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Monday, April 6, 2020

RedHill Bio doses first COVID-19 patient with Opaganib in Israel

RedHill Biopharma (NASDAQ:RDHL) has dosed the first patient with COVID-19 infection with its IND, opaganib (Yeliva, ABC294640), in Israel.
The treatment is administered under a compassionate use program in accordance with the Israeli Ministry of Health guidelines, with additional patients expected to be treated in coming days.
RedHill is also preparing for potential ramp-up of manufacturing of opaganib.
Shares are up 9% premarket.
https://seekingalpha.com/news/3558482-redhill-bio-doses-first-covidminus-19-patient-opaganib-in-israel-shares-up-9-premarket

Singapore: The Model for COVID-19 Response?

Can Singapore’s response to the novel coronavirus guide the U.S.’s own actions?
Former FDA Commissioner Scott Gottlieb, MD, congratulated Singapore last month on its “exquisite reporting” of COVID-19 cases. And a preprint of a Harvard study, published in medRxiv, characterized Singapore’s “strong epidemiological surveillance and contact tracing” as the “gold standard.”
Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, called Singapore’s response “the model to emulate” in the New York Times last week.
Even CDC Director Robert Redfield applauded the city-nation for its “aggressive containment strategy” and “aggressive case findings.”
Asked what Singapore had gotten right, Redfield said, “it’s early diagnosis, isolation, contact tracing, and some very targeted mitigation steps” that included closing schools in areas with high case load.
Not every country has to succumb to the “accelerated expansion” of the virus as Korea, Italy, and Iran have, he told MedPage Today last Thursday.
Redfield said the experience in those countries shows it is indeed possible to lose control of the situation. But Hong Kong and Singapore serve as counterexamples, “where they’ve had a lot of imported cases” but with “an effective public health response” to contain them.
Asked whether the U.S. could replicate their approach, Redfield said, “that’s our plan,” but it all depends on early case recognition.
Osterholm also stressed the importance of “extensive contact follow-up.”
With each new case in Singapore, public health officials look for the contacts of that individual to see if they’re infected and “then you keep going to the next level, the contacts of the contacts, if they’re infected.”
But it’s a labor-intensive process, he said. Given that the U.S. whose population dwarfs Singapore’s, he said it is “not practical” to think those contact tracing capabilities could be replicated here.
Talking to the Public
One area where the U.S. can follow Singapore’s lead is through communication and public education, Osterholm said.
Singapore government officials have been “straightforward” about what could happen if the virus begins to spread in the community.
“They’ve had lots of transparency, they’ve been very proactive and they’ve not tried to minimize it,” Osterholm said.
People need to hear “in stark terms” what could happen next, he said.
While there are those who believe troubling information “makes people freak out or panic,” Osterholm said, “there’s really no evidence to that at all.”
People just want to know fair and accurate information, and then “they don’t freak out,” he said.
“What we need to do is to basically be able to share the news of what we know and don’t know, but then tell people what are we going to do about it, how are we going to respond,” Osterholm said. “And that’s what they’re doing in Singapore.”
The other thing that separates the U.S. and Singapore is the ability to have a unified response.
In the U.S., policy and science officials’ message has been “pretty much all over the board,” said Osterholm.
On Feb. 25, Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, told reporters community spread was expected: “It’s not a question of ‘if’ anymore.” That same day, Larry Kudlow, the president’s chief economic adviser, told reporters that “we have contained this.”
And President Trump said incorrectly that the number of cases was declining, and on multiple occasions that COVID-19 would “go away in April.”
“We’ve got different messages coming out of federal government. We need a message,” Osterholm said.
“That’s where Singapore’s been different … They actually have been trying to provide a consistent message … there’s no division between the prime minister and the minister of health, the local authorities, it’s all basically been one message,” he said.
Singapore’s Response
Singapore, the tropical city-nation at the tip of the Malaysian peninsula has a population of about 5.7 million.
As of March 4, the city-nation had 112 cases of coronavirus.
In early January, only a few days after the WHO announced a cluster of pneumonia cases in Wuhan, China, Singapore began temperature screenings at airports, and by mid-January it launched a multi-ministry task force to address the virus.
“While we hope for the best, we must plan for the worst,” Gan Kim Yong, Singapore’s health minister, told other government officials in a Feb. 3 speech.
He explained that masks were to be used by those who are sick to prevent others from catching the virus. Those who are healthy should focus on washing their hands and avoid touching their faces.
