More than 100 Americans have died after taking hydroxychloroquine for COVID-19

More than 100 Americans have died after taking hydroxychloroquine in a misguided effort to treat or prevent coronavirus so far this year, a new report reveals.

In the first six months of 293 people died after taking hydroxychloroquine, according to the Milwaukee Journal Sentinel’s review of the Food and Drug Administration’s (FDA) adverse events reporting system. 

That’s compared to just 75 in the first half of 2019. 

Much like public health experts use the number of ‘excess’ deaths to estimate how many people died of coronavirus but have not yet been counted, the Sentinel looked at data on those other 218 deaths. 

The reason ‘more than half’ of those people had been taking hydroxychloroquine or chloroquine was COVID-19. 

It comes after the overwhelming majority of big, credible studies on using the malaria drug to treat coronavirus showed – despite Trump’s repeated optimism over it – that it offered no benefit to people with the viral infection. 

More than 100 people died after taking hydroxychloroquine to treat COVID-19, an analysis of adverse event data from the FDA reveals

Some of those studies were even stopped short due to concerns over its potential to cause fatal heart arrhythmias, or after the group given the drug began dying at higher rates than those given just supportive care. 

When early studies suggested that hydroxychloroquine might have antiviral effects and improve recovery and survival odds for infected people, President Trump raved that it was safe – a conclusion he drew based on the fact that the drug is FDA-approved. 

‘What do you have to lose?’ Trump asked as he encouraged the us of hydroxychloroquine to treat coronavirus. 

The drug is indeed approved by the regulatory body to treat the mosquito-borne disease malaria and autoimmune diseases like lupus and rheumatoid arthritis. 

To get that seal of approval, it did go through rigorous safety testing, but it also comes with a warning that it can cause heart arrhythmias that might be virtually unnoticeable in some, but lead to severe heart dysfunction and even death in others.  

People with heart disease are also at greater risk of getting severely ill from or dying of COVID-19.  

President Trump has urged people to try hydroxychloroquine to treat coronavirus, asking 'what do you have to lose' (file)

President Trump has urged people to try hydroxychloroquine to treat coronavirus, asking ‘what do you have to lose’ (file) 

On Sunday, Admiral Brett Giroir said on Meet the Press that he 'can't recommend' taking hydroxychloroquine for coronavirus treatment or prevention

On Sunday, Admiral Brett Giroir said on Meet the Press that he ‘can’t recommend’ taking hydroxychloroquine for coronavirus treatment or prevention 

Doctors may not prescribe hydroxychloroquine, even for its approved uses, to people with pre-existing heart conditions. 

But after Trump’s endorsement, doctors began prescribing it left and right. The number of hydroxychloroquine prescriptions filled in one week in March was more than 2,000 percent higher than fills for the same drug a year prior. 

As more studies warned of the alarming arrhythmias seen in trial participants treated with the drug and suspiciously high death rates, the FDA issued a warning that the drug should only be used to experimentally treat COVID-19 under the close supervision of a doctor. 

By June, the agency revoked its emergency use authorization for hydroxychloroquine to treat coronavirus altogether. 

But it may not have been enough to stop the drug from being used inappropriately, and with potentially deadly consequences. 

Between January and June of 2020, there were 6,588 adverse events related to the drug reported to the FDA, and 6,223 of them ‘serious’ meaning they could left the epson hospitalized, disabled or dead. 

That was about twice as many total adverse events as were reported in conjunction with the drug in 2019, and nearly three times as many ‘serious’ adverse events. 

In recent weeks, three of the most prominent members of Trump’s own task force – Dr Deborah Birx, Dr Anthony Fauci and Admiral Brett Giroir – have warned against the use of hydroxychloroquine to treat coronavirus. 

But the drug needs to remain on the market. It’s an important preventive and treatment for malaria, and the only drug that brings relief for some lupus patients. 

So long as it is approved for these uses, doctors can prescribe hydroxychloroquine to people with COVID-19, however inadvisable that may be.

If patients continue to be given the unproven drug to treat coronavirus, an excess of dangerous side effects or deaths linked to it seems doomed to persist, so it will be in the hands of providers to protect their patients. 

New Hampshire woman, 52, becomes first American to get a SECOND face transplant

For the second time in a decade, a New Hampshire woman has a new face.   

Carmen Blandin Tarleton’s face was left disfigured after she was attacked by her estranged husband with a baseball bat and doused with lye in 2007.  

Six years ago, she received a face transplant at Brigham and Women’s Hospital in Boston, but, in 2019, doctors discovered tissue damage.

Luckily, surgeons were able to find a new donor and she received the transplant in July, the first American and second person globally to have the procedure done a second time. 

The 52-year-old former nurse is expected to resume her normal routine, which all but ended when the first transplant failed.  

‘I’m elated,’ Tarleton told The Associated Press, in an exclusive telephone interview from her home in Manchester. 

She is still healing from the operation so photos are not being made available of her new face.

‘The pain I had is gone,’ she said. ‘It’s a new chapter in my life. I’ve been waiting for almost a year. I’m really happy. It’s what I needed. I got a great match.’

