There are green shoots of hope says WHO chief

Tedros Adhanom Ghebreyesus WHO

The World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus in opening remarks at the media briefing on COVID-19 on June 17, 2020 informed:

The world has now recorded more than 8 million cases of COVID-19. In the first two months, 85,000 cases were reported. But in the past two months 6 million cases have been reported.

There have been more than 435,000 deaths and in the Americas, Africa and South Asia; cases are still rapidly rising.

The WHO chief said:

There are green shoots of hope, which show that together through global solidarity, humanity can overcome this pandemic.

We now have good examples of many countries that have shown how to effectively suppress the virus with a combination of testing, tracing, and quarantining patients and caring for those that get sick.

Lab capacity has been dramatically enhanced across the world to boost COVID-19 testing, which is critical for identifying where the virus is and informing government actions.

New mega hubs have been established that are now key to the distribution of personal protective equipment, which includes millions of masks, goggles, aprons and gloves; as well as other medical supplies.

Tech companies have developed applications that can assist with the critical task of contact tracing.

And there has been an enormous effort to accelerate the science around the pandemic.

Tedros Adhanom said:

Early on in the outbreak; on February 11, WHO convened a Research and Innovation Forum on COVID-19, where hundreds of researchers came together from across the world with the aim of quickly developing quality diagnostics, therapeutics and vaccines.

One of the key priorities identified was for the world to focus on accelerating research around treating patients with COVID-19.

Specifically, researchers agreed to investigate existing drugs with potential, including steroids.

WHO also developed a core protocol, which has been adapted and used by researchers around the world.

He mentioned a development:

On June 16, 2020, there was the welcome news of positive initial results from the RECOVERY trial in the United Kingdom.

Dexamethasone, a common steroid, has been shown to have a beneficial effect on those patients severely ill with COVID-19.

According to the early findings shared with WHO, for patients on oxygen alone the treatment was shown to reduce mortality by about one fifth.

And for patients requiring a ventilator, mortality was reduced by about one third.

However, dexamethasone was shown to not have a beneficial effect for those with milder disease, who did not need respiratory support.

This is very welcome news for those patients with severe illness, these drugs should only be used under close clinical supervision.

We need more therapeutics that can be used to tackle the virus, including those with milder symptoms.

He added:

WHO has now started to coordinate a meta-analysis pooling data from several clinical trials to increase our overall understanding of this intervention.

WHO will update our clinical guidance to reflect how and when dexamethasone should be used to treat COVID-19.

He thanked the UK government, the University of Oxford, and the many hospitals, researchers, patients and families who have contributed to this scientific breakthrough.

Tedros Adhanom said:

WHO will continue to work with all partners to develop other therapeutics and vaccines for COVID-19, including through the Access to COVID-19 Tools Accelerator.

He expressed the hope that over the coming weeks and months, there will be more treatments that improve patient outcomes and save lives.

He said:

While we are searching for COVID-19 treatments we must continue strong efforts to prevent as many infections as possible by finding, isolating, testing and caring for every case; and tracing and quarantining every contact.

COVID-19 is affecting the whole world but it’s important to remember that for the most vulnerable communities, this is just one of many threats they face.

Ensure essential health services

The WHO chief reminded to consistently stress the importance to continue ensuring essential health services, including routine vaccination and services for malaria, TB and HIV.

He mentioned the Neglected Tropical Diseases (NTD), a group of 20 diseases including elephantiasis, sleeping sickness, leprosy, trachoma and intestinal worms that collectively wreak havoc on the poorest and most marginalized communities.

These diseases disfigure, disable and can kill, and they strike hardest in places of poverty and in remote areas where access to quality health services is extremely limited.

A new roadmap

He said that WHO and partners have developed a new roadmap, which moves away from single disease programs to integrated approaches to the prevention, diagnosis and treatment of NTD, as part of an overall movement toward universal health coverage. The NTD roadmap for greater collaboration between governments, academia and all related parties.

WHO moves to update COVID-19 guidance after ‘great news’ in drug study

A Reuters report datelined June 17, 2020 said:

The WHO said it was moving to update its guidelines on treating people stricken with COVID-19 to reflect results of a clinical trial that showed a cheap, common steroid can help save critically ill patients.

Trial results announced on Tuesday by researchers in Britain showed dexamethasone, used since the 1960s to reduce inflammation in diseases such as arthritis, cut death rates by around a third among the most severely ill COVID-19 patients admitted to hospital.

Britain has increased the amount of dexamethasone it has in stock and on order to 240,000 doses, health minister Matt Hancock said.

But some doctors were cautious, citing possible side effects and asking to see more data.

The WHO’s clinical guidance for treating patients infected with the new coronavirus is aimed at doctors and other medical professionals and seeks to use the latest data to inform clinicians on how best to tackle all phases of the disease, from screening to discharge.

Although the dexamethasone study’s results are preliminary, the researchers behind the project said it suggests the drug should immediately become standard care in severely stricken patients.

