Coronavirus therapeutics 'more complicated' than vaccine, expert says

WHO warns of surge in coronavirus cases in Europe

EEurope is seeing more weekly coronavirus cases than it did in March’s peak; Amy Kellogg reports.

Editors of a highly respected medical journal discussed on Wednesday "Operation Warp Speed" and the government's response to COVID-19, focusing mostly on therapeutics.

"Operation Warp Speed" is the U.S. government's plan to quickly ramp up the development and production of vaccines, therapeutics and diagnostics.

“Therapeutics are, in a way, more complicated than vaccines," said Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine (NEJM). “There are a limited number of approaches to vaccination and a similarly limited number of endpoints, but for therapeutics, there is an enormously wide range of targets and goals.”

Rubin explained that therapeutics can take a number of approaches, like trying to target the virus, target the host or target the interface between the host and the virus, all possibly leading to different consequences. Researchers can opt for small synthetic molecules or large biological macromolecules, also leading to different development paths, he said.

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“Therapeutics are, in a way, more complicated than vaccines," said Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine (NEJM)." 
(iStock)

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“The development time from discovery all the way to a useful drug is even longer than in vaccines, it’s often extending for decades," he said.

Rubin said "Operation Warp Speed" set three criteria for supported therapeutics: the candidate has to be ready for clinical testing this fall, there must be strong preclinical data supporting its use, and any candidate chosen must be deliverable at scale by the end of 2020.

Rubin said the criteria “strictly limit” the potential candidates. However, antibody-based therapies were said to have several advantages due to their well-understood development and production processes, in addition to their relatively known safety margins.

It was noted that small molecules like the experimental antiviral remdesivir and dexamethasone were previously shown to have some success. While the former can benefit patients earlier on in infection, the latter showed to lower the fatality rate of patients with more severe disease.

While remdesivir may benefit patients earlier on in infection, dexamethasone showed to lower the fatality rate of patients with more severe disease. 
(iStock)

“Dexamethasone sets a very high bar because it’s cheap and widely available and most of the other things that we’re talking about are antibodies or expensive small molecules so they’ll have to do better than dexamethasone in order to be widely adopted," Rubin said.

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These small molecules were said to have unique properties, and it’s difficult to generalize between them, even within the same chemical class. Each drug has its own pharmacology, subject to investigation and safety testing.

Rubin explained that “often times, it’s very difficult to guess what the issues are going to be for a small molecule as opposed to some of the, for example, antibodies, so there are often not very good guesses about potential toxicities before you get into people.”

Dr. Lindsey Baden, deputy editor of NEJM and co-principal investigator for Moderna’s Phase 3 trial, is involved with "Operation Warp Speed." Baden questioned how to bring out the best in the U.S. government, industry and academia to create a fast, appropriate response to the global health crisis.

“It’s a real balance because we don’t want to get lost in for-profit considerations but we also need responses that are temporally appropriate, so speed, and how to do things quickly in response to this pandemic that is spreading so fast,” Baden said. “It’s something that the different communities haven’t always thought about together that this crisis forced us to [do]

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"I think the speed with which this response is occurring on the biomedical side is encouraging in many ways despite some failings in our response," Baden added.

Finally, Baden addressed the question on the minds of many: How can drug developers speed along these clinical trials without risking safety in the end product?

“There are ways to take risks in manufacturing that are financial that don’t engender safety risks in the studies and those financial risks have to be thought about in the manufacturing side and the delivery side, that I would argue are appropriate risks in this setting," Baden said, elaborating on the nations' daily new case and death count, which is around 36,000 and 750, respectively, per the AP.

He said shaving off a week, month or just a day "has significant potential implications," given the widespread disease.

Click here to listen to the NEJM interview.

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Fewer kids may be carrying coronavirus without symptoms than believed, study says

(HealthDay)—Are infected-but-healthy children major “silent spreaders” of the new coronavirus? New research out of northern Italy, once a COVID-19 hotspot, suggests they might not be.

