Katherine Jenkins health: ‘My liver wasn’t working properly’ Stars unusual condition

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Katherine Jenkins, 40, is the Welsh songbird who has released numerous albums that have performed well on both British and foreign charts. The songstress has become a regular face on television screens thanks in part to her alluring beauty and perfectly pitched voice. The star has enjoyed a quieter existence focussing on her growing family. It was during her pregnancy, however, that she discovered a health condition she was suffering from which she had never heard about. Katherine chose to speak out about the condition in the hopes of informing other pregnant woman about a liver condition which causes itchiness in pregnancy. What is it?

Katherine said in an interview with The Sun last year: “With my second pregnancy there was a little bit of a complication.

“I got a thing called cholestasis, I had itchy skin and at first I thought it was just stretching.

“Eventually I had a blood test and I found that my liver wasn’t working properly which can have really serious effects.

“I had literally never heard of the condition before and I didn’t realise it was serious and I think it’s something that people should talk about more,” she added.

The songstress is now using her experience to encourage other expectant mothers who suffer with itchy skin to “go get a blood test”.

Cholestasis is a condition that affects around one in 140 pregnant women in the UK.

Symptoms typically start from around 30 weeks of pregnancy, but it’s possible to develop the condition as early as eight weeks.

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There are two types of cholestasis: intrahepatic cholestasis and extrahepatic cholestasis. Intrahepatic cholestasis originates within the liver. It can be caused by:

  • Disease
  • Infection
  • Drug use
  • Genetic abnormalities
  • Hormonal effects on bile flow

The main symptom is itching, usually without a rash, according to the NHS.

It explains: “For many women with cholestasis, the itching is often more noticeable on the hands and feet but can be all over the body or worse at night.

“Other symptoms include dark urine, pale poo, yellowing of the skin and whites of the eyes, but this is less common.

“Wearing loose clothes may help prevent itching, as your clothes are less likely to rub against your skin and cause irritation.

“You may also want to avoid synthetic materials and opt for natural ones, such as cotton, instead.”

Cholestasis that occurs during pregnancy can be an inherited condition. If your mother or sister had this condition during pregnancy, you may have an increased risk for also developing obstetric cholestasis.

It’s strongly advised to see your GP if you have itching in pregnancy.

Some over-the-counter medications, such as antihistamines or anti-itch creams containing cortisone, are generally ineffective for treating this condition and may harm your unborn baby.

Instead, your GP can prescribe drugs that help with the itchiness but won’t harm your baby.

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Any Potential COVID-19 Vaccine Will Have to Pass These FDA Requirements

  • During a daylong meeting, experts advising the FDA on coronavirus vaccines talked about the approval process, ongoing clinical trials, and public concerns.
  • Vaccine makers will be required to monitor clinical trial participants for an average of 2 months after their final dose to measure safety.
  • Any approved vaccine will need to show at least 50 percent efficacy.
  • Even after the phase 3 trials are concluded, additional clinical trials will be required to determine safety and efficacy in children, pregnant people, and other groups not included in the initial trials.

Members of an expert panel advising the Food and Drug Administration (FDA) on coronavirus vaccines met on Thursday, Oct. 22 to discuss key issues around the review of potential vaccines and how to convince the public to get vaccinated.

No specific vaccines were reviewed because phase 3 clinical trials are still ongoing.

The FDA expects to reconvene the expert panel in the future when vaccine makers apply for emergency authorization or standard approval.

Here are the key takeaways from this daylong meeting.

Speed is good, but safety comes first

It normally takes years to develop a new vaccine, but the development of COVID-19 vaccines has moved at a breathtaking pace.

This has been aided by advances in technology and a rapid influx of funding from government and industry.

However, some people have been concerned that the process may be moving too quickly. These concerns have been fueled by President Trump’s continued push for an approved coronavirus vaccine before Election Day on Nov. 3.

Marion Gruber, PhD, director of the FDA’s vaccine research office, sought to allay these fears. “Vaccine development can be expedited. However, I want to stress that it cannot — and must not — be rushed,” she said.

In a briefing document released prior to the meeting, the FDA also laid out what it expects from companies during phase 3 trials.

Vaccine makers will need to follow participants for an average of 2 months after their final dose. They will also need to see at least 5 severe COVID-19 cases in the group that received the inactive placebo.

The FDA will also require that a vaccine show at least 50 percent efficacy. This means that a person in a phase 3 trial who received the vaccine would have a 50 percent lower risk of symptomatic COVID-19 compared to someone who got the placebo.

These and other guidelines are intended to ensure that companies have enough data about the risks and benefits of a vaccine before submitting an application to the FDA.

Emergency authorization is not the end of trials

There are two regulatory approval routes that a coronavirus vaccine can follow.

The first is emergency use authorization (EUA), which is a faster approval process reserved for public health emergencies, such as during a pandemic. The second is the standard regulatory review.

Vaccine makers can apply for emergency authorization as soon as they have enough data showing that a vaccine provides some benefit. This could occur before the phase 3 trials — which include 30,000 or more participants — are finished.

