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AHA Plugs 'Dietary Patterns' Over Dietary Cholesterol Targets – TCTMD

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The new science advisory seeks to dispel confusion around the relevance of dietary cholesterol for heart health.

With a flurry of New Year’s resolutions around the corner, a newly released advisory paper from the American Heart Association (AHA) is seeking to dispel lingering confusion over dietary cholesterol intake that may have arisen when specific targets were eliminated in the recent guidelines.

Instead, the document emphasizes that a diet rich in fruits, vegetables, whole grains, low-fat or fat-free dairy products, lean protein sources, nuts, seeds, and liquid vegetable oils is the better bet for promoting cardiovascular health.

Whereas the 2010 Dietary Guidelines for Americans once put a limit on the consumption of dietary cholesterol at less than 300 mg/day, the 2016 update removed this specific threshold and shifted focus to more general healthy eating patterns.

“A recommendation that gives a specific dietary cholesterol target within the context of food-based advice is challenging for clinicians and consumers to implement; hence, guidance focused on dietary patterns is more likely to improve diet quality and to promote cardiovascular health,” write Jo Ann S. Carson, PhD, RDN (University of Texas Southwestern Medical Center, Dallas), and colleagues in their review paper published online in Circulation.

“There’s just a lot of confusion out there,” Andrew M. Freeman, MD (National Jewish Health, Denver, CO), who was not involved with the document, told TCTMD, calling the 300-mg cholesterol limit “arbitrary.”

“A lot of people interpreted that as you can have a free for all and eat whatever you want, and that’s obviously that’s not what the message was,” he said. “You still have to eat well, and diets that are heart healthy are naturally low in cholesterol. So that’s the key message there.” What has complicated matters in the interim is that a variety of food industries have spun the removal of the specific cholesterol threshold to mean people can eat however much of a once-limited food item they want, Freeman added.

Stop Counting, Think Holistically

In the paper, Carson and colleagues outline all of the contemporary studies looking at dietary cholesterol as well as egg consumption and cardiovascular risk, including a meta-analysis published in March showing a positive association (HR 1.17; 95% CI, 1.09-1.26). They note some discrepancies in the literature, but ultimately conclude that it “is difficult to distinguish between the effect of dietary cholesterol per se and the effect of dietary patterns high in cholesterol or saturated fat, for example, sausage or bacon eaten with eggs.”

There’s just a lot of confusion out there. Andrew M. Freeman

Additionally, studying dietary cholesterol can be complicated by the type of dietary fat included, they write. “In many intervention studies, the fatty acid composition of the diets was not matched; likewise, because the majority of observational studies do not adjust for saturated, monounsaturated, and polyunsaturated fat, it can be difficult to distinguish between the independent effects of dietary cholesterol and dietary fat type.”

There are two aspects of diet that cannot be ignored when considering the relationship between dietary cholesterol and risk of cardiovascular disease, the authors conclude. “First, most foods contributing cholesterol to the US diet are usually high in saturated fat or consumed with foods high in saturated fat. Second, heart-healthy dietary patterns (eg, Mediterranean-style and DASH-style diets) are inherently low in cholesterol, with typical menus containing < 300 mg/d cholesterol, similar to the current US intake.”

Freeman added that there are variations in metabolisms among people, giving the example that some can eat eggs without increasing their cholesterol and others have trouble doing so. “There are some studies from a long time ago that basically showed that if you’re eating a standard American diet and you add a few eggs, your overall cholesterol number may not go up very much,” he said. “But if you’re not used to eating that amount and then you suddenly eat some, your cholesterol can go up quite a bit, and I think that’s the distinction.”

Ultimately, “it’s not so important to count the amount of cholesterol that one’s consuming, . . . but there does seem to be an increased risk of cardiovascular events when people are consuming lots of eggs,” Freeman said.

For physicians advising patients with known cardiovascular disease, “the evidence to date, at least in my mind, still significantly pushes us toward a predominantly low fat, whole food, plant-based diet,” he concluded. “And then if you have a patient that’s particularly high risk, you might really want to push them to being very, very strict and not having lots of shellfish or eggs or whatever it may be.”

 

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Race for a COVID-19 vaccine raises cost, safety—and trust—issues – The Georgia Straight

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As COVID-19 numbers rise again, the prime minister has re-emerged as a regular fixture at daily government briefings.

On September 25, Justin Trudeau announced that the federal government has signed another agreement to buy a vaccine. This time with AstraZeneca for up to 20 million doses of its COVID–19 vaccine.

That brings the number of agreements signed by the government with vaccine manufacturers to seven. The others are with Sanofi, GlaxoSmithKline, Johnson and Johnson, Novavax, Pfizer, and Moderna.

Three of the companies have vaccine candidates in phase three trials. In all, the government has committed to purchasing some 300 million doses from vaccine manufacturers.

The Trudeau government has also announced its participation in the COVID-19 accine Global Access Facility, or COVAX. It’s part of the World Health Organization’s (WHO) effort to deliver “fair, equitable and timely access to COVID-19 vaccines.”

