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Hydroxychloroquine is not dead yet

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Hydroxychloroquine, the anti-malarial drug touted and previously taken by President Donald Trump to fight coronavirus, has fallen out of favor and public view as studies — like one halted Friday — have suggested it does little to treat infection while exposing users to dangerous side effects.

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.

On Thursday, three authors retracted a widely publicized study about the use of the drug in coronavirus patients. The authors had found COVID-19 patients who took the drug were more likely to die. After its publication in the influential British medical journal The Lancet, however, the authors faced criticism over their data.

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.

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.

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.”

“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.”

Source:- NBC News

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Health Canada approves updated Novavax COVID-19 vaccine

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Health Canada has authorized Novavax’s updated COVID-19 vaccine that protects against currently circulating variants of the virus.

The protein-based vaccine, called Nuvaxovid, has been reformulated to target the JN.1 subvariant of Omicron.

It will replace the previous version of the vaccine, which targeted the XBB.1.5 subvariant of Omicron.

Health Canada recently asked provinces and territories to get rid of their older COVID-19 vaccines to ensure the most current vaccine will be used during this fall’s respiratory virus season.

Earlier this week, Health Canada approved Moderna’s updated mRNA COVID vaccine.

It is still reviewing Pfizer’s updated mRNA vaccine, with a decision expected soon.

This report by The Canadian Press was first published Sept. 19, 2024.

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

Note to readers: This is a corrected story. A previous version erroneously described the Novavax vaccine as an mRNA shot.

The Canadian Press. All rights reserved.

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Health Canada approves updated Moderna COVID-19 vaccine

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TORONTO – Health Canada has authorized Moderna’s updated COVID-19 vaccine that protects against currently circulating variants of the virus.

The mRNA vaccine, called Spikevax, has been reformulated to target the KP.2 subvariant of Omicron.

It will replace the previous version of the vaccine that was released a year ago, which targeted the XBB.1.5 subvariant of Omicron.

Health Canada recently asked provinces and territories to get rid of their older COVID-19 vaccines to ensure the most current vaccine will be used during this fall’s respiratory virus season.

Health Canada is also reviewing two other updated COVID-19 vaccines but has not yet authorized them.

They are Pfizer’s Comirnaty, which is also an mRNA vaccine, as well as Novavax’s protein-based vaccine.

This report by The Canadian Press was first published Sept. 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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These people say they got listeria after drinking recalled plant-based milks

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TORONTO – Sanniah Jabeen holds a sonogram of the unborn baby she lost after contracting listeria last December. Beneath, it says “love at first sight.”

Jabeen says she believes she and her baby were poisoned by a listeria outbreak linked to some plant-based milks and wants answers. An investigation continues into the recall declared July 8 of several Silk and Great Value plant-based beverages.

“I don’t even have the words. I’m still processing that,” Jabeen says of her loss. She was 18 weeks pregnant when she went into preterm labour.

The first infection linked to the recall was traced back to August 2023. One year later on Aug. 12, 2024, the Public Health Agency of Canada said three people had died and 20 were infected.

The number of cases is likely much higher, says Lawrence Goodridge, Canada Research Chair in foodborne pathogen dynamics at the University of Guelph: “For every person known, generally speaking, there’s typically 20 to 25 or maybe 30 people that are unknown.”

The case count has remained unchanged over the last month, but the Public Health Agency of Canada says it won’t declare the outbreak over until early October because of listeria’s 70-day incubation period and the reporting delays that accompany it.

Danone Canada’s head of communications said in an email Wednesday that the company is still investigating the “root cause” of the outbreak, which has been linked to a production line at a Pickering, Ont., packaging facility.

Pregnant people, adults over 60, and those with weakened immune systems are most at risk of becoming sick with severe listeriosis. If the infection spreads to an unborn baby, Health Canada says it can cause miscarriage, stillbirth, premature birth or life-threatening illness in a newborn.

The Canadian Press spoke to 10 people, from the parents of a toddler to an 89-year-old senior, who say they became sick with listeria after drinking from cartons of plant-based milk stamped with the recalled product code. Here’s a look at some of their experiences.

Sanniah Jabeen, 32, Toronto

Jabeen says she regularly drank Silk oat and almond milk in smoothies while pregnant, and began vomiting seven times a day and shivering at night in December 2023. She had “the worst headache of (her) life” when she went to the emergency room on Dec. 15.

“I just wasn’t functioning like a normal human being,” Jabeen says.

Told she was dehydrated, Jabeen was given fluids and a blood test and sent home. Four days later, she returned to hospital.

“They told me that since you’re 18 weeks, there’s nothing you can do to save your baby,” says Jabeen, who moved to Toronto from Pakistan five years ago.

Jabeen later learned she had listeriosis and an autopsy revealed her baby was infected, too.

“It broke my heart to read that report because I was just imagining my baby drinking poisoned amniotic fluid inside of me. The womb is a place where your baby is supposed to be the safest,” Jabeen said.

Jabeen’s case is likely not included in PHAC’s count. Jabeen says she was called by Health Canada and asked what dairy and fresh produce she ate – foods more commonly associated with listeria – but not asked about plant-based beverages.

She’s pregnant again, and is due in several months. At first, she was scared to eat, not knowing what caused the infection during her last pregnancy.

“Ever since I learned about the almond, oat milk situation, I’ve been feeling a bit better knowing that it wasn’t something that I did. It was something else that caused it. It wasn’t my fault,” Jabeen said.