In comments submitted ahead of the meeting, drugmaker Pfizer indicated that if its vaccine receives an EUA, the company would like to be able to provide the vaccine to study participants who had received the placebo.

The phase 3 vaccine trials are “blind,” meaning that participants don’t know if they’re receiving the candidate vaccine or the placebo.

However, during the meeting, Dorian Fink, a deputy director in the FDA’s Division of Vaccines and Related Products Applications, said that the phase 3 trials should continue as long as possible in order to provide additional safety and efficacy data on the vaccines.

“Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back and that controlled follow-up is lost forever,” he said.

The FDA also indicated that it wouldn’t consider emergency use authorization of a vaccine a reason for a company to end the phase 3 trial — the vaccine would remain experimental even after an EUA.

A key reason for keeping the phase 3 trials going as long as possible is that data required for an EUA is less stringent than what’s needed for full review. Also, some adverse events may not show up until larger numbers of people have been vaccinated.

In addition, EUA’s are sometimes revoked when later data is collected, as happened earlier this year with hydroxychloroquine, a drug that was proposed as a treatment for COVID-19 but turned out to offer few benefits.

Additional clinical trials will be needed even after approval

Even if the phase 3 trials are allowed to run fully to the end, additional clinical trials will be needed. Some of these are currently being planned.

This includes phase 3 trials in children and pregnant people, groups that haven’t been included in the ongoing trials.

Without trials involving these groups, scientists wouldn’t know if the vaccines are safe and effective in these populations.

Pfizer announced last week that it would start enrolling children as young as 12 years old in a vaccine trial.

Other studies will look at the link between vaccination coverage — how many people get vaccinated in an area — and rates of COVID-19 in those areas.

Scientists will also continue to monitor the virus for genetic changes to see if any of these mutations reduce the protection offered by an approved vaccine.

And then there’s the ongoing safety monitoring that’s routinely carried out by the FDA and Centers for Disease Control and Prevention (CDC) for all vaccines.

Work needs to be done to build public support of a vaccine

During the meeting, the Reagan-Udal Foundation, a nonprofit established by Congress to assist the FDA, talked about its efforts to counteract public concerns about coronavirus vaccines or the approval process.

Their initial outreach identified several of these, including distrust of the healthcare system, concern about the speed of vaccine development, and distrust of the government.

There were also concerns among certain groups that the vaccine wouldn’t work for their community.

Some people who provided comments to Reagan-Udal questioned whether enough marginalized communities had been included in the vaccine trials.

During the public comment period for the FDA meeting, Claire Hannan, executive director of the Association of Immunization Managers, said transparency and openness about the vaccine approval process is needed.

“Holding open online meetings allows the public to see for themselves how the process works,” she said.

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Jimmy Kimmel Gives New Look at Son's Health Journey: 'Vote With Your Heart'

Brave Billy. Jimmy Kimmel and his wife, screenwriter Molly McNearney, shared never-before-seen footage of their 3-year-old son’s health journey on Thursday, October 22.

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“We’re two weeks away from the election, and there is so much more than the election on the line,” the Jimmy Kimmel Live! host, 52, said on his ABC show. “I want to bring us back to focus on something we can’t afford to forget, [which] is healthcare.”

The New York native went on to introduce a video segment, explaining, “My wife made a video that deals with our experience when it comes to preexisting conditions. We’d like you to watch this and pass it around to anyone who may have forgotten what this election is about.”

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In the footage, McNearney, 42, documented their baby boy’s congenital heart condition, from his tetralogy of Fallot with pulmonary atresia diagnosis to the three heart surgeries that followed. The Missouri native showed the little one’s scars as well as photos of him hooked up to different machines and tubes over the years.

“Over 60 doctors’ appointments in three years,” the actress, who also shares daughter Jane, 6, with Kimmel, wrote alongside the video.

McNearney urged viewers to “vote with your heart” before sharing videos of Billy laughing and playing with his family. “We are raising him to fight for less fortunate kids,” she concluded. “Americans take care of one another.”

Kimmel first revealed his youngest child’s heart condition in May 2017, explaining that Billy’s pulmonary valve was blocked and there was a hole in his heart wall. “On Monday morning, Dr. Vaughn Starnes opened his chest and fixed one of the two defects in his heart,” the Emmy nominee said at the time. “He went in there with a scalpel and did some kind of magic that I couldn’t even begin to explain. He opened the valve, and the operation was a success. It was the longest three hours of my life.”

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Two years later, the Serious Goose author exclusively told Us Weekly that the toddler was “doing great,” adding, “He thinks he’s Spider-Man now, so we’re safe from crime. He wears the costume all the time. He’s shooting webs all over the house.”

The comedian is also the father of Katie, 29, and Kevin, 27, with his ex-wife, Gina Kimmel.

For access to all our exclusive celebrity videos and interviews – Subscribe on YouTube!

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Type 2 diabetes – drinking pomegranate juice may lower high blood sugar levels

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Type 2 diabetes is the eventual outcome of processes in the body that are not functioning properly. Namely, your pancreas is not producing enough insulin or the insulin it does produce is not being absorbed efficiently by the cells. Insulin is a hormone that polices blood sugar levels in the body.

