SCOTUS mifepristone case: Justices focus on anti-abortion groups’ legal standing

<img src="https://rassegna.lbit-solution.it/wp-content/uploads/2024/03/scotus-mifepristone-case-justices-focus-on-anti-abortion-groups-legal-standing.jpg" alt="Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the US Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024 in Washington, DC.”>
Enlarge / Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the US Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024 in Washington, DC.

The US Supreme Court on Tuesday heard arguments in a case seeking to limit access to the abortion and miscarriage drug mifepristone, with a majority of justices expressing skepticism that the anti-abortion groups that brought the case have the legal standing to do so.

The case threatens to dramatically alter access to a drug that has been safely used for decades and, according to the Guttmacher Institute, was used in 63 percent of abortions documented in the health care system in 2023. But, it also has sweeping implications for the Food and Drug Administration’s authority over drugs, marking the first time that courts have second-guessed the agency’s expert scientific analysis and moved to restrict access to an FDA-approved drug.

As such, the case has rattled health experts, reproductive health care advocates, the FDA, and the pharmaceutical industry alike. But, based on the line of questioning in today’s oral arguments, they have reason to breathe a sigh of relief.

Standing

The case was initially filed in 2022 by a group of anti-abortion organizations led by the Alliance for Hippocratic Medicine. They collectively claimed that the FDA’s approval of mifepristone in 2000 was unlawful, as were FDA actions in 2016 and 2021 that eased access to the drug, allowing for it to be prescribed via telemedicine and dispensed through the mail. The anti-abortion groups justified bringing the lawsuit by claiming that the doctors in their ranks are harmed by the FDA’s actions because they are forced to treat girls and women seeking emergency medical care after taking mifepristone and experiencing complications.

The FDA and numerous medical organizations have emphatically noted that mifepristone is extremely safe and the complications the lawsuit references are exceedingly rare. Serious side effects occur in less than 1 percent of patients, and major adverse events, including infection, blood loss, or hospitalization, occur in less than 0.3 percent, according to the American College of Obstetricians and Gynecologists. Deaths are almost non-existent.

Still, a conservative federal judge in Texas sided with the anti-abortion groups last year, revoking the FDA’s 2000 approval. A conservative panel of judges for the Court of Appeals for the 5th Circuit in New Orleans then partially overturned the ruling, undoing the lower court’s ruling on the 2000 approval, allowing the FDA’s approval to stand, but still finding the FDA’s 2016 and 2021 actions unlawful. The ruling was frozen until the Supreme Court weighed in.

Today, many of the Supreme Court Justices went back to the very beginning: the claimed scenario that the plaintiff doctors have been or will imminently be harmed by the FDA’s actions. At the outset of the hearings, Solicitor General Elizabeth Prelogar argued that the plaintiffs had not been harmed, and, even if they were, they already had federal protections and recourse. Any doctor who consciously objects to caring for a patient who has had an abortion already has federal protections that prevent them from being forced to provide that care, Prelogar argued. As such, hospitals have legal obligations and have set up contingency and staffing plans to prevent violating those doctors’ federal conscious objection protections.

https://arstechnica.com/?p=2012710




Lifesaving gene therapy for kids is world’s priciest drug at $4.25M

A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.
Enlarge / A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004.

In a medical triumph, US Food and Drug Administration on Monday approved a gene therapy that appears to trounce a rare, tragic disease that progressively steals children’s ability to talk, move, and think, leading to a vegetative state and death. For those who begin to slip away in infancy, many die by age 5. But, with the new therapy, 37 children in an initial trial were all still alive at age 6. Most could still talk, walk on their own, and perform normally on IQ tests, which was unseen in untreated children. Some of the earliest children treated have now been followed for up to 12 years—and they continue to do well.

But, the triumph turned bittersweet today, Wednesday, as the company behind the therapy, Lenmeldy, set the price for the US market at $4.25 million, making it the most expensive drug in the world. The price is $310,000 higher than what experts calculated to be the maximum fair price for the lifesaving drug; the nonprofit Institute for Clinical and Economic Review, or ICER, gave a range last October of between $2.29 million to $3.94 million.