The Canadian government is contributing $220 million to the facility. Its mandate includes delivering vaccines to “low- and middle-income countries.” Canada’s participation in the effort gives it the option of purchasing another 15 million doses of a vaccine.

“We cannot beat this virus in Canada unless we end it everywhere,” Trudeau says.

But while Trudeau is pushing an international approach to find a vaccine, other countries are going it alone.

The COVAX facility is backed by some 172 countries, but the U.S. is not supporting the effort. Neither is China or Russia.

And while the race to find a COVID-19 vaccine has seen unprecedented cooperation between nations, some experts say it seems to be headed for the kind of scenario that plagued the search for a vaccine for AIDS in the ’80s and ’90s.

Back then, pharmaceutical companies and their research and development backers chased profits, making what treatments became available unaffordable for many, especially in the developing world.

In Canada, where large pharmaceuticals enjoy high-level access in Ottawa, who pays for a COVID-19 vaccine and whether it is subsidized are also emerging questions.

Canadians could be asked to pick up some of the cost.

“There’s a lot of money on the table,” says Thomas Tenkate, an associate professor at Ryerson University’s School of Occupational and Public Health.

He notes that pharmaceutical companies and their shareholders have historically placed a steep price on their research and development of new drugs.

While vaccines developed in the world have been distributed universally—polio comes to mind—the scenario with COVID-19 is shaping up to be much different. In all likelihood there will be multiple manufacturers distributing their own variations of the vaccine in different countries.

“With so many clinical trials on the boil you’ve got to think there will be a range available,” Tenkate says.

Tenkate says most researchers and countries will be looking to see what the U.S. does. “There’s a lot of political pressure in the U.S. to have something done [a vaccine] quickly.”

FDA approval usually opens the floodgates to approvals in other countries. But not necessarily in Canada, where Health Canada rules around the approval of new drugs are notoriously stringent.

At his press conference, Trudeau made a point of stressing that any vaccine approved for distribution in Canada will have to pass Health Canada standards. But that process can also be prone to politics.

Questions of transparency, for example, were recently raised about the government’s own Vaccine Task Force. The task force is made up of infectious disease experts and representatives of pharmaceutical companies. It’s advising the government on what research projects to explore.

Gary Kobinger, director of the Infectious Disease Research Centre at the Université Laval, quit the group last week citing potential conflicts among group members as a reason. “You need people to trust the vaccine,” Kobinger told the CBC.

The government responded by bringing in protocols that require potential conflicts of task force members to be made public.

It usually takes anywhere from five to 10 years to develop a vaccine. But the big money is on a vaccine for COVID-19 by next spring or a little later. That’s a year and a half roughly since the onset of the disease.

Russia is already claiming to have developed a vaccine. The U.S. says it’s close. China has said a vaccine may be ready by November. The predictions are overly optimistic. Most of the larger clinical trials have just started in recent months.

There are some 126 clinical trials on the WHO’s radar. Some 26 involve human trials. Nine of those have reached phase three, but none will be completed until late 2022 at the earliest.

The largest human trial of 60,000 participants by Belgium-based Johnson and Johnson company Janssen Pharmaceutica won’t be completed until 2023, according to documents submitted to WHO.

The company says that it “anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective”.

Further monitoring of subjects after the trials are completed will be needed to make sure any side effects are manageable.

Tenkate worries that “corners may have to be cut because of the reduced timelines” to find a vaccine.

Whatever vaccine we end up with in the short term will be more akin to treatment than a cure.

When politicians talk about a vaccine for COVID-19, it’s easy to jump to conclusions, but there is no magic pill. And there won’t be for some time, given that almost 20 years later there is no vaccine for SARS—COVID-19’s, genetic predecessor.

The danger with a COVID vaccine is that we will, in all likelihood, not know enough about the side effects.

Each country will have its own approval process. And while the rules around those “are pretty consistent around the world,” says Tenkate, there are differences. What is greenlighted for sale in Russia may not receive approval in other Western countries.

For Canada, it will come down to “understanding the risks,” Tenkate says, particularly with the possibility of multiple vaccines. “Ultimately, for a lot of people, it’s going to come down to trust.”

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Oxford-Astra COVID vaccine review to start in Europe – BNN

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European regulators are set to start an accelerated review of a COVID-19 vaccine front-runner from the University of Oxford and AstraZeneca Plc, according to a person with knowledge of the situation, in a sign the shot could be the first to seek approval in the region.

The European Medicines Agency is expected to announce the “rolling review” as soon as this week, according to the person, who didn’t want to be identified because the decision is still private. Such assessments are used in emergencies to allow regulators to see trial data while the development is ongoing to speed up approvals of drugs and vaccines that are urgently needed.

The move would be a key step forward for the Oxford-AstraZeneca shot after trials were halted earlier this month due to concerns about a participant in the U.K. study who became ill. The partners, along with companies such as Pfizer Inc. and Moderna Inc., are sprinting ahead with experimental shots as governments look for a way out of the global crisis.

The death toll from the disease exceeded 1 million this week, while the infection rate has rapidly picked up again in Europe.