Blood sugar – also known as glucose – is obtained through the foods we eat and is the main type of sugar found in blood.

The sugar supplies the body with energy and nourishes the body’s organs, muscles and nervous system.

However, regularly having high blood sugar levels for long periods of time can result in permanent damage to parts of the body such as the eyes, nerves, kidneys and blood vessels.

Insulin therefore plays a protective role by regulating the supply of blood sugar in the body.

Poor insulin production therefore puts people with diabetes at a higher risk of severe complications.

Luckily, you can control blood sugar through another means – healthy dietary choices.

According to research published in the journal Nutrition Research, pomegranate juice may perform this function.

The researchers were interested in assessing whether the benefits of drinking pomegranate juice, which include lowering blood pressure due to its antioxidant properties, extend to lowering blood sugar.

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To investigate this, they recruited 85 people with type 2 diabetes and assigned them to receive 1.5 millilitres of pomegranate juice per kilogram of body weight.

Blood sugar and insulin levels, and beta cell function were assessed three hours after ingestion.

Beta cells are unique cells in the pancreas that produce, store and release the hormone insulin.

Results showed that pomegranate juice was associated with significant lower fasting glucose levels compared with control participants.

While the exact mechanisms involved remain unclear, the researchers suggest it may lie in juice’s antioxidant ability, which helps to thwart oxidative stress.

Oxidative stress is an imbalance of unstable atoms called free radicals and antioxidants in the body, which can lead to cell and tissue damage.

Oxidative stress plays a pivotal role in the development of diabetes complications.

General tips to lower blood sugar

There’s nothing you cannot eat if you have type 2 diabetes, but you’ll have to limit certain foods.

That’s because certain foods can send blood sugar levels soaring; the worst being carbohydrates.

Carbohydrate is broken down into glucose relatively quickly and therefore has a more pronounced effect on blood sugar levels than either fat or protein.

Physical exercise helps lower your blood sugar level – you should aim for 2.5 hours of activity a week, advises the NHS.

“You can be active anywhere as long as what you’re doing gets you out of breath,” it adds.

Type 2 diabetes – how to spot it 

Many people have type 2 diabetes without realising – this is because symptoms do not necessarily make you feel unwell.

Symptoms of type 2 diabetes include:

  • Peeing more than usual, particularly at night
  • Feeling thirsty all the time
  • Feeling very tired
  • Losing weight without trying to
  • Itching around your penis or vagina, or repeatedly getting thrush
  • Cuts or wounds taking longer to heal
  • Blurred vision.

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Gout symptoms: The first sign you could have the potentially disabling form of arthritis

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This debilitating condition arises when excess uric acid collects in the body. What is the first sign of gout? And how can it be treated?

The American College of Rheumatology revealed the first sign of gout could be painful swelling in the big toe.

In the beginning, gout attacks could appear in the night, followed by no symptoms.

As uric acid continues to build up in the body, the affected area may be red and warm.

Needle-like urate crystals deposit in the toe joint, which attracts white blood cells.

This can lead to severe, painful gout attacks, and it’s not only the big toe that is affected.

Gout can affect any joint, meaning uric acid based crystals can form in various different areas.

These swollen growths under the skin are known as tophi, and they damage the joints.

There are two possible reasons as to why uric acid builds up in the body over time.

The first culprit could simply be an increase in uric acid production.

Alternatively, the kidneys could be struggling to remove uric acid from the body.

Certain foods and medicines may raise uric acid levels, leading to gout attacks.

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For example, shellfish, red meat and liver are high in purines (which form uric acid).

In addition, excess alcohol, sugary drinks high in fructose, and certain diuretics, such as hydrochlorothiazide, could increase uric acid.

Gout is strongly linked to obesity, hypertension, high cholesterol and diabetes.

One active treatment for the condition is colchicine, which can be effective if given early in the gout attack.

However, this medication can cause nausea, vomiting, diarrhoea and other side effects.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs) can help decrease inflammation and pain in joints.

The most common NSAIDs used to treat gout include indomethacin (Indocin) and naproxen (Naprosyn).

People on medication for blood thinners, impaired kidney function or ulcer disease aren’t able to take NSAIDs.

The alternative is corticosteroids, such as prednisone, methylprednisolone, and triamcinolone.

If only one to two joints are affected, the doctor can inject these medicines directly into the joint.

The American College of Rheumatology star that cherries and unsweetened cherry juice may reduce gout flares.

In addition, a daily glass of skimmed milk may also help to lower uric acid over time.

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Restrictions tightened, but no new virus lockdown in Belgium

Belgian Prime minister Alexander De Croo stopped short Friday of imposing another full lockdown, as the country did in March, but introduced a series of new restrictive measures as the number of COVID-19-related hospital admissions and deaths continues to soar.

Already severely hit during the first wave of the pandemic, Belgium is now the second-worst country in the European Union in terms of coronavirus infections per 100,000 inhabitants.

“We want to ensure that our doctors and hospitals can keep doing their work, that children can continue attending schools and that businesses can continue working while preserving as much as possible the mental health of our population,” De Croo said as he unveiled the new restrictions during a press conference.

