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Older dogs who sleep badly may have dementia, study says | CNN

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CNN
—

In a veterinary lab in North Carolina, Woofus, a 15-year-old basset hound mix, is allowing researchers to attach an electroencephalogram, or EEG, electrodes to his head before padding off to a dark, cozy room for an afternoon nap.

During his snooze, the study team will analyze Woofus’ brain waves to judge the quality of his sleep. Woofus has canine cognitive dysfunction syndrome, or CCDS, the doggie disorder that’s similar to Alzheimer’s disease in people. The elderly dog’s owners say he is struggling to get enough rest at night.

“Just like humans with Alzheimer’s disease, dogs with CCDS experience sleep disruptions, such as insomnia and sleep fragmentation,” said veterinarian Dr. Natasha Olby, a professor of neurology, neurosurgery and gerontology at North Carolina State College of Veterinary Medicine in Raleigh.

Woofus isn’t the only sleep-deprived dog in this study. On other days in the clinic, Jake, a 13-year-old pointer, and Coco, a 12-year-old dachshund, among others, might be taking a siesta while researchers peer inside their brains.

“Owners of dogs with CCDS report their dogs suffer from difficulty sleeping at night, increased sleeping during the day or both, as well as pacing and vocalizations at night,” Olby said. “This can be very hard on the dog’s owners — not only are they worried for their pet, their sleep is also significantly disrupted.”

To find out whether sleep problems in dogs indicate early signs of dementia as they do in people, Olby and her team turned to a group of senior dogs enrolled in an ongoing study testing antiaging supplements. The dogs visit twice a year “and do all kinds of really fun cognitive testing,” she said. “They really enjoy it and like the handlers they work with.”

To be considered for the antiaging study, the dog must have lived more than 75% of the expected life span for their breed or mix of breeds. A dog also could not be crippled by arthritis or going blind, as the pet needed to be able to perform tasks designed to test their cognitive capabilities.

A dog might be asked, for example, to find a treat hidden under a cup or a snack inside a cylinder in which one end had been closed by a researcher. By repeating the tasks at the clinic every six months, any decline in the dog’s mental agility or performance can be tracked.

Woofus, 15-year-old basset hound mix, plays

For the new study measuring a dog’s brain waves during sleep, researchers used a form of electroencephalogram called polysomnography, used in sleep clinics to diagnose sleep problems in people.

“It’s the gold standard method to look at what the brain is doing during sleep,” Olby said, adding this is the first canine study to apply the same technology used on humans.

“We glue these electrodes on with a really great conductive glue that’s water soluble. Then we just wash it off afterwards,” she said. “We don’t use anywhere near as many electrodes as you see on people in a sleep lab, because dogs have far less cortex and surface area to cover.”

Already at ease with the staff, it wasn’t too difficult to train 28 senior dogs to wear electrodes and walk around with dangling wires without complaint, she said.

Jake, a 13-year-old pointer, was one of 28 dogs trained to sleep with EEG electrodes.

To make the dogs more comfortable during their siestas, owners bring their dogs’ beds from home, which are placed in a protected room with white noise.

“Staff sit with them while they nap to make sure that they’re not trying to pull out or eat the electrodes or do anything that might hurt them,” Olby said.

When sleeping brain waves were compared with a dog’s cognitive testing, researchers found that dogs with greater dementia spent less time in deep and REM sleep, just as people do. The study was recently published in the journal Frontiers in Veterinary Science.

“Dogs that did worse on our memory tests had levels of REM sleep which were not as deep as they should be,” Olby said. “We found the same when it came to deep sleep.”

While no one knows the exact mechanism at work — either in people or in dogs — research like this study may help scientists better understand the process and find ways to treat it, Olby said.

“There’s a possibility we might be able to identify an early signature of change on the EEG that can tell us, ‘Hey, things are starting to slide.’ Because with a chronic neurodegenerative process, of course we’d love to be able to intervene sooner rather than later.”

In the meantime, there are medications for anxiety and melatonin for sleep that veterinarians can prescribe as a dog ages, Olby said. And as with people, diet and exercise appears to be a factor.

“There’s been some very nice studies showing diets that are enriched in flavonoids and antioxidants and medium-chain fatty acids could possibly slow the development of dementia in dogs,” she said. “It’s just like people — if you can eat a Mediterranean diet and do your exercise, you’re going to do better.”

Doggie dementia is a worrisome reality for many senior dogs. Research has found that by 11 or 12 years of age, 28% of dogs had mild and 10% had severe cognitive impairment. By the time the dogs reached age 15, the risk had risen to 68% for mild and 35% for severe cognitive impairment. A 2022 study found the odds of canine cognitive dysfunction increased by 52% with each year of age, Olby said.

Pet owners can look for signs that their dog’s mental functions are declining. According to Olby, vets use an acronym called DISHA-AL, which stands for disorientation, interaction changes, sleep/wake cycle alterations, house soiling; activity changes (increased or decreased); and anxiety and learning & memory.

“One of the earliest signs is you’ll start to see a little confusion just like you do with people, they suddenly start to make some mistakes and things you wouldn’t expect them to do. Very similar to us,” Olby said.

Dogs and cats who share their human's bed tend to have a

A dog who sleeps at the end of the bed with their face toward the door might have a more protective personality, Varble said.</p><p>

Is sleeping with your pets good for them?

Dogs may also lose learned behaviors, or forget their house training and begin to have unintentional accidents around the house, she added.

“A classic problem is wandering around and getting lost under the table or something — they just can’t process the information and figure out where they are. Changes in sleep cycle, increased anxiety, all of these things are classic signs of dementia,” she said.

Don’t assume that is what is wrong with your dog, however. Just like in people, other health problems such as metabolic disease, urinary tract infections or even brain tumors can mimic classic signs of dementia.

“High blood pressure can make dogs anxious, for example,” Olby said, “so a vet needs to thoroughly check the dog to rule out disease.”

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Don’t use sugar substitutes for weight loss, World Health Organization advises | CNN

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CNN
—

Don’t use sugar substitutes if you are trying to lose weight, according to new guidance from the World Health Organization.

The global health body said a systematic review of the available evidence suggests the use of non-sugar sweeteners, or NSS, “does not confer any long-term benefit in reducing body fat in adults or children.”

“Replacing free sugars with non-sugar sweeteners does not help people control their weight long-term,” said Francesco Branca, director of WHO’s department of nutrition and food safety. “We did see a mild reduction of body weight in the short term, but it’s not going to be sustained.”

The guidance applies to all people except those with preexisting diabetes, Branca said. Why? Simply because none of the studies in the review included people with diabetes, and an assessment could not be made, he said.

The review also indicated that there might be “potential undesirable effects” from the long-term use of sugar substitutes such as a mildly increased risk of type 2 diabetes and cardiovascular diseases.

