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FDA approves first treatment for kids with peanut allergy

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WASHINGTON —
The first treatment for peanut allergies is about to hit the market, a big step toward better care for all kinds of food allergies — but still a long way from a cure.

Friday’s approval by the Food and Drug Administration promises to bring some relief to families who’ve lived in fear of an accidental bite of peanuts at birthday parties and play dates, school cafeterias and restaurants. Named Palforzia, it was developed by Aimmune Therapeutics.

“It’s been a life-changer,” said Nina Nichols, 18, of Washington, whose first encounter with peanuts as a toddler — a peanut butter cracker shared by a friend — required a race to the emergency room. She entered a Palforzia research study as a teen and calls it “a security blanket.”

The treatment is a specially prepared peanut powder swallowed daily in tiny amounts that are gradually increased over months. It trains children’s and teens’ bodies to better tolerate peanut so that an accidental bite is less likely to cause a serious reaction, or even kill in severe cases.

Palforzia users still must avoid peanuts just like they always have.

The treatment is not for everyone. Palforzia can cause side effects, including occasional severe allergic reactions. The FDA is requiring that doctors and their patients enrol in a special safety program, and patients must take the first dose and each increased dose under supervision in a certified health centre.

And if youngsters stop taking the daily dose, they lose the protection.

Shots have long been used to induce tolerance for allergies to bee stings or pollen. But swallowing an allergen to build tolerance is a new twist – one that scientists call “oral immunotherapy.” And peanuts are just the first food to be tackled. Tests for eggs, milk and tree nuts are underway.

But because of the drawbacks, scientists also are developing next-generation options that work differently. Next up for FDA review: A skin patch for peanut allergy.

“For so long, we had nothing to offer these patients,” said Dr. Pamela Guerrerio of the National Institutes of Health, which funded much of the research that led to food allergy therapies. “We finally have a treatment. That’s a big step.”

Aimmune executives said Friday they hope doctors can begin prescribing the treatment in “a matter of weeks.” They set the treatment’s list price at $890 a month, but how much patients will pay depends on their insurance. Aimmune says it is working with insurance companies for coverage, and will offer a patient co-pay assistance program.

FOOD ALLERGY IS A GROWING PROBLEM

Millions of Americans have food allergies, including about 1 in 13 children, and the numbers have increased in recent years. Peanut allergy is the most common one among children, and among the most dangerous. Accidental exposures are frequent, with about 1 in 4 affected children winding up in the emergency room every year.

What happens: The immune system overreacts to the food by triggering an inflammatory cascade. On average, children can experience hives, wheezing or worse from just a 30th of a single peanut, sometimes even less, said Dr. Hemant Sharma, who leads oral treatment studies at Children’s National Hospital in Washington.

Until now, all doctors could advise was to read food labels and avoid anything that might contain hidden peanuts. Decades ago, attempts at shots were deemed too risky for food allergies. Then, in 2006, researchers at Duke University and the University of Arkansas reported tantalizing signs that swallowed treatments might work instead.

HOW IT WORKS

Doctors prescribe a miniscule Palforzia starting dose. The powder, stored in a capsule, is mixed into any unheated food, such as Nichols’ favourite fruit smoothies. Patients take the first dose in a doctor’s office, in case of a bad allergic reaction. Every few weeks, the dose is increased until after about six months, they’re taking the equivalent of about one peanut.

In a study of nearly 500 children, two-thirds who received Palforzia could eat the equivalent of two peanuts – and some three or four – compared to just 4% of patients given a dummy drug.

A few hundred allergy doctors around the country already offer their own version of the treatment, using store-bought peanut flour – or similar options for other food allergies – to customize doses for patients outside of research studies.

THE WARNINGS

Palforzia users still must carry their rescue medicine, such as EpiPens, to treat severe allergic reactions. Most experience at least mild side effects, such as hives or stomachaches, and about a fifth dropped out of the study, said Dr. Scott Sicherer, a pediatric allergist at Mount Sinai Hospital in New York.