Belgium had already introduced a list of measures aimed at slowing infections, including a night-time curfew and closing bars and restaurants. Visits at nursing homes have also been limited, but many health experts think the new curtailment won’t be enough to break the contagion chain.

“We were told strong and hard measures would be announced, we don’t see them,” epidemiologist Yves Coppieters told broadcaster RTBF.

According to the latest official figures, some 10,000 new people are infected on a daily basis by the virus, which has already killed more than 10,500 people in the small nation of just 11.5 million. The health situation is so dramatic in nine out of 10 of Belgium’s provinces that authorities have recently warned intensive care units will hit their capacity by mid-November if new coronavirus cases continue to soar at the same pace.

To avoid a collapse of the health system, health minister Frank Vandenbroucke said that the number of beds available in ICUs will be increased to 2,300, while nonurgent operations will be postponed over the next four weeks.

Following government talks held via video conference after several ministers got infected by the virus, De Croo decided to reinforce the sanitary protocols mainly in the culture and sports sectors. Until Nov. 19, theaters and cinemas will be allowed to accommodate a maximum audience of 200, while sports fans are banned from attending matches. In amateur sports, competitions involving over-18 athletes are suspended.

“It’s a tough blow, but the moment is serious and we need to show solidarity,” said Mehdi Bayat, the president of the Belgian soccer union.

Detailing the measures, Flemish Minister-President Jan Jambon said attendance at universities will be limited to 20 percent of capacity in lecture halls, while amusement parks will be closed from Friday.

De Croo also sent a message of support to business owners and workers affected by the measures who struggle financially and are losing their jobs.

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COVID-19 anxiety linked to body image issues

A new study has found that anxiety and stress directly linked to COVID-19 could be causing a number of body image issues amongst women and men.

The research, led by Professor Viren Swami of Anglia Ruskin University (ARU) and published in the journal Personality and Individual Differences, involved 506 UK adults with an average age of 34.

Amongst women, the study found that feelings of anxiety and stress caused by COVID-19 were associated with a greater desire for thinness. It also found that anxiety was significantly associated with body dissatisfaction.

Amongst the male participants, the study found that COVID-19-related anxiety and stress was associated with greater desire for muscularity, with anxiety also associated with body fat dissatisfaction.

Negative body image is one of the main causes of eating disorders, such as anorexia and bulimia, and this new study adds to recent research indicating that fears around COVID-19, and the consequences of the restrictions introduced to help tackle it, could be contributing to a number of serious mental health issues.

Lead author Viren Swami, Professor of Social Psychology at Anglia Ruskin University (ARU), said: “In addition to the impact of the virus itself, our results suggest the pandemic could also be leading to a rise in body image issues. In some cases, these issues can have very serious repercussions, including triggering eating disorders.

“Certainly during the initial spring lockdown period, our screen time increased, meaning that we were more likely to be exposed to thin or athletic ideals through the media, while decreased physical activity may have heightened negative thoughts about weight or shape. At the same time, it is possible that the additional anxiety and stress caused by COVID-19 may have diminished the coping mechanisms we typically use to help manage negative thoughts

“Our study also found that when stressed or anxious, our pre-occupations tend to follow gender-typical lines. During lockdown, women may have felt under greater pressure to conform to traditionally feminine roles and norms, and messaging about self-improvement may have led to women feeling dissatisfied with their bodies and having a greater desire for thinness.

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Plasma therapy for COVID-19: Updates from Prof. Arturo Casadevall

Back in May, Medical News Today spoke to Prof. Arturo Casadevall, from Johns Hopkins, about the potential of using convalescent plasma therapy in the treatment of COVID-19. Now, we follow up with Prof. Casadevall on the latest findings.

In May, we spoke to Prof. Arturo Casadevall — chair of the Molecular Microbiology & Immunology Department at the Johns Hopkins Bloomberg School of Public Health in Baltimore, MD — about the possibility of using convalescent plasma to treat cases of COVID-19.

This procedure requires the use of donated plasma, a component of blood, from people who have had and recovered from COVID-19 to treat or prevent the disease in those most at risk of developing it.

That is because convalescent plasma from people who have recovered from COVID-19 usually contains antibodies against SARS-CoV-2. This is the virus that causes the disease.

On August 23, 2020, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) for convalescent plasma in the treatment of COVID-19.

However, some scientists have called this move controversial due to a lack of conclusive evidence regarding this therapy’s effectiveness.

Now, MNT have caught up with Prof. Casadevall, who was the co-senior author on one of the trials that informed the FDA’s decision. We asked Prof. Casadevall what he thinks of the EUA and what has changed in convalescent plasma research since the last time we spoke.

We have lightly edited the interview transcript for clarity.

The EUA and research since May

MNT: The FDA granted EUA for plasma therapy on August 23, but this decision sparked some controversy. What is your take on the matter?

Prof. Casadevall: The first thing I would say is that all the issues of controversy have been [based on] newspaper reports. The truth is that I don’t even know if there is any real controversy. I think that it’s been reported to be a controversy. But let’s just assume that what they reported is correct.