The price raises questions about whether state, federal, and private health insurance plans will be able to shoulder the costs. “Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes,” Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, told CNN.

It’s also unclear whether the drug can reach the children who need it in time. Lenmeldy must be given before symptoms develop or early on in symptom development in children. However, diagnosis of the rare genetic condition can be slow, and many children treated so far were identified because older siblings, now too old for treatment, developed the condition first.

Devastating disease

Stat, for instance, spoke with the mother of an 8-year-old with the condition, who can no longer talk or move, has frequent seizures, and requires a feeding tube and 28 different medications. Meanwhile, her 3-year-old brother, who has the same genetic mutation, is a typical toddler—he was able to get the new treatment when he was six months old. To get it, the family flew him to Milan, Italy, where Lenmeldy was first developed. It was approved for use in Europe in 2021.

The condition Lenmeldy treats is called metachromatic leukodystrophy (MLD), which occurs in about 40 children in the US each year. MLD is caused by a mutation in the gene that codes for the enzyme arylsulfatase A (ARSA). Without this enzyme, the body can’t break down sulfatides, a fatty substance that then builds up to toxic levels in the brain and peripheral nervous system. Sulfatides are essential components of myelin, the fatty insulation on nerve cells critical for quick transmission of electrical impulses. But, too much sulfatides leads to a loss of myelin, which gradually destroys myelin producing cells and leads to nervous system damage.

Lenmeldy prevents that damage by giving the body a working copy of the ARSA gene. In a one-time infusion, patients are given a dose of their own blood stem cells that have been genetically engineered to contain a functional ARSA gene. Patients undergo chemotherapy to clear out their own stem cells from bone marrow so the genetically modified cells can replace them. The engineered stem cells then produce myeloid cells that travel around the body in the blood, producing ARSA enzyme that can halt progression of MLD.

It’s unknown how long the therapy lasts, but it’s clearly buying children time and giving them hope for a full, normal life.

“MLD is a devastating disease that profoundly affects the quality of life of patients and their families,” Nicole Verdun, director of the FDA’s Office of Therapeutic Products, said in a statement. “Advancements in treatment options offer hope for improved outcomes and the potential to positively influence the trajectory of disease progression.”

It “has the potential to stop or slow the progression of this devastating childhood disease with a single treatment, particularly when administered prior to the onset of symptoms,” Bobby Gaspar, CEO of Lenmeldy’s maker, Orchard Therapeutics, said in a statement Wednesday. “We are committed to enabling broad, expedient, and sustainable access to this important therapy for eligible patients with early-onset MLD in the US.”

The company is working on expanding newborn screening to include tests for MLD, to try to find children early, Orchard reported. Still, with such a rare condition, it’s unclear if the pricey drug will be a moneymaker for the company. Stat notes that Orchard has previously abandoned four therapies for other rare genetic conditions because of the difficulty in meeting regulatory standards for essentially custom therapies and questions about whether health plans will pay the steep, multimillion-dollar prices. In April of last year, Belgium, Ireland, and the Netherlands walked away from price negotiations with the company, saying they couldn’t come to an agreement on this “extremely expensive therapy.”

https://arstechnica.com/?p=2011685




Deadly morel mushroom outbreak highlights big gaps in fungi knowledge

Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China's Ningxia Hui Autonomous Region.
Enlarge / Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China’s Ningxia Hui Autonomous Region.

True morel mushrooms are widely considered a prized delicacy, often pricey and surely safe to eat. But these spongey, earthy forest gems have a mysterious dark side—one that, on occasion, can turn deadly, highlighting just how little we know about morels and fungi generally.

On Thursday, Montana health officials published an outbreak analysis of poisonings linked to the honeycombed fungi in March and April of last year. The outbreak sickened 51 people who ate at the same restaurant, sending four to the emergency department. Three were hospitalized and two died. Though the health officials didn’t name the restaurant in their report, state and local health departments at the time identified it as Dave’s Sushi in Bozeman. The report is published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

The outbreak coincided with the sushi restaurant introducing a new item: a “special sushi roll” that contained salmon and morel mushrooms. The morels were a new menu ingredient for Dave’s. They were served two ways: On April 8, the morels were served partially cooked, with a hot, boiled sauce poured over the raw mushrooms and left to marinate for 75 minutes; and on April 17, they were served uncooked and cold-marinated.

