Category Archives: Clinical Testing

Gilead says critical study of Covid-19 drug shows patients are responding to treatment

Posted on by • Posted in Clinical Research, Clinical Testing, Coronavirus, Emergency Use Authorization, Food and Drug Administration (FDA), Pharmaceutical Industry, Remdesivir • Leave a comment

Critical study of Gilead’s Covid-19 drug shows patients are responding to treatment, NIH says

Gilead: Critical study of Covid-19 drug shows patients respond to ...

A government-run study of Gilead’s remdesivir, perhaps the most closely watched experimental drug to treat the novel coronavirus, showed that the medicine is effective against Covid-19, the disease caused by the virus.

Gilead made the announcement in a statement Wednesday, stating: “We understand that the trial has met its primary endpoint.” The company said that the National Institute of Allergy and Infectious Diseases, which is conducting the study, will provide data at an upcoming briefing.

The finding — although difficult to fully characterize without any data for the study — would represent the first treatment shown to improve outcomes in patients infected with the virus that put the global economy in a standstill and killed at least 218,000 people worldwide.

Over the past few weeks, there have been conflicting reports about the potential benefit of remdesivir, a drug that was previously tried in Ebola. As previously reported by STAT, an early peek at Gilead’s study in severe Covid-19 patients, based on data from a trial at a Chicago hospital, suggested patients were doing better than expected on remdesivir. Days later, a summary of results from a study in China showed that patients on the drug did not improve more than those in a control group.

Full results from the China study were also released Wednesday.

But the NIAID study, which was not expected to be released so soon, was by far the most important and rigorously designed test of remdesivir in Covid-19. The study compared remdesivir to placebo in 800 patients, with neither patients nor physicians knowing who got the drug instead of a placebo, meaning that unconscious biases will not affect the conclusions.

The main goal of the study is the time until patients improve, with different measures of improvement depending on how sick they were to begin with. While the result means that the drug helps patients improve faster, it is not possible to say how dramatic those improvements are.

Scott Gottlieb, the former commissioner of the Food and Drug Administration, said he expected there was enough evidence for the agency to issue an “emergency use authorization” for remdesivir.

“Remdesivir isn’t a home run but looks active and can be part of a toolbox of drugs and diagnostics that substantially lower our risk heading into the fall,” he said.

The FDA previously issued an emergency authorization for the malaria drug hydroxychloroquine to treat Covid-19, even though at least some studies suggesting the medicine was not effective. “If hydroxychloroquine met [the emergency] standard, then remdesivir would have seemed to cross that line a while ago, especially in the setting of treating critically ill patients,” Gottlieb said.

Remdesivir, which must be given intravenously, is likely to remain a treatment for patients who are hospitalized. But it is also likely that it will be most effective in patients who have been infected more recently, said Nahid Bhadelia, medical director of the special pathogens unit at Boston Medical Center.

“We know that with most antiviral medications the earlier you give it the better it is.” said Bhadelia, who had experience giving remdesivir as an experimental treatment for Ebola in Africa, where results are less encouraging. That means that better diagnostic testing will be essential to identifying patients who could benefit. “What will be important is that we find people on the outpatient side,” Bhadelia said. “Again, testing becomes important, we want to have them come to the hospital as soon as possible. “

Gilead also released results Wednesday from its own study of remdesivir in patients with severe Covid-19. This study showed similar rates of clinical improvement in patients treated with a five-day and 10-day course of remdesivir, the company said.

“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, in a prepared statement.

Gilead said that its own study in severe patients showed that it may be possible to treat patients with a five-day treatment of remdesivir, not the 10-day course that was used in the NIAID trial.

The company’s study is enrolling approximately 6,000 participants from 152 different clinical trial sites all over the world. The data disclosed Thursday are from 397 patients, with a statistical comparison of patient improvement between the two remdesivir treatment arms — the five-day and 10-day treatment course. Improvement was measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.

The study design means that by itself it doesn’t reveal much about how well remdesivir is working, because there is no group of patients who were not treated with the drug. The conclusion is that the two durations of treatment are basically the same.

