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Pfizer says its antiviral pill slashes risk of severe COVID-19 by 89%

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Pfizer Inc’s experimental antiviral pill to treat COVID-19 was shown to cut by 89% the chances of hospitalization or death for adults at risk of developing severe disease, the company said on Friday, offering what could be a promising new weapon in the fight against the pandemic.

The trial’s results suggest that the oral drug surpasses Merck & Co Inc’s pill, molnupiravir, which was shown last month to halve the risk of dying or being hospitalized for COVID-19 patients at high risk of serious illness.

Pfizer’s pill, with the brand name Paxlovid, could secure U.S. regulatory approval by the end of the year. The Pfizer trial was stopped early due to its high success rate. Full trial data is not yet available from either company.

President Joe Biden said the U.S. government has secured millions of doses of the Pfizer drug.

“If authorized by the FDA we may soon have pills that treat the virus in those who become infected,” Biden said. “The therapy would be another tool in our toolbox to protect people from the worst outcomes of COVID.”

Shares in Pfizer, which also makes one of the mostly widely used COVID-19 vaccines, were up 9% to $47.82, while Merck’s were down 9.3% to $82.09. Shares of vaccine makers took a hit, with Moderna Inc, Pfizer’s German partner BioNTech SE and Novavax all down 13-21%.

The pill is given in combination with an older antiviral called ritonavir. The treatment consists of three pills given twice daily. It has been in development for nearly two years.

Pfizer is in discussions with 90 countries over supply contracts for its pill, Chief Executive Officer Albert Bourla said in an interview.

Bourla said Pfizer expects to price its treatment close to where Merck has priced its pill. Merck’s U.S. contract price for its pill is around $700 for a five-day course of therapy.

Even with the potential offered by the Pfizer and Merck pills, preventing COVID-19 infections through broad use of vaccines remains the best way to control a pandemic that has killed more than 5 million people worldwide, including more than 750,000 in the United States, according to infectious disease experts.

“Vaccines are going to be the most effective and reliable tool that we have in this pandemic,” said Dr. Grace Lee, professor of pediatrics at Stanford University School of Medicine. “These oral medications are going to augment our ability to really reduce the risk of severe disease, hospitalization and death, which is huge, but it won’t prevent infection.”

While more than 7 billion vaccine doses have been administered worldwide, that has covered only about half the world’s people. In the United States, 58% of all people, including 70% of adults, are fully vaccinated. There are more than 400,000 new COVID-19 cases daily worldwide, with infections rising in 50 countries.

Mizuho analyst Vamil Divan forecast a “very minor impact” from the Pfizer drug on vaccination among people who do not want the vaccine or a booster shot as recommended by U.S. health regulators.

“I think there’s a small percentage of people that may decide not to get vaccinated, now that there are good treatment options,” Divan said.

SUBMITTING RESULTS

Pfizer said it plans to submit interim trial results for its pill to the Food and Drug Administration (FDA) before the U.S. Thanksgiving holiday on Nov. 25.

The company said it expects to manufacture 180,000 treatment courses by the end of this year and at least 50 million courses by the end of next year, including 21 million in the first half of 2022.

Antivirals need to be given as early as possible, before an infection takes hold, to be most effective.

The planned analysis of 1,219 patients in Pfizer’s study examined hospitalizations or deaths among people diagnosed with mild to moderate COVID-19 with at least one risk factor for developing severe disease, such as obesity or older age.

Among those given Pfizer’s drug within three days of symptom onset, the pill lowered the chances of hospitalization or death for adults at risk of developing severe COVID-19 by 89% compared to patients who received a placebo. Among these patients, 0.8% were hospitalized and none died by 28 days after treatment, compared to a 7% hospitalization rate and seven deaths in the placebo group.

Rates were similar for patients treated within five days of symptoms: 1% of the treatment group was hospitalized, compared to 6.7% for the placebo group, which included 10 deaths. Pfizer said that works out to being 85% effective at preventing hospitalization or death.

An FDA panel of outside experts is scheduled to meet Nov. 30 to discuss Merck’s pill, which was approved by British regulators https://www.reuters.com/business/healthcare-pharmaceuticals/britain-approves-mercks-oral-covid-19-pill-2021-11-04 in a world first on Thursday. Pfizer said it did not know if Paxlovid would be reviewed at that meeting.

Pfizer did not detail side any effects but said adverse events happened in about 20% of both treatment and placebo patients. Possible side effects include nausea and diarrhea.

Pfizer is holding discussions about a license for generic manufacturing of the pill for low-income countries, Unitaid’s Medicines Patent Pool said in a statement.

(Reporting by Deena Beasley; additional reporting by Ankur Banerjee, Leroy Leo and Manojna Maddipatla in Bengaluru; Julie Steenhuysen, Trevor Hunnicut, Michael Erman and Francesco GuarascioEditing by Will Dunham, Anil D’Silva, Caroline Humer and Mark Potter)

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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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Alberta to launch new primary care agency by next month in health overhaul

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CALGARY – Alberta’s health minister says a new agency responsible for primary health care should be up and running by next month.