I [and Prof. Nigel Paneth] wrote an op-ed in The Wall Street Journal a couple of weeks ago, arguing that the issue seems to be [based on] differences on the degree of certainty. That is, the FDA made this decision based on its regulatory power for the laws of the land that say that once […] the information is there that [a treatment] may be effective and that it is reasonably safe, that they can issue an EUA. That’s what it says.

Everyone, including myself, feels that just because an EUA has been issued doesn’t necessarily mean that one has proven beyond reasonable doubt the efficacy of plasma.

[Given] the regulatory landscape [of] the FDA, this was, in our mind, the correct decision. It is also the correct decision to continue to do randomized clinical trials. So these two are not in conflict with one another.

Because in many places, there is no randomized clinical trial. So if you get sick in a place and you go to a hospital where there is no randomized clinical trial, you can’t even join to be able to be randomized to the plasma group.

So, what this decision says is [that] the available data suggest[s] that this [therapy] may be effective if given early with a sufficient amount of antibodies.

That’s the decision. In the meantime, it is very important to continue to do all we can to establish efficacy.

MNT: Some have expressed a worry that, like vaccines, plasma therapy may be pushed out too soon.

Prof. Casadevall: You know, I’m not worried about that. I will tell you that I worked with the government scientists, the FDA, [and] the people who made this decision for months before it was [taken], and I can assure you — and I can assure [your readers] — that these government scientists are very devoted and dedicated people, and I’m not worried about that myself, based on what I know.

I think that when the regulatory agencies give the go-ahead, it will be based on science. And I would say to you, look at hydroxychloroquine: Based on the initial results, [the FDA] issued an EUA, [but] when the data was not there [to support the initial findings], they pulled it.

And that’s very important to keep in mind — that these agencies are responding to the available knowledge. And we’re in the middle of a pandemic, and we’ve got to try to make the best decisions with the available information.

MNT: The last time we spoke, in May, there was less research and less evidence around the safety and efficacy of plasma therapy for COVID-19. How has the research around plasma therapy developed since?

Prof. Casadevall: There has been a lot of new evidence. The evidence comes in four categories. The first one is — we now have reports [from] five randomized control trials.

Three had to be stopped prematurely because they ran out of [participants]. That’s in China, in Spain, and in the Netherlands.

And then there are two [more]. One was completed in India, and it did not show an effect [on] mortality, but there were problems in the study because over a third of the units did not have antibodies.

So that is a problem in the study itself. And then there is another small study from Iraq, [a] randomized control trial, showing that [plasma therapy] reduced mortality.

So the data that you have out there in the randomized control trials is suggestive that this is doing some benefit, but it’s not conclusive for a variety of issues, ranging from the changing epidemic to the problems with trials.

Then, you have the observational studies, and those are suggesting that, if given early, [convalescent plasma] is associated with a great reduction in mortality. [By] great, I mean about half.

And the two studies that I would point people to look at [are] the Houston Methodist [Hospital] study, published in the American Journal of Pathology, and then there’s one from [Mount] Sinai [Icahn School of Medicine], published in Nature Medicine.

The third piece of data — it comes from the FDA themselves, where they looked at a large number of people in a cohort that didn’t have a control [group].

But it didn’t matter, [because] when you looked at it, you saw that if you gave [convalescent plasma] early and if you gave a significant amount, there was less mortality than if you gave it late or if you gave less.

In that study, there is a really important piece of data. There is a dose response. And whenever [we] see a dose response in science, we tend to consider that [to be] very important because it’s part of what we use for assigning causality — that is, causality that [the] antibody is the active agent.

And then the fourth piece of data is coming from experiments of nature. These are people who don’t have antibodies because of congenital disease. When they get COVID-19, it becomes intractable.

And then [for] the administration of plasma — even though these are case reports, they are powerful evidence that when you give the plasma, you shut down viral replication and you clear it.

So what I would say to you is, do we have the definitive data today? No, definitive data is coming. Numerous randomized control trials have been done in the United States, in England, and [in] other parts of the world, and we will know more in the next few months, but it’s October 9 [at the date of this interview]. As you look at the data that we have today, it is suggesting that the early administration of plasma with sufficient titer is beneficial.

‘What have we learned?’

MNT: Based on the information that has emerged from the studies conducted since May and until now, have your views about plasma therapy changed in any way?

Prof. Casadevall: Certainly there is a massive amount of data available in October that was not available in May, and most of it is positive.

So [some important things that] we learned is that this is a therapy that is going to take a while to figure out how to make work well, that this is not a simple therapy, that you need to have a set amount of antibodies in the plasma, that you need to give it early, [and] that it works best in non-intubated patients.

We did not know any of this in May. In fact, I would argue that if we had designed a randomized control trial then, it would have become obsolete by now, because the information used to design the trial would have been superseded by what we have learned since then.

So I think that we have learned a lot since then.

MNT: With the research that you were involved in, what were the main challenges, and how do you think you might overcome them in future trials?