She’s since joined a proposed class action lawsuit launched by LPC Avocates against the manufacturers and sellers of Silk and Great Value plant-based beverages. The lawsuit has not yet been certified by a judge.

Natalie Grant and her seven year-old daughter, Bowmanville, Ont.

Natalie Grant says she was in a hospital waiting room when she saw a television news report about the recall. She wondered if the dark chocolate almond milk her daughter drank daily was contaminated.

She had brought the girl to hospital because she was vomiting every half hour, constantly on the toilet with diarrhea, and had severe pain in her abdomen.

“I’m definitely thinking that this is a pretty solid chance that she’s got listeria at this point because I knew she had all the symptoms,” Grant says of seeing the news report.

Once her daughter could hold fluids, they went home and Grant cross-checked the recalled product code – 7825 – with the one on her carton. They matched.

“I called the emerg and I said I’m pretty confident she’s been exposed,” Grant said. She was told to return to the hospital if her daughter’s symptoms worsened. An hour and a half later, her fever spiked, the vomiting returned, her face flushed and her energy plummeted.

Grant says they were sent to a hospital in Ajax, Ont. and stayed two weeks while her daughter received antibiotics four times a day until she was discharged July 23.

“Knowing that my little one was just so affected and how it affected us as a family alone, there’s a bitterness left behind,” Grant said. She’s also joined the proposed class action.

Thelma Feldman, 89, Toronto

Thelma Feldman says she regularly taught yoga to friends in her condo building before getting sickened by listeria on July 2. Now, she has a walker and her body aches. She has headaches and digestive problems.

“I’m kind of depressed,” she says.

“It’s caused me a lot of physical and emotional pain.”

Much of the early days of her illness are a blur. She knows she boarded an ambulance with profuse diarrhea on July 2 and spent five days at North York General Hospital. Afterwards, she remembers Health Canada officials entering her apartment and removing Silk almond milk from her fridge, and volunteers from a community organization giving her sponge baths.

“At my age, 89, I’m not a kid anymore and healing takes longer,” Feldman says.

“I don’t even feel like being with people. I just sit at home.”

Jasmine Jiles and three-year-old Max, Kahnawake Mohawk Territory, Que.

Jasmine Jiles says her three-year-old son Max came down with flu-like symptoms and cradled his ears in what she interpreted as a sign of pain, like the one pounding in her own head, around early July.

When Jiles heard about the recall soon after, she called Danone Canada, the plant-based milk manufacturer, to find out if their Silk coconut milk was in the contaminated batch. It was, she says.

“My son is very small, he’s very young, so I asked what we do in terms of overall monitoring and she said someone from the company would get in touch within 24 to 48 hours,” Jiles says from a First Nations reserve near Montreal.

“I never got a call back. I never got an email”

At home, her son’s fever broke after three days, but gas pains stuck with him, she says. It took a couple weeks for him to get back to normal.

“In hindsight, I should have taken him (to the hospital) but we just tried to see if we could nurse him at home because wait times are pretty extreme,” Jiles says, “and I don’t have child care at the moment.”

Joseph Desmond, 50, Sydney, N.S.

Joseph Desmond says he suffered a seizure and fell off his sofa on July 9. He went to the emergency room, where they ran an electroencephalogram (EEG) test, and then returned home. Within hours, he had a second seizure and went back to hospital.

His third seizure happened the next morning while walking to the nurse’s station.

In severe cases of listeriosis, bacteria can spread to the central nervous system and cause seizures, according to Health Canada.

“The last two months have really been a nightmare,” says Desmond, who has joined the proposed lawsuit.

When he returned home from the hospital, his daughter took a carton of Silk dark chocolate almond milk out of the fridge and asked if he had heard about the recall. By that point, Desmond says he was on his second two-litre carton after finishing the first in June.

“It was pretty scary. Terrifying. I honestly thought I was going to die.”

Cheryl McCombe, 63, Haliburton, Ont.

The morning after suffering a second episode of vomiting, feverish sweats and diarrhea in the middle of the night in early July, Cheryl McCombe scrolled through the news on her phone and came across the recall.

A few years earlier, McCombe says she started drinking plant-based milks because it seemed like a healthier choice to splash in her morning coffee. On June 30, she bought two cartons of Silk cashew almond milk.

“It was on the (recall) list. I thought, ‘Oh my God, I got listeria,’” McCombe says. She called her doctor’s office and visited an urgent care clinic hoping to get tested and confirm her suspicion, but she says, “I was basically shut down at the door.”

Public Health Ontario does not recommend listeria testing for infected individuals with mild symptoms unless they are at risk of developing severe illness, such as people who are immunocompromised, elderly, pregnant or newborn.

“No wonder they couldn’t connect the dots,” she adds, referencing that it took close to a year for public health officials to find the source of the outbreak.

“I am a woman in my 60s and sometimes these signs are of, you know, when you’re vomiting and things like that, it can be a sign in women of a bigger issue,” McCombe says. She was seeking confirmation that wasn’t the case.

Disappointed, with her stomach still feeling off, she says she decided to boost her gut health with probiotics. After a couple weeks she started to feel like herself.

But since then, McCombe says, “I’m back on Kawartha Dairy cream in my coffee.”

This report by The Canadian Press was first published Sept. 16, 2024.

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

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