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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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Here is how to prepare your online accounts for when you die

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LONDON (AP) — Most people have accumulated a pile of data — selfies, emails, videos and more — on their social media and digital accounts over their lifetimes. What happens to it when we die?

It’s wise to draft a will spelling out who inherits your physical assets after you’re gone, but don’t forget to take care of your digital estate too. Friends and family might treasure files and posts you’ve left behind, but they could get lost in digital purgatory after you pass away unless you take some simple steps.

Here’s how you can prepare your digital life for your survivors:

Apple

The iPhone maker lets you nominate a “ legacy contact ” who can access your Apple account’s data after you die. The company says it’s a secure way to give trusted people access to photos, files and messages. To set it up you’ll need an Apple device with a fairly recent operating system — iPhones and iPads need iOS or iPadOS 15.2 and MacBooks needs macOS Monterey 12.1.

For iPhones, go to settings, tap Sign-in & Security and then Legacy Contact. You can name one or more people, and they don’t need an Apple ID or device.

You’ll have to share an access key with your contact. It can be a digital version sent electronically, or you can print a copy or save it as a screenshot or PDF.

Take note that there are some types of files you won’t be able to pass on — including digital rights-protected music, movies and passwords stored in Apple’s password manager. Legacy contacts can only access a deceased user’s account for three years before Apple deletes the account.

Google

Google takes a different approach with its Inactive Account Manager, which allows you to share your data with someone if it notices that you’ve stopped using your account.

When setting it up, you need to decide how long Google should wait — from three to 18 months — before considering your account inactive. Once that time is up, Google can notify up to 10 people.

You can write a message informing them you’ve stopped using the account, and, optionally, include a link to download your data. You can choose what types of data they can access — including emails, photos, calendar entries and YouTube videos.

There’s also an option to automatically delete your account after three months of inactivity, so your contacts will have to download any data before that deadline.

Facebook and Instagram

Some social media platforms can preserve accounts for people who have died so that friends and family can honor their memories.

When users of Facebook or Instagram die, parent company Meta says it can memorialize the account if it gets a “valid request” from a friend or family member. Requests can be submitted through an online form.

The social media company strongly recommends Facebook users add a legacy contact to look after their memorial accounts. Legacy contacts can do things like respond to new friend requests and update pinned posts, but they can’t read private messages or remove or alter previous posts. You can only choose one person, who also has to have a Facebook account.

You can also ask Facebook or Instagram to delete a deceased user’s account if you’re a close family member or an executor. You’ll need to send in documents like a death certificate.

TikTok

The video-sharing platform says that if a user has died, people can submit a request to memorialize the account through the settings menu. Go to the Report a Problem section, then Account and profile, then Manage account, where you can report a deceased user.

Once an account has been memorialized, it will be labeled “Remembering.” No one will be able to log into the account, which prevents anyone from editing the profile or using the account to post new content or send messages.

X

It’s not possible to nominate a legacy contact on Elon Musk’s social media site. But family members or an authorized person can submit a request to deactivate a deceased user’s account.

Passwords

Besides the major online services, you’ll probably have dozens if not hundreds of other digital accounts that your survivors might need to access. You could just write all your login credentials down in a notebook and put it somewhere safe. But making a physical copy presents its own vulnerabilities. What if you lose track of it? What if someone finds it?

Instead, consider a password manager that has an emergency access feature. Password managers are digital vaults that you can use to store all your credentials. Some, like Keeper,Bitwarden and NordPass, allow users to nominate one or more trusted contacts who can access their keys in case of an emergency such as a death.

But there are a few catches: Those contacts also need to use the same password manager and you might have to pay for the service.

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Is there a tech challenge you need help figuring out? Write to us at onetechtip@ap.org with your questions.

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Pediatric group says doctors should regularly screen kids for reading difficulties

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The Canadian Paediatric Society says doctors should regularly screen children for reading difficulties and dyslexia, calling low literacy a “serious public health concern” that can increase the risk of other problems including anxiety, low self-esteem and behavioural issues, with lifelong consequences.

New guidance issued Wednesday says family doctors, nurses, pediatricians and other medical professionals who care for school-aged kids are in a unique position to help struggling readers access educational and specialty supports, noting that identifying problems early couldhelp kids sooner — when it’s more effective — as well as reveal other possible learning or developmental issues.

The 10 recommendations include regular screening for kids aged four to seven, especially if they belong to groups at higher risk of low literacy, including newcomers to Canada, racialized Canadians and Indigenous Peoples. The society says this can be done in a two-to-three-minute office-based assessment.

Other tips encourage doctors to look for conditions often seen among poor readers such as attention-deficit hyperactivity disorder; to advocate for early literacy training for pediatric and family medicine residents; to liaise with schools on behalf of families seeking help; and to push provincial and territorial education ministries to integrate evidence-based phonics instruction into curriculums, starting in kindergarten.

