawsuit too late.
Plaintiffs contend that their claim is a proper legal action.
Was it a mistake for the FDA to approve mifepristone under current regulations at the time?
Mifepristone was originally approved in 2000 under a set of rules called “Subsection H”, which was created to expedite the approval of drugs “that have been studied for their safety and efficacy in the treatment of serious or life-threatening diseases”.
The lawsuit alleges that mifepristone does not qualify for this type of approval, as the plaintiffs say “pregnancy is not a disease.”
The approval process for mifepristone was not expedited—it took more than four years—but the FDA invoked Subpart H, which allowed the agency to impose additional restrictions on the drug’s use, including requiring medical professionals to be specially qualified to prescribe and dispense it. it is only in certain medical institutions.
The FDA states that the term “disease” is generally applied to medical conditions, not just diseases. The agency says any semantic confusion was cleared up a few years later when Congress created a new regulatory framework that used the term “disease or condition.”
Are Abortion Medicines Dangerous?
The plaintiffs allege that the pills they call “chemical abortion” cause “cramps, severe bleeding and severe pain” and that the FDA has never adequately assessed the scientific evidence for safety.
The FDA strongly disputes this claim, as do the mainstream medical organizations. They say that bleeding and cramps are normal consequences of the process, a sign that pregnancy tissue is being removed, and cite years of scientific research that shows serious complications are rare. The organizations note that mifepristone is actually much more heavily regulated and studied more intensively than most other drugs.
For a decade, the FDA has placed additional limits and controls on mifepristone called Risk assessment and mitigation strategyor REMS. This is the framework that was used for only about 300 other drugs. In recent years, the FDA has carefully reviewed new data on mifepristone and concluded that the drug is safe enough to remove some restrictions, including the requirement that patients receive the drug in person from a provider.
When the headmistress of North London Collegiate School told Lillian Lindsey that she should become a teacher and that she would not let her find any other job, Lindsey retorted: “You can’t stop me from becoming a dentist.”
“I knew nothing about dentistry,” Lindsey wrote in her unpublished autobiography, “but having boldly declared that I should become a dentist, there was nothing else for me to do.”
There were no certified female dentists in Britain in the 1890s; the profession was considered unfeminine and women were considered physically unsuitable for the job.
Her first attempt, in 1892, was rejected when she applied to study at the English National Dental Hospital. Dean Henry Weiss was so concerned that she would be a distraction to male students that he only interviewed her on the sidewalk outside the school.
Later that year, she left for Scotland, where the rules were a bit lenient. She was accepted as the first student at the Edinburgh Dental Hospital and School, although not everyone was happy about this.
“Do you understand that you will be taking bread from the mouth of some poor fellow?” Henry Littlejohn, then considered a public health expert, told her.
In Edinburgh, Lindsey struggled to pay for food and lodging. But she was young, determined and inspired by her work.
“The money was only enough to pass the lessons and pass the exams,” she wrote in her autobiography. “I must not fail.”
She found her calling. By the time she received her degree in 1894, she had won the Wilson Medal for Dental Surgery and Pathology, and the Medal for Academic Achievement in Medicine and Therapy.
The following year, she was accredited to the British Dental Association meeting, becoming the first certified female dentist in the UK. In the United States, women also entered the profession in the late 1800s.
She subsequently became a prominent figure in British dentistry: the first female President of the British Dental Society in 1946; first female president of the Society for the Study of Orthodontics; and founder and longtime curator of the British Dental Association Library, which she directed for three decades.
She was also the editor of the British Dental Journal and the author of numerous articles and two books: A Brief History of Dentistry, considered one of the first serious histories of the profession, and a translation of a classic French text called Dental Surgeon.
An article in the British Dental Journal written after her death described her as “strong but retiring, caring, driven, modest, humorous and engaging”.
A stenographer who worked at the library when Lindsey was in her 60s, Florence Messner, said she always dressed in black, had her wavy gray hair pulled back into a small bun, and wore gold-rimmed glasses that “made her eyes stand out.” “very stable, clear and kind.”
Lindsey opened the door for female dentists, and while change has been slow, today, according to the General Dental Council, which governs the profession, more than half of British dentists are women.
Lillian Murray was born on 24 July 1871 in Holloway, London, the third of 11 children of James Morrison Murray, a church organist and singing teacher, and Margaret Amelia (Bennett) Murray.
The family ran into difficulties after the death of James Murray in 1885 and Lindsey won a scholarship to the University School of North London. It was there that headmistress Frances Bass insisted that she become a teacher. When Lindsey refused, the headmistress withdrew her scholarship, forcing her to leave school in 1889 and hit the road on her own.
In the United States, the first woman to enter a regular dental practice was Emeline Roberts Jones, who joined her husband’s practice in 1859. jar of teeth she filled. She later opened her own office in New Haven, Connecticut.
Lucy Hobbs Taylor was the first American woman to receive a dental degree in 1866. “People were amazed,” wrote one critic, “to learn that a young girl had so forgotten her femininity that she wanted to study dentistry.” She taught the art to her husband, a Civil War veteran and railcar painter, and together they opened a practice in Lawrence, Kansas.