For patients on ventilators, the treatment was shown to reduce mortality by about one third, and for patients requiring only oxygen, mortality was cut by about one fifth, according to preliminary findings shared with WHO.

The benefit was only seen in patients seriously ill with COVID-19 and was not observed in patients with milder disease.

The positive news comes as coronavirus infections accelerated in some places including the U.S. and as Beijing cancelled scores of flights to help contain a fresh outbreak in China’s capital.

South Korea’s top health official cautioned about the use of the drug for COVID-19 patients due to potential side effects.

“Some experts have warned of the drug not only reducing the inflammatory response in patients, but also the immune system and may trigger side effects,” said Jeong Eun-kyeong, head of Korea Centers for Disease Control and Prevention.

“We have been burned before, not just during the coronavirus pandemic but even pre-COVID, with exciting results that when we have access to the data are not as convincing,” said Dr. Kathryn Hibbert, director of the medical intensive care unit at Harvard’s Massachusetts General Hospital.

Another media report said:

Dexamethasone is currently on the U.S. Food and Drug Administration’s list of drugs in shortage. Still several suppliers including one of the largest – Germany’s Fresenius SE – say they have the drug on the hand.

Dexamethasone: A potential game-changer in coronavirus treatment?

Nial Wheate, Associate Professor and Program Director, Undergraduate Pharmacy, University of Sydney, wrote on June 18, 2020 in The Conversation:

First, we tried the antimalarial drug hydroxychloroquine. Then we tested the antiviral drug remdesivir. But new UK research gives the strongest indication yet we may have found a useful treatment for COVID-19.

This time it’s an old anti-inflammatory drug, dexamethasone, which has been described as cheap, old and boring.

Preliminary results from a clinical trial just released indicate the drug seems to reduce your chance of dying from COVID-19 if you are in hospital and need oxygen or a machine to help you breathe.

The results were significant enough for the UK to recommend its use for severe COVID-19.

What is dexamethasone?

Dexamethasone has been used since the late 1950s, so doctors are familiar with it. It is also inexpensive, with a packet of 30 tablets costing around A$22 (for general patients) under Australia’s Pharmaceutical Benefits Scheme.

So if it does work for COVID-19, this cheap and boring drug, already available in Australia with a prescription, would be easy to add to current treatments.

Dexamethasone belongs to a class of drugs known as corticosteroids and is used to treat a range of conditions related to inflammation. These include severe allergies, some types of nausea and vomiting, arthritis, swelling of the brain and spinal cord, severe asthma, and for breathing difficulties in newborn babies.

And it is dexamethasone’s application to those latter two respiratory conditions that prompted doctors to think it may also help patients severely affected by COVID-19.

What did the trial find?

The recently reported results come from the Randomised Evaluation of COVID-19 Therapy, or RECOVERY, trial.

The researchers put patients into one of three groups: those needing ventilation (a machine that helps them breath); those who just needed oxygen therapy; and those who needed no treatment to help them breathe.

Patients in each of those groups were given dexamethasone (6mg once a day, either as a tablet or via intravenous injection), for ten days. A fourth group (a control group) was not given the drug.

Dexamethasone was most useful for the ventilated patients; deaths for this group dropped by about one-third with drug treatment. In contrast, deaths only dropped by one-fifth for those patients who were only receiving oxygen therapy. There was no benefit to patients who could breathe normally.

The researchers calculated that giving dexamethasone to eight ventilated patients would prevent one from dying, on average. And giving it to around 25 patients needing oxygen alone would prevent one death.

How might dexamethasone work for COVID-19?

When a patient has severe COVID-19, their immune system ramps up to catch and control the virus in the lungs.

In doing this, their body produces more infection-fighting white blood cells. This results in inflammation and pressure on their lungs, making it very difficult for them to breath.

It’s therefore likely dexamethasone reduces this inflammation, and so reduces pressure on the lungs.

What are the downsides?

There are potential complications with using dexamethasone.

First, dexamethasone also suppresses the immune system when it reduces inflammation. So, it is not usually recommended for people who are sick, or could be sick, from other infections. So doctors will need to make sure patients have no other infections before they are prescribed the drug.

If the results of this trial are correct though, the drug does not appear to compromise the patient’s ability to fight COVID-19; it might just affect their ability to fight off other diseases.

Second, the drug is only useful for patients with difficulty breathing and needing some assistance either through ventilation in a hospital or from oxygen therapy.

There appears to be no benefit for patients who do not need help breathing. So we should not be giving it to everyone who tests positive to the virus.

Third, like all drugs, dexamethasone has side effects that need to be monitored. Serious, but rare ones include: severe stomach or intestinal pain, sudden changes with vision, fits, significant psychiatric or personality changes, severe dizziness, fainting, weakness and chest pain or irregular heartbeat, and swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing.

What happens next?