The mystery poison worked fast. Symptoms began, on average, about an hour after eating at the restaurant. And it was brutal. “Vomiting and diarrhea were reportedly profuse,” the health officials wrote, “and hospitalized patients had clinical evidence of dehydration. The two patients who died had chronic underlying medical conditions that might have affected their ability to tolerate massive fluid loss.”

Of the 51 sickened, 46 were restaurant patrons and five were employees. Among them, 45 (88 percent) recalled eating morels. While that’s a high percentage for such an outbreak investigation, certainly enough to make the morels the prime suspect, the health officials went further. With support from the CDC, they set up a matched case-control study, having people complete a detailed questionnaire with demographic information, food items they ate at the restaurant, and symptoms.

Mysterious poison

Forty-one of the poisoned people filled out the questionnaire, as did 22 control patrons who ate at the restaurant but did not report subsequent illness. The analysis indicated that the odds of recalling eating the special sushi roll were nearly 16 times higher among the poisoned patrons than among the controls. The odds of reporting any morel consumption were nearly 11 times higher than controls.

The detailed consumption data also allowed the health officials to model a dose response, which suggested that with each additional piece of the special roll a person recalled eating, their odds of sickness increased nearly threefold compared with people who reported eating none. Those who ate four or more pieces of the roll had odds nearly 22.5 times higher. A small analysis focusing on the five employees sickened, which was not included in the published study but was noted by the Food and Drug Administration, echoed the dose-response finding, indicating that sickness was linked with larger amounts of morel consumption.

When the officials broke down the analysis by people who ate at the restaurant on April 17, when the morels were served uncooked, and those who ate at the restaurant on April 8, when the mushrooms were slightly cooked, the cooking method seemed to matter. People who ate the uncooked rather than the slightly cooked mushrooms had much higher odds of sickness.

This all strongly points to the morels being responsible. At the time, the state and local health officials engaged the FDA, as well as the CDC, to help tackle the outbreak investigation. But the FDA reported that “samples of morel mushrooms collected from the restaurant were screened for pesticides, heavy metals, toxins, and pathogens. No significant findings were identified.” In addition, the state and local health officials noted that DNA sequencing identified the morels used by the restaurant as Morchella sextelata, a species of true morel. This rules out the possibility that the mushrooms were look-alike morels, called “false morels,” which are known to contain a toxin called gyromitrin.

The health officials and the FDA tracked down the distributor of the mushrooms, finding they were cultivated and imported fresh from China. Records indicated that 12 other locations in California also received batches of the mushrooms. Six of those facilities responded to inquiries from the California health department and the FDA, and all six reported no illnesses. They also all reported cooking the morels or at least thoroughly heating them.

https://arstechnica.com/?p=2010513




Apple’s AirPods Pro could be getting a “hearing aid mode” later this year

AirPods arranged at an Apple Store
Enlarge / Apple AirPods on display at the company’s Fifth Avenue store in New York in Feb. 2024.
Bing Guan/Bloomberg via Getty Images

Apple’s AirPods Pro are getting closer to becoming fully fledged hearing aids and marketed as such, according to Bloomberg’s Mark Gurman. The move could have a large impact on the hearing aid market, which has already been recently shaken up by over-the-counter models.

Gurman writes that AirPods Pro are due to receive a hearing-aid function in iOS 18, arriving this fall and likely to be announced and outlined at a Worldwide Developers Conference in June. The Wall Street Journal reported in the fall of 2021 that Apple was working toward a future AirPods Pro model that functioned as a hearing aid and would also be able to monitor body posture and even body temperature.