Carmen Tarleton, 52, has become the first American and second person globally to undergo a second face transplant. Pictured: Tarleton speaks at Brigham and Women’s Hospital in Boston following a face transplant, 2013

Tarelton needed to undergo a second transplant and the donor skin she initially receivd six years ago started to fail. Pictured: Drs Kamen V. Vlassalov (front) and Lindsay Wahl lead Tarleton to the operating room for her second face transplant, July 2020

Tarelton needed to undergo a second transplant and the donor skin she initially receivd six years ago started to fail. Pictured: Drs Kamen V. Vlassalov (front) and Lindsay Wahl lead Tarleton to the operating room for her second face transplant, July 2020

In 2007, Tarleton's estranged husband broke into her home and began beating her with a baseball bat. Pictured: Tarleton before the attack, undated

fterwards, he sprayed lye, a detergent that can leave chemical burns. all over her face and body. Pictured: Tarleton before the attack, undated

In 2007, Tarleton’s estranged husband broke into her home and began beating her with a baseball bat. Afterwards, he sprayed lye, a detergent that can leave chemical burns. all over her face and body. Pictured, left and right: Tarleton before the attack, undated

More than 40 patients worldwide have received face transplants, including 16 in the US. None of the American patients had lost their donor faces until Tarleton.

But in January 2018, a French man, Jerome Hamon, whose immune system rejected his donor face eight years after his first transplant underwent a second surgery.

The surgeon who performed the transplant, Dr Laurent Lantieri of Georges-Pompidou European Hospital in Paris, said Harmon is ‘doing very well.’

Dr Bohdan Pomahac, who did Tarleton’s first face transplant, was hesitant to perform another and favored doing reconstruction surgery instead. 

But his team became convinced of the merits of a second transplant after Tarleton described how much the first one improved her life.

‘She really wanted to try one more time,’ said Pomahac, who led the 20-hour, second operation. 

A team of around 45 clinicians removed the failing transplant and then prepared sensory nerves and blood vessels in the neck for the surgical connection. 

The face was then transplanted, and Tarleton will gain sensory and motor function in the coming months.

Unlike her first transplant, the donor this time around was considered a much better tissue match. 

Because of her previous injuries before the first transplant, 98 percent of donors were incompatible matches. 

Even then, the first face led to several cases of acute rejection, in which the body attacks the new face and strong drugs are needed to suppress the immune system.

‘Now, I am very optimistic and hopeful that it will last a lot longer than the first transplant,’ said Pomahac, who has described the match as miraculous. 

‘But, of course, that is wishful thinking, speculation. I don’t know. She really got lucky.’ 

The first transplant transformed Tarleton's life, helping her get off strong medication for her pain and begin traveling. Pictured: Tarleton on 'This Morning' in London, January 2014

The first transplant transformed Tarleton’s life, helping her get off strong medication for her pain and begin traveling. Pictured: Tarleton on ‘This Morning’ in London, January 2014

Last year, the face began to fail and Tarleton (left and right_experienced scarring, tightness and pain because of a loss of blood flow to her face. Pictured; Tarleton after the attack

Black patches appeared on her face, her eyelids contracted and her lips began disappearing. Pictured; Tarleton after the attack

Last year, the face began to fail and Tarleton (left and right_experienced scarring, tightness and pain because of a loss of blood flow to her face. Black patches appeared on her face, her eyelids contracted and her lips began disappearing.

Brian Gastman, a plastic surgeon at the Cleveland Clinic who led its last two face transplants, said Tarleton’s case illustrates the limitations of these procedures.

‘When you look at most organ transplants, there is a shelf life,’ Gastman, who was not involved in Tarleton’s surgery, said. 

‘We are getting to the point where these face transplantations are hitting against the maximum number of years someone can have one in.’

Tarleton was burned on over 80 percent of her body and blinded in 2007 when her estranged husband, Herbert Rodgers, beat her with a baseball bat and doused her body with lye, a detergent that can burn the skin because he thought she was seeing another man. 

In 2009, Rodgers pleaded guilty to maiming his wife in exchange for a prison sentence of at least 30 years. He died while serving in 2017.

The first transplant transformed Tarleton’s life. She was able to wean herself off strong medications for her pain, took up the piano and banjo, and began walking five miles a week.

She has been able to travel and give inspirational speeches, often speaking of how she had forgiven Rodgers.   

Tarleton also became close friends with the daughter of her first donor, a 56-year-old woman who died of a stroke. She also got a synthetic cornea in her left eye.

But, by last year, the face was failing. She began experiencing scarring, tightness and pain because of a loss of blood flow to her face. 

Black patches appeared on her face, her eyelids contracted and her lips began disappearing, making it difficult to eat. She was mostly housebound and resumed taking strong pain medications.

‘I couldn’t do anything,’ Tarleton said. ‘I was pretty much in pain.’

In 2009, Tarleton's estranged husband, Herbert Rodgers (pictured), pleaded guilty to maiming her in exchange for a prison sentence of at least 30 years. He died in prison in 2017

In 2009, Tarleton’s estranged husband, Herbert Rodgers (pictured), pleaded guilty to maiming her in exchange for a prison sentence of at least 30 years. He died in prison in 2017

Tarleton is currently recovering at home and the donor this time is considered a much better tissue match. Pictured: Dr Bodhan Pomahac (at podium) with his surgical team, speaks to reporters regarding the face transplant of Tarleton (pictured left) in February 2013

Tarleton is currently recovering at home and the donor this time is considered a much better tissue match. Pictured: Dr Bodhan Pomahac (at podium) with his surgical team, speaks to reporters regarding the face transplant of Tarleton (pictured left) in February 2013

She also became close friends with Marinda Righter, the daughter of her first donor, Cheryl Denelli-Righter, a 56-year-old woman who died of a stroke. Pictured: Righter holds up a photo of her mother a press conference, May 2013

She also became close friends with Marinda Righter, the daughter of her first donor, Cheryl Denelli-Righter, a 56-year-old woman who died of a stroke. Pictured: Righter holds up a photo of her mother a press conference, May 2013

Face transplant patients are even at greater risk for rejection than recipients of solid organs because the skin is very immunogenic, meaning it is likely to elicit an immune response. 