However, “this recommendation is not meant to comment on safety of consumption,” Branca said. “What this guideline says is that if we’re looking for reduction of obesity, weight control or risk of noncommunicable diseases, that is unfortunately something science been unable to demonstrate,” he said. “It’s not going to produce the positive health effects that some people might be looking for.”

Non-sugar sweeteners are widely used as an ingredient in prepackaged foods and beverages and are also sometimes added to food and drinks directly by consumers. WHO issued guidelines on sugar intake in 2015, recommending that adults and children reduce their daily intake of free sugars to less than 10% of their total energy intake. Following that recommendation, interest in sugar alternatives intensified, the review said.

“This new guideline is based on a thorough assessment of the latest scientific literature, and it emphasises that the use of artificial sweeteners is not a good strategy for achieving weight loss by reducing dietary energy intake,” said nutrition researcher Ian Johnson, emeritus fellow at Quadram Institute Bioscience, formerly the Institute of Food Research, in Norwich, United Kingdom.

“However, this should not be interpreted as an indication that sugar intake has no relevance to weight-control,” Johnson said in a statement.

Instead, one should cut back on using sugar-sweetened drinks, and try to use “raw or lightly processed fruit as a source of sweetness,” Johnson added.

Dr. Keith Ayoob, scientific adviser for the Calorie Control Council, an international association representing the low-calorie food and beverage industry, told CNN via email the WHO’s “insistence on focusing only on prevention of unhealthy ‎weight gain and non-communicable diseases is at the very least, misguided.”

Robert Rankin, president of the Calorie Control Council, said “low- and no-calorie sweeteners are a critical tool that can help consumers manage body weight and reduce the risk of non-communicable diseases.”

The guidance is meant for government health organizations in countries who may wish to use the scientific analysis to implement policy changes for their citizens, Branca said.

“That will likely depend on the way that which sweeteners are consumed in a specific country,” he said. “For example, in a country where consumption patterns are high, those countries might decide to take action in a way or another.”

A total of 283 studies were included in the review. Both randomized controlled trials, considered the gold standard of research, and observational studies were included. Observational studies can only show an association, not direct cause and effect.

Results from randomized trials found the use of non-sugar sweeteners had a “low” impact on reducing body weight and calorie intake when compared with sugar, and no change in Intermediate markers of diabetes such as glucose and insulin, according to the report.

Observational studies also found a low impact on body weight and fat tissue, but no change in calorie intake. However, those studies found a low increase in risk for type 2 diabetes, high blood pressure, stroke, heart disease and death from heart disease, the report noted. A very low risk was also found for bladder cancer and an early death from any cause.

WHO said that the recommendation was “conditional” because the identified link between sweeteners and disease outcomes might be confounded by complicated patterns of sweetener use and the characteristics of the study participants.

In an emailed statement, the International Sweeteners Association, an industry assocation, said “it is a disservice to not recognise the public health benefits of low/no calorie sweeteners and is disappointed that the WHO’s conclusions are largely based on low certainty evidence from observational studies, which are at high risk of reverse causality.”

However, observational studies that follow people over time are important, Branca said. “To show that overweight people can reduce their body weight requires a long-term study. And we’re not seeing that impact from the research we have.”

The recommendation included low or no calorie synthetic sweeteners and natural extracts, which may or may not be chemically modified, such as acesulfame K, aspartame, advantame, cyclamates, neotame, saccharin, sucralose, stevia and stevia derivatives and monkfruit, the report said.

“Stevia and monkfruit are newer sweeteners so so there’s less published research in the scientific literature,” Branca said. “However they probably work in the body with a similar physiological mechanism as other sweeteners. We cannot say they are different from the others based on the data we have — they play the same role.”

Many people consider stevia products to be more “natural,” since they are derived from the stevia plant. Some natural and artificial sweeteners add bulking sugars to their products to cut their sweetness and add bulk to the product for baking.

A recent study by researchers at the US-based Cleveland Clinic found erythritol — used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products — was linked to blood clotting, stroke, heart attack and early death.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, the study found.

Just as many people have learned to eat and cook without salt, they can learn to reduce their dependence on free sugars and non-nutritive sweetners, Branca said.

“We need to target children in early life,” he said. “For example, why do parents typically use sweeteners as a reward for children and after almost every meal? We need to recommend to parents to avoid building that sweetness Interest in young children — that’s a very important action to take.”

Even if you are a true sugar “addict,” the good news is that you can tame your sweet tooth, registered dietitian Lisa Drayer said in an article for CNN. She provides the following steps:

Train your taste buds. If you gradually cut back on sugar — including artificial sweeteners — and include more protein and fiber-rich foods in your diet, that can help you crave less sugar, Drayer said.

“When we consume protein and fiber, it slows the rise in blood sugar if we consume it with a sugar-containing food. It can help satisfy us and help us reduce our sugar intake as well,” she said in a previous interview.

Choose no-sugar-added foods and avoid all sugar-sweetened drinks. For example, choose whole-grain cereal or Greek yogurt with no sweeteners. The sugar-sweetened drinks to take off your grocery list should include sodas, energy drinks, sports drinks and fruit punch. Choose water instead.

“If you like sweet carbonated beverages, add a splash of cranberry or orange juice to seltzer or try flavored seltzers. You can also flavor your own waters with fruit slices for natural sweetness or try herbal fruit teas,” Drayer said.

Drink coffee and tea with no or fewer sugars. Be careful at coffee shops, Drayer suggested. All those lattes and flavored coffees can have as much sugar as a can of soda, or more.

Enjoy fruit for dessert. Try cinnamon baked apples, berries or grilled peaches instead of cookies, cake, ice cream, pastries and other sweet treats, Drayer said.

Watch for stealth sugars. Added sugars are often present in foods that you might not think of as “sweet,” like sauces, breads, condiments and salad dressings, Drayer said.

“Pre-packaged sauces — like ketchup, BBQ sauce and tomato sauce — tend to be some of the biggest offenders of hidden added sugars in the diet,” Kristi King, senior pediatric dietitian at Texas Children’s Hospital and a national spokesperson for the Academy of Nutrition and Dietetics, told Drayer in a prior interview.

Check nutrition facts labels. All foods and beverages must list the amount and kind of sugar on the label.

Added sugars can go by other names such as “agave, brown sugar, corn sweetener, corn syrup, dextrose, evaporated cane juice, fructose, fruit juice concentrate, fruit nectar, glucose, high-fructose corn syrup, honey, invert sugar, lactose, malt syrup, maltose, molasses, maple syrups, raw sugar, sucrose, trehalose and turbinado sugar,” Drayer said.

The higher up these added sugars are on the ingredients list, the greater the amount of added sugar in the product, she said.

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Covid-19 is no longer a public health emergency, but others remain | CNN

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CNN
—

The Covid-19 pandemic hit a major milestone this month as public health emergency declarations were ended by both the United States government and the World Health Organization. Emergency declarations for mpox also recently ended.

This doesn’t mean Covid-19 and mpox are no longer of concern, but it does mark the end of the availability of certain logistical capabilities to manage them.