It was not clear from Gurman or the Journal’s reporting whether the hearing aid function would be available only in a new model of AirPods Pro or offered as a software update on prior models. Since the Journal’s report, Apple has released both a second-generation model of AirPods Pro and a refresh of that model with a USB-C port.

“Hearing aid” may also not be technically accurate, depending on Apple’s aims. The US Food and Drug Administration in 2022 provided for a new category of “Personal sound amplification products,” or PSAPs, that do not need to meet the stricter requirements for an FDA-approved hearing aid. This new category offered huge cost savings to people with mild to moderate hearing loss and kicked off a generation of hearing aids that connected to a smartphone over Bluetooth for setup, tuning, and monitoring. These are distinct from over-the-counter hearing aids, which, while still notably cheaper than “professional fit” hearing aids, are still regulated by the FDA.

A study in late 2022 found that first-generation AirPods Pro, with their “Live Listen” feature activated, could meet four of the five PSAP standards and just barely missed a sound-pressure threshold. Notably, the AirPods Pro, tested in relatively quiet environments, helped people hear about as well as hearing aid models that cost up to $10,000, within the PSAP standards.

The next version of Apple’s mobile operating system, iOS 18, is rumored to contain a multitude of features beyond AirPods updates. MacRumors (leaning on Gurman’s subscriber-only newsletter reporting) suggests that generative AI features, RCS support for text messages, and revamps to many core Apple apps are due.

https://arstechnica.com/?p=2009584




New FDA-approved drug makes severe food allergies less life-threatening

Peanuts
Enlarge / Peanuts

Living with food allergies can be a fraught existence. There is no cure, and the standard management is to be ever vigilant of everything you eat and have an emergency shot of epinephrine constantly handy in case an accidental ingestion leads to a swift, life-threatening reaction. But, for the millions of people in the US who live with such allergies, a new drug may dull the threat.

On Friday, the Food and Drug Administration approved the antibody drug omalizumab (brand name Xolair) as an injection to lessen allergic reactions to foods in people ages 1 and up. In a trial of 168 children and adults with multiple food allergies, participants who received shots of omalizumab for 16 to 20 weeks were much more likely to tolerate a test dose of allergy-inducing foods at the end than those who received a placebo.

Omalizumab—which was previously approved to treat asthma, hives, and nasal polyps—works by binding to a class of antibodies in the body called immunoglobulin E (IgE) that are specifically involved in allergic responses. The monoclonal antibody drug binds IgE, blocking it from binding to its target receptor, thus preventing it from triggering the immune responses that lead to allergy symptoms.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in today’s announcement. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

The trial began in 2019 and was run by the National Institute of Allergy and Infectious Diseases and is still ongoing. But an interim analysis of early data was enough to convince the FDA of the drug’s benefit.

More tolerance

For the trial, researchers recruited people who had an allergy to peanuts, as well as at least two other food allergies, including milk, egg, wheat, cashew, hazelnut, or walnut. Those assigned to get omalizumab received shots every two to four weeks for 16 to 20 weeks. Afterward, researchers looked at whether participants could handle 600 milligrams or more of peanut protein, which is equivalent to eating about 2.5 or more peanuts. Of those who got the shot, 68 percent (75 of 110 subjects) handled the peanut doses without moderate to severe allergy symptoms, such as whole-body hives, persistent coughing, or vomiting. In the placebo group, only 6 percent (3 of 55 subjects) managed this.

As secondary tests, the researchers tried other allergy-triggering foods at the higher dose of 1,000 milligrams or more. For cashews, 42 percent (27 of 64) of participants who received omalizumab tolerated the challenge without moderate or severe allergic reactions, compared with 3 percent (1 of 30) in the placebo group. For milk, 66 percent (25 of 38 subjects) who received the drug tolerated the dairy, while only 11 percent (2 of 19) of the placebo group did so. For egg, 67 percent (31 of 46 subjects) on the drug tolerated the dose, compared to 0 percent of the 19 who received placebo.

The benefits of omalizumab were not universal. The FDA notes that 17 percent of the people who received the drug had no significant improvement in their sensitivity to allergy-triggering food. As such, the FDA cautions that even if people receive Xolair, they should still avoid the foods that trigger their allergies.