Dr. Scott McLeod, one of the authors and chair of the society’s mental health and developmental disabilities committee, said a key goal is to catch kids who may be falling through the cracks and to better connect families to resources, including quicker targeted help from schools.

“Collaboration in this area is so key because we need to move away from the silos of: everything educational must exist within the educational portfolio,” McLeod said in an interview from Calgary, where he is a developmental pediatrician at Alberta Children’s Hospital.

“Reading, yes, it’s education, but it’s also health because we know that literacy impacts health. So I think that a statement like this opens the window to say: Yes, parents can come to their health-care provider to get advice, get recommendations, hopefully start a collaboration with school teachers.”

McLeod noted that pediatricians already look for signs of low literacy in young children by way of a commonly used tool known as the Rourke Baby Record, which offers a checklist of key topics, such as nutrition and developmental benchmarks, to cover in a well-child appointment.

But he said questions about reading could be “a standing item” in checkups and he hoped the society’s statement to medical professionals who care for children “enhances their confidence in being a strong advocate for the child” while spurring partnerships with others involved in a child’s life such as teachers and psychologists.

The guidance said pediatricians also play a key role in detecting and monitoring conditions that often coexist with difficulty reading such as attention-deficit hyperactivity disorder, but McLeod noted that getting such specific diagnoses typically involves a referral to a specialist, during which time a child continues to struggle.

He also acknowledged that some schools can be slow to act without a specific diagnosis from a specialist, and even then a child may end up on a wait list for school interventions.

“Evidence-based reading instruction shouldn’t have to wait for some of that access to specialized assessments to occur,” he said.

“My hope is that (by) having an existing statement or document written by the Canadian Paediatric Society … we’re able to skip a few steps or have some of the early interventions present,” he said.

McLeod added that obtaining specific assessments from medical specialists is “definitely beneficial and advantageous” to know where a child is at, “but having that sort of clear, thorough assessment shouldn’t be a barrier to intervention starting.”

McLeod said the society was partly spurred to act by 2022’s “Right to Read Inquiry Report” from the Ontario Human Rights Commission, which made 157 recommendations to address inequities related to reading instruction in that province.

He called the new guidelines “a big reminder” to pediatric providers, family doctors, school teachers and psychologists of the importance of literacy.

“Early identification of reading difficulty can truly change the trajectory of a child’s life.”

This report by The Canadian Press was first published Oct. 23, 2024.

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UK regulator approves second Alzheimer’s drug in months but government won’t pay for it

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LONDON (AP) — Britain’s drug regulator approved the Alzheimer’s drug Kisunla on Wednesday, but the government won’t be paying for it after an independent watchdog agency said the treatment isn’t worth the cost to taxpayers.

It is the second Alzheimer’s drug to receive such a mixed reception within months. In August, the U.K. regulator authorized Leqembi while the same watchdog agency issued draft guidance recommending against its purchase for the National Health Service.

In a statement on Wednesday, Britain’s Medicines and Healthcare regulatory Agency said Kisunla “showed some evidence of efficacy in slowing (Alzheimer’s) progression” and approved its use to treat people in the early stages of the brain-robbing disease. Kisunla, also known as donanemab, works by removing a sticky protein from the brain believed to cause Alzheimer’s disease.

Meanwhile, the National Institute for Health and Care Excellence, or NICE, said more evidence was needed to prove Kisunla’s worth — the drug’s maker, Eli Lilly, says a year’s worth of treatment is $32,000. The U.S. Food and Drug Administration authorized Kisunla in July. The roll-out of its competitor drug Leqembi has been slowed in the U.S. by spotty insurance coverage, logistical hurdles and financial worries.

NICE said that the cost of administering Kisunla, which requires regular intravenous infusions and rigorous monitoring for potentially severe side effects including brain swelling or bleeding, “means it cannot currently be considered good value for the taxpayer.”

Experts at NICE said they “recognized the importance of new treatment options” for Alzheimer’s and asked Eli Lilly and the National Health Service “to provide additional information to address areas of uncertainty in the evidence.”

Under Britain’s health care system, most people receive free health care paid for by the government, but they could get Kisunla if they were to pay for it privately.

“People living with dementia and their loved ones will undoubtedly be disappointed by the decision not to fund this new treatment,” said Tara Spires-Jones, director of the Centre for Discovery Brain Sciences at the University of Edinburgh. “The good news that new treatments can slow disease even a small amount is helpful,” she said in a statement, adding that new research would ultimately bring safer and more effective treatments.

Fiona Carragher, chief policy and research officer at the Alzheimer’s Society, said the decision by NICE was “disheartening,” but noted there were about 20 Alzheimer’s drugs being tested in advanced studies, predicting that more drugs would be submitted for approval within years.

“In other diseases like cancer, treatments have become more effective, safer and cheaper over time,” she said. “ We hope to see similar progress in dementia.”

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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.

The Canadian Press. All rights reserved.

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