Not all researchers have given up on the drug, however, and recent developments show it is not yet dead as a potential weapon against COVID-19, especially as a preventative in people not yet exposed to the virus.
When the company that supplied the data declined to provide the full data set and other information for review, three of the study’s four authors wrote, “Based on this development, we can no longer vouch for the veracity of the primary data sources.”
A day earlier, the World Health Organization recommended that its researchers continue to study the drugs’ potential use against coronavirus, restarting a paused trial.
And researchers across the U.S. are still testing the drug. The 48 or more trials still underway include at least 17 that are testing whether it could still play a role as a prophylactic preventing COVID-19 infection, even if it may not help treat patients who are already infected with the coronavirus.
May 19, 202006:56
On Wednesday, the New England Journal of Medicine published the results of a University of Minnesota trial that showed the drug did not help prevent COVID-19 trial in patients who were already exposed to the virus.
Dr. Bradley Connor, the lead investigator for The New York Center for Travel and Tropical Medicine’s trial, was undeterred by the Minnesota results. “Science is based on multiple studies. This doesn’t change anything.”
Connor’s trial examines whether hydroxychloroquine could be a prophylactic prior to exposure to the virus. “I think this deserves further study given the preliminary data from Europe and the in-vitro data would suggest that we need more information.” Connor says enrollment for his team’s double-blinded, randomized placebo-controlled trial is set to begin over the next two weeks and is focused on pre-exposure for healthcare workers.
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With eyes on the drug’s preventative role, teams at Duke University Medical Center, ProHEALTH and UnitedHealth Group, NYU Langone Health in New York and Hackensack Meridian Health Corporation in New Jersey tell NBC News they’re continuing or have concluded their trials regardless of recent findings.
A decades-old drug, hydroxychloroquine is traditionally used to treat autoimmune disorders including lupus and arthritis medicine and is also prescribed to prevent malaria. Early in the COVID-19 pandemic, there was evidence the medication might help treat patients with the coronavirus.
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It’s known to have side effects, including muscle weakness and heart arrhythmia, although experts say it’s generally considered safe for a healthy population as long as it’s not prescribed with other medications that could cause arrhythmias.
April 13, 202002:29
The University of Minnesota’s study of the antimalarial did not find serious side effects such as cardiac complications, though participants were more likely to have minor gastrointestinal effects like nausea or diarrhea.
Experts say that data point is critical.
“The main takeaway from this study is that hydroxychloroquine, as we suspected, is generally safe. Although the drug did not show a statistically significant benefit when people took it immediately after exposure, it may still have a benefit for prevention prior to exposure,” says Dr. Adrian Hernandez, principal investigator of the HERO research program coordinated by the Duke Clinical Research Institute. Compared to the Minnesota study, the HERO study will give the drug earlier and for a longer duration — 30 days instead of five days.
“This is a well done, really informative study,” says Dr. Daniel Griffin, chief of infectious disease for UnitedHealth Group and ProHEALTH New York. Griffin is leading a two-pronged trial of hydroxychloroquine’s effectiveness preventatively as well as in patients taking it within the first day or two of illness.
In early April, when Griffin’s team first took up their trial, many people had already begun taking the anti-malarial. “It wasn’t so much that I was impressed by any early data,” he said. “It was more that I realized that this was something that people were using. And it was really important to know whether or not it was safe and effective.”
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“The reason I say I don’t think it’s a nail in the coffin is that, fortunately, they didn’t find any serious adverse effects … no one’s actually being killed by hydroxychloroquine and that’s what I think puts a nail in the coffin.”
Dr. Michael Belmont, medical director at NYU Langone Orthopedic Hospital, says he is “not especially encouraged, given the experience with active treatment, given the experience with post-exposure prophylaxis, but I still want to complete my study looking at pre-exposure prophylaxis.”
Belmont is the principal investigator of NYU Langone Health’s ongoing trial of hydroxychloroquine for pre-exposure prophylaxis.
May 19, 202002:31
Belmont says he has used the drug on rheumatoid arthritis and lupus patients for 35 years without much short-term toxicity, adding that he still sees a possibility that a lower dosage of the drug may prevail in “reducing either the occurrence of symptomatic infection at all, or at least have a mitigating effect so for those that become symptomatic it’s less likely they’ll require hospitalization, ICU, and intubation.”
Politics meets science
Hydroxychloroquine initially became a lightning rod after Trump repeatedly touted it as a preventative measure against the virus. On Wednesday, the White House released results of the president’s latest physical, including that he had taken a two-week course of the drug as well as zinc and vitamin D following the COVID-19 diagnosis of two West Wing staffers.
Medical teams tell NBC News the politicization of the drug has complicated the trial enrollment processes.
“It’s become quite a challenge I think to enroll people in a lot of these trials and actually ever find out if it is particularly attractive preventative or early treatment,” Griffin said.
In his study’s case, initial enrollment was set at 850 participants, although the team is not enrolling new people at the moment. Instead, it’s monitoring the 50 or so participants already enrolled, most of which are healthcare workers. So far, Griffin says there is no evidence of harm or serious adverse effects caused by the trial.
“What we found in our trials was a combination of people not being interested in enrolling, a number of people withdrawing from the trials because either they were concerned or their physician was concerned — and so we ended up in our trials with very limited enrollment,” Griffin explained.
Belmont says while his trial is still on track for completion this September, his team’s experience recruiting their initial target of 350 healthcare worker participants has been similarly paused.
Over the course of recruitment, initial enthusiasm for hydroxychloroquine in active treatment waned and the overall number of acutely ill COVID-19 patients entering NYU’s medical center and exposing themselves to workers declined. Currently there are about 100 participants enrolled in the trial after some workers opted to provide blood samples for the trial’s observational arm instead of taking the drug.
A pharmacist shows a bottle of the drug hydroxychloroquine, in Oakland, Calif. on April 6, 2020.Ben Margot / AP file
As a result, said Belmont, “I fear I may have lost the ability” to demonstrate a meaningful effect of hydroxychloroquine on acquiring the infection, “but that’s the reality of doing clinical science.” He still hopes to provide insight into how patients tolerate the drug and address other exploratory goals.
Still, at least five groups previously conducting clinical trials of hydroxychloroquine on healthcare workers told NBC News their teams had failed to be approved by review boards, withdrawn, or suspended their trials due to recent trial results, safety concerns or difficulty in enrolling participants.
Montefiore Medical Center in New York officially withdrew its trial of the drug’s treatment of healthcare workers after it was deferred by its IRB, or review board. The study’s principal investigator, Dr. Priya Nori told NBC News, “We didn’t pursue the study further because we just didn’t feel it was worthwhile.” Nori said that hydroxychloroquine was removed from the center’s treatment protocols weeks ago.
Texas Cardiac Arrhythmia Research Foundation in Austin also withdrew its proposal before receiving approval due to safety concerns. Dr. Adam Singer of Stony Brook University in New York said his team did not move forward with its approved trial because “we cannot get healthcare workers to agree to participate in the study.”
In anticipation of a possible second wave of the virus in the fall, Griffin said his team will continue to engage therapies beyond hydroxychloroquine. “As each week, as each month goes by, my hope is that there are more things that are being developed specifically for COVID-19, with even more exciting potential therapeutics and prophylactic medicines that we may want to focus our resources on.”
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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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.
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.