Rigorous COVID-19 testing of children and adults admitted to a hospital in Milan for reasons other than coronavirus found that just over 1% of kids tested positive for SARS-CoV-2, compared to more than 9% of adults.

That suggests a very low rate of asymptomatic infection among children, and does “not support the hypothesis that children are at higher risk of carrying SARS-CoV-2 asymptomatically than adults,” the researchers reported in the Sept. 14 online edition of JAMA Pediatrics.

One U.S. expert in infectious disease found the report encouraging.

“Since the start of the pandemic it has been very difficult to determine what the actual role of children in the spread of the virus is,” said Dr. Amesh Adalja, senior scholar at the Center for Health Security at Johns Hopkins University, in Baltimore.

“It is becoming clear that they do not amplify this virus the way they do influenza when it comes to community spread,” Adalja said.

In the new study, physicians led by Dr. Carlo Agostoni, of the Ca’Granda Foundation Maggiore Polyclinic Hospital in Milan, conducted two sets of nasal swab tests, up to two days apart, on 214 newly admitted patients.

Eighty-three of these new admissions were children and 131 were adults. All were admitted to the hospital in March and April, at the height of northern Italy’s COVID-19 outbreak. However, all of the patients were admitted for reasons unconnected to COVID-19, and none had shown any symptoms of the illness.

So how many were secretly carrying the virus nonetheless? Based on the swab tests, only 1.2% of the pediatric patients turned up positive for infection, compared to 9.2% of adults.

The low rate of carriage among kids in a city with a burgeoning number of COVID-19 cases suggests “that [children’s] role as facilitators of the spreading of SARS-CoV-2 infection could be reconsidered,” the study authors wrote.

Still, the researchers stressed that this is a small sample from just one hospital, so the findings shouldn’t be considered definitive.

And of course community outbreaks of COVID-19 tied to asymptomatic but infected children are happening in the United States. On Friday, researchers from the U.S. Centers for Disease Control and Prevention issued a report on a cluster of cases originating from two Salt Lake City day care facilities. The report found that 12 youngsters infected with coronavirus (only three showed any symptoms) enrolled at two day care centers easily passed SARS-CoV-2 to at least 12 family members, one of whom ended up hospitalized.

So as millions of children head back to school, uncertainty as to their role in the spread of COVID-19 continues, Adalja said.

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Mum says 'flashing the wilderness' helped her love her post-mastectomy body

Could the secret to body confidence post-mastectomy lie in stripping off in the middle of the wilderness?

Cat Levitt reckons so.

The mum-of-one was diagnosed with stage 2B invasive ductal carcinoma breast cancer in June 2018.

Within months she had a double mastectomy, followed by four rounds of gruelling chemotherapy.

Thankfully, Cat has been given the all-clear – but she has struggled with the feeling of ‘not being a full woman’ since losing both nipples.

Rather than mourning her old body, Cat, 35, decided to celebrate her post-cancer breasts… by trekking to the top of mountains, getting topless, and ‘flashing the wilderness’.

She credits those excursions with helping her to embrace her body again.

So far, Cat has visited – and flashed – more than 10 beauty spots, including Ice Lake in Colorado, US, and has sparked a trend among other breast cancer survivors.

Cat, from Aspen, in Colorado, US, said: ‘Flashing the wilderness is a way for me to show everybody there’s strength in your scars and strength in breast cancer.

‘I never thought I’d get to where I am now and love my scars. After you go through these surgeries you feel really awful.

‘At first I didn’t have confidence and self-love – now I do. I felt like a piece of what made me a woman and a mother were missing. I felt like I wasn’t whole.

‘I know a lot of women that are going through chemotherapy, or who have just had surgery, and they don’t know if they’ll ever get that strength back. It takes a while but you do.

‘I do it a lot – I’ve always flashed the wilderness.’

Cat’s flashing photos are taken by her boyfriend Isaac, who saved her life by finding a lump in her breast and urging her to get checked.

‘We met a couple of months before I was diagnosed,’ says Cat ‘We were at a brewery and our dogs got tangled up. It’s like a Hollywood movie.

‘That was a month before I was diagnosed with breast cancer. We weren’t together very long and he found my breast cancer.’