Still, other critical health challenges were identified as health emergencies years before the start of the Covid-19 pandemic and continue to be so: the opioid crisis in the US and the global spread of poliovirus.

Some public health concerns can be serious health threats without a formal emergency declaration, said Dr. Tom Frieden, former director of the US Centers for Disease Control and Prevention.

It largely boils down to the logistics of government operations.

“When there’s an unusual situation that requires multiple parts of an agency or multiple parts of the government or multiple parts of society to come together and coordinate, collaborate and work efficiently, then an emergency declaration can be a useful tool,” said Frieden, president and CEO of Resolve to Save Lives, an organization focused on global epidemic prevention and cardiovascular health.

“Sometimes, an emergency is declared to make the point that it’s a big problem, to get people’s attention. Sometimes, an emergency is declared to get things done because that’s the only way you can bring certain governmental capacities to bear.”

According to WHO, a public health emergency of international concern is “an extraordinary event” that poses public health risk through the international spread of disease.

It creates an agreement between countries to abide by WHO’s recommendations for managing the emergency, often requiring a “coordinated international response.” Each country, in turn, declares its own public health emergency – declarations that carry legal weight. Countries use them to marshal resources and waive rules in order to ease a crisis.

In the US, the secretary of the Department of Health and Human Services can declare a public health emergency for diseases or disorders that pose a threat, including “significant outbreaks” of an infectious disease, bioterrorist attacks or otherwise.

This triggers the availability of a set of resources and actions for the federal government, such as additional funds and data and reporting requirements.

Emergency declarations typically last up to 90 days, with formal renewal required as necessary every three months after that.

The opioid crisis was determined to be a public health emergency in October 2017, during the Trump administration, driven by the rising rates of opioid-related deaths and opioid use disorder.

The declaration has been renewed for more than five years, most recently at the end of March.

According to the CDC, the opioid epidemic started in 1999 with a rise in prescription opioid overdose deaths. Deaths started to increase precipitously as synthetic opioids – particularly fentanyl – started to take over in 2013.

In 2021, overdose deaths reached record levels in the US, and about three-quarters – more than 80,000 deaths – involved opioids.

Within the first year of the opioid emergency declaration, HHS used expanded authorities to field a survey about treatment for opioid use disorder among providers and to expedite research on the topic.

Public health emergencies are also declared to help with recovery after natural disasters, most recently for severe storms that hit Mississippi in March.

However, the Government Accountability Office considers both federal management of the public health emergency system and efforts to combat drug misuse to be “high-risk” areas that are vulnerable or in need of broad reform.

In a recent report, the federal watchdog group said that it has found “persistent deficiencies in HHS’s leadership role preparing for and responding to public health emergencies” and no demonstrated progress in federal agencies’ actions to address drug misuse.

WHO has considered poliovirus a public health emergency of international concern since 2014.

A committee formed to address the emergency reviewed the most recent data on cases and spread this month and voted unanimously that ongoing risks merited an extension of the emergency declaration, which the director-general formalized Friday.

The committee was “encouraged by reported progress” but says that risks remain high for factors including weak vaccination rates that could have been affected by the Covid-19 pandemic.

WHO identified seven counties with potential risk for international spread. And the US is among a group of 37 countries with recently detected cases.

In July, a polio case identified in New York became the first in the US in nearly a decade. The identified case, along with several positive wastewater tests in nearby communities, met WHO criteria to consider the US a country with circulating poliovirus.

Experts warned that it could just be the “tip of the iceberg,” with hundreds of cases spreading silently.

Childhood vaccination rates in the US dropped during the Covid-19 pandemic. A CDC report found that about 93% of kindergarteners enrolled in the 2021-22 school year got the required vaccines, including measles, mumps and rubella (MMR); diphtheria, tetanus and acellular pertussis (DTaP); and polio. Coverage fell for the second year in a row amid the pandemic, from about 94% the previous year and below the federal target of 95%.

While no longer under a formal emergency declaration, Covid-19 continues to be part of the “landscape of health threats,” Frieden said.

But the efficiency and coordination that the formal declaration helps facilitate should always be the goal.

“I think there are really important lessons from Covid, including the need to have a much more resilient public health system so that we can find problems quickly and implement effective solutions quickly,” Frieden said.

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Sleeping will be one of the challenges for astronauts on Mars missions | CNN

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CNN
—

Astronauts have been adjusting to the challenges of sleeping in space for years — and the lessons learned from their zero gravity slumbers will ensure that one day the first crewed missions to Mars will have gotten enough rest before exploring the red planet.

Rotating crews have spent an average of six months living and working aboard the International Space Station for nearly 23 years, and they struggle with sleep issues just like people on Earth. Some of the challenges are similar to those of shift workers or people with abnormal schedules, but others are more unique to the space environment.

NASA astronaut Josh Cassada is bundled up in his crew quarters on the International Space Station on March 2.

For example, most people don’t have to worry about floating away from their beds due to zero gravity. Don’t worry — astronauts use special restraints to keep them from floating through the space station while asleep.

Two of the biggest challenges for astronauts include their sleep environment and the establishment of a natural sleep cycle.

Astronauts have dark, quiet and private crew quarters on the space station conducive to good sleep — but that won’t always be the case on other space missions, said Dr. Erin Flynn-Evans, director of the Fatigue Countermeasures Laboratory at NASA’s Ames Research Center in Mountain View, California.

Like their historic Apollo predecessors, the Orion capsules that will be used during future Artemis missions to the moon are small vehicles with limited space for crews and sleeping bags for rest periods.

“I think of it like camping,” Flynn-Evans said. “If it’s for a couple days, probably no big deal. But the longer you’re in close quarters with someone, the more disruptive that can be.”

While the space station affords incredible views of Earth, the 16 sunrises an astronaut witnesses a day can wreak havoc on circadian rhythm, the body’s natural clock for sleeping and waking.

On Earth, disruptions to circadian rhythm occur for people who work overnight shifts or experience jet lag while traveling across time zones.

“Light is what resets our circadian rhythm and keeps us organized to that day-night cycle, but in space we have several challenges,” Flynn-Evans said.

The space station orbits around Earth every 90 minutes, creating alternating cycles of darkness and light. Rather than force the astronauts to adapt to such a strange cycle, experts at NASA have added lighting to the interior of the space station that mimics what people experience during a normal day on Earth.

“We have to try to block out the light from windows during the night,” she said, “and we have to really try to maximize the light either through windows or with internal lighting to make sure the crew are getting that synchronizing stimulus so that they’re able to stay awake and asleep at the right time.”

Jet lag begins before astronauts ever arrive at the space station, and their sleep schedules are shifted for days before liftoff based on the time of day and time zone from which they will launch. Once they reach the space station, each astronaut is shifted to Greenwich Mean Time, “a nice middle ground between all of the countries that participate,” Flynn-Evans said.