Peter Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Medical Center, said he is eager to see the data from the NIAID study but renewed his criticism of Gilead’s severe study for lacking a control group of untreated patients. That would have allowed researchers to make important conclusions about how the drug works that are just not possible now, he said.

“They’ve squandered an unbelievable opportunity,” Bach said. “It’s not going to tell us what to do with 80-year-olds with multiple comorbidities compared to 30-year-olds who are otherwise healthy. We’re still going to be foundering around in the dark, or at least in a dim room, when we could have learned more.”

In the study, the median time to clinical improvement was 10 days in the five-day treatment group and 11 days in the 10-day treatment group. More than half of the patients in both groups were discharged from the hospital by day 14. At day 14, 64.5% of the patients in the five-day group and 53.8% of the patients in the 10-day group achieved clinical recovery.

Patients in the trial generally lived, though this may be because their illness was not that severe to begin with. For most of the study, patients already on ventilators were not enrolled.

Eight percent of the patients treated with five days of remdesivir died, compared to 11% of the patients treated for 10 days. Outside of Italy, where 77 patients were treated, the overall mortality rate across the entire study was 7%, Gilead said. Those mortality rates are lower than those seen in other studies, which have been in the teens and twenties.

Only 5% of patients in the five-day group and 10% in the 10-day group had side effects that led to a discontinuation. The most common bad effects — and it’s impossible to tell which were from the drug — were nausea and acute respiratory failure. High liver enzymes occurred in 7.3 percent of patients, with 3 percent of patients discontinuing the drug due to elevated liver tests.

A full evaluation of the results will have to wait until complete data are available.

In the China study, also published Wednesday in The Lancet, investigators found that remdesivir “did not significantly improve the time to clinical improvement, mortality, or time to clearance of virus in patients with serious COVID-19 compared with placebo.”

There was a 23% improvement in time to clinical improvement for remdesivir compared to placebo, but the difference was not statistically significant. At the median, remdesivir-treated patients improved in 20 days compared to 23 days for placebo patients. At one month, 14% of the remdesivir patients had died compared to 13% of the placebo-treated patients.

The China study enrolled patients with more severe Covid-19 than the study conducted by NIAID. The China study was also stopped early because of difficulties enrolling patients as the pandemic waned in China.

 

 

 

US surpasses 1 million COVID-19 cases

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Emergency Preparedness, Health Policy, Infection Control, Infectious Virus, Mortality, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Safety, Quarantine, Social Distancing • Leave a comment

https://thehill.com/policy/healthcare/494792-us-surpasses-1-million-covid-19-cases

Did the Trump Administration Overpromise 1 Million COVID-19 ...

More than a million people in the United States have tested positive for the coronavirus, a sobering milestone that experts say represents only the beginning of a months-long battle to end the pandemic.

The United States has now registered about a third of all confirmed cases of COVID-19 around the globe, according to data compiled by the Center for Systems Science and Engineering at Johns Hopkins University. More than 57,000 people have died in the United States, about a quarter of the known COVID-19 deaths around the globe.

The United States has now registered more confirmed cases than the next five countries suffering the largest outbreaks — Spain, Italy, France, Germany and the United Kingdom — combined.

Those numbers are partly a reflection of population, but there are troubling signs for the United States.

While those countries have reduced the pace of transmission and the growth in the number of new cases they are seeing on a daily basis, the United States has not similarly bent the curve.

Instead, it is stuck at a deadly plateau: In the last week, the U.S. has reported between 24,000 and 41,000 new cases a day, and between 1,200 and 2,600 deaths per day, according to The Covid Tracking Project, a group of researchers who keep tallies of case counts around the country.

Even as some states begin to relax orders that closed retail and service stores, experts warned the country is still at risk of a new rush of cases, and that the downslope of declining case counts will be much longer than the sudden surge the United States saw in April.

“We’re in the opening stages of this,” said Michael Osterholm, director of the Center for Infectious Disease Research and Prevention at the University of Minnesota. States “are not in the mountains, they’re in the foothills. The mountains are still to come.”