As for severe reactions, they struck about 9% of patients treated in the Palforzia study, nearly three times the number in the placebo group and prompting debate about the drug’s usefulness.

“There is a trade-off,” Sicherer said. Families and doctors together will have to decide “does it make sense for me or my child?”

OTHER OPTIONS

Other allergy treatments in the pipeline:

— DBV Technologies’ Viaskin is a daily patch that contains small amounts of peanut protein absorbed through the skin, in hopes of fewer side effects.

— Allergen drops under the tongue are in early-stage testing but showed promise in a recent study from the University of North Carolina, Chapel Hill.

— Shots to block allergic reactions deliver antibodies that tamp down the inflammatory cascade that follows accidental exposure. A Stanford University pilot study suggested a single shot could block a peanut reaction for two to six weeks.

“Palforzia is a step forward,” said Children’s National’s Sharma. “What all of us hope for that would be truly revolutionary is a treatment that’s curative, that really gets rid of the food allergy permanently.”

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Whooping cough is at a decade-high level in US

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MILWAUKEE (AP) — Whooping cough is at its highest level in a decade for this time of year, U.S. health officials reported Thursday.

There have been 18,506 cases of whooping cough reported so far, the Centers for Disease Control and Prevention said. That’s the most at this point in the year since 2014, when cases topped 21,800.

The increase is not unexpected — whooping cough peaks every three to five years, health experts said. And the numbers indicate a return to levels before the coronavirus pandemic, when whooping cough and other contagious illnesses plummeted.

Still, the tally has some state health officials concerned, including those in Wisconsin, where there have been about 1,000 cases so far this year, compared to a total of 51 last year.

Nationwide, CDC has reported that kindergarten vaccination rates dipped last year and vaccine exemptions are at an all-time high. Thursday, it released state figures, showing that about 86% of kindergartners in Wisconsin got the whooping cough vaccine, compared to more than 92% nationally.

Whooping cough, also called pertussis, usually starts out like a cold, with a runny nose and other common symptoms, before turning into a prolonged cough. It is treated with antibiotics. Whooping cough used to be very common until a vaccine was introduced in the 1950s, which is now part of routine childhood vaccinations. It is in a shot along with tetanus and diphtheria vaccines. The combo shot is recommended for adults every 10 years.

“They used to call it the 100-day cough because it literally lasts for 100 days,” said Joyce Knestrick, a family nurse practitioner in Wheeling, West Virginia.

Whooping cough is usually seen mostly in infants and young children, who can develop serious complications. That’s why the vaccine is recommended during pregnancy, to pass along protection to the newborn, and for those who spend a lot of time with infants.

But public health workers say outbreaks this year are hitting older kids and teens. In Pennsylvania, most outbreaks have been in middle school, high school and college settings, an official said. Nearly all the cases in Douglas County, Nebraska, are schoolkids and teens, said Justin Frederick, deputy director of the health department.

That includes his own teenage daughter.

“It’s a horrible disease. She still wakes up — after being treated with her antibiotics — in a panic because she’s coughing so much she can’t breathe,” he said.

It’s important to get tested and treated with antibiotics early, said Dr. Kris Bryant, who specializes in pediatric infectious diseases at Norton Children’s in Louisville, Kentucky. People exposed to the bacteria can also take antibiotics to stop the spread.

“Pertussis is worth preventing,” Bryant said. “The good news is that we have safe and effective vaccines.”

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AP data journalist Kasturi Pananjady contributed to this report.

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The Associated Press Health and Science Department receives support from the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

The Canadian Press. All rights reserved.

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Scientists show how sperm and egg come together like a key in a lock

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How a sperm and egg fuse together has long been a mystery.

New research by scientists in Austria provides tantalizing clues, showing fertilization works like a lock and key across the animal kingdom, from fish to people.

“We discovered this mechanism that’s really fundamental across all vertebrates as far as we can tell,” said co-author Andrea Pauli at the Research Institute of Molecular Pathology in Vienna.