Prof. Casadevall: So [one of the trials] I’ve been involved with [is] the Mayo study, [where] Michael Joyner was the [principal investigator]. So the challenge there is to try to understand efficacy in a situation where you don’t have a control group. And that is a big challenge. It hasn’t been done before, and yet, I think that we learned a lot from that.

At Hopkins, we have two randomized control trials. They’re headed by David Sullivan and Shmuel Shoham, and these are in the outpatient space. And when we talked in May, they were theoretical.

Since then, they have been put in place, and they are rapidly accruing [participants]. The most important thing that we learned is how hard it is to set up randomized control trials in the middle of a pandemic and to keep them going when the [number of] cases switch from one part to another.

For example, one of the things that have become very apparent is that these trials are very difficult to do in any one location.

So the trials now in the U.S. [take place] in many states because the epidemic changes, you know. You had [a high number of cases in] New York City in March and April, and then you had [the same in] Arizona in the summer, and now it is moving to the Midwest.

So that is the big lesson, but the good thing is that they’re in place, they’re recruiting, [and] they’re very clean studies, because they’re happening in the outpatient space.

These [participants] are not [taking] corticosteroids. They’re not on remdesivir. They are at home, and if they’re sick, you give them a unit of plasma and you ask the question: “Do [they] progress?”

Or, the other trial looks at prophylaxis. [The participants] are at home. They’re exposed [to SARS-CoV-2] because a family member may have [COVID-19]. If you give them human plasma, do you prevent disease?

So these [studies] are happening, and I guess what you asked me [was], if we had to do everything over again, what have we learned? I think the most important thing to have learned is that […] we need to think about flexible trial design, because even if you had been able to get all the resources and get going in March and April, the information that we have learned on a weekly basis often makes the assumption that you start with obsolete.

And one of the great challenges in getting really good information in the middle of a pandemic, where science is generating information by the week, is the ability to do flexible clinical trial design that would allow some of these things to happen. And this falls into the science of clinical trials, and I think “trial” is an issue on how to go forward.

MNT: Earlier, you also mentioned a lack of resources. What resources did you feel you were missing?

Prof. Casadevall: Early on, there were very [few] resources. The only resources that we had was … the Bloomberg Philanthropies gave us some money, and the state gave us some money. We used that money to set up the clinical trials, which, months later, the government funded very well. We are funded now by the Department of Defense.

So I think the early lesson is that [receiving] money upfront can make a big difference. Because the early days are critical. The other thing that we have learned is … think about it, if you were designing a clinical trial in March or April, you didn’t have the assays.

They had not been validated. How would you have decided what plasma to use when the antibody assays and the neutralization assays and all that [were] being validated very rapidly? It’s another example of the need for flexibility, and we need to think [about] how to do this thing and how to do it better, because humanity is going to be confronting other pandemics.

And the question is, you know, how are we going to do it when bird flu comes, or when another pox virus or something [comes], or coronavirus number seven?

Out of this experience, one of the things that I hope people focus on is that the line of defense — humanity’s line of defense — is science.

You know, the military budget doesn’t help you against coronavirus.

And […] the line of defense, science‚ was actually pretty stressed before this began, you know, with funding cuts in most places, problems […] with employment and all that. Yet it is amazing when you think over 100 vaccines are in development.

We can always do things better, but we also have to celebrate the tremendous amount of work that has gone on and the options that are available in October as a result of having a vibrant worldwide scientific enterprise.

More conclusive data may be available ‘in the next 2 months’

MNT: It is sometimes easier to judge than it is to celebrate, especially when the world is in this atmosphere of anxiety, where people do not always understand what is going on, and they may start to lose trust in science. So, on a related note, what will it take to conclusively prove or disprove the efficacy of plasma therapy for COVID-19?

Prof. Casadevall: I think that certainly having a large, well-designed randomized control trial, where the plasma is given early, in high amounts … if you got [confirmation of] efficacy [in such a trial], then it would be very convincing.

If you do not get efficacy, then I am the first person to say to you: “We read all the trials, bias has crept in.”

Because we need to retain equipoise — as a scientist, one always has to basically say what will convince you that it didn’t work. And to me, it would have to be a confirmation from those [new] trials.

Trials in which this is done in patients who are intubated, or [where] there are problems with the plasma, are inconclusive. One of the most frustrating things is that a lot of the information that is coming out is simply inconclusive.

[This is] not because people aren’t working really hard to [find conclusive evidence], but because the trials [were] often designed without all the information that was needed.

The best example of that appears to be the Indian trial — a massive amount of effort … [I have] great admiration for my Indian colleagues, but when this decision was made to seek plasma, a lot of their donors had mild disease. Mild disease does not result in high antibody titers. They didn’t know that when [the trial] was set up.

But I will tell you, plasma has already given humanity a tremendous piece of information. It is safe. It cleared the way for monoclonals. It cleared the way for a lot of things.

Back in May, when we were talking, there was still a lot of discussion of an antibody-dependent enhancement. Are you going to give anti-antibodies to a patient? Are you going to trigger a cytokine storm [by doing that]?

None of that happened. So the great use of plasma […] [in] over 100,000 patients established the safety of giving antibodies to somebody who’s sick.