At the end of 2019, Cat was given the all-clear and told she was finally in remission after a challenging 18 months of juggling being a mum to her little girl Addie, five, and going through treatment for cancer.

Now she uses her following to teach women of all ages that they’re ‘not dead after a breast cancer diagnosis’.

Cat said: ‘Now I have no evidence of disease. I was given the all-clear around October 2019.

‘On January 1 [2019], I had my exchange surgery where they exchange the expanders [that stretch remaining breast tissue and skin] and put in the implants.

‘Then I had a fat transfer surgery from my stomach to the top of my breasts to make them fuller [in May 2019].

‘It’s really common not to reconstruct the nipple. There’s advocacy for surgeons paying more attention and doing nipple reconstruction.

‘It was definitely something I struggled with but flashing the wilderness is a way for me to process it as well.’

Cat says she’s received messages from women all around the world who have been inspired to do their own topless photos to embrace their bodies.

And as well as inspiring others, the mountain-top adventures has helped Cat, too.

‘Sometimes I feel like I’m not a full woman because I don’t have nipples,’ the mum says. ‘It’s a way for me to build confidence too.

‘I hike a lot so it’s really freeing to feel like I did it [each time]. I’m free and open and it’s a much more positive way to look at my boobs, as opposed to most of the other pictures that are posted.

‘I try to post pictures that are really positive associations with breast cancer and how we look afterwards. It reminds people to check their breasts.

‘That’s why I do the wilderness posts too. I’ve always hiked and I can show people that you can conquer anything after a breast cancer diagnosis, you can still feel alive.

‘It’s not just women over 50 who suffered with this awful disease. I know so many women that are my age or younger that have it – hundreds of women.

‘We can empower each other through these pictures and stories, and letting people know breast cancer doesn’t look like what it used to in the past.

‘I have loads of comments from people who say how important it is for them to see this.’

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WHO says food safe from coronavirus

The World Health Organization (WHO) on Thursday urged people not to fear catching the novel coronavirus from food, after Chinese testers found traces on food and food packaging.

The virus was found Tuesday in the Chinese city of Shenzhen during a routine check on samples of frozen chicken wings imported from Brazil, city authorities said.

The authorities said they immediately screened people who had been in contact with the contaminated products, plus their relatives, and all the tests came back negative.

In China’s eastern Anhui province, the mayor of Wuhu announced Thursday that the virus had been discovered on the packaging of shrimp imported from Ecuador, which had been kept in a restaurant freezer.

The WHO said there was no need to panic—and there were no examples of the respiratory disease being transmitted through food.

“People are already scared enough and fearful enough in the COVID pandemic,” WHO emergencies director Michael Ryan told a virtual press conference in Geneva.

“People should not fear food or food packaging or the processing or delivery of food.

“There is no evidence that food or the food chain is participating in the transmission of this virus.

“Our food, from a COVID perspective, is safe.”

Maria Van Kerkhove, the WHO’s COVID-19 technical lead, said the United Nations health agency was aware of the reports and understood that China was looking for the virus on food packaging.

“They’ve tested a few hundred thousand samples of looking at packaging and have found very, very few, less than 10 positive in doing that,” she said.

“We know that the virus can remain on surfaces for some time.

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Easy to overdose on paracetamol if you’re selenium deficient, says research

A lack of the mineral selenium in the diet puts people at risk of paracetamol overdose, even when the painkiller is taken at levels claimed to be safe on the packaging, according to collaborative research emerging from the University of Bath and Southwest University in China.

Paracetamol (also called Tylenol) is best known for relieving mild pain and fever, and is a leading cause of liver failure when taken at dangerous levels. For adults, the recommended maximum daily dosage is 4g (amounting to two 500mg tablets taken four times). However, the team from Bath and Chongqing has found that the micronutrient selenium affects the speed at which the painkiller is flushed from the body. As a result, taking 4g of the medication in a given day can be dangerous for people with low levels of selenium in their bodies.