According to NYU Langone Magazine, of the roughly 40 transplants performed around the world, only two have yet to experience a rejection episode.

Tarleton requested in October to be put the hospital’s list for a second face. 

That process took much longer, in part, because she was taken off the list for two months because of the coronavirus pandemic. She was added back on when the state allowed elective surgeries to resume.

Now that she has her new face, Tarleton is hoping to once again travel and give inspirational speeches – those will be on Zoom until there is a coronavirus vaccine. 

For now, she is still getting used to her new appearance.

‘This face looks very different than my first one and I can appreciate that. It’s a different person,’ she said, adding the new face allows her to ‘fit in a little better, don’t get stared at so easily.’

‘It is strange. I am not going to lie,’ she added.

‘I’ll have to get used to it. My sister will have to get used to it. It takes a while for my friends and family to get used to what I look like now.’

‘I was not a typical battered wife’: Mother-of-two who had two face transplants after her estranged husband doused her in detergent says she’s forgiven her attacker 

Carmen Tarleton, 52, says she has forgiven her estranged husband and is moving on with her life after she had to have two  face transplants following the horrific attack.

Tarleton was doused in lye by Herbert Rodgers in 2007 and battered with a baseball bat after the thought she was seen another man

The mother-of-two said that the decision to forgive her former husband, ‘left me with room to grow, to move on with my life and free to meet someone and trust them.’

She suffered chemical burns over 80 percent of her body, and she was left completely disfigured and blind.

Tarleton and Rodgers married in 2001 and she said the marriage had been a happy one.

‘We didn’t have a lot of complicated issues,’ she said. ‘I was not a typical battered wife and he had never been abusive to me before. So it was more than shocking when it happened.’

It was when the couple moved from Los Angeles to Tarleton’s native Vermont that the problems started.

‘[Rodgers] did start to unravel the year we moved back,’ she said. ‘I knew he was struggling but I didn’t know what to do or how to help him.’ 

The couple, who had two daughters, separated but remained good friends. However, a few days after an argument about the sale of their house, Tarleton woke up at 2.30am to find someone in her home. 

She thought it was a burglar, but soon realized it was Rodgers. 

He pushed her down on the bed and started beating her with a baseball bat so viciously that she could hear her bones being broken. 

Before blacking out, she called out to her daughters, then ages 12 and 14, to lock themselves in the bathroom and phone the police.

It was then that Rodgers produced a bottle of industrial-strength cleaning fluid which he had brought with him, and sprayed her face and body. He then waited for the police to arrive and was arrested at the scene. 

Tarleton was in a coma for three months after the attack and lost the sight in both eyes, although the sight in one has now returned. 

In February 2009, Rodgers was sentenced to a maximum of 70 years in prison, 30 of them without parole, for the attack.

He died while serving his sentence in 2017. 

 

Pfizer Inc signs multi-year deal to manufacture Gilead’s coronavirus antiviral remdesivir

Pfizer Inc signs multi-year deal to manufacture Gilead’s coronavirus antiviral remdesivir to boost production of the drug

  • Pfizer Inc has signed a multi-year deal with Gilead Sciences Inc to manufacture and supply the antiviral remdesivir 
  • The drug is the only one approved in the US to treat coronavirus patients by emergency use after it was shown to reduce the length of hospital stays 
  • The company will use its plant in McPherson, Kansas to produce the drug, but no other details are available
  • On Thurday, Gilead announced it had ramped up production of remdesivir 50-fold and promised 12.5 million doses by year-end

Pfizer Inc has signed a deal to manufacture remdesivir, the only drug approved for emergency use authorization in the US to treat severely ill coronavirus patients.

The New York-based pharmaceutical company says the multi-year agreement will help ramp up supply of the the antiviral, which has been shown to shorten recovery time.

‘From the beginning it was clear that no one company or innovation would be able to bring an end to the COVID-19 crisis,’ Pfizer CEO Albert Bourla told CNBC in a statement.  

‘Pfizer’s agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions. Together, we are more powerful than alone.’ 

Pfizer Inc has signed a multi-year deal with Gilead Sciences Inc to manufacture and supply the antiviral remdesivir (pictured)

The company (pictured) will use its plant in McPherson, Kansas to produce the drug, the only one approved in the US to treat severely ill coronavirus patients after it was shown to reduce the length of hospital stays

The company (pictured) will use its plant in McPherson, Kansas to produce the drug, the only one approved in the US to treat severely ill coronavirus patients after it was shown to reduce the length of hospital stays

According to CNBC, Pfizer will manufacture the drug at its plant in McPherson, Kansas.

Remdesivir was developed to treat Ebola, the deadly fever that emerged in West Africa in 2014.

While it was unsuccessful in treating Ebola, the drug appears to interfere with the ability of the coronavirus to copy its genetic material. 

In April, the National Institutes of Health released results from a study that found remdesivir helped patients recover 31 percent faster.

Patients being given the drug improved after 11 days, four days faster than those who didn’t receive the medication.    

However, remdesivir has not improved survival according to preliminary results after two weeks of follow-up. Results after four weeks are expected soon.

Several countries, including the US, have approved the use of the treatment in severely ill patients.

However, there are concerns over supply of the drug, particular after the Trump administration revealed it had bought most of the entire world supply of remdesivir.