Yong drew on Singaporeans’ sense of moral and civic duty: “All of us must play our part and exercise social responsibility, to prevent or to curb the potential spread of the virus in the community.”
“Here I want to reiterate the government’s firm commitment that we will spare no efforts in protecting our people. We will act swiftly and share information on the novel coronavirus openly and as soon as possible,” he said.
In a video press release on Feb. 8, Prime Minister Lee Hsien Loong also addressed his citizens. He reassured viewers that Singapore had learned a lot from SARS. “We know that we can get through this too,” he said. He explained the differences between SARS and coronavirus — coronavirus is “harder to stop” but much “less deadly.” He said the new coronavirus’s mortality rate was 0.2% outside of the Wuhan area (it later became much higher), compared to the 0.01% from seasonal flu and the 10% fatality rate with SARS.
Loong described some of the measures already being taken to prevent the viruses spread, in addition to isolating confirmed cases and quarantining their contacts, the government called for “reducing mingling in schools,” tightening access to hospitals, and taking extra precautions during large public events.
He acknowledged that if the number of cases continue to grow and the virus becomes more widespread, “we will have to reconsider our strategy.”
It may be that the government would direct those with only mild cases to visit their general practitioner so that hospitals remain available for the more severely ill patients.
“I’m sharing these possibilities with you so that we are all mentally prepared for what may come,” he said.
In closing, he told Singaporeans to take “sensible precautions” and urged them to “stay calm and carry on with our lives.”
Public Alerts
Singaporeans can subscribe to WhatsApp updates from the Ministry of Health or find them on the ministry’s website. These updates summarize the current situation in the country.
For example, the update on March 3 stated:
As of 12pm:
New cases: 2
Total COVID-19 cases in Singapore: 110
Discharged today: 0
Total discharged: 78
Total remaining in Hospital: 32
1 new case is linked to a known cluster, contact tracing is underway for the other case.
Most in hospital are stable or improving. 7 are in the ICU.
These updates usually clarify whether any new case is of unknown origin or if it’s linked to a previous cluster.
The government also issues updates by WhatsApp and a press release on “entry approvals” for individuals wishing to return to Singapore from affected countries, travel advisories, and guidelines on swab tests at checkpoints. These come with warnings about prosecution for those who don’t comply with testing, as well as on contact tracing scams.
Yong, the health minister, told Singapore’s parliament on March 5 that the country still faces a major threat from COVID-19 and the situation may get worse, according to The Straits Times.
He noted the spread outside China. “This is worrying, as they pose a high risk of importation of cases into Singapore,” he said. “Even among our closest neighbours, the situation is also evolving. Therefore, it is likely that this disease will stay with us for a long time.”
Yong also said border controls will probably lose their effectiveness soon: “We cannot ban visitors from every country and shut ourselves out from the world.”
Enforcing Quarantine, Finding a Single Voice
The U.S. has already borrowed from Singapore’s playbook in certain respects, ramping up testing, implementing “social distancing” in some locales, and at-home quarantines. But Singapore is often described as a police state, albeit a relatively gentle one, and some of its threats would be less credible in the U.S.: jail for those who violate their 14-day quarantine rules, fines for providing false information to government agents.
Lawrence Gostin, JD, who holds appointments at Georgetown University School of Medicine and Johns Hopkins University, said it was “unlikely” that U.S. health officials would be so “prescriptive and punitive” as to impose penalties for non-compliance with quarantine and isolation protocols.
While containment strategies such as school closures will probably increase, “the U.S. will try to do most of its social distancing through voluntary measures” and “only rarely use coercive measures like mandatory quarantines,” he predicted in an email to MedPage Today.
On the communications front, it appears the Trump administration, or at least HHS, is listening to the advice of experts like Osterholm and attempting to speak with one voice.
At a hearing on coronavirus in the Senate, Health, Education, Labor and Pensions Committee on Tuesday, witnesses from different arms of HHS — the FDA, CDC, the National Institutes of Health, and the Office of the Assistant Secretary for Preparedness and Response — submitted a single document as written testimony for all four witnesses.
And in a speech on Wednesday, Vice President Pence described the “whole-of-government” approach “deployed” by President Trump in response to coronavirus, perhaps channeling Yong’s speech which described Singapore’s own “whole-of-government” strategy.
Whether this more unified front or appearance of one can hold, only time and Twitter will tell.
https://www.medpagetoday.com/infectiousdisease/covid19/85254