At the Fatigue Countermeasures Laboratory, Flynn-Evans and her colleagues develop tools to help astronauts overcome sleep challenges. Some of the strategies involve managing when the astronauts are exposed to blue light, the primary synchronizing wavelength for the circadian system, and when to reduce blue light to help them sleep.

Astronauts have regimented schedules, but the arrival of resupply missions or new crews sometimes interrupt those. Flynn-Evans and other researchers develop approaches to shifting sleep safely for the astronauts, such as determining when to take naps or stay up later to accommodate schedule changes.

The same tips that help astronauts sleep also apply on Earth, including following a regular schedule with waking and falling asleep at the same time as much as possible and limiting exposure to blue light before going to bed, which is emitted by LED TVs, smartphones, computers and tablets.

Although scientists have sleep data from years of spaceflight, conducting simulated missions on Earth allow for more control.

“We do fake space missions all the time,” Flynn-Evans said. “We have what we call an analog space environment at Johnson Space Center called the Human Exploration Research Analog or HERA, and that’s basically a small habitat.”

The CHAPEA crew will live in a habitat with individual quarters at NASA's Johnson Space Center in Houston.

The habitat mimics the size of a lunar base or small spacecraft and can house crews of four people for long periods of time. Flynn-Evans was involved in a study in which crews spent 45 days in the habitat and were restricted to five hours of sleep on weeknights and eight hours on weekends. The participants were tested for alertness and performance.

Findings from the experiment showed that if crew members only got five hours of sleep one night, they needed more opportunities to catch up on sleep on subsequent nights to prevent the ill effects of sleep deprivation. The current requirement is that crew members get 8½ hours of sleep per night on missions to avoid long-term sleep loss, fatigue-induced errors and health complications, according to NASA.

In June, NASA will begin the first experiment in a new 3D-printed Martian habitat at Johnson Space Center called the Crew Health and Performance Exploration Analog, or CHAPEA.

Over the course of one year, a four-person crew will live and work inside a 1,700-square-foot (158-square-meter) space to simulate living on Mars. The focus for the first experiment is nutrition, but Flynn-Evans and her fellow researchers will also monitor how well the crew sleeps.

Habitats such as HERA and CHAPEA allow scientists to simulate surprises that may happen on a real mission to the moon or Mars, such as limited resources, failing equipment, communication issues and other stressors of small habitats.

An unexpectedly rich source of sleep data has proven to be studying the Earth-bound scientists and engineers who work on Mars missions such as the Perseverance rover.

A day on Mars lasts about 39 minutes longer than one on Earth, but it’s just enough that the members of Mars mission control have to adjust their schedules constantly to stay on Perseverance’s timetable.

“If you’re shifting 39 minutes a day, that means that you’re basically going to bed 39 minutes later every day,” Flynn-Evans said. “It doesn’t seem that bad on a single night. But after five days, it’s like you’ve crossed like six time zones. It’s a real stressor on the body.”

Many unknowns still exist about being on “Mars time,” such as how the time shift affects the human body’s metabolism.

Understanding how people on Earth adapt to live on Mars time is one way of preparing for future missions to the red planet. Flynn-Evans and her team are working closely with those planning the Artemis lunar missions to optimize the astronauts’ schedules and ensure that the lighting is sufficient and the noise is dampened inside Orion when they need to sleep.

Researchers also want to study how much caffeine astronauts require for alertness to make sure crews don’t run out of coffee in a spacecraft with limited storage.

“Sleep is intimately tied with performance, alertness, interpersonal communication and relationships,” Flynn-Evans said, “so we want to make sure that the crews are set up for success and getting that sleep they need.”

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How the nursing shortage may lead to gaps in sexual assault care | CNN

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Missoula, Montana
KFF Health News
—

Jacqueline Towarnicki got a text as she finished her day shift at a local clinic. She had a new case, a patient covered in bruises who couldn’t remember how the injuries got there.

Towarnicki’s breath caught, a familiar feeling after four years of working night shifts as a sexual assault nurse examiner in this northwestern Montana city.

“You almost want to curse,” Towarnicki, 38, said. “You’re like, ‘Oh, no, it’s happening.’”

These nights on duty are Towarnicki’s second job. She’s on call once a week and a weekend a month. A survivor may need protection against sexually transmitted infections, medicine to avoid getting pregnant, or evidence collected to prosecute their attacker. Or all the above.

When her phone rings, it’s typically in the middle of the night. Towarnicki tiptoes down the stairs of her home to avoid waking her young son, as her half-asleep husband whispers encouragement into the dark.

Her breath is steady by the time she changes into the clothes she laid out close to her back door before going to bed. She grabs her nurse’s badge and drives to First Step Resource Center, a clinic that offers round-the-clock care for people who have been assaulted.

She wants her patients to know they’re out of danger.

“You meet people in some of their most horrifying, darkest, terrifying times,” Towarnicki said. “Being with them and then seeing who they are when they leave, you don’t get that doing any other job in health care.”

A former travel nurse who lived out of a van for years, Towarnicki is OK with the uncertainty that comes with being a sexual assault nurse examiner.

Most examiners work on-call shifts in addition to full-time jobs. They often work alone and at odd hours. They can collect evidence that could be used in court, are trained to recognize and respond to trauma, and provide care to protect their patients’ bodies from lasting effects of sexual assault.

But their numbers are few.

As many as 80% of U.S. hospitals don’t have sexual assault nurse examiners, often because they either can’t find them or can’t afford them. Nurses struggle to find time for shifts, especially when staffing shortages mean covering long hours. Sexual assault survivors may have to leave their town or even their state to see an examiner.

Gaps in sexual assault care can span hundreds of miles in rural areas. A program in Glendive, Montana — a town of nearly 5,000 residents 35 miles from the North Dakota border — stopped taking patients for examinations this spring. It didn’t have enough nurses to respond to cases.

“These are the same nurses working in the ER, where a heart attack patient could come in,” said Teresea Olson, 56, who is the town’s part-time mayor and also picked up on-call shifts. “The staff was exhausted.”

The next closest option is 75 miles away in Miles City, adding at least an hour to the travel time for patients, some of whom already had to travel hours to reach Glendive.

Nationwide, policymakers have been slow to offer training, funding, and support for the work. Some states and health facilities are trying to expand access to sexual assault response programs.

Oklahoma lawmakers are considering a bill to hire a statewide sexual assault coordinator tasked with expanding training and recruiting workers. A Montana law that takes effect July 1 will create a sexual assault response network within the Montana Department of Justice. The new program aims to set standards for that care, provide in-state training, and connect examiners statewide. It will also look at telehealth to fill in gaps, following the example of hospitals in South Dakota and Colorado.

There’s no national tally of where nurses have been trained to respond to sexual assaults, meaning a survivor may not know they have to travel for treatment until they’re sitting in an emergency room or police department.

Sarah Wangerin, a nursing instructor with Montana State University and former examiner, said patients reeling from an attack may instead just go home. For some, leaving town isn’t an option.