To amend this issue, Gilead announced it has entered voluntary licensing agreements with nine generic manufacturers around the globe.

The company says this will expand supply of remdesivir to 127 countries, most low-income and lower-middle income countries, across three continents. 

On Thursday, it announced it has also ramped up production by 50 percent and expects to  produce more than two million treatment courses – equivalent to 12.5 million doses – by the end of the year.

The news of Pfizer’s deal also comes hours after Hikma Pharmaceuticals, in Britain, announced it has started manufacturing remdesivir for an undisclosed amount at its facility in Portugal.

The company will supply the first batches of the antiviral drug ‘soon,’ and Gilead is expected to distribute the treatment.

‘The terms of the deal are confidential, we are simply a contract manufacturer for Gilead – they order products from us as they expect the sales to be,’ CEO Siggi Olafsson told Reuters on Friday.

Koala Babycare Koala Hugs Nursing V Pillow Review Amazon

‘A must-have for mums-to-be’: Expecting mums are praising this KHugs maternity pillow for a better nights sleep and nursing

Pregnancy and the anticipation of a new addition to your family is exciting, but it can be an uncomfortable time for mums-to-be too.

Whether you’re having trouble sleeping or you’re after something to ease your back while you’re sitting on the sofa, according to Amazon shoppers and expecting mums, the Koala Babycare Koala Hugs Nursing V Pillow is the perfect solution.

Not only does the KHugs maternity pillow help reduce pain, make you more comfortable, and ultimately allow you to get a better night’s sleep, it can be used as a bumper or cot reducer and nursing pillow too.

Thanks to the practical laces you can safely tie the pillow to the sides of the bed, making your baby feel pampered and safe

Now on sale with 35 per cent off, the multi-functional Koala Babycare Koala Hugs Nursing V Pillow is a must-have for mums-to-be 

The highly-rated V pregnancy pillow (also known as maternity pillow or body pillow) has received a near-perfect star rating of 4.7 out of 5 from over 2,200 reviews. In fact, 80 per cent of shoppers awarded the pillow a full five stars.

A lot of the glowing reviews highlight the pillow’s positive effects on the user’s aches and pains. And unlike other inexpensive options, mums-to-be praise the pillow for the support it provides to the hips, back, neck and head. Plus, now with 35 per cent off, it’s a cheap and cheerful option costing just £20.70.

‘What’s an absolute dream this pillow is!’ wrote one Amazon shopper in their review. ‘It comes vacuum packed, and initially, I wasn’t sure on how much it would fill out, but it’s lovely and firm (but still soft enough to be comfortable).

The length of it means you can really get it into a position to relieve any aches and pains (mostly hip pain for me) and it still supports your bump beautifully. I can’t wait to use it for all of its other uses once baby is here!.’

Another delighted shopper raved: ‘I was feeling extremely uncomfortable by the time I was six months pregnant and literally tried about five pregnancy pillows before finding the perfect one.

Others were just too big and took up the who bed much to my partner dismay, and we both had sleepless less nights because of lack of room or being too hot. And this is before the baby’s arrival!.’

The Amazon bestseller can be used as a breastfeeding pillow: this practice is very useful because in addition to being comfortable it is a strong ally against positional plagiocephaly

The Amazon bestseller can be used as a breastfeeding pillow: this practice is very useful because in addition to being comfortable it is a strong ally against positional plagiocephaly

‘Finally, a perfect product! Great nights sleep, perfect size and works great when breastfeeding, and once your baby can sit up, you can use the pillow to pop them in the middle. ‘

‘A must-have for mums-to-be,’ commented another shopper. ‘So happy that I purchased this item. After a few nights using this pillow, the hip pain I have been getting for months at night has eased to almost none. I have much more comfortable nights now. Would definitely recommend to other pregnant ladies.’

The KHugs pregnancy pillow’s design means it can cover the needs of pregnancy and the first months of life of your child. It can be used as a nursing pillow by feeding your baby while resting or as a bumper or cot reducer to make your baby will feel in a safer and more comfortable.

The polka dot pillow is available in six colourways and the brands KHugs Plus design, which costs £40.95, comes with a comfortable, removable mini-pillow, that can be used in different positions to ensure maximum comfort for you and your back.

MailOnline may earn commission on sales from the links on this page.

How your diet could be affecting your hair and scalp

Is there a dandruff diet? Top trichologist Stephanie Sey explains how what you eat could affect your hair and scalp

A dry, itchy scalp can be frustrating, and the dandruff flakes that come with it can leave you feeling embarrassed.

However, keeping your scalp healthy needn’t be a hard task according to top trichologist Stephanie Sey. She explains that your diet is hugely important to the health of your hair and it plays a part in the most common hair and scalp problems.

‘A balanced diet, comprising of carbohydrates, healthy fats, proteins, fibre, vitamins and minerals is the best thing for the hair, Stephanie says. 

Top trichologist Stephanie Sey explains that your diet is hugely important to the health of your hair and it plays a part in the most common hair and scalp problems

‘Eating a diet that is rich in fresh vegetables, meat, and fruit supports healthy growth for thick, full hair.’

She adds: ‘Processed foods like fast food and ready meals are typically high in sugar, salt and unhealthy fats as well as chemical additives. These foods typically have very little in the way of the nutrients that our body needs to stay healthy, such as vitamins, minerals and antioxidants.

‘The hair is the very last systems in your body to receive nutrients (as it is one of the least essential), so if your body is not receiving adequate nutrients, your hair will likely be affected.’