How Gig Nurses Can Stay Safe

Demand for healthcare professionals is at an all-time high due to COVID-19, and this includes gig nurses. Unlike other industries that are shuttering or moving to remote interaction, the nursing profession is facing unprecedented demand. Nurses cannot self-quarantine; they are on the front lines providing care to patients in need day in and day out. Now that the world is in the throes of a pandemic, the question, unfortunately, isn’t if nursing professionals will get sick, but when. And when full-time staff numbers begin to dwindle due to sickness, quarantine, and lack of willingness to work, who will step into healthcare facilities and continue to provide much-needed care?
Gig Nurses Will be More in Demand than Ever
Before COVID-19, the healthcare industry was already facing a staffing crisis – the nursing shortage. The U.S. simply does not have the number of nurses necessary to meet the rising demand for direct care.
Fortunately, gig brands have emerged to help optimize the nursing workforce. Driven by smart matching technology and data science, gig work allows nurses to achieve a greater work-life balance. For healthcare facilities, it allows them to augment their own full-time staff, helping to reduce staff burnout and turnover. In times like these, where full-time nursing staff will inevitably burn out (or worse, become exposed to the virus), gig nurses will be integral to filling the gaps in care that facilities desperately have.
It’s worth noting that the gig economy in nursing, for all its merits, also comes with the alarming reality of extra touchpoints of care. Gig nurses that build their own schedule through staffing apps are likely moving from facility to facility, working varied shift times, and interfacing with more patients — which can increase the risk of exposure across multiple settings. If gig economy companies working in healthcare proceed without necessary caution, they have the potential to exacerbate the COVID-19 pandemic.
Fortunately, with some thoughtful planning and the application of technology, there are plenty of necessary steps gig economy companies can take to help facilities and their workforce avoid spreading COVID-19 in the healthcare staffing setting.
Educate Yourself and Stay Informed
Oftentimes, per-diem gig nurses don’t have time to walk through all of a facility’s protocols before their shift, so providing nurses with training that can be completed on their device prior to arriving at the facility is key to ensuring that the entire workforce is well-equipped to treat and prevent the spread of COVID-19. Also, as personal protective equipment (PPE) supplies start to run low, nurses should also be kept informed on best practices to mitigate their exposure, even without adequate PPE on hand. It’s essential that any education is continually updated with the latest guidelines from the Centers for Disease Control and Prevention (CDC) and that nurses are retested when those updates go live.
Up-Front Symptom Screening
Facilities are concerned about who is coming into their facility, and nurses are concerned about who they are working with. To protect facilities, staff, and patients from unnecessary exposure to COVID-19, gig economy companies can implement an online symptoms questionnaire that workers can complete before shifts to confirm they are not experiencing symptoms consistent with COVID-19. If a nurse confirms they are experiencing COVID-19 symptoms, they can be removed from the shift without penalty. With the much-needed help of technology, gig brands can implement this screening mechanism in an efficient and effective way so that nursing professionals who are healthy can get back to work, and those that are sick can be removed from the network.
Keep Track of Exposure Updates
Due to the rapid spread of COVID-19, it is safe to assume that facilities and/or staff will face exposure to the virus, which is why gig companies need to be proactive about their protocol. If a worker or facility reports exposure, technology can contact and alert the entire network of exposed facilities so that workers can take necessary precautions and quarantine themselves, if needed.
At this stage of the COVID-19 epidemic, whether a nurse works full-time at a facility, or works per-diem at multiple facilities, providing direct care in a healthcare setting presents a high-risk for exposure to the virus. The bottom line is that facilities, their staff, and their patients will need gig nurses to pick up the torch as this pandemic rages on, and gig nurses will need their employers to provide them with innovative solutions to ensure that they can keep themselves, and their patients, safe from COVID-19.
David Coppins is the cofounder and chief executive officer at IntelyCare, a nursing agency in Quincy, Massachusetts.
https://www.medpagetoday.com/infectiousdisease/covid19/85765

NMC Health lender applies to court for administration

One of the United Arab Emirates’ largest banks has applied to the UK’s High Court to appoint administrators for the troubled private hospital operator NMC Health.
The UK-listed firm has been under scrutiny for alleged unauthorised financial activities.
The Abu Dhabi Commercial Bank wants administrators to launch a full investigation into its conduct.
The lender said the move was aimed at safeguarding the future of the company.
The Abu Dhabi Commercial Bank, also known as ADCB, is one of NMC Health’s largest lenders with an exposure of $981m (£800m).
NMC Health, which has a debt of $6.6bn, is estimated to have borrowings with more than 80 regional and international creditors.
The country’s fourth largest lender, Dubai Islamic Bank, said on Sunday that it had an exposure of $541m to the troubled hospital operator.