That is a huge contribution, because we heard, for example, that monoclonal antibodies … they are now trying to push them forward with a fraction of the experience, but that experience is resting on the plasma experience.

That is a big, big, big contribution.

And the other thing is that we — certainly [if we are based] in well-resourced areas — we have a tremendous responsibility to figure out what’s going on with plasma, because in regions that don’t have a lot of resources, this is going to have to be the therapy for the next few months, even years, because monoclonal antibodies are going to be unaffordable. We don’t have, in the immediate future, any new antiviral[s].

So plasma may be — in the U.S., in well-resourced areas — plasma may be a stopgap between a time in which you have nothing to a time when you have monoclonals and you have other reagents. [M]uch of the world may still need plasma, and we need to figure out when and how and if to use it, because that information can be life saving in those circumstances.

MNT: One last question: How long until we know when, how, and if to use plasma therapy for COVID-19?

Prof. Casadevall: Since we talked in May, we have learned that [plasma therapy] is safe, we have learned that [it has to have] high titer, and we have learned that you have to use it before people get ventilated.

So I think that there is a very high probability that, in the next 2 months, some of these trials will provide additional information. My hope is that they are conclusive.

However, if you publish a trial with 1,000 people where the average day when the plasma was given was day 8, day 10, that’s not conclusive. But I would say that if you go to PubMed and if you go to the archives and if you look [for] “convalescent plasma,” you would see an enormous amount of information that has been generated since May.

And the information is already telling you that [it] is [safe], and if you’re going to use it, use it early and make sure that the plasma has sufficient antibody content.

So I think that those are tremendous advances in relatively few months, when you consider what the situation is.

MNT: Thank you so much for your time and for all of the updates. Do you have any final remarks for our readers?

Prof. Casadevall: I would say that papers are coming out by the week, and […] I urge the [readers] and I urge anyone who’s interested to approach the data carefully […] [and] ask the question: Did they give [convalescent plasma] early, did they give enough, and what were the conditions of the [trial]?

And you can often find that information [in the studies]. And certainly, even when [convalescent plasma] is given late, we’re not getting [conclusive] results or side effects. But [in terms of establishing] the efficacy — it’s early [days].

And for those of you who are planning clinical trials, please incorporate this information into [the study papers], because it’s very important to have conclusions.

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‘Foreign disinformation’ social media campaigns linked to falling vaccination rates

‘Foreign disinformation’ social media campaigns are linked to falling vaccination rates, reveals an international time trends analysis, published in the online journal BMJ Global Health.

Every 1 point increase in effort is tied to an average 2% drop in annual coverage around the globe, and a 15% increase in the number of negative tweets about vaccination, shows the study, which forms part of a BMJ Collection on Democracy and Health published for the World Health Summit this weekend.

Last year, the World Health Organization (WHO) listed vaccine hesitancy—reluctance or refusal to be vaccinated because of safety concerns—-as one of the top 10 threats to world health.

While vaccine hesitancy isn’t new, the proliferation of ‘anti-vaxx’ messaging on social media is of particular public health concern, given that vaccination is seen as a key route out of the current coronavirus pandemic, say the researchers.

Deliberate ‘disinformation’ campaigns by foreign agencies on social media also have their part to play, they add.

To gauge the impact of social media use and foreign disinformation campaigns on vaccine hesitancy around the world, the researchers analysed two different dimensions of social media activity for up to 190 countries.

These were: the public use of Twitter to organise action/resistance; and the amount of tweets expressing negative sentiments about vaccines.

They also drew on national survey data about public attitudes to vaccination safety and annual vaccination rates for the 10 most commonly reported vaccine doses between 2008 and 2018.

They used recognised analytical tools to measure sentiment (Polyglot Python Library); public use of social media to organise (Digital Society Project or DSP); foreign sources of disinformation (Varieties of Democracy Institute expert network + DSP); public attitudes to vaccine safety (2019 Wellcome Global Monitor).

They also logged measures of GDP (gross domestic product) per head of the population for each country and levels of internet usage.

Analysis of all the data revealed that the prevalence of foreign disinformation activity was “highly statistically and substantively significant” in predicting a drop in average vaccination rates.

A one-point shift upwards in the five-point disinformation scale was associated with an average fall in the annual vaccination rate of 2 percentage points, and a cumulative drop of 12 percentage points across the decade.

A belief that vaccines are inherently unsafe was associated with organisation of action/resistance on social media: and the more organisation on social media, the greater was the level of belief that vaccines are unsafe.

Foreign disinformation was also associated with negative social media activity about vaccination, boosting the number of negative vaccine tweets by 15%, on average.

While the study is unique, it wasn’t able to specify the particulars of foreign disinformation campaigns or the prevalence of anti-vacccination propaganda, the researchers acknowledge.

What’s more, Twitter isn’t used in every country, and the survey data were only available at one point in time.

Nevertheless, write the researchers: “Foreign disinformation campaigns are robustly associated with declines in [average] vaccination rates. The use of social media to organise offline action is highly associated with an increase in public belief in vaccines being unsafe.