This spring, Wangerin called county hospitals and sheriff’s offices to map where sexual assault nurse examiners operate in Montana. She found only 55. More than half of the 45 counties that responded didn’t have any examiners. Just seven counties reported they had nurses trained to respond to cases that involve children.

“We’re failing people,” Wangerin said. “We’re re-traumatizing them by not knowing what to do.”

First Step, in Missoula, is one of the few full-time sexual assault response programs in the state. It’s operated by Providence St. Patrick Hospital but is separate from the main building.

The clinic’s walls are adorned with drawings by kids and mountain landscapes. The staff doesn’t turn on the harsh overhead fluorescent lights, choosing instead to light the space with softer lamps. The lobby includes couches and a rocking chair. There are always heated blankets and snacks on hand.

Kate Harrison turns on her pager at the start of her night shift as a sexual assualt nurse examiner.

First Step stands out for having nurses who stay. Kate Harrison waited roughly a year to join the clinic and is still there three years later, in part because of the staff support.

The specially trained team works together so no one carries too heavy a load. While being on night shift means opening the clinic alone, staffers can debrief tough cases together. They attend group therapy for secondhand trauma.

Harrison is a cardiac hospital nurse during the day, a job that sometimes feels a little too stuck to a clock.

At First Step, she can shift into whatever role her patient needs for as long as they need. Once, that meant sitting for hours on a floor in the lobby of the clinic as a patient cried and talked. Another time, Harrison doubled as a DJ for a nervous patient during an exam, picking music off her cellphone.

“It’s in the middle of the night, she just had this sexual assault happen, and we were just laughing and singing to Shaggy,” Harrison said. “You have this freedom and grace to do that.”

When the solo work is overwhelming or she’s had back-to-back cases and needs a break, she knows a co-worker would be willing to help.

“This work can take you to the undercurrents and the underbelly of society sometimes,” Harrison said. “It takes a team.”

That includes co-workers like Towarnicki, who dropped her work hours at her day job after having her son to keep working as a sexual assault nurse examiner. That meant adding three years to her student loan repayment schedule. Now, pregnant with her second child, the work still feels worth it, she said.

On a recent night, Towarnicki was alone in the clinic, clicking through photos she took of her last patient. The patient opted against filing a police report but asked Towarnicki to log all the evidence just in case.

Towarnicki quietly counted out loud the number of bruises, their sizes and locations, as she took notes. She tells patients who have gaps in their memories that she can’t speculate how each mark got there or give them all the answers they deserve.

But as she sat in the blue light of her computer screen long after her patient left, it was hard to keep from ruminating.

“Totally looks like a hand mark,” Towarnicki said, suddenly loud, as she shook her head.

All the evidence and her patient’s story were sealed and locked away, just feet from a wall of thank-you cards from patients and sticky notes of encouragement among nurses.

On the harder evenings, Towarnicki takes a moment to unwind with a pudding cup from the clinic’s snacks. Most often, she can let go of her patient’s story as she closes the clinic. Part of her healing is “seeing the light returned to people’s eyes, seeing them be able to breathe deeper,” which she said happens 19 out of 20 times.

“There is that one out of 20 where I go home and I am spinning,” Towarnicki said. In those cases, it takes hearing her son’s voice, and time to process, to pull her back. “I feel like if it’s not hard sometimes, maybe you shouldn’t be doing this work.”

It was a little after 11 p.m. as Towarnicki headed home, an early night. She knew her phone could go off again.

Eight more hours on call.

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FDA advisers narrowly vote in favor of experimental gene therapy for rare muscle disease | CNN

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CNN
—

Most parents wouldn’t be thrilled with the idea of their kids getting hooked up to an IV bag filled with trillions of viruses.

But for Melanie Hennick, whose son, Connor, has Duchenne muscular dystrophy, it was an opportunity she hoped would change his life.

“We knew this wasn’t a cure,” Hennick said. “But it was a chance.”

Connor is one of just dozens of kids to have received SRP-9001, an experimental gene therapy that aims to slow or stop the progression of Duchenne muscular dystrophy, or DMD. Current treatments for the disease – which primarily affects boys because of the way it’s inherited – include steroids and, later, heart drugs. But none stop it.

SRP-9001 uses viruses to ferry a copy of a gene to muscles to help make up for one that’s causing the disease. Hennick and many other parents like her advocated for the treatment’s accelerated approval Friday in a meeting of outside advisers to the US Food and Drug Administration.

The advisers voted 8-6 in favor of approving the treatment, and the FDA will now decide whether to follow their advice.

“The decision the FDA has to make doesn’t just affect the patients in study 301 [an ongoing confirmatory trial that Sarepta is running]; it affects the entire field of drug development for Duchenne,” said Dr. Caleb Alexander, a professor of epidemiology and medicine in the Bloomberg School of Public Health at Johns Hopkins University, who voted against recommending approval. “The totality of evidence … simply doesn’t rise to the threshold that’s required for accelerated approval.”

Dr. Raymond Roos, a neurology professor at the University of Chicago Medical Center, voted in favor. “The downside of the gene therapy here is relatively small compared to whether it really helps the patient, and for this reason, I voted yes,” he said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said his agency will take the recommendation and “do something that we have to do every day at FDA. … We have to manage through the uncertainty here.”

The FDA’s decision, expected by the end of the month, will have implications not just for families like Connor’s but for how the agency regulateths treatments like this one more broadly: It would be the first of its kind of medicine – one-time treatments delivering a gene to try to fix a disease – to get accelerated approval, a faster track through the regulatory process. Its approval would set a precedent for other drugs like this based on so-called surrogate endpoints, a measure of what the drug does in the body, before further clinical evidence is available.

“Approval of a gene therapy for Duchenne muscular dystrophy will be huge,” said Jeffrey Chamberlain, a professor at the University of Washington School of Medicine who helped pioneer gene therapy approaches for the disease. “This, I think, will spur further research and further development of gene therapies for other diseases.”

DMD patients don’t have a lot of time to wait. Kids with Duchenne typically lose the ability to walk before they’re teenagers and often don’t live well into their 30s, Chamberlain said. He’s not directly involved with SRP-9001, which is being developed by Sarepta Therapeutics, and is on the scientific advisory board for another company working on DMD gene therapies, Solid Biosciences.

“Gene therapy appears to be a really good approach to try to treat this disease, because it’s a genetic disease,” Chamberlain said. “The cause of the disease is a mutation in a single gene.”

That gene is responsible for the production of dystrophin, a protein key to the structure of muscle cells.

“It’s kind of like the two-by-fours that make up your house,” Chamberlain said. “It’s really important for just holding everything together.”

SRP-9001, invented at Nationwide Children’s Hospital in Columbus, Ohio, before being licensed for development by Sarepta, delivers a miniaturized version of the dystrophin gene to cells, aiming to help them make a version of the muscle-preserving protein.