Trouble starts

Abu Dhabi-based NMC Health is one of the largest healthcare providers in the Middle East with 200 hospitals, clinics and other sites in 19 countries. Most are based in the UAE.
It was founded by Indian billionaire, BR Shetty, in 1974. The company was listed on the London stock exchange in 2012, and in 2017 it was included in the FTSE 100.
The following year the company’s market value topped $10bn.
Trouble started for the firm last year after a report by US-based activist investor Muddy Waters alleged that NMC Health had inflated its cash balances, overpaid for assets and understated its debt.
It then made a series of damaging disclosures including alleged theft and excess undisclosed borrowings by former directors. The company lost more than half of its market value within a few weeks and share trading was suspended in February amid several high-profile sackings.
Faisal Belhoul, who was appointed the company’s new executive chairman last week, said in a statement that any move to put the group into administration would destabilize its businesses at a time when it was playing an ”important role” in the UAE’s response to Covid-19.
After his appointment, Mr.Belhoul had pledged to work with UAE and UK regulators to recover any misused funds.
https://www.bbc.com/news/business-52172006

Novacyt wins French approval for COVID testing kit

Novacyt’s COVID-19 diagnostic test has been approved by France’s CNR arm of the Institut Pasteur, making it available for immediate distribution in France, the healthcare company said on Monday.
The company added that last week, it had also won approval for its COVID-19 test from Thailand’s Ministry of Health.
Novacyt has already won orders in the UK for its Primerdesign COVID-19 detection kit and has won regulatory approval for it from the U.S. Food & Drug Administration.
“The Institut Pasteur’s evaluation and approval of our COVID-19 test is an important validation … We look forward to supporting the French authorities in their COVID-19 testing requirements,” said Novacyt CEO Graham Mullis.
https://www.reuters.com/article/us-health-coronavirus-novacyt/novacyt-wins-french-approval-for-covid-testing-kit-idUSKBN21O0GL

UK’s plan B if ‘Team Johnson’ is incapacitated

Britain’s constitution offers no clear answer to the question now on many Britons’ minds: what happens if Prime Minister Boris Johnson, undergoing tests in hospital after persistent symptoms of coronavirus, cannot continue to lead.
Johnson was admitted to hospital on Sunday in what his office said was a “precautionary step” after testing positive 10 days ago and still suffering from a high temperature. He remains in charge of the government, his office said.
Johnson has said he can keep working from self-isolation in his Downing Street residence, just as his health secretary, Matt Hancock, who also tested positive for the virus, has done.
But the fact that two such crucial leaders in the UK’s fight against the pandemic have contracted the disease has raised questions about how the government would function without them at a time of global crisis.
The constitution — an unwieldy collection of sometimes ancient and contradictory precedents — offers no clear, formal “Plan B” or succession scenario, experts said.
“We’ve not been in that kind of situation, we’ve not had to think about it from that point of view before,” Catherine Haddon, a senior fellow at the Institute for Government, told Reuters soon after Johnson was first diagnosed.
Whereas in the United States the vice president steps up if the president dies or becomes incapacitated, Britain has no formal deputy or caretaker prime minister who would take over.
Downing Street has already said, however, that Foreign Secretary Dominic Raab would deputise if necessary.
Nor is there any guidance for such circumstances in the Cabinet Manual which sets out the rules and conventions for the running of government, and there is little precedence.
When asked about who would stand in for the prime minister, his spokesman said: “The prime minister has the power to delegate responsibility to any of his ministers, but for now it is the prime minister and then the foreign secretary.”

CHURCHILL’S STROKE

In June 1953, then-Prime Minister Winston Churchill suffered a stroke while in office. His illness was kept so secret that some senior ministers were unaware.
Churchill surprised doctors by recovering to carry on his duties, returning to Downing Street and running the cabinet two months later.
More recently, Tony Blair twice underwent treatment for a heart condition while prime minister in the early 2000s, each time briefly cutting back on his workload for a couple of days.