More than a quarter million residents of New York have tested positive for the virus, and commuter suburbs in New Jersey and Connecticut have reported tens of thousands of cases. More than 50,000 residents of Massachusetts have tested positive, and California, Illinois and Pennsylvania have all confirmed more than 40,000 cases.

There are growing signs that the virus is shifting into new, more rural territory. States like Arkansas, Kansas, Minnesota, Nebraska, New Mexico, Rhode Island, Tennessee and Virginia all recorded substantial growth in the number of new cases they had confirmed in the last few days.

That pattern of viral spread beginning in large urban cores and eventually making its way to rural areas is typical, experts said, given societal connections between urban areas, suburbs and more rural areas.

“Epidemiologists know that this pattern is a very expectable one, that rural areas are going to have lagged waves of cases. So we’ve been bracing for that,” said Nita Bharti, a biologist at the Center for Infectious Disease Dynamics at Penn State University. “What they’re experiencing now is what cities have been seeing. It’s the same, it’s just delayed, and we knew it would happen.”

About six months after the coronavirus outbreak was detected in Wuhan, China, and four months after the first case arrived on American shores, the United States still lags the world in testing capacity. States have bolstered their capacity in recent days, conducting more than 225,000 tests per day over four of the last five days, the capacity needed to ensure the virus can be brought under control lags substantially.

An analysis by Harvard researchers for the scientific publication STAT found more than half of states would have to significantly bolster their testing capacity in order to safely begin easing stay-at-home orders in May. The hardest-hit state, New York, will have to be able to test at least 100,000 more people every day than it is currently able to; New Jersey’s capacity would need to increase by 68,000 a day.

Smaller states and those that have yet to experience thousands of new cases — places like Mississippi, Idaho, Montana, Wyoming, Arizona and New Mexico — already have the testing capacity they need to identify and squelch any new viral hotspots. Even Washington state, the first state to confirm a positive case, has built its capacity to meet demand.

Public health experts say a robust testing program must be supplemented by armies of contact tracers who can track down those who are at risk of contracting the virus.

Already, Massachusetts has partnered with the nonprofit Partners In Health to deploy about 1,000 contact tracers across the state. Alaska has managed to trace the contacts of each of its 341 positive cases. New York City Mayor Bill de Blasio said Monday that the city would hire 1,000 contact tracers of its own, and former Mayor Mike Bloomberg has pledged $10 million to kick start a contact tracing program in the tri-state area.

On Monday, a bipartisan group of top public health experts led by President Trump‘s former FDA commissioner Scott Gottlieb and President Obama’s former Centers for Medicare and Medicaid Services administrator Andy Slavitt called on Congress to spend $46 billion to expand contact tracing capacity, including $12 billion to hire 180,000 new workers.

It is unclear how the outbreak in the United States compares with outbreaks in authoritarian countries like China, Russia and Iran, which do not report reliable numbers.

But even in the United States, where state and local governments are transparent about the data they collect, the actual number of cases and deaths are higher — likely significantly so. Early antibody tests in places like New York City and Miami show a significant number of people contract the virus without showing symptoms, and as studies show people who died inexplicably over the last several months tested positive for the virus.

 

 

 

The only way to get back to normal this summer is to test everyone in the United States, Nobel Prize-winning economist says

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Employee Furlough, Employee Layoffs, Employee Pay Cuts, Health Policy, Infection Control, Infectious Virus, Pandemic, Public Health, Public Safety, Social Distancing, Unemployment, Unemployment Insurance • Leave a comment

https://www.washingtonpost.com/business/2020/04/27/economy-coronavirus-romer-reopen/?fbclid=IwAR0AI-Cmf34bjZwphHNREngiy6CoKIbYHU2zb1QlnBg_jm7MXgWObMTVjZ4&utm_campaign=wp_main&utm_medium=social&utm_source=facebook

Coronavirus tests should be as cheap as a 'morning latte' to ...

Paul Romer estimates that testing every American would cost $100 billion, a hefty sum but less than the $2 trillion Congress has spent so far.

Nobel Prize-winning economist Paul Romer says a return to nearly normal life is possible this summer if the United States does wide-scale testing for the coronavirus.