While the British regulator cleared the Oxford-Astra trial to restart less than a week after it was paused, U.S. authorities have yet to give the go-ahead for trials to resume in the country. Studies in South Africa, Brazil and India have also restarted.

The EMA’s head of vaccines, Marco Cavaleri, said in July the agency would start rolling reviews of potential candidates after the summer. The approach means that a final approval could be granted a matter of days after the review period ends. Cavaleri said at the time the first approval of a vaccine could come by the end of the year.

In a normal environment, drugmakers submit trial data to the regulator for a review that can take many months. Once that’s complete, an opinion is given on whether the product should be authorized for use, which must be signed off by the European Commission.

In emergencies like a pandemic, a rolling review avoids delays so that an EMA recommendation and approval from the European Commission can be sought as quickly as possible. The agency started such an evaluation of remdesivir to treat COVID-19 in April, while trials were ongoing, and the drug was given conditional approval three months later.

AstraZeneca declined to comment. A spokesperson for the EMA declined to comment on the review.

“EMA has always stated that it will communicate the start of a rolling review for COVID-19 treatments or vaccines,” it said in a statement. “We have not made such an announcement for a vaccine.”

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Surge in health-care worker COVID-19 cases causing burnout, nurses union says – CBC.ca

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Nearly two-thirds of Manitoba health-care workers who contracted COVID-19 did so in the past two months, data from the province suggests, and unions representing front-line staff say that’s contributing to burnout.

In a seven-week period in August and September, 61 health-care workers tested positive, making up the bulk of the roughly 100 such cases over the past six months, according to COVID-19 surveillance data from the province.

The recent uptick is adding strain to several health-care sectors, where employees are being required to work more overtime due to staffing shortages, said the Manitoba Nurses’ Union and the Canadian Union of Public Employees.

“Nurses are incredibly stressed,” said nurses union president Darlene Jackson. “It’s increasing, and then when you add an outbreak at a facility or on a unit, and you have staff off self-isolating, it’s the perfect storm. It just makes things even worse.” 

Jackson said 27 nurses have tested positive since March. That represents a quarter of all health-care worker cases.

Between mid-March and early May, the province reported 36 cases of health-care workers testing positive. That trend flatlined for months amid mass closures and pandemic restrictions, before picking up again on the heels of loosened rules this summer.

Spikes in Prairie Mountain Health led to the reintroduction of restrictions at the end of last month. Similar rules were imposed in Winnipeg and surrounding communities this week amid what Manitoba’s chief provincial health officer recently called evidence of a second wave.

Sample results fast tracked

As of Tuesday, Winnipeg was home to more than 80 per cent of Manitoba’s 606 active cases. That has led to a rise in demand at COVID-19 test sites, resulting in hours-long wait times, particularly at drive-thru sites in Winnipeg.

The province opened a new mobile screening station Wednesday, but Jackson still worries about long wait times for nurses who can’t work until results are in.

“We’ve had staff shortages for a very long time,” she said. “Now, if you have an outbreak in your facility, we have nurses and health-care aides off self-isolating, waiting for test results. That has absolutely increased the shortage in nursing.” 

A provincial spokesperson said when it comes to getting tested, health-care workers have to stand in line like the rest of the public. But at the lab, their samples are flagged to reduce turnaround times.

A union that represents health-care aides, transporters, ward clerks, security guards and more said it’s seeing signs of a stressed-out workforce in its members.

Staff at personal care homes and home-care workers appear to be among those most affected by burnout, said the president of CUPE Local 204.

“Anxiety levels have come up big time with COVID just because they don’t know who they’re coming in contact with,” said Debbie Boissonneault.

At least 18 front-line workers represented by CUPE have tested positive in the past six months, she said.

‘It’s been a problem’

Workloads have also increased and staff are spread thin filling in holes when peers are off sick, she said.

“Someone calls in sick, the employer doesn’t replace that person, so now you have three people doing the work of four, and sometimes two [doing] the work of four,” said Boissonneault.

“It’s been a problem long before COVID, and with COVID it’s even become more.”

Darlene Jackson is president of the Manitoba Nurses’ Union. (Jeff Stapleton/CBC)

An outbreak at Winnipeg’s Health Sciences Centre early in the pandemic resulted in 16 staff members testing positive, along with five patients and four close contacts. Two people died as a result of that outbreak.

After emerging from the first wave with no serious care home outbreaks, Manitoba has faced several in recent weeks, including one at Bethesda Place personal care home in Steinbach that has resulted in four deaths.

Jackson said cuts and closures stemming from the Pallister government’s health-care overhaul led to an increase in vacant nursing positions before the pandemic hit. That void contributed to a nurse workload that is “much heavier than it’s ever been,” said Jackson.

Jackson said appropriate personal protective equipment isn’t always available in some facilities, and that absence is also weighing on an already tired workforce.

“These nurses are incredibly stressed because not only do you have the workload and the staff shortage, now you have concerns about, ‘Am I protected? Are my residents or patients protected? And what am I taking home to my family?”

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