To ensure you’re not missing out on vital nutrients and minerals, Stephanie recommends ensuring your diet includes foods such as protein (hair is made of protein) to make your locks strong and promote growth, as well as fish to provide healthy omega-3 fatty acids, which are important for sebum production to keep your hair and scalp moisturised.

While a good diet is useful for healthy hair and scalp, a good shampoo is also essential. 

Stephanie’s Scalp Food Dos and Don’ts 

EAT

  • Green leafy vegetables
  •  Legumes such as beans
  • Healthy Fats – like avocado, and oily fish
  • Water
  • Proteins – fish, meat, eggs 

AVOID 

  • Fast food
  • Sweets
  • Chocolate
  • Biscuits
  • Fizzy drinks 

If you’re looking to score a healthier head of hair, you may want to introduce a shampoo into your routine that treats the root cause as opposed to just the symptoms.

Nizoral Anti-Dandruff Shampoo is no stranger to scalp health and preventing dandruff. The brand is a tried-and-true solution for thousands of Amazon shoppers, who have awarded the affordable shampoo an average star rating of 4.5 out of 5 from over 4,300 reviews. 

Shoppers say the £5 shampoo relieves the symptoms of dandruff and soothes a red and itchy scalp without stripping your hair.

‘This stuff is absolutely amazing,’ writes one Amazon shopper in their review. ‘I had dandruff for years also dry skin on [my] face at times. This completely cleared it up in one week. A big thumbs up. I can’t recommend this stuff enough.’

The medicated formula, which contains 2 per cent ketoconazole; a powerful anti-fungal ingredient, is a big hit as it gets to work fast, helping treat the underlying cause of the condition and restoring the scalp to its normal healthy state.

Stepahine says: ‘Ketoconazole is an anti-fungal agent that stops the growth of the yeast malassezia.

‘Malassezia is a contributing factor to dandruff, so using Nizoral helps control and effectively treat the cause, as well as the symptoms.’

For best results, apply a small amount of the shampoo to your hand and massage into a lather, leave on the scalp for an optimum time of three to five minutes, then rinse thoroughly.

MailOnline may earn commission on sales from the links on this page. 

Gilead says it has ramped up production of remdesivir by 50-fold

Gilead Sciences Inc says it has ramped up production of its antiviral remdesivir and expects to produce millions of vials soon enough.

The California-based pharmaceutical company announced in a statement on Thursday that it has increased supply by more than 50-fold since January.

Officials say they expect to meet ‘real-time global demand’ beginning in October and anticipates producing more than two million treatment courses – equivalent to 12.5 million doses – by year-end. 

Remdesivir has been at the forefront of the battle against COVID-19, the disease caused by the virus, after the medicine was shown to shorten hospital recovery times in a clinical trial run by the National Institutes of Health (NIH).     

Gilead Sciences says it has ramped up production its antiviral, remdesivir, by 50-fold since January. Pictured: A laboratory technician holds a box of remdesivir at Eva Pharma Facility in Cairo, Egypt, June 25

More than two million treatment courses - equivalent to 12.5 million doses - are expected to be made available by the end of 2020. Pictured: Nurses Catrina Rugar (second from left), Hannah Woodward (second from right) and Veronica Gomez (right)  treat a coronavirus patient in Edinburg, Texas, July 20

More than two million treatment courses – equivalent to 12.5 million doses – are expected to be made available by the end of 2020. Pictured: Nurses Catrina Rugar (second from left), Hannah Woodward (second from right) and Veronica Gomez (right)  treat a coronavirus patient in Edinburg, Texas, July 20

Several countries, including the US, have approved the use of the treatment in severely ill patients.

However, there are concerns over supply of the drug, particular after the Trump administration revealed it had bought most of the entire world supply of remdesivir.

To amend this issue, Gilead announced it has entered voluntary licensing agreements with nine generic manufacturers around the globe.

The company says this will expand supply of remdesivir to 127 countries, most low-income and lower-middle income countries 

‘Gilead has completed technology transfers with these companies, and they are beginning the manufacturing process,’ the statement read.

Remdesivir was developed to treat Ebola, the deadly fever that emerged in West Africa in 2014.

While it was unsuccessful in treating Ebola, the drug appears to interfere with the ability of the coronavirus to copy its genetic material. 

In April, the NIH released results from a study that found remdesivir helped patients recover 31 percent faster.

Patients being given the drug improved after 11 days, four days faster than those who didn’t receive the medication.    

However, remdesivir has not improved survival according to preliminary results after two weeks of follow-up. Results after four weeks are expected soon.

It comes a little more than a month after Gilead announced it will charge different prices for different patients taking remdesivir.

For people covered by government healthcare in the US, the company will charge $390 per vial or $2,340 for a five-day course.

For US private insurance companies, the cost will be $520 per vial, or a total of $3,120 per patient.

The amount that patients pay out of pocket depends on insurance, income and other factors, Gilead said. 

‘We’re in uncharted territory with pricing a new medicine, a novel medicine, in a pandemic,’ chief executive, Daniel O’Day, told The Associated Press.

‘We believe that we had to really deviate from the normal circumstances’ and price the drug to ensure wide access rather than based solely on value to patients, he said.

 

 

 

ince January, Gilead has taken multiple steps to ramp up production and rapidly build supply of our investigational COVID-19 treatment Veklury® (remdesivir), preparing for potential global demand at risk, in recognition of the lengthy manufacturing timeline. In addition to process improvements that have shortened the manufacturing timeline to six months, Gilead has expanded its global network of both internal manufacturing sites and external organizations, including partnering with industry peers, to add manufacturing capacity around the world. Our Veklury manufacturing network now includes more than 40 companies in North America, Europe and Asia.