The trial is ongoing, and researchers plan to look at the longevity of the drug’s effectiveness and whether it can be paired with another strategy to ratchet down food allergies: oral immunotherapy (OIT), which uses small, daily doses of an allergen to build tolerance over time. For the look at longevity, some trial participants will get shots for an additional 24 weeks, followed by more food challenges to see if the drug remains useful at easing allergic responses over the prolonged time period. For the OIT part of the trial, participants will get another 16 weeks of injections and, halfway through that, some will undergo multi-allergen OIT. They will then be followed for 44 additional weeks.

The FDA says the most common side effects of omalizumab are injection site reactions and fever, but the agency also warns of the possibility of joint pain, rash, parasitic infections, malignancies, and abnormal laboratory tests.

https://arstechnica.com/?p=2004231




Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

Can you sanitize the inside of your nose to prevent COVID? Nope, FDA says.

More than four years after SARS-CoV-2 made its global debut, the US Food and Drug Administration is still working to clear out the bogus and unproven products that flooded the market claiming to prevent, treat, and cure COVID-19.

The latest example is an alcohol-based sanitizer meant to be smeared inside the nostrils. According to its maker, the rub can protect you from becoming infected with SARS-CoV-2 and other nasty germs, like MRSA, and that protection lasts up to 12 hours after each swabbing. That all sounds great, but according to the FDA, none of it is proven. In a warning letter released Tuesday, the agency determined the sanitizer, called Nozin, is an unapproved new drug and misbranded.

While ethyl alcohol is used in common topical antiseptics, like hand sanitizers, the FDA does not generally consider it safe for inside the nostrils—and the agency is unaware of any high-quality clinical data showing that Nozin is safe, let alone effective. The FDA also noted that, for general over-the-counter topical antiseptics, calling out specific pathogens it can fight off—like SARS-CoV-2 and MRSA—is not allowed under agency rules without further FDA review. Making claims about protection duration is also not allowed.

The FDA’s warning letter is nothing to sneeze at; the letter threatens seizure and injunction for failing to adequately respond.

Nozin’s maker, Maryland-based Global Life Technologies Corp., did not immediately respond to a request for comment from Ars. On its website, the company touts its product’s effectiveness with a link to a published study from 2014, indicating that use of Nozin lowered the colonization levels of S. aureus and other bacteria in the noses of 20 healthy health care workers. The study did not address protection from infection or carriage of any viruses. The company also lists unpublished studies indicating that the product can kill bacteria in laboratory conditions, does not irritate skin, and lowered bacterial growth in the noses of 30 people over a 12-hour period.

This is far from the first dubious, nasal-based COVID product the FDA has called out. There was the Corona-cure nasal spray of 2020, and the Halodine and NanoBio Protect nasal antiseptics of 2021. That year, the Federal Trade Commission sued a company called Xlear over allegedly false claims that its nasal spray can prevent and treat COVID-19. At least two more nasal spray makers received FDA warning letters in 2022.

To date, the FDA has not approved any nasal sprays to prevent or treat COVID-19, and the scant data on their efficacy remains inconclusive. But there are still plenty of such products for sale online. Most, like Nozin, claim to work by killing bacteria and viruses directly. One product, a nitric oxide nasal spray called Sanotize, is currently in a Phase III clinical trial to test whether it can prevent SARS-CoV-2 infections. Others claim to work by coating the nasal passage with the gelling agent iota-carrageenan to provide a barrier to viral entry. A pilot clinical trial of 400 health care workers in Argentina published in 2021 found that the use of an iota-carrageenan nasal spray led to a 4 percent absolute risk reduction in SARS-CoV-2 infection.

https://arstechnica.com/?p=2003503




We may now know who’s behind the lead-tainted cinnamon in toddler fruit pouches

The three recalled pouches linked to lead poisonings.
Enlarge / The three recalled pouches linked to lead poisonings.