“Both of these findings suggest that combating disinformation and misinformation regarding vaccines online is critical to reversing the growth in vaccine hesitancy around the world.”

They add: “These findings are especially salient in the context of the COVID-19 pandemic, given that the vaccines under development will require deployment globally to billions of people in the next year.”

Public outreach and education campaigns will, of course, be needed, but they won’t be enough by themselves to counter the tide of mistrust, they emphasise.

“First, governments must mandate that social media companies are responsible for taking down anti-vaccination content (whether originating from genuine domestic actors or foreign propaganda operations),” they advise.

“Second, foreign disinformation campaigns should be addressed at their source. A preponderance of such campaigns amplifying anti-vaccination content originate from within Russia or via pseudo-state actors informally associated with Russia,” they warn.

None of this will be easy, they acknowledge, because it means reconciling the principles of free speech with the policing of social media for “damaging falsehoods,” and persuading Russia to adopt a ceasefire on internet information warfare in the interests of the health of its own people.

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More than half of Americans know someone infected or ill with COVID: Poll

(HealthDay)—More than half of all Americans have been personally affected by COVID-19 at this point in the pandemic, according to a new HealthDay-Harris Poll survey.

The national survey was conducted by The Harris Poll between Oct. 8 and 12. It found that 55% of U.S. adults now say they know someone in their immediate or extended network of family and acquaintances who’s been infected, hospitalized or passed away from COVID-19.

About two in every five people said they’d had even more direct experience with COVID-19, with either themselves or someone very close to them falling ill, being hospitalized or dying.

“By now, we’re all accustomed to regularly seeing the sobering figures for COVID infection and death rates, but these findings translate to something so much bigger in terms of the full and relentless impact of the virus on millions of Americans,” said Robyn Bell Dickson, managing director of The Harris Poll.

These results come in the midst of a COVID-19 resurgence in the United States, with the nation averaging 59,000 new cases a day. There have been more than 8.3 million reported infections, and around 220,000 U.S. deaths caused by COVID-19.

The online poll of 2,021 U.S. adults also found that 39% reported a direct impact on their lives from the pandemic, including:

  • Having personally had COVID-19 (7%) or being hospitalized (4%) from their infection.
  • Residing in a household with someone who had COVID-19 (6%).
  • Having a close friend, family member or loved one who became infected with COVID-19 (34%), was hospitalized (19%), or passed away (13%).

Overall, more than one in 10 adults have a loved one who has passed away due to COVID-19, the survey found.

Shifts in outlook

People who’ve been personally affected by COVID-19 tend to see the pandemic differently from those who’ve so far remained relatively untouched by the virus, the results showed.

Those who have direct experience with COVID-19, either personally or through a loved one, are more likely to be very concerned that they or a loved one will die from COVID-19. Nearly two-thirds (64%) reported this high level of concern, versus 52% of those with no direct experience or whose only experience is through an acquaintance.

Those without direct experience are also likely to be more optimistic that the pandemic will be under control by early 2021, 56% versus 49% of those with direct experience.

Adults whose personal experience of COVID-19 was more severe, with either themselves or a loved one struggling for life in a hospital or dying, were also more likely to agree with these statements:

  • I wish more people took COVID-19 seriously (87%, versus 80%).
  • I am extremely worried about getting COVID-19 (78%, versus 59%).
  • I am very concerned that I or a loved one will die from COVID-19 (73%, versus 53%).

“It makes sense that people who have experience with the disease will carry a different outlook with them, given that at the beginning of 2020 no one knew much at all about the burgeoning threat of coronavirus,” said Lynn Bufka, senior director of practice transformation and quality at the American Psychological Association.

“As people have more experience with COVID, they are finding the messages regarding the pandemic to be more consistent and mapped on to their own experience,” Bufka said.

Anxiety and resilience

The growing number of people who have personal experience with COVID-19 is adding to the uncertainty that already disrupts the daily lives of all Americans, Bufka said.

“Collectively, we’re all faced with this pandemic, not knowing when it will end. We have no way to put some predictions around it and feel comfortable with those predictions,” she added.

“We’re all sitting in a period of uncertainty with the pandemic, with the economic impact of it, and then you layer in other issues like grappling with systemic racism and the political discourse, there are just a lot of things that are elevating our levels of uncertainty,” Bufka continued. “We know that uncertainty is connected to anxiety. It would not be surprising at minimum to see more individuals struggling with anxiety right now, because it’s harder to feel safe, secure and in control when so much feels outside of your control.”

People also are dealing every day with feelings of loss and grief, ranging from things as profound as illness and death down to the simple need for a regular routine, Bufka said.

“Routines help us in so many ways because they make our lives predictable. They make things less uncertain. They also free up our mental space for tackling the things that are novel,” Bufka said.

“If your schedule changes dramatically or if the kinds of decisions you’re having to make vary day to day, that takes mental energy, which is harder to deal with,” she explained. “So we see people struggling with decision making, with handling novel problems, all of that because mentally, cognitively, their attention is taken with what they’re dealing with in the pandemic.”

It’s also becoming harder to expect help from those around you, she suggested.

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