Adriana LaGrange says Primary Care Alberta will work to improve Albertans’ access to primary care providers like family doctors or nurse practitioners, create new models of primary care and increase access to after-hours care through virtual means.

Her announcement comes as the provincial government continues to divide Alberta Health Services into four new agencies.

LaGrange says Alberta Health Services hasn’t been able to focus on primary health care, and has been missing system oversight.

The Alberta government’s dismantling of the health agency is expected to include two more organizations responsible for hospital care and continuing care.

Another new agency, Recovery Alberta, recently took over the mental health and addictions portfolio of Alberta Health Services.

This report by The Canadian Press was first published Oct. 15, 2024.

The Canadian Press. All rights reserved.

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Experts urge streamlined, more compassionate miscarriage care in Canada

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Rana Van Tuyl was about 12 weeks pregnant when she got devastating news at her ultrasound appointment in December 2020.

Her fetus’s heartbeat had stopped.

“We were both shattered,” says Van Tuyl, who lives in Nanaimo, B.C., with her partner. Her doctor said she could surgically or medically pass the pregnancy and she chose the medical option, a combination of two drugs taken at home.

“That was the last I heard from our maternity physician, with no further followup,” she says.

But complications followed. She bled for a month and required a surgical procedure to remove pregnancy tissue her body had retained.

Looking back, Van Tuyl says she wishes she had followup care and mental health support as the couple grieved.

Her story is not an anomaly. Miscarriages affect one in five pregnancies in Canada, yet there is often a disconnect between the medical view of early pregnancy loss as something that is easily managed and the reality of the patients’ own traumatizing experiences, according to a paper published Tuesday in the Canadian Medical Association Journal.

An accompanying editorial says it’s time to invest in early pregnancy assessment clinics that can provide proper care during and after a miscarriage, which can have devastating effects.

The editorial and a review of medical literature on early pregnancy loss say patients seeking help in emergency departments often receive “suboptimal” care. Non-critical miscarriage cases drop to the bottom of the triage list, resulting in longer wait times that make patients feel like they are “wasting” health-care providers’ time. Many of those patients are discharged without a followup plan, the editorial says.

But not all miscarriages need to be treated in the emergency room, says Dr. Modupe Tunde-Byass, one of the authors of the literature review and an obstetrician/gynecologist at Toronto’s North York General Hospital.

She says patients should be referred to early pregnancy assessment clinics, which provide compassionate care that accounts for the psychological impact of pregnancy loss – including grief, guilt, anxiety and post-traumatic stress.

But while North York General Hospital and a patchwork of other health-care providers in the country have clinics dedicated to miscarriage care, Tunde-Byass says that’s not widely adopted – and it should be.

She’s been thinking about this gap in the Canadian health-care system for a long time, ever since her medical training almost four decades ago in the United Kingdom, where she says early pregnancy assessment centres are common.

“One of the things that we did at North York was to have a clinic to provide care for our patients, and also to try to bridge that gap,” says Tunde-Byass.

Provincial agency Health Quality Ontario acknowledged in 2019 the need for these services in a list of ways to better manage early pregnancy complications and loss.

“Five years on, little if any progress has been made toward achieving this goal,” Dr. Catherine Varner, an emergency physician, wrote in the CMAJ editorial. “Early pregnancy assessment services remain a pipe dream for many, especially in rural Canada.”

The quality standard released in Ontario did, however, prompt a registered nurse to apply for funding to open an early pregnancy assessment clinic at St. Joseph’s Healthcare Hamilton in 2021.

Jessica Desjardins says that after taking patient referrals from the hospital’s emergency room, the team quickly realized that they would need a bigger space and more people to provide care. The clinic now operates five days a week.

“We’ve been often hearing from our patients that early pregnancy loss and experiencing early pregnancy complications is a really confusing, overwhelming, isolating time for them, and (it) often felt really difficult to know where to go for care and where to get comprehensive, well-rounded care,” she says.

At the Hamilton clinic, Desjardins says patients are brought into a quiet area to talk and make decisions with providers – “not only (from) a physical perspective, but also keeping in mind the psychosocial piece that comes along with loss and the grief that’s a piece of that.”

Ashley Hilliard says attending an early pregnancy assessment clinic at The Ottawa Hospital was the “best case scenario” after the worst case scenario.

In 2020, she was about eight weeks pregnant when her fetus died and she hemorrhaged after taking medication to pass the pregnancy at home.

Shortly after Hilliard was rushed to the emergency room, she was assigned an OB-GYN at an early pregnancy assessment clinic who directed and monitored her care, calling her with blood test results and sending her for ultrasounds when bleeding and cramping persisted.

“That was super helpful to have somebody to go through just that, somebody who does this all the time,” says Hilliard.

“It was really validating.”

This report by The Canadian Press was first published Oct. 15, 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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