In a key clinical trial, the therapy appeared to do that. But it didn’t meet another main goal: showing a benefit on a measure of muscle function, complicating SRP-9001’s path through the FDA.

Sarepta blamed the outcome on an imbalance in how the trial separated patients into the placebo and treatment groups. But key FDA reviewers appear unconvinced.

“The clinical studies conducted to date do not provide unambiguous evidence that SRP-9001 is likely beneficial for ambulatory patients with DMD,” agency reviewers wrote in briefing documents released ahead of Friday’s meeting, referring to patients who can still walk – the group who will initially be eligible for the treatment if it gets approved.

Family after family who participated in Sarepta’s trials, like the Hennicks, disagree with the reviewers. They say they believe that the treatment has helped keep their kids walking and running in ways they never would have without it.

“It’s really miraculous,” said Nate Plasman, whose son Andrew got SRP-9001 as part of the trial in January 2019, at age 4.

Sara, left, Andrew and Nate Plasman on the day he was dosed in the trial in January 2019.

Andrew was away from school for more than two months when he got the experimental therapy, Plasman said, and when he returned, “his teachers at the preschool were blown away,” he recalled. “They’re like, ‘Who is this kid?’ He’s running. He’s jumping. He’s pedaling the tricycle. He’s getting up and down off the ground” – all things he couldn’t do as well before the therapy.

Marit Sivertson, mom to 9-year-old Brecken, agrees.

“We’ve seen the incredible changes with our son,” she said. “He’s not just walking around. He’s running; he’s swimming; he’s diving. He’s truly living the life that every 9-year-old boy ought to be living.”

Dr. Jerry Mendell of Nationwide Children's Hospital in Ohio, who developed the gene therapy, left, with Brecken Kinney.

Sivertson and Plasman also spoke at Friday’s meeting. Their goal isn’t to secure the therapy for their own kids; because it’s designed as a one-time treatment, they wouldn’t take it again. They say they’re speaking up on behalf of children who are still waiting.

That wait is especially painful for Daniel and Lindsey Flessner, who have two sons with DMD. Their 5-year-old son, Mason, is in the SRP-9001 clinical trial. Their 2-year-old, Dawson, is still too young.

“With every trip, every fall, every time he stands up by walking up his legs using his hands to help stabilize him, it just keeps chipping away at us,” Flessner said. “It’s very painful as the parents watching your children struggling knowing all you can do is wait, when waiting is what you don’t have time for.”

Lindsey and Daniel Flessner's sons, Mason and Dawson, both have DMD.

In addition to questions about how well the treatment works, the FDA reviewers raised concerns about safety, particularly “related to the possibility of administering an ineffective gene therapy.”

The reviewers focused on opportunity cost: Because of the viruses used to deliver the gene, patients can develop an immune response that could render future doses ineffective.

Chamberlain said work is underway to find ways to be able to administer more doses, if needed, but it’s currently a one-and-done treatment.

For now, he thinks this approach is the best hope for DMD patients.

“It’s not perfect,” he acknowledged. “It’s not a complete cure, but from what I can gauge from the clinical results that have been released by Sarepta and some of the other companies, I think the micro-dystrophin gene therapy is working better than any other drug that’s been tried for Duchenne muscular dystrophy.”

It’s unclear how long the effects will last; Sarepta is continuing trials, and a confirmatory study would be required as part of accelerated approval. Sarepta has proposed a trial that it’s already running to satisfy that requirement, with results expected later this year.

For families facing DMD, there’s an opportunity cost to waiting, too. In its briefing documents for the FDA meeting, Sarepta estimated that accelerated approval would speed up broad access to SRP-9001 by at least a year, a time in which about 400 boys could lose the ability to walk and another 400, whose disease is more advanced, would die.

Melanie Hennick said Connor was admitted to the trial just weeks before he’d have aged out, at 8 years old. She said she believes the therapy is the reason Connor’s doing so well.

“We had the opportunity to see Connor grow as an 8-, 9-, 10-, 11- and 12-year-old with more capacity than we ever dreamed,” she said. “He climbs stairs unaided; he runs around; he plays football; he plays hockey; he plays on a baseball team. … Those are things that we never thought we would be able to see him do, especially at 12.”

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How a medication abortion, also known as an ‘abortion pill,’ works | CNN

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CNN
—

While legal battles over access to mifepristone, one of two drugs used for medication abortions, play out in court, the drug continues to be available in states which consider abortion legal.

“While many women obtain medication abortion from a clinic or their OB-GYN, others obtain the pills on their own to self-induce or self-manage their abortion,” said Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

“A growing body of research indicates that self-managed abortion is safe and effective,” he said.

Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. The drug is approved to end a pregnancy through 10 weeks’ gestation, which is “70 days or less since the first day of the last menstrual period,” according to the FDA.

In a medication abortion, a second drug, misoprostol, is taken within the next 24 to 48 hours. Misoprostol causes the uterus to contract, creating cramping and bleeding. Approved for use in other conditions, such as preventing stomach ulcers, the drug has been available at pharmacies for decades.

Together, the two drugs are commonly known as the “abortion pill,” which is now used in more than half of the abortions in the United States, according to the Guttmacher Institute, a research group that supports abortion rights.

“Some people do this because they cannot access a clinic — particularly in states with legal restrictions on abortion — or because they have a preference for self-care,” said Grossman, who is also the director of Advancing New Standards in Reproductive Health, a research group that evaluates the pros and cons of reproductive health policies and publishes studies on how abortion affects a woman’s health.

What happens during a medication abortion? To find out, CNN spoke with Grossman. The conversation has been edited for clarity.

CNN: What is the difference between a first-trimester medication abortion and a vacuum aspiration in terms of what a woman experiences?

Dr. Daniel Grossman: A vacuum aspiration is most commonly performed under a combination of local anesthetic and oral pain medications or local anesthetic together with intravenous sedation, or what is called conscious sedation.

An injection of local anesthetic is given to the area around the cervix, and the cervix is gently dilated or opened up. Once the cervix is opened, a small straw-like tube is inserted into the uterus, and a gentle vacuum is used to remove the pregnancy tissue. Contrary to what some say, if the procedure is done before nine weeks or so, there’s nothing in the tissue that would be recognizable as a part of an embryo.

The aspiration procedure takes just a couple of minutes; then the person is observed for one to two hours until any sedation has worn off. We also monitor each patient for very rare complications, such as heavy bleeding.

Grossman: A medication abortion is a more prolonged process. After taking the pills, bleeding and cramping can occur over a period of days. Bleeding is typically heaviest when the actual pregnancy is expelled, but that bleeding usually eases within a few hours. On average people continue to have some mild bleeding for about two weeks or so, which is a bit longer than after a vacuum aspiration.

Nausea, vomiting, fever, chills, diarrhea and headache can occur after using the abortion pill, and everyone who has a successful medication abortion usually reports some pain.