Romer is calling on the U.S. government to test everyone in the nation once every two weeks and isolate people who test positive for the deadly coronavirus. He estimates that doing so would cost $100 billion, a hefty sum but far less than the $2 trillion Congress has spent so far and less than the cost of keeping the economy partly closed for months to come.

“I’m on the optimistic end of how quickly we can scale testing up,” said Romer, who won the 2018 Nobel Prize for economics. “I do think there’s a way most people could feel safe returning to what feels like normal life this summer if we do this wide-scale testing.”

So far, the nation has tested about 5 million people — or less than 2 percent of the population. Last week, Congress approved an additional $25 billion for testing as part of the latest funding bill, which Romer calls a good start but not enough.

Restarting the U.S. economy isn’t just about government officials clearing certain businesses to reopen. People have to feel safe enough to venture out. Romer says that will happen only when nearly everyone in the country is getting tested on a regular basis and people who are sick are being quarantined.

“It’s totally in our control to fix this,” Romer said in a phone interview. “We should be spending $100 billion on the testing. We should just get it going. It’s just not that hard.”

He advises starting with screening all health-care and front-line workers in the next month and then scaling up the testing to the rest of the nation this summer by using university labs to process tests.

Romer says massive testing is the only viable option for the nation. Otherwise, the economy will limp along, leaving millions of people unemployed and forcing small businesses to shut forever. It could take years to recover from that kind of pain. On the flip side, reopening much of the nation too soon could cause deaths to skyrocket again.

Top White House officials voiced support for more testing over the weekend. Treasury Secretary Steven Mnuchin said on Fox News Sunday that the Trump administration would “balance” reopening the economy with “more testing” to “monitor this very, very carefully.”

Deborah Birx, the White House’s coronavirus task force coordinator, said Sunday that more testing would be needed and that “social distancing will be with us through the summer.“

As Congress and the White House debate another round of economic relief, it’s unclear how much more money will be allocated for testing. Evidence from China and Germany, which have begun to reopen much of their economies, shows that people remain reluctant to go out and spend again. Subways in China remain half full, big public spaces such as casinos remain nearly empty and economic activity is still way off from normal.

Although some have balked at the cost of testing every American, Romer points out that the United States is losing at least $500 billion a month from the Great Lockdown. His estimate is more modest than some other economists such as St. Louis Federal Reserve President Jim Bullard, who says the nation is losing $25 billion a day right now. Bullard has also endorsed universal testing as the only way to fix the nation’s health — and economic — problems.

“Every month of delay makes the recovery slower — and take longer,” Romer said.

Romer won the Nobel Prize for modeling the U.S. and global economies. A former chief economist at the World Bank, he has built a career thinking through big international problems and what to do about them. But the coronavirus fight is also personal for him. He has a daughter who is an intensive care physician in Philadelphia.

 

 

 

Covid-19 Testing is increasing, but still not good enough

Posted on by • Posted in Clinical Testing, Coronavirus, Emergency Preparedness, Health Policy, Infection Control, Infectious Virus, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Safety, Social Distancing • Leave a comment

https://www.axios.com/newsletters/axios-vitals-daff1b24-727d-44eb-adb9-9f33cd61bc16.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

The Daily Shot: So Far, About 5% of Small Businesses Received ...

The good news is that the number of daily coronavirus tests is going up again. The bad news is that it’s still not nearly enough for the country to safely reopen.

Why it matters: If we don’t know who has the virus, we can’t stop it from spreading without resorting to stringent social distancing measures.

Driving the news: On Saturday, Anthony Fauci said that the U.S. is testing roughly 1.5 million to 2 million people a week, but “we probably should get up to twice that as we get into the next several weeks, and I think we will.”

  • Deborah Birx, the White House coronavirus task force coordinator, said yesterday that “we have to realize that we have to have a breakthrough innovation in testing.” She said we’ll need tests that can detect antigen, or the part of a pathogen that triggers an immune response.

Between the lines: Testing has been hampered by shortages of supplies like swabs and test kits. There has also been a lack of coordination between labs with excess testing capacity and communities struggling to meet testing demand.

What we’re watching: Some major cities and states — including New York and California — have begun to expand testing beyond the sickest patients, which is a good sign.