A spice grinder named Carlos Aguilera of Ecuador is the likely source of contaminated cinnamon containing extremely high levels of lead and chromium, which made its way into the apple cinnamon fruit pouches of US toddlers, according to an announcement by the Food and Drug Administration this week.

To date, there have been 413 cases of poisoning across 43 US states, according to the Centers for Disease Control and Prevention.

The FDA said Ecuadorian officials at the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) identified Aguilera as the cinnamon processor and reported to the FDA that his business is no longer operating. Aguilera received raw cinnamon sticks sourced from Sri Lanka, which, according to raw sample testing conducted by ARCSA, had no lead contamination upon their arrival. After Aguilera processed the cinnamon, it was supplied by a company called Negasmart to Austrofoods, the manufacturer of the apple cinnamon pouches.

According to FDA inspection documents obtained by CBS News, Austrofoods never tested its product for heavy metals at any point in production and repeatedly failed to identify the cinnamon as a raw ingredient needing such testing. “[Y]ou did not sample and test the raw material or the finished product for heavy metals,” the FDA wrote in its inspection report. Testing by the FDA immediately identified high levels of lead in the finished apple cinnamon puree and in the ground cinnamon powder Austrofoods used for the purees. The regulator also observed problems with Austrofood’s pasteurization and sanitation procedures and noted equipment in poor condition that could have allowed metal pieces to break loose and get into food products.

Austrofood’s apple cinnamon fruit puree pouches were sold under three brands, all of which have been recalled: WanaBana apple cinnamon fruit puree pouches, Schnucks brand cinnamon-flavored applesauce pouches, and Weis brand cinnamon applesauce pouches.

The FDA reported that ARCSA’s investigation and legal proceedings are still ongoing to determine the ultimate responsibility for the contamination. The FDA acknowledged that it has “limited authority over foreign ingredient suppliers who do not directly ship product to the US. This is because their food undergoes further manufacturing/processing prior to export. Thus, the FDA cannot take direct action with Negasmart or Carlos Aguilera.”

Testing by the FDA hints that the cinnamon was contaminated with lead chromate, a vibrant yellow substance often used to bolster a spice’s appearance and weight artificially. It has frequently been found contaminating turmeric sourced from India and Bangladesh.

The children exposed to the purees face uncertain long-term health effects. The effects of ingesting chromium are unclear, and it’s also not clear what form of chromium the children ingested from the pouches. Lead, on the other hand, is a potent neurotoxic metal that can damage the brain and nervous system. In young children, the effects of acute exposures could manifest as learning and behavior problems, as well as hearing and speech problems in the years to come.

Last year, the CDC reported that exposed children had shown blood lead levels as high as 29 micrograms per deciliter (µg/dL), more than eight times the 3.5 µg/dL threshold the agency considers the cutoff for high exposure.

https://arstechnica.com/?p=2001859




Anti-abortion group’s studies retracted before Supreme Court mifepristone case

Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.
Enlarge / Mifepristone (Mifeprex) and misoprostol, the two drugs used in a medication abortion, are seen at the Women’s Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 17, 2022.

Scientific journal publisher Sage has retracted key abortion studies cited by anti-abortion groups in a legal case aiming to revoke regulatory approval of the abortion and miscarriage medication, mifepristone—a case that has reached the US Supreme Court, with a hearing scheduled for March 26.

On Monday, Sage announced the retraction of three studies, all published in the journal Health Services Research and Managerial Epidemiology. All three were led by James Studnicki, who works for The Charlotte Lozier Institute, a research arm of Susan B. Anthony Pro-Life America. The publisher said the retractions were based on various problems related to the studies’ methods, analyses, and presentation, as well as undisclosed conflicts of interest.

Two of the studies were cited by anti-abortion groups in their lawsuit against the Food and Drug Administration (Alliance for Hippocratic Medicine v. FDA), which claimed the regulator’s approval and regulation of mifepristone was unlawful. The two studies were also cited by District Judge Matthew Kacsmaryk in Texas, who issued a preliminary injunction last April to revoke the FDA’s 2000 approval of mifepristone. A conservative panel of judges for the 5th Circuit Court of Appeals in New Orleans partially reversed that ruling months later, but the Supreme Court froze the lower court’s order until the appeals process had concluded.