The team found that three proteins on the sperm join to form a sort of key that unlocks the egg, allowing the sperm to attach. Their findings, drawn from studies in zebrafish, mice, and human cells, show how this process has persisted over millions of years of evolution. Results were published Thursday in the journal Cell.

Scientists had previously known about two proteins, one on the surface of the sperm and another on the egg’s membrane. Working with international collaborators, Pauli’s lab used Google DeepMind’s artificial intelligence tool AlphaFold — whose developers were awarded a Nobel Prize earlier this month — to help them identify a new protein that allows the first molecular connection between sperm and egg. They also demonstrated how it functions in living things.

It wasn’t previously known how the proteins “worked together as a team in order to allow sperm and egg to recognize each other,” Pauli said.

Scientists still don’t know how the sperm actually gets inside the egg after it attaches and hope to delve into that next.

Eventually, Pauli said, such work could help other scientists understand infertility better or develop new birth control methods.

The work provides targets for the development of male contraceptives in particular, said David Greenstein, a genetics and cell biology expert at the University of Minnesota who was not involved in the study.

The latest study “also underscores the importance of this year’s Nobel Prize in chemistry,” he said in an email.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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Older patients, non-English speakers more likely to be harmed in hospital: report

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Patients who are older, don’t speak English, and don’t have a high school education are more likely to experience harm during a hospital stay in Canada, according to new research.

The Canadian Institute for Health Information measured preventableharmful events from 2023 to 2024, such as bed sores and medication errors,experienced by patients who received acute care in hospital.

The research published Thursday shows patients who don’t speak English or French are 30 per cent more likely to experience harm. Patients without a high school education are 20 per cent more likely to endure harm compared to those with higher education levels.

The report also found that patients 85 and older are five times more likely to experience harm during a hospital stay compared to those under 20.

“The goal of this report is to get folks thinking about equity as being a key dimension of the patient safety effort within a hospital,” says Dana Riley, an author of the report and a program lead on CIHI’s population health team.

When a health-care provider and a patient don’t speak the same language, that can result in the administration of a wrong test or procedure, research shows. Similarly, Riley says a lower level of education is associated with a lower level of health literacy, which can result in increased vulnerability to communication errors.

“It’s fairly costly to the patient and it’s costly to the system,” says Riley, noting the average hospital stay for a patient who experiences harm is four times more expensive than the cost of a hospital stay without a harmful event – $42,558 compared to $9,072.

“I think there are a variety of different reasons why we might start to think about patient safety, think about equity, as key interconnected dimensions of health-care quality,” says Riley.

The analysis doesn’t include data on racialized patients because Riley says pan-Canadian data was not available for their research. Data from Quebec and some mental health patients was also excluded due to differences in data collection.

Efforts to reduce patient injuries at one Ontario hospital network appears to have resulted in less harm. Patient falls at Mackenzie Health causing injury are down 40 per cent, pressure injuries have decreased 51 per cent, and central line-associated bloodstream infections, such as IV therapy, have been reduced 34 per cent.

The hospital created a “zero harm” plan in 2019 to reduce errors after a hospital survey revealed low safety scores. They integrated principles used in aviation and nuclear industries, which prioritize safety in complex high-risk environments.

“The premise is first driven by a cultural shift where people feel comfortable actually calling out these events,” says Mackenzie Health President and Chief Executive Officer Altaf Stationwala.

They introduced harm reduction training and daily meetings to discuss risks in the hospital. Mackenzie partnered with virtual interpreters that speak 240 languages and understand medical jargon. Geriatric care nurses serve the nearly 70 per cent of patients over the age of 75, and staff are encouraged to communicate as frequently as possible, and in plain language, says Stationwala.

“What we do in health care is we take control away from patients and families, and what we know is we need to empower patients and families and that ultimately results in better health care.”

This report by The Canadian Press was first published Oct. 17, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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