The results of the clinical trial are preliminary. So we need to wait for the full study data and scientific peer-review before we can make a definitive decision as to whether dexamethasone treatment is a worthwhile, and safe, addition to COVID-19 therapy in Australia.

But take the news with a grain of salt

A media report said:

Some health experts are warning the public to interpret the results with caution — especially in light of a recent scandal in which two prominent medical journals, the Lancet and the New England Journal of Medicine, had to retract high-profile studies on potential COVID-19 treatments due to suspect data.

“It will be great news if dexamethasone, a cheap steroid, really does cut deaths by 1/3 in ventilated patients with COVID-19, but after all the retractions and walk backs, it is unacceptable to tout study results by press release without releasing the paper,” influential surgeon and author Dr. Atul Gawande wrote on Twitter.

The anti-malarial drug hydroxychloroquine serves as a cautionary tale. A small French study from March sparked a flurry of excitement (and glowing praise from President Donald Trump) over hydroxychloroquine’s potential to treat COVID-19. But as more robust studies came out, findings began to suggest the drug is at best ineffective, and at worst potentially harmful. Eventually, the growing body of research led the U.S. Food and Drug Administration to revoke the drug’s emergency use authorization.

The hope, of course, is that no such thing happens with dexamethasone. If the drug truly works as well as the early results suggest, it could revolutionize the way severe COVID-19 is treated. But the rapidly evolving COVID-19 pandemic, which has spurred scientists to produce a staggering amount of work in record time, has also exposed the drawbacks of accelerating past the traditionally slow-and-steady scientific review process. Mistakes happen, and conclusions change — especially when the whole world is impatient for answers.

Britain’s health ministry wasted no time, saying the drug had been approved for use in the state-run health service, export restrictions had been introduced and 200,000 courses of the treatment had been stockpiled.

“This is a (trial) result that shows that if patients who have COVID-19 and are on ventilators or are on oxygen are given dexamethasone, it will save lives, and it will do so at a remarkably low cost,” said Martin Landray, an Oxford University professor co-leading the trial, known as the RECOVERY trial.

“For less than 50 pounds ($63), you can treat eight patients and save a life,” he said in an online briefing. One death would be prevented in every 25 COVID-19 patients on oxygen that received the drug, he calculated.

His co-lead investigator, Peter Horby, called dexamethasone “a major breakthrough.”

No treatment for COVID-19, the disease caused by the new coronavirus, which has killed more than 431,000 people globally, has been shown to reduce the mortality of the disease, although Gilead Sciences Inc’s remdesivir shortened the recovery time for hospital patients.

“This blows remdesivir out of the water in terms of the effect size and the kind of effect,” said Dr. Mark Wurfel, professor of medicine at the University of Washington.

Wurfel cautioned that it is important that the data be released and reviewed, “but this magnitude of improvement in mortality for a critically ill population is about the largest effect size that we’ve ever seen,” he said.

Drug availability

The RECOVERY trial compared outcomes of around 2,100 patients who were randomly assigned to get the steroid, with those of around 4,300 patients who did not get it.

“We hope the data on which these results are based will be published as soon as possible so that doctors can confidently put the treatment into practice,” said Robin Ferner, honorary professor of clinical pharmacology at University of Birmingham.

Dr. Thomas McGinn, deputy physician-in-chief at Northwell Health, New York’s largest healthcare system, told Reuters that physicians at Northwell hospitals have been using steroids on a case-by-case basis because they can suppress patients’ immune systems and possibly make them susceptible to other infections.

He said that if the data is peer-reviewed and legitimized, it could spread the use of steroids in the sickest COVID-19 patients.

“Across the country now intensivists have been using it based on their judgment calls. If this is legitimate, you may find … instead of say five out of 10 intensive-care COVID patients getting it, maybe everybody would get it,” McGinn said.

Stocks rise on coronavirus treatment hopes despite second wave fears

European stocks rallied as markets opened on Wednesday, as a coronavirus treatment “breakthrough” outweighed new fears of a second wave.

The WHO called a clinical trial led by Oxford University “great news.” It said the study was the first treatment shown to reduce the number of deaths among severely ill patients reliant on ventilators.

France’s CAC 40 was up by 1.1% in early trading. Britain’s FTSE 100 rose 0.9% after its strongest gains in a month on Tuesday. Germany’s DAX was trading 0.8% higher, and the pan-European STOXX 600 index was up 0.7% at around 9am in London.

U.S. stock futures also pointed to a higher open. S&P500, Dow Jones and Nasdaq futures were all up 0.6% at around 4am eastern time.

It continued a global market rally on Tuesday after U.S. retail sales leapt by a record 17.7% in May, making up more than half their losses in the past two months.

But fears of a resurgence of the pandemic had capped gains in Asian overnight, and sent the Nikkei down 0.5%. China’s Shanghai Composite index closed 0.2% higher and the Hong Kong Hang Seng Index rose 0.3%.

It came as Chinese authorities imposed a fresh lockdown in Beijing and six US states reported a record rise in new infections.



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