 

 

 

 

U.S. coronavirus updates

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Emergency Preparedness, Employee Benefits, Employee Furlough, Employee Layoffs, Employee Pay Cuts, Employer-Based Health Insurance, False Hope, Health Insurance Coverage Adequacy, Health Policy, Healthcare Providers, Intensive Care (ICU), Job Market, Job Search, Job Security, Leadership Decentralized, Mortality, Nurses, Out of Pocket Expenses, Pandemic, Personal Protective Equipment (PPE), Physician, Preexisting Conditions, Protest, Public Health, Public Safety, Social Distancing, Surprise Bills, Uncertainty, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Unrealistic Expectations, Vaccination, Vaccine, Ventilators • Leave a comment

https://www.axios.com/coronavirus-west-virginia-first-case-ac32ce6d-5523-4310-a219-7d1d1dcb6b44.html

Coronavirus outbreak is level of public pain we haven't seen in ...

 

The pandemic is a long way from over, and its impact on our daily lives, information ecosystem, politics, cities and health care will last even longer.

The big picture: The novel coronavirus has infected more than 939,000 people and killed over 54,000 in the U.S., Johns Hopkins data shows. More than 105,000 Americans have recovered from the virus as of Sunday.

Lockdown measures: Demonstrators gathered in Florida, Texas and Louisiana Saturday to protest stay-at-home orders designed to protect against the spread of COVID-19, following a week of similar rallies across the U.S.

  • 16 states have released formal reopening plans, Vice President Mike Pence said at Thursday’s White House briefing. Several Southern states including South Carolina have already begun reopening their economies.
  • Alaska, Oklahoma and Georgia reopened some non-essential businesses Friday. President Trump said Wednesday he “strongly” disagrees with Georgia Gov. Brian Kemp on the move.
  • California’s stay-at-home orders and business restrictions will remain in place, Gov. Gavin Newsom made clear at a Wednesday news briefing. But some local authorities reopened beaches in Southern California Saturday.
  • New York recorded its third-straight day of fewer coronavirus deaths Friday. Still, Gov. Andrew Cuomo said he’s not willing to reopen the state, citing CDC guidance that states need two weeks of flat or declining numbers.

Catch up quick: Deborah Birx said Sunday that it “bothers” her that the news cycle is still focused on Trump’s comments about disinfectants possibly treating coronavirus, arguing that “we’re missing the bigger pieces” about how Americans can defeat the virus.

  • Anthony Fauci said Saturday the U.S. is testing roughly 1.5 million to 2 million people a week. “We probably should get up to twice that as we get into the next several weeks, and I think we will,” he said.
  • The number of sailors aboard the USS Kidd to test positive for the coronavirus has risen from 18 Friday to 33, the U.S. Navy said Saturday. It’s the second major COVID-19 outbreak on a U.S. naval vessel, after the USS Theodore Roosevelt, where a total of 833 crew members tested positive, per the Navy’s latest statement.
  • The first person known to have the coronavirus when they died was killed by a heart attack “due to COVID-19 infection” on Feb. 6, autopsy results obtained by the San Francisco Chronicle on Saturday show.
  • Some young coronavirus patients are having severe strokes.
  • Trump tweeted Saturday that White House press conferences are “not worth the time & effort.” As first reported by Axios, Trump plans to pare back his coronavirus briefings.
  • The South is at risk of being devastated by the coronavirus, as states tend to have at-risk populations and weak health care systems.
  • New York Gov. Andrew Cuomo said Friday Trump was right to criticize the World Health Organization’s handling of the global outbreak.
  • Trump signed legislation Friday for $484 billion in more aid to small businesses and hospitals.
  • The House voted along party lines on Thursday to establish a select committee to oversee the federal government’s response to the crisis.
  • Unemployment: Another 4.4 million Americans filed last week. More than 26 million jobless filings have been made in five weeks due to the pandemic.