By working together in a coordinated fashion, this network of partners is supporting us to meet global patient needs. We have increased supply more than 50-fold since January and anticipate being able to meet real-time global demand starting in October. We plan to produce more than two million treatment courses by the end of the year, and we anticipate producing several million more in 2021, if needed.

‘Physical stress’ at work linked to signs of brain aging and memory loss

Scientists have linked on-the-job stress to brain aging and memory loss for the first time, according to new research from Colorado State University. 

Their findings pertain to a very specific kind of stress. Through surveys about people’s most recent jobs, memory tests and scans of their brains they found brain changes and recall problems in people who found their jobs physically stressful. 

But, interestingly, the people who reported ‘physical stress’ at work did not necessarily have labor-intensive jobs.  

Yet mental stress at work was not associated with loss of volume in the hippocampus – a part of the brain critical to memory – or difficulty completing memory-based tasks. 

The researchers aren’t yet sure exactly why the perception of physical stress might lead to faster brain-aging, but their work could shed light on ‘the darker side of physical activity,’ lead study author Dr Aga Burzynska told DailyMail.com. 

Stress is well known to be destructive to the mind, but most research on its effects pertains to chronic stress, such as worry over finances, health issues, abusive relationships, or racism – not a person’s occupation. 

Brain scans revealed that people who said they felt ‘physically stressed’ at work had less volume in their hippocampus (highlighted), a region of the brain crucial to memory 

Scientists at Colorado State University (CSU) compared the size of a part of the brain largely responsible for memory, called the hippocampus, in older people with various occupations. 

The brain scans that they took showed that those whose most recent jobs had been physically stressful had smaller hippocampuses than those who reported mental stress at work. 

And those same physically stressed people struggled more with tasks that required them to recall information. 

Although the study subjects were cognitively healthy at the time of the research, the changes to the brains and recall abilities could be concerning signs that they will face faster declines earlier on compared to others.

The CSU researchers asked 99 people between ages 60 and 79 about their most recent jobs. 

Participants were quizzed on what their occupation was, their titles in those professions, how many years of education they’d had, their household incomes , the types of tasks they were required to do and they sorts of stress that they experienced on the job. 

That data was compared to MRI scans of participants’ brains and their performance on memory tasks. 

During the screening process for the study, none of the participants showed obvious signs of cognitive issues, had suffered any mental or neurological illnesses and had never (to their knowledge) had strokes.  

So in terms of brain structure, it could be expected that their brains would be somewhat similar. 

But both the scans and the memory tasks showed a marked difference in the minds of those who felt that their jobs were physically stressful. 

To be clear: these were not physical laborers. In fact, when asked to categorize the type of work they did, only one of the study participants would be considered a physical laborer. 

Most of the study subjects, who were recruited from a university town were well-educated, had relatively high incomes and were primarily ‘officials’ or managers. 

Lead study author Dr Aga Burzynska (pictured) says her findings don't implicate problems from physical activity - which is linked better brain health - but raise questions about how the perception of physical effort at a job might alter its effects on our brains

Lead study author Dr Aga Burzynska (pictured) says her findings don’t implicate problems from physical activity – which is linked better brain health – but raise questions about how the perception of physical effort at a job might alter its effects on our brains 

So the physical demands of their work were more likely to be lifting things, walking or standing, or even the physical taxation of sitting at a desk all day. 

‘If people perceive their work that their work requires excessive reaching or effort -even if they have not a physical job worse,’ it may lead them to describe their job as physically stressful, explained Dr Burzynska. 

The results of her study, published in Frontiers in Human Neuroscience, run counterintuitive to the generally accepted benefits of exercise for brain health. 

In fact, they run counter to Dr Burzynska’s own work. Her previous research followed in the footsteps of other research and verified that aerobic exercise is good for the brain. 

The new study is ‘the first evidence that leisure health behavior, such as phys activity, and what we experience at work have competing associations with our [brain health],’ she says. 

‘We overlook the effects – if aerobic exercise helps your brain, we think that then every [kind of] physical work will help brain. 

‘Well, perhaps not. That activity may not be aerobic,’ or might for other reasons not offer the same benefits as exercise in leisure time. 

Her new study even accounted for that and, once again, exercise in downtime was not linked to memory trouble or accelerated brain aging, as measured by shrinkage in the hippocampus. 

‘If you perceive that you have physical demand, it may be that that’s not good for the brain,’ said Dr Burzynska. 

‘Or maybe you perceive physical effort as unwelcome, if not objectively hard – that may reflect lifestyle or health views that we just didn’t capture. 

‘We have to dig deeper into what it means. Knowing how long we are staying in the workforce’ – about 40 years – ‘I think it’s very important to understand this.’ 

Gilead says it has ramped up production of remdesivir by 50-fold

Gilead Sciences Inc says it has ramped up production of its antiviral remdesivir and expects to produce millions of vials soon enough.

The California-based pharmaceutical company announced in a statement on Thursday that it has increased supply by more than 50-fold since January.

Officials say they expect to meet ‘real-time global demand’ beginning in October and anticipates producing more than two million treatment courses – equivalent to 12.5 million doses – by year-end. 

Remdesivir has been at the forefront of the battle against COVID-19, the disease caused by the virus, after the medicine was shown to shorten hospital recovery times in a clinical trial run by the National Institutes of Health (NIH).     