The first professional dentist in America, Lindsay wrote in an essay that Robert Wufendale, who in 1766 traveled from Britain to the colonies, where he made, in her words, “the first complete set” of false teeth “ever seen in America.”
Others, including the patriot Paul Revere, a jeweler, worked part-time as a dentist.
On her first day in Edinburgh, she met her future husband, Robert Lindsey, a teacher. They married in 1905 when she was 34 and he was 40. He died in 1930.
Among the more famous professors she encountered in Edinburgh were William Bowman Macleod, who was famous for his research on the effects of bagpipe playing on teeth; and Joseph Bell, whose gift for surprising conclusions led one of his students, Arthur Conan Doyle, to use him as a model for his fictional detective Sherlock Holmes.
Lillian Lindsey then moved to London, where she spent the next decade practicing to pay off her student loan, and then began practicing with her husband in Edinburgh.
In 1920, Robert Lindsay was appointed Secretary of the British Dental Association. The couple moved to London where Lillian founded the British Dental Association Library. Over the next 30 years, she developed it into one of the most complete dental libraries in Europe.
By examining the context of her own achievements, she became one of the first people in Britain to take a serious interest in the history of dentistry.
She learned French, German, Latin, and some Old English and Spanish to broaden her horizons. Her history of dentistry and published articles are rich in details about the “weird and terrible” procedures of past centuries:
14th-century dental charlatans who pulled out teeth “on the tip of a sword” as a brass band played to draw a crowd; tooth transplant using sheep, dog or even baboon teeth; an army officer who ordered an assistant to stand by during the transplant in case he needed one of his teeth; and a quaint king who asked his dentist to serve him a glass of brandy, not to drink but “to make sure his hand was steady”.
Lindsey’s status grew over the years as she received several honorary degrees and memberships and became the first woman to hold a number of influential positions in dentistry.
In 1946, she was named Commander-in-Chief of the British Empire, one rank below the knighthood.
Lillian Lindsay died on January 31, 1960. She was 89 years old.
By the time she sat down to write her autobiography, she had a new perspective on her confrontation half a century ago with Frances Bass, the autocratic headmistress.
“Perhaps,” she wrote, “she underestimated Bass, “because of a feeling of resentment, which later changed.”
“There are natures who need opposition and obstacles to achieve their goal,” she wrote. Her feelings eventually “mellowed into a sense of gratitude and recognition that Miss Bass was, after all, ‘the deity who defines our goals'”.
NHS managers in the southwest of England have introduced new rules that could deny thousands of children autism assessments, which parents say “puts children at serious risk”.
Earlier this month, NHS commissioners in Bristol, North Somerset and South Gloucestershire announced new referral criteria for childhood autism assessment effective immediately without notice or consultation.
NHS leaders say the new restrictions are needed because the number of local children waiting for an autism assessment has increased by 350% since the peak of the pandemic, with waiting times exceeding two years.
Under the new rules, children and teens will only be referred for autism screening if they meet one of six criteria, including rejection of a place of study, risk of family breakdown, and very low levels of communication associated with autism.
The new criteria were introduced by the local NHS Integrated Care Board (ICB) and Sirona, a non-profit organization providing NHS services in the ICB area. A Sirona spokesperson said that due to the changes, autism referrals were expected to decrease, but “any child referred before March 1 will be assessed against the previous criteria.”
However, Jaime Breitnauer found that her youngest son, Eli, was denied priority under the new criteria despite already having a referral. Eli initially waited nine months before going to the local pediatrician, who referred him for an autism evaluation. By the time the new criteria were introduced, he had been waiting a year just to be put on the waiting list for an autism assessment.
But this month, Breitnauer received a letter saying that while Eli was on the waiting list for evaluation under the old criteria, the new criteria would determine his position on the list.
“So even though [some children are] on the waiting list, they will never make it to the top,” Breitnauer said.
Eli, now 11, struggled with the transition to high school but was denied access to an education, health and care program that provides facilities for children with special educational needs. His attendance has dropped.
“Part of the statement Sirona made is that children don’t need a diagnosis to meet their educational needs. And I know that this is a legal position. But this is not what happens in our schools,” Breitnauer said.
Approximately 4,500 children in the ICB area are on a waiting list for either triage or an autism assessment. Sirona’s letter seen observers, says “an average of 40% of current referrals” will meet the new criteria, although this may include referrals to pediatric community services as well as autism assessments.
“We believe that changes in referral criteria are naive and irresponsible. We believe this puts children at real risk,” Breitnauer said. She is a member of the local campaign group Assess for Autism, which is raising funds for a possible legal challenge to the new rules.
“The risk of suicide is actually higher for autistic people without mental retardation. These are autistic people who most often disguise themselves, most often look normal. This is a group of children who would not be on Sirona’s priority list because they have developed coping mechanisms that mask an urgent need for diagnosis and support.”
Sirona said in a statement: “We have changed our referral criteria so that our resources can be directed to children who have the highest clinical needs or are the most vulnerable. It is important that we do not continue to accept more children and young people than we can see and appreciate, and our new approach has also brought us more in line with services across the country.”