Officials said that if Blair were to have been incapacitated, his then-deputy John Prescott would have taken over until a new leader was elected.
There is no suggestion Johnson is unable to perform his job. Since his diagnosis, he has carried on leading the government’s efforts through the use of teleconferencing.

MUDDLE THROUGH?

Bob Kerslake, head of the civil service from January 2012 to September 2014, said Johnson’s role was crucial at this time, stressing that visible leadership was essential.
Kerslake, speaking to Sky News last month after Johnson tested positive, said officials would need to know what would happen if senior ministers were unable to do their jobs.
Losing Cabinet Office minister Michael Gove, who coordinates policy across government, would be a serious blow.
“He is critical to all of this,” Kerslake said. “If, for whatever reason, he was ill, who takes over from him?”
Haddon from the Institute for Government said some powers were specifically vested in cabinet ministers, so there was an issue of what happened if they were unavailable.

“If you got to a stage where … you had secretaries of state who aren’t able to perform their functions, then there are question marks about whether junior ministers in their department act on their behalf,” she said.
One lawmaker in Johnson’s party, who has repeatedly tried to bring in a law to formalise who would replace a prime minister in the event of incapacity, said last month that no one seemed to know what would happen.
“In a national emergency, you don’t want to be scrabbling around worrying about who’s in charge,” Peter Bone told the Mirror newspaper.
https://www.reuters.com/article/us-health-coronavirus-britain-johnson-il/uks-plan-b-if-team-johnson-is-incapacitated-answer-is-unclear-idUSKBN21N0XI

Japan to declare state of emergency for about a month: PM

Japan is to declare a state of emergency in Tokyo and six other prefectures as early as Tuesday in a bid to stop the coronavirus, the prime minister said, with the government preparing a stimulus package to soften the economic blow.
More than 3,500 people have tested positive for the coronavirus in Japan and 85 have died – not a huge outbreak compared with some hot spots, but the numbers keep rising with particular alarm over the spread in Tokyo, which has more than 1,000 cases, including 83 new ones on Monday.
Prime Minister Shinzo Abe made the announcement on the state of emergency in remarks to media televised live.
An emergency, which Abe said would last about a month, will give governors authority to call on people to stay at home and businesses to close, but not to order the kind of lockdowns seen in other countries. In most cases, there are no penalties for ignoring requests, and enforcement will rely more on peer pressure and respect for authority.
Pressure had been mounting on the government to take the step although Abe has voiced concern about being too hasty, given the restrictions on movement and businesses that would ensue.
The stimulus package of hundreds of billions of dollars is due to be rolled out this week.

An emergency would appear to have public support. In a poll published on Monday by JNN, run by broadcaster TBS, 80% of those surveyed said Abe should declare it while 12% said it was not necessary. His approval rating fell by 5.7 points from last month to 43.2%, the survey showed.
Kenji Shibuya, director of the Institute for Public Health at King’s College, London, said the emergency was too late given the explosive increase in cases in Tokyo.
“It should have been declared by April 1 at the latest,” he said.

CALL FOR CALM

Sounding alarm over the high rate of cases that could not be traced, Tokyo Governor Yuriko Koike indicated last week that she would favour a state of emergency as a way to help her urge residents to adhere to stronger social-distancing measures.
An expert on the government’s coronavirus panel said Japan could avoid an explosive rise by reducing person-to-person contact by 80%.
Under a law revised in March to cover the coronavirus, the prime minister can declare a state of emergency if the disease poses a “grave danger” to lives and if its rapid spread could have a big impact on the economy.
Economy Minister Yasutoshi Nishimura called for calm saying there was no need for people in designated prefectures to flee to other regions, which could spread infections, NHK reported.
While Japan’s coronavirus epidemic is dwarfed by the 335,000 infections and more than 9,500 deaths in the United States alone, experts worry a sudden surge could overwhelm Japan’s medical system.
Abe must seek formal advice from a panel of experts before deciding to go ahead and declare the emergency.
Governors in Tokyo and elsewhere have asked citizens to stay home on weekends, avoid crowds and evening outings, and work from home. That has had some effect, but not as much as many experts said was needed.
https://www.reuters.com/article/us-health-coronavirus-japan/japan-to-declare-state-of-emergency-for-about-a-month-pm-idUSKBN21N0ZS