Gilead Sciences says it has ramped up production its antiviral, remdesivir, by 50-fold since January. Pictured: A laboratory technician holds a box of remdesivir at Eva Pharma Facility in Cairo, Egypt, June 25

More than two million treatment courses - equivalent to 12.5 million doses - are expected to be made available by the end of 2020. Pictured: Nurses Catrina Rugar (second from left), Hannah Woodward (second from right) and Veronica Gomez (right)  treat a coronavirus patient in Edinburg, Texas, July 20

More than two million treatment courses – equivalent to 12.5 million doses – are expected to be made available by the end of 2020. Pictured: Nurses Catrina Rugar (second from left), Hannah Woodward (second from right) and Veronica Gomez (right)  treat a coronavirus patient in Edinburg, Texas, July 20

Several countries, including the US, have approved the use of the treatment in severely ill patients.

However, there are concerns over supply of the drug, particular after the Trump administration revealed it had bought most of the entire world supply of remdesivir.

To amend this issue, Gilead announced it has entered voluntary licensing agreements with nine generic manufacturers around the globe.

The company says this will expand supply of remdesivir to 127 countries, most low-income and lower-middle income countries 

‘Gilead has completed technology transfers with these companies, and they are beginning the manufacturing process,’ the statement read.

Remdesivir was developed to treat Ebola, the deadly fever that emerged in West Africa in 2014.

While it was unsuccessful in treating Ebola, the drug appears to interfere with the ability of the coronavirus to copy its genetic material. 

In April, the NIH released results from a study that found remdesivir helped patients recover 31 percent faster.

Patients being given the drug improved after 11 days, four days faster than those who didn’t receive the medication.    

However, remdesivir has not improved survival according to preliminary results after two weeks of follow-up. Results after four weeks are expected soon.

It comes a little more than a month after Gilead announced it will charge different prices for different patients taking remdesivir.

For people covered by government healthcare in the US, the company will charge $390 per vial or $2,340 for a five-day course.

For US private insurance companies, the cost will be $520 per vial, or a total of $3,120 per patient.

The amount that patients pay out of pocket depends on insurance, income and other factors, Gilead said. 

‘We’re in uncharted territory with pricing a new medicine, a novel medicine, in a pandemic,’ chief executive, Daniel O’Day, told The Associated Press.

‘We believe that we had to really deviate from the normal circumstances’ and price the drug to ensure wide access rather than based solely on value to patients, he said.

 

 

 

ince January, Gilead has taken multiple steps to ramp up production and rapidly build supply of our investigational COVID-19 treatment Veklury® (remdesivir), preparing for potential global demand at risk, in recognition of the lengthy manufacturing timeline. In addition to process improvements that have shortened the manufacturing timeline to six months, Gilead has expanded its global network of both internal manufacturing sites and external organizations, including partnering with industry peers, to add manufacturing capacity around the world. Our Veklury manufacturing network now includes more than 40 companies in North America, Europe and Asia.

By working together in a coordinated fashion, this network of partners is supporting us to meet global patient needs. We have increased supply more than 50-fold since January and anticipate being able to meet real-time global demand starting in October. We plan to produce more than two million treatment courses by the end of the year, and we anticipate producing several million more in 2021, if needed.

Coronavirus: Vaccine may be less effective in obese adults

It’s already well-known that being overweight is a major risk factor for contracting the novel coronavirus.

But some health experts fear that when a vaccine finally becomes available, it may not protect obese Americans as well as the general population.. 

Previous studies have found that inoculations for influenza and hepatitis B have been less effective in obese adults, making them more prone to illness and severe complications such as organ failure and  death.

Researchers theorize a COVD-19 vaccine may result in similar circumstances, leaving one of the most at-risk populations vulnerable during the pandemic that has already sickened 4.8 million and killed more than 158,000 in the US.

Previous studies have found that vaccines for the fu and hepatitis B are less effective in obese adults than non-obese adults. Pictured: Brazilian pediatrician Monica Levi (right) receives an experimental coronavirus vaccine as part of a clinical trial in Sao Paulo, July 24

Some theorize this is because those who are obese have an impaired T-cell response, a type of immune system cell, to vaccines, and that obese people may not be as protected with a coronavirus vaccine. Pictured: A laboratory technician holds a dose of a COVID-19 vaccine candidate in Thailand, May 23

Some theorize this is because those who are obese have an impaired T-cell response, a type of immune system cell, to vaccines, and that obese people may not be as protected with a coronavirus vaccine. Pictured: A laboratory technician holds a dose of a COVID-19 vaccine candidate in Thailand, May 23

‘It is not a question of not working, it is more of a question of efficacy,’ Dr Chad Petit, an assistant professor in the department of biochemistry and molecular genetics at the University of Alabama at Birmingham, told DailyMail.com.

‘In other words, the vaccine [could work] but it [may not be] as effective.’

According to the Centers for Disease Control and Prevention, 42.4 percent of the US adult population is obese as are 18.5 percent of American children.

Obesity is known as a risk factor for several chronic health conditions including type 2 diabetes, stroke, heart attack and even certain types of cancer.

Experts have warned that the proportion of obese adults will only grow as younger generations do. 

This also means that it may take longer for severely overweight Americans to return to work or go about their day-to-day lives if they have weakened immune systems.   

Among those who are of a healthy weight, the immune system can cause inflammation when it calls on cells to fight bacteria, viruses and other pathogens, but it can also turn inflammation off. 

However, obesity increases the immune response, leading to excessive inflammation, which makes the body less able to fight off invaders.  