 

 

 

 

Learning from the largest US study of coronavirus patients

Posted on by • Posted in Blood Clots, Chronic Diseases, Clinical Testing, Coronavirus, Diabetes, Intensive Care (ICU), Mortality, Organ Failure, Pandemic, Ventilators • Leave a comment

https://mailchi.mp/0d4b1a52108c/the-weekly-gist-april-24-2020?e=d1e747d2d8

ICU patients with coronavirus and pneumonia treated in Wuhan ...

A study published this week in JAMA provides a look at the largest series of COVID-19 hospitalized patients studied to date in the US, reporting that almost all patients treated had at least one underlying condition. Physicians from Northwell Health evaluated the outcomes, comorbidities and clinical course of 5,700 confirmed coronavirus patients hospitalized between March 1st and April 4th across the New York City area. Hospitalized patients, 60 percent of whom were men, had a high burden of chronic disease.

Similar to other reports, older patients, and those with a higher chronic disease burden (especially diabetes) were both more likely to require mechanical ventilation, and more likely to die. Only nine of the 436 patients under age 50 who had no significant cormorbidities (as measured by the Charlson Comorbidity Index) had died. One number received the most press coverage: as reported in the abstract, 88 percent of patients who received mechanical ventilation died. Digging into the details of the series, this may end up being an overestimation, as the statistic is based on a subset of 320 ventilated patients who either died or were discharged by April 4th. At that time, 831 patients remained in the hospital on ventilators, with outcomes still to be determined. Ultimately, the mortality rate of full cohort of ventilated patients could fall nearer to the 50-60 percent range seen in other studies.

Regardless, the rich dataset of the Northwell report adds to the body of evidence that severe COVID-19 infections and deaths involve several organ systems. This Science article provides a thorough (and comprehensible to the non-clinician) review of how the virus invades the body. While the lungs remain “ground zero” for infection, critically ill patients may experience serious kidney, cardiac, or even nervous system involvement. A host of chronic diseases predispose patients for worse outcomes—yet doctors remain puzzled that they aren’t seeing “a huge number of asthmatics” in ICUs. Patients are presenting with dangerously low oxygen levels but less distress than expected, likely because they are able to still “blow off” carbon dioxide, limiting the body’s ability to sense the seriousness of their condition.

Many dying patients are overwhelmed by a “cytokine storm”—an overreaction of the immune system that compounds organ failure. And new evidence suggests that large numbers of critically ill patients may experience abnormal blood clotting, contributing to the high mortality rates of the disease. The more doctors and scientists learn about coronavirus, the more complex the disease process seems—leaving doctors with work to do to understand, manage, and treat the tens of thousands of these seriously ill patients.

 

 

 

Tentative steps toward recovering from a deadly pandemic

Posted on by • Posted in 2020 Election Issues, Center for Medicare and Medicaid Services (CMS), Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Economic Crisis, Economic Stimulus, Economy, Elective Procedures, Elective Surgery, Health Policy, Health System, Hospital, Hospital Industry, Infection Control, Infectious Virus, Medicare, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Safety, Quarantine, Safety Net Hospitals, Safety-Net Providers, Social Distancing, The CARES Act • Leave a comment

https://mailchi.mp/0d4b1a52108c/the-weekly-gist-april-24-2020?e=d1e747d2d8

Baby Steps – Selah Someonetotalkto's Blog

The death toll from the novel coronavirus continued to mount this week, with more than 50,000 deaths reported in the US, and over 900,000 confirmed cases nationwide. Globally, the disease has infected more than 2.7M people and killed nearly 200,000. On Tuesday, public health officials in California announced that two people who died in Santa Clara County in early February were victims of COVID-19, making them the earliest known fatalities in the US, and altering experts’ understanding of how long the disease has been spreading in the country. New modeling from researchers at Northeastern University this week suggested that the virus may have been spreading widely in several cities by early February, but went undetected because of restrictions on testing.

National attention has remained focused on the subject of testing, as states and localities scramble to secure enough testing supplies and equipment to allow them to understand community spread and identify new cases. President Trump signed an emergency $484B relief bill on Friday that will provide $25B to ramp up testing, give additional aid to businesses forced to shutter, and send hospitals $75B in additional emergency funding.