In fact, the pain of medication abortion can be quite intense. In the studies that have looked at it, the average maximum level of pain that people report is about a seven to eight out of 10, with 10 being the highest. However, people also say that the pain can be brief, peaking just as the pregnancy is being expelled.

The level of cramping and pain can depend on the length of the pregnancy as well as whether or not someone has given birth before. For example, a medical abortion at six weeks or less gestation typically has less pain and cramping than one performed at nine weeks. People who have given birth generally have less pain.

CNN: What can be done to help with the pain of a medication abortion?

Grossman: There are definitely things that can be used to help with the pain. Research has shown that ibuprofen is better than acetaminophen for treating the pain of medication abortion. We typically advise people to take 600 milligrams every six hours or so as needed.

Some people take tramadol, a narcotic analgesic, or Vicodin, which is a combination of acetaminophen and hydrocodone. Recent research I was involved in found medications like tramadol can be helpful if taken prophylactically before the pain starts.

Another successful regimen that we studied combined ibuprofen with a nausea medicine called metoclopramide that also helped with pain. Other than ibuprofen, these medications require a prescription.

Another study found that a TENS device, which stands for transcutaneous electrical nerve stimulator, helps with the pain of medication abortion. It works through pads put on the abdomen that stimulate the nerves through mild electrical shocks, thus interfering with the pain signals. That’s something people could get without a prescription.

Pain can be an overlooked issue with medication abortion because, quite honestly, as clinicians, we’re not there with patients when they are in their homes going through this. But as we’ve been doing more research on people’s experiences with medication abortion, it’s become quite clear that pain control is really important. I think we need to do a better job of treating the pain and making these options available to patients.

CNN: Are there health conditions that make the use of a medication abortion unwise?

Grossman: Undergoing a medication abortion can be dangerous if the pregnancy is ectopic, meaning the embryo is developing outside of the uterus. It’s rare, happening in about two out of every 100 pregnancies — and it appears to be even rarer among people seeking medication abortion.

People who have undergone previous pelvic, fallopian tube or abdominal surgery are at higher risk of an ectopic pregnancy, as are those with a history of pelvic inflammatory disease. Certain sexually transmitted infections can raise risk, as does smoking, a history of infertility and use of infertility treatments such as in vitro fertilization (IVF).

If a person is on anticoagulant or blood thinning drugs or has a bleeding disorder, a medication abortion is not advised. The long-term use of steroids is another contraindication for using the abortion pill.

Anyone using an intrauterine device, or IUD, must have it removed before taking mifepristone because it may be partially expelled during the process, which can be painful.

People with chronic adrenal failure or who have inherited a rare disorder called porphyria are not good candidates.

CNN: Are there any signs of trouble a woman should watch for after undergoing a medication abortion?

Grossman: It can be common to have a low-grade fever in the first few hours after taking misoprostol, the second drug in a medication abortion. If someone has a low-grade fever — 100.4 degrees to 101 degrees Fahrenheit — that lasts more than four hours, or has a high fever of over 101 degrees Fahrenheit after taking the medications, they do need to be evaluated by a health care provider.

Heavy bleeding, which would be soaking two or more thick full-size pads an hour for two consecutive hours, or a foul-smelling vaginal discharge should be evaluated as well.

One of the warning signs of an ectopic pregnancy is severe pelvic pain, particularly on one side of the abdomen. The pain can also radiate to the back. Another sign is getting dizzy or fainting, which could indicate internal bleeding. These are all very rare complications, but it’s wise to be on the lookout.

We usually recommend that someone having a medication abortion have someone with them during the first 24 hours after taking misoprostol or until the pregnancy has passed. Many people specifically choose to have a medication abortion because they can be surrounded by a partner, family or friends.

Most people know that the abortion is complete because they stop feeling pregnant, and symptoms such as nausea and breast tenderness disappear, usually within a week of passing the pregnancy. A home urine pregnancy test may remain positive even four to five weeks after a successful medication abortion, just because it takes that long for the pregnancy hormone to disappear from the bloodstream.

If someone still feels pregnant, isn’t sure if the pregnancy fully passed or has a positive pregnancy test five weeks after taking mifepristone, they need to be evaluated by a clinician.

People should know that they can ovulate as soon as two weeks after a medication abortion. Most birth control options can be started immediately after a medication abortion.

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‘We never want to have this happen again,’ FDA official testifies about formula shortage | CNN

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CNN
—

In a rare moment of bipartisan agreement, lawmakers were highly critical of the US Food and Drug Administration’s handling of the infant formula shortage Thursday.

The hearing of the US House Oversight and Accountability Subcommittee on Health Care and Financial Services was one of several Congress has held to better understand what contributed to the recent formula shortage and to understand how to prevent more problems down the road.

Rep. Lisa McClain, R-Michigan, said that the FDA has not been fully forthcoming with Congress and the public.

“Why was the FDA unprepared for the crisis?” she asked in her opening statement.

She said that the agency failed to prioritize food safety. “The FDA has not taken the action needed to prevent a similar crisis from happening again.”

Rep. Katie Porter, D-California, said she agreed with McClain that another shortage could happen, “and that is a deadly serious problem.”

“There is a lot of blame to go around,” Porter added. “It’s clear with today’s witness selection that Republicans want to blame the FDA, and I’ll level with you, I think some of that blame is well-placed. We’ve had two subsequent infant formula recalls in 2023 already, and we’re still seeing that the FDA can make further improvements on internal processes, intervene in issues sooner and follow through with more inspections to prevent further contamination.”

Three major manufacturers in the US control over 90% of the formula market, and that consolidation is a “serious concern” that “contributed significantly to shortages,” according to Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, who testified Thursday.

A shortage that started in 2021 was exacerbated when the country’s largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February 2022 and had to pause production at its plant in Sturgis, Michigan, after FDA inspectors found potentially dangerous bacteria.

The plant inspection was tied to an outbreak of Cronobacter sakazakii that had sickened at least four infants and killed two, although investigations did not find a genetic link between bacteria samples from the facility and bacteria found in the water and powder used to mix the formula that the infants had consumed.

Mayne testified that it was difficult to trace the cases and determine how big of a concern the outbreak was. The bacteria is a common pathogen in the environment “but one about which we have limited information.”

The FDA has urged the US Centers for Disease Control and Prevention to make Cronobacter infection a notifiable disease – meaning providers would be required to report cases to local or state public health officials – so public health experts would be able to more quickly determine the source of any contamination.

In addition to the bacteria, an FDA inspection of the Sturgis plant found unsanitary conditions and several violations of food safety rules.

A whistleblower had alerted the FDA to alleged safety lapses at the plant in February 2021, months before Abbott’s formula was recalled. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.

Like other FDA leaders who have been called before Congress, Mayne testified that she was not made aware of the complaint right away. She called it “a failure of escalation.”