Mifepristone, considered safe and effective by the FDA and medical experts, is used in over half of abortions in the US.

Criticism

Amid the legal dispute, the now-retracted studies drew immediate criticism from experts, who pointed out flaws. Of the three, the most influential and heavily criticized is the 2021 study titled “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015” (PDF). The study suggested that up to 35 percent of women on Medicaid who had a medication abortion between 2001 and 2015 visited an emergency department within 30 days afterward. Its main claim was that medication abortions led to a higher rate of emergency department visits than surgical abortions.

Critics noted a number of problems: The study looked at all emergency department visits, not only visits related to abortion. This could capture medical care beyond abortion-related conditions, because people on Medicaid often lack primary care and resort to going to emergency departments for routine care. When the researchers tried to narrow down the visits to just those related to abortion, they included medical codes that were not related to abortion, such as codes for ectopic pregnancy, and they didn’t capture the seriousness of the condition that prompted the visit. Medication abortions can cause bleeding, and women can go to the emergency department if they don’t know what amount of bleeding is normal. The study also counted multiple visits from the same individual patient as multiple visits, likely inflating the numbers. Last, the study did not put the data in context of emergency department use by Medicaid beneficiaries in general over the time period.

In contrast to Studnicki’s study, the American College of Obstetricians and Gynecologists notes that studies looking at tens of thousands of medication abortions have concluded that “serious side effects occur in less than 1 percent of patients, and major adverse events—significant infection, blood loss, or hospitalization—occur in less than 0.3 percent of patients. The risk of death is almost non-existent.”

https://arstechnica.com/?p=2001534




US verges on vaccination tipping point, faces thousands of needless deaths: FDA

A child with measles.
Enlarge / A child with measles.

The US may be heading to a “dangerous vaccination tipping point,” with immunization rates falling so low that population-level immunity is now at risk, and we will likely see thousands of needless deaths this respiratory virus season, two top officials for the Food and Drug Administration warned in a recent JAMA commentary.

FDA Commissioner Robert Califf and top FDA vaccine regulator Peter Marks noted the profound benefits of lifesaving vaccines—which save millions of lives in the US each year—and their established safety, which is monitored both passively and actively through multiple, overlapping federal safety monitoring systems. And yet, “an increasing number of people in the US are now declining vaccination for a variety of reasons, ranging from safety concerns to religious beliefs,” thanks to the rise of anti-vaccine misinformation spread on social media and elsewhere on the Internet.

Data from the Centers for Disease Control and Prevention last year found that, for the third consecutive year, vaccination rates among kindergartners had continued to slip, with rates of non-medical vaccination exemptions rising to an all-time high. There are now 10 states with vaccination exemption rates over 5 percent, meaning that even if clinicians and health officials manage to vaccinate all non-exempt children, the state will not be able to reach the target of 95 percent coverage needed to curb the spread of disease on a population level.

Califf and Marks lamented that the efficacy of vaccines has meant that the “disturbing” suffering and deaths from vaccine-preventable diseases, such as the extremely contagious measles, are no longer visible to people in the US. Thus, vaccines’ benefits are underappreciated. But that reality is changing as vaccination rates slip, particularly in small pockets of the country.

“Regrettably, pediatric vaccine hesitancy now has been responsible for several measles outbreaks in the US, including a recent one in central Ohio involving local-acquired cases in 85 children, 36 of whom (42 percent) had to be hospitalized for complications,” Califf and Marks write.

A measles outbreak is ongoing in Philadelphia, where an unvaccinated person who contracted the virus outside the US exposed other unvaccinated people at the Children’s Hospital of Philadelphia and an area daycare. So far, eight cases have been confirmed (one adult and seven children), six of which were hospitalized. Some of the cases occurred when an infected, unvaccinated child broke quarantine and attended the daycare.