Poor immune responses from obese adults after being vaccinated has been seen in the past.

A May 2017 study found that antibody responses to the hepatitis B vaccine were significantly reduced in obese people compared to non-obese people. 

A second study from that year showed that obese adults who were vaccinated against the flu were less likely than non-obese adults to develop the flu or a flu-like illness.

‘While it is not certain, it is thought that this may be due to an impaired T-cell response to the vaccine,’ Petit said.

‘T-cells play a significant role in the adaptive immune response and are necessary for protection against influenza.’ 

Another hypothesis is that obesity-related chronic inflammation leads to reduced production of macrophages, specialized cells that destroy harmful organisms.

Dr William Schaffner, a professor of preventive medicine and infectious diseases at the Vanderbilt University Medical Center in Nashville, says for those who are obese, the vaccine needle size matters.

An immunization using a standard one-inch needle may provide a weaker effect for severely overweight people than a jab with a longer needle.

‘Physicians have to very mindful what needle-length to use so that, if you’re giving an intramuscular injection, it can actually reach the muscle,’ he told DailyMail.com.

He added that, despite the theories and fears, it is better and safer for obese people – and all Americans – to get vaccinated than to forego shots.  

‘The answer is a resounding: “Yes” with an exclamation mark,’ Schaffner said. 

‘We want to encourage everyone to get the flu shot. This winter, both Covid and flu will be active. The flu vaccine isn’t perfect, but we know it can prevent infection and. even if not, it will be milder.’ 

Petit agrees and says even if the vaccine doesn’t work very well, it’s better than nothing. 

‘Obese adults that received the influenza vaccine in that study were still protected, just not as well as non-obese individuals.’ he said.

‘In other words, less protection is definitely better than no protection.’

Coronavirus outbreak spread to 929 meat plant workers in five weeks

Meat plants in the US and abroad have been especially hard-hit by coronavirus – and an outbreak at one South Dakota facility spread like wildfire to more than 900 workers in just five weeks, a Centers for Disease Control and Prevention (CDC) report reveals. 

Dozens of meat and poultry processing plants across the US have overwhelmed by coronavirus, which is transmitted easily in confined spaces with a high density of people in them. 

The South Dakota plant’s outbreak quickly exploded from a first case diagnosed in March to 929 of its 3,635 employees by April 25. 

Two of those employees died of the disease that has ravaged the world. 

Yet, the processing plant did not begin to close down until April 12, by which point, 369 cases had already been confirmed, a fact that has the CDC urging similar facilities to take more aggressive action as soon as a first case is identified. 

An outbreak of coronavirus at a Souh Dakota meat plant exploded from one case confirmed in March to 929 employees and 210 contacts by late April, a CDC report reveals

The CDC report does not name the meat plant its report describes, but the details appear very similar to those of a Smithfield facility near Sioux Falls that was the biggest coronavirus hotspot in the US for a brief time in April. 

After the South Dakota Department of Health confirmed the first case of coronavirus at the plant on March 24, the meat plant did trace the person’s contacts there and tested them. 

By April 2, that process had led to the diagnosis of 19 cases of coronavirus. 

Following the identification of that considerable cluster, the facility stepped up its screening, testing anyone with coronavirus-like symptoms such as cough, fever or shortness of breath. 

Even that modestly increased effort in testing turned up a massive number of additional infections. 

As of April 11 – just two-and-a-half weeks after the first case was identified – 369 workers at the factory had coronavirus. 

Nealy 370 people at the plant had already been infected by the time it began its phased shut down on April 12, a CDC graph shows

Nealy 370 people at the plant had already been infected by the time it began its phased shut down on April 12, a CDC graph shows 

A dozen cases had been cause to test. Hundreds were cause for closing the facility down, which it began to do on April 12. 

But the closure was done in phases and much of the damage had likely been done. 

By the time the CDC finished its investigation of the factory – at the request of the state’s health department – 929 people had been infected. 

That represented more than a quarter of the meat processing plant’s total workforce. 

According to the CDC report, an average of 67 new cases were being identified a day at the peak of the outbreak at the facility. 

Unsurprisingly, the virus spread most quickly through three departments where employees could not maintain six feet of distance between them throughout their long workdays.  

The infection spread fastest in departments like 'cut' portion of the facility where employees work less than six feet apart from one another (file)

The infection spread fastest in departments like ‘cut’ portion of the facility where employees work less than six feet apart from one another (file) 

Nearly 40 employees and nine contractors had to be hospitalized. 

Two of the employees died. 

Infectious disease experts believe that people who are exposed over and over again to greater loads of coronavirus are more likely to get severely ill if they contract coronavirus. 

A meat plant, in that sense, is a perfect petri dish for infections, as it spreads to workers who return day after day to work shoulder-to-shoulder in the confines of the facility. 

In April, meat plants like the South Dakota one were considered the driving force of coronavirus hotspots across the US. 

The CDC report sheds light on how outbreaks spread beyond the walls of the factories themselves. 

Of the 2,403 contacts of the meat plant workers, 210 – about 10 percent – contracted coronavirus, too, illustrating how the single facility fueled the larger community’s outbreak. 

‘This large outbreak of COVID-19 among employees at a meat processing facility highlights the potential for rapid transmission of SARS-CoV-2 in these types of facilities,’ the CDC investigators wrote in their report. 

‘Factors that might have contributed to infection among employees at this facility include high employee density in work and common areas, prolonged close contact between employees over the course of a shift, and substantial SARS-CoV-2 transmission in the surrounding community.’