“I do wish I had been made aware of this particular whistleblower complaint, but just to reiterate, the complaint was acted upon,” Mayne said. However, she noted, it was “less than ideal” how quickly there was an FDA inspection of the plant and how quickly the agency was able to act.

When the whistleblower made the complaint, there was no process within the FDA to escalate it. The process has since changed so that if a complaint meets certain criteria involving vulnerable populations, hospitalizations or deaths, leadership would be immediately informed. If a consumer complaint involves an infant death or hospitalization, it also immediately gets escalated to leadership.

To prevent future shortages, Mayne testified, it won’t just be the FDA that needs to change. The industry should do more to adopt enhanced food safety measures to “deliver the safest possible” infant formula, she said.

The agency would also like better regulations. There have been been two infant formula recalls already in 2023, and in neither case was the manufacturer required to notify the FDA that it had found contamination before the formula left the plant.

The FDA has asked formula makers to inform the agency about positive tests, but such reporting is only voluntary. If it were mandatory, the FDA could know about problems in real time and could take action.

“Our food safety experts, our compliance experts can work with the manufacturers,” Mayne said. In such a collaboration, they could quickly identify what product to focus on to prevent a shortage.

The FDA has taken recent steps to improve. In February, it announced that it is restructuring its food division to be more responsive and that it is creating an office of critical foods. The FDA is also hiring specialized infant formula inspection staff, Mayne said.

The infant formula supply is generally in good shape, she said, but there are still some distribution issues.

The in-stock rate is near 90%, even higher than pre-recall levels. But some rural areas are having a hard time getting all the formula they need.

Formula manufacturers have been producing more than is being purchased week after week to build up supply, Mayne said. The Biden administration has also worked to bring in formula from manufacturers overseas.

But another shortage is not out of the question, particularly if one of the country’s main manufacturers is taken offline for any significant amount of time.

“We never want to have this happen again,” Mayne said.

Lawmakers have proposed significant cuts, about 22%, to the FDA’s budget for 2023. Mayne said that consumers and the industry would be “adversely affected” if the cuts go through.

“Broadly, across the FDA, I can say it would be devastating,” she said, resulting in a loss of 32% of domestic inspections and 22% of foreign inspections. The cuts would also disproportionately affect its food programs, which get much of their funding from the budget, unlike divisions involving drugs that get money from user fees.

“We would be unable to do what I think American consumers expect us to do,” Mayne said.

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FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

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CNN
—

Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

“Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

“I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.

In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.

“This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.

A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

“We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

Murray said the lack of sufficient information from the study poses challenges for approval.

“It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

“I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

“The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

“The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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Millions of people are prescribed antidepressants for chronic pain. Do they work? | CNN

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Around one-third of people globally live with chronic pain — pain experienced for more than three months — and millions of people are prescribed antidepressants to relieve the condition.

However, a new review of prior research published Tuesday has found that most antidepressants used to relieve chronic pain are being prescribed without sufficient reliable evidence of their effectiveness. What’s more, potential harms haven’t been well studied.

A two-year study by the nonprofit group Cochrane found that only one antidepressant, duloxetine, was effective for short-term pain relief based on the available evidence. Cochrane is an international collaboration of researchers that produces the Cochrane Library, which includes a database of systematic summaries addressing key questions in health care.

Sold under the brand names Irenka and Cymbalta, duloxetine is a serotonin and norepinephrine reuptake inhibitor, or SNRI, and also boosts levels of the feel-good neurochemical dopamine.

“This is a global public health concern,” said lead author Tamar Pincus, a professor and chronic pain researcher at the University of Southampton in the United Kingdom.

“Chronic pain is a problem for millions who are prescribed antidepressants without sufficient scientific proof they help, nor an understanding of the long-term impact on health.”

The review included 176 studies with a total of 28,664 participants and looked at 25 different antidepressants. The studies mainly investigated three types of chronic pain: fibromyalgia, nerve pain and musculoskeletal pain.

The average length of the study was 10 weeks, and the studies were randomized controlled trials — regarded as the gold standard in medical research. Seventy-two of the studies were funded by pharmaceutical companies.

The most commonly prescribed antidepressant for chronic pain globally was amitriptyline, the study said. Sold in the United States under the brand names Elavil and Vanatrip, the antidepressant was approved in 1961 by the US Food and Drug Administration to treat depression in adults. The medication has significant side effects, so it is not commonly used for depression, but is prescribed to treat migraines and chronic pain such as diabetic neuropathy.

However, the authors found most of the studies on amitriptyline’s effectiveness were small and the evidence was not reliable.

Milnacipran, which is approved by the FDA for fibromyalgia, was also effective at reducing pain, the review found, but the scientists were not as confident about this drug compared with duloxetine due to limited studies with few people.

Anyone taking antidepressants for chronic pain relief should speak to their doctor before stopping their medication due to concerns over the new report, the authors stressed.

Antidepressants are thought to help with pain because the bodily systems that regulate mood and pain overlap, explained Ryan Patel, a research fellow studying chronic pain at the Wolfson Centre for Age-Related Diseases at King’s College London.

He said the key question for researchers to answer was not whether antidepressant drugs were effective for treating pain but “for whom are antidepressants effective?”

“Even when the cause of chronic pain is the same, the biological changes that occur in the nervous system are varied and so it is no surprise that pain presents differently from person to person, and not everyone will respond to the same drugs,” said Patel, who wasn’t involved in the review.

“What this comprehensive analysis demonstrates is that when clinical trials are designed poorly under the assumption that everyone’s experience of pain is uniform, most antidepressants appear to have limited use for treating chronic pain,” Patel added in a statement.

Even for the antidepressant duloxetine, there was no research looking at long-term use of the drug, the review found.

“Though we did find that duloxetine provided short-term pain relief for patients we studied, we remain concerned about its possible long-term harm due to the gaps in current evidence,” Pincus said.

The report said future research should address any unwanted effects of using antidepressants for chronic pain, noting that the existing data on this was “poor.”

“It (duloxetine) does look really good at the moment for short term pain relief, but I want to emphasize that patients aren’t prescribed duloxetine or any antidepressant for three weeks, four weeks, six weeks, they’re prescribed it for six months. So it’s really shocking that we don’t have any evidence for long term use of even duloxetine,” Pincus said.

Dr. Cathy Stannard, the clinical lead for the UK National Institute for Health and Care Excellence (NICE) guideline for chronic pain, and a pain specialist for NHS Gloucestershire’s Integrated Care Board in the UK, said that it was important to emphasize the social and psychological influences on how people experience pain and the importance of a patient’s relationship with their doctor.

“There is good evidence that for people with pain, compassionate and consistent relationships with clinicians remain the foundations of successful care,” Stannard, who wasn’t involved in the research, said in a statement.

“Research shows that what people want most is a strong, empathic relationship with their care provider. They want time to discuss what matters to them and they want easy access to support and to be partners in their care.”

Non-pharmaceutical interventions, such as support with mobility, debt management, trauma and social isolation, were also likely to help people living with pain, she added.

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