While childhood vaccination rates suffer and bygone diseases flare, there’s also concern for older people and more familiar diseases. The respiratory virus season is now peaking. Influenza-like illness activity—which can capture not just flu but also RSV and COVID-19—is high and rising throughout much of the country, posing a high risk to older people. Flu is infecting the most people right now, but COVID-19 is causing more than six times more deaths, with over a thousand deaths a week in recent weeks. Yet, the CDC estimates that only about 19 percent of adults have gotten the latest COVID-19 vaccine booster so far, while nearly 45 percent have gotten their annual flu shot.

Califf and Marks pose the question of what can be done to reverse course, and they point to a possible solution of calling on doctors, nurses, and even pharmacists to speak up about the benefits and importance of vaccination. Clinicians who provide care remain the most trusted sources of information for health decisions, they write.

“We believe that the best way to counter the current large volume of vaccine misinformation is to dilute it with large amounts of truthful, accessible scientific evidence,” they conclude. They called on health care providers to take every chance to help people make well-informed decisions about vaccinations. “By doing so, we can both help prevent pediatric infectious diseases and dramatically reduce the harm from pathogens such as COVID-19, influenza, and respiratory syncytial virus [RSV] disease before we have another large wave of any of these vaccine-preventable illnesses.”

https://arstechnica.com/?p=1995211




Canada vows to defend its drug supply against Florida importation plan

A Royal Canadian Mounted Police officer stands guard outside the Senate of Canada prior to the Speech from the Throne on September 23, 2020, in Ottawa.
Enlarge / A Royal Canadian Mounted Police officer stands guard outside the Senate of Canada prior to the Speech from the Throne on September 23, 2020, in Ottawa.

Canada issued a warning Monday that it stands ready to defend its prescription drug supply from US importation plans—and also said the plans wouldn’t work for the US, anyway. “Bulk importation will not provide an effective solution to the problem of high drug prices in the US,” Health Canada said in a statement.

The defensive stance comes just days after the US Food and Drug Administration granted Florida authorization to directly import cheaper prescription drugs from Canada in an effort to help drag down America’s uniquely stratospheric drug pricing. Florida is the first state to win such an authorization, and Florida Governor Ron DeSantis celebrated it, claiming the drug imports will save the state “up to $180 million in the first year alone.” There are caveats, though. Before Florida can import any drugs, it must complete several obligations, including submitting to the FDA additional drug-specific information, testing the drugs for authenticity and FDA compliance, and relabeling them in accordance with FDA labeling.

The FDA authorized the importation program in accordance with section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The move stems from President Biden’s “Executive Order on Promoting Competition in the American Economy,” which directed the FDA to help develop such programs.

“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert Califf said in the agency’s authorization announcement. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”

Proponents of the program in the US say that importing cheaper drugs from abroad could help lower US drug prices by offering more competition on the market. Canada, like other countries, has lower drug prices than the US, partly because the country’s national health system negotiates prices for prescription drugs. The US government only began negotiating prices last year—and is currently being sued by several pharmaceutical companies over the move.

But Canada, which has a population around nine times smaller than the US, has been staunchly opposed to the US importing its drugs. It has repeatedly said that diverting medicines to the US could lead to drug shortages in Canada, make existing shortages worse, and/or cause price spikes.

In its statement Monday, Canada said it was mounting defenses against such possibilities in light of the FDA’s authorization. “The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need,” it said.

“Health Canada is actively monitoring the Canadian drug supply,” it continued and cited recent Canadian regulations that prevent the distribution of drugs outside the country if it could cause or worsen a drug shortage within Canada. “The Department will not hesitate to take immediate action to address non-compliance, ranging from requesting a plan for corrective measures, issuing a public advisory or other forms of communication, to taking action on the licenses of regulated parties who contravene the export prohibition if warranted.”

Drug makers in the US also intend to fight the plans. Stephen Ubl, CEO of the powerful trade group PhRMA—Pharmaceutical Research and Manufacturers of America—said in a statement that the group is “deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan” and claimed importation “poses a serious danger to public health.” Ubl concluded that “PhRMA is considering all options for preventing this policy from harming patients.”

https://arstechnica.com/?p=1994816