“People with a selenium deficiency can struggle to eliminate the drug fast enough to keep their livers healthy,” explained Dr. Charareh Pourzand who led the collaborative research from the University of Bath’s Department of Pharmacy and Pharmacology. “They can overdose even when they follow dosage guidelines.”

A huge amount of Paracetamol is consumed around the world, with an average person in the UK popping 70 tablets (or 35 grams) every year. Dr. Pourzand said: “For most people, paracetamol is safe up to the stated dose. But if you are frail, malnourished or elderly, your levels of selenium are likely to be somewhat depleted, and for these people I think it’s a bad idea to take paracetamol at the maximum level currently considered safe.”

It is thought that insufficient selenium intake affects up to 1 billion people worldwide—or one in seven of the globe’s population. It may be tempting to boost selenium levels through supplements, but based on the results of this study, Dr. Pourzand advises against this course of action, as an excess of the micronutrient can be just as dangerous to the body as a deficiency.

“There is a rather limited dose range for the beneficial effects of selenium,” she said. “Both mild selenium deprivation in the body and excess supplementation increase the severity of liver injury after you’ve taken paracetamol.”

She added: “This study shows that the link between selenium status in the diet and paracetamol toxicity is very important. I hope people pay attention to these findings, given everyone has paracetamol in their home. And now with people falling ill with COVID-19, paracetamol is being taken more than ever.”

Selenium helps maintain a healthy redox balance in the body within antioxidant enzymes called selenoproteins (selenium-containing proteins). Redox balance describes the mechanism by which each cell maintains a subtle balance between antioxidant and pro-oxidant levels (where some atoms gain electrons and others lose them, becoming free radicals). When the body’s selenium levels fall out of the beneficial range, antioxidant enzyme activities are decreased and too many free radicals are formed in liver—the main organ where paracetamol is metabolized. This results in damage both to an individual’s DNA and to their proteins.

Dr. Pourzand emphasizes the importance of a good diet in keeping selenium levels within the recommended range. “A healthy, balanced diet is especially important if you take paracetamol on a regular basis, for instance for chronic pain,” she said.

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Here's What It Really Means When a Narcissist Says 'I'm Sorry'

Clinical psychologist and therapist Dr. Ramani Durvasula makes videos educating people about how to best spot harmful toxic behavior in others, and what to do to protect yourself and limit the damage that can be wrought when you have a narcissist in your life. Having previously explained why it’s not wise to call out a narcissist, Durvasula’s most recent post explores how to respond if a narcissist actually apologizes for the way they have acted.

“The idea that their apology means they understand what they did, and they’re going to change their behavior, it isn’t true,” she says, “and if you hold that belief, it’s likely that you’re going to be very disappointed.”

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“An apology, done correctly, is taking responsibility; addressing the other person’s feelings, striving for reconciliation, and committing to learning from it,” she continues. “Unfortunately, that’s not what a narcissistic apology is. A narcissistic apology is sort of a way of keeping the trains running on time, of getting off the hook for something, of getting back to the way they want things to be.”

A narcissist doesn’t actually care that they hurt somebody else, and often, Durvasula points out, an apology only comes after a lengthy argument where they believe the person they hurt may take away their “supply.” And in each instance, the narcissist does not learn from the experience or adapt their behavior, and the cycle continues.

It’s pretty easy to identify a narcissist’s apology, simply because they won’t take responsibility for what they did. We’ve all heard that particular kind of non-apology, when somebody sounds like they’re apologizing but really they’re talking around their own accountability by saying things like “I’m sorry you feel that way.”

“In all of these apologies, what you see is that they are not apologizing for something they did or said,” says Durvasula. “They are in essence, though, using the apology as a way of gaslighting you and invalidating your experience: ‘I’m sorry you feel that way,’ meaning ‘you probably shouldn’t.'”

A healthy apology, Durvasula explains, involves acknowledging and owning the original action, not just the reaction. There’s a huge difference between saying “I’m sorry you’re hurt” and “I’m sorry I hurt you, I’ll try to do better.” Durvasula’s three hallmarks of a healthy apology are responsibility, acknowledgment, and commitment.

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