The new money for hospitals is in addition to $100B already approved by Congress for a “provider relief fund” as part of the CARES Act. Having already distributed $30B of the initial grant money to hospitals, the Department of Health and Human Services (HHS) was expected to pay out an additional $20B today, this time according to a formula based on the net patient revenue of each hospital, rather than the earlier approach based on Medicare billings. The shift is expected to address concerns among children’s hospitals, safety-net providers, and others who were disadvantaged by the Medicare-based approach. It is unclear how the newly approved $75B of additional funding will be allocated.

Meanwhile, states began to plan for the reopening of their economies, with most governors taking a measured approach in coordination with neighboring states. A handful of states moved to loosen stay-at-home restrictions in advance of meeting the Trump administration’s “gating” criteria, including Florida, which reopened some beaches for recreational use, Oklahoma, and Georgia, which controversially allowed gyms, bowling alleys, hair and nail salons, and tattoo parlors to reopen on Friday.

Many states began to put in place plans to restart elective surgeries, which had been curtailed by a patchwork of differing state and local directives. The Centers for Medicare and Medicaid Services (CMS) released guidelines this week to help local officials decide when and how to restart surgeries. Whether for healthcare services or other types of economic activity, states will (and should) be guided by the ability to conduct widespread testing, robust contact tracing, and isolation of those infected with the virus. Ensuring that ability will likely make the next phase of the pandemic a protracted and frustrating “dance” of fits and starts, likely to last into the summer months and beyond.

 

 

 

Cartoon – At last a Sport We can Watch

Posted on by • Posted in 2020 Election Issues, Blame, Cartoon, Clinical Testing, Coronavirus, Crisis, Crisis Management, Denial, Emergency Preparedness, False Hope, Health Policy, Infection Control, Infectious Virus, Mislead, Misleading, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Safety, Social Distancing, Supply Chain • Leave a comment

KAL's cartoon | The world this week | The Economist

70% Of Americans Want Officials To Prioritize Public Health Over Restarting Economy

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economy, Health Policy, Infection Control, Infectious Virus, Mortality, Pandemic, Partisanship, Public Health, Public Safety, Social Distancing • Leave a comment

https://www.forbes.com/sites/arielshapiro/2020/04/23/70-of-americans-want-officials-to-prioritize-public-health-over-restarting-economy-trump-kemp/?utm_source=newsletter&utm_medium=email&utm_campaign=news&utm_campaign=news&cdlcid=#74a9d5ce68d3

The ICU nurse who stood masked and silent at the rally to open Arizona

A wide majority of Americans are not ready to resume public life, according to a poll released Thursday by CBS News and YouGov, as governors in Georgia, Tennessee and South Carolina plan to allow stay-at-home orders to expire next week.

KEY FACTS

Only 30% of people surveyed said the government’s priority should be restarting the economy; 70% said the focus should be on slowing the virus through social distancing measures.

The polling shows a partisan divide—while 91% of Democrats and 69% of Independents favor focusing on public health, 52% of Republicans say the economy should take precedence.

29% of those polled said they would feel comfortable eating at a restaurant; Georgia Governor Brian Kemp will allow certain businesses, including restaurants, to open on April 27, 2020.

A minority of respondents said they would be comfortable going to work right now (44%) and even fewer said they would attend a large entertainment or sports event (13%), but the social isolation is taking its toll—54% said they would be willing to visit their friends.

KEY BACKGROUND

Protests against stay-at-home orders have cropped up around the country in states like California and Michigan, initially with President Donald Trump’s support. Although the movement is vocal, its support is limited. Less than a quarter of the poll’s respondents said they support the protests, and only 7% think that Trump should encourage them. The president is starting to change his tune, criticizing Georgia Governor Kemp’s plan to reopen businesses at the White House briefing on Wednesday.

WHAT TO WATCH FOR

Florida Governor Ron DeSantis said he is coordinating with neighboring governors on how to proceed, but has not yet announced whether he will extend the state’s stay-at-home order or let it expire. Florida has had more than 28,000 cases of COVID-19, more than any other southern state. A Quinnipiac poll released Wednesday shows that Florida residents’ opinions on reopening the economy reflect those of the country: Only 22% said that the state should loosen social distancing rules at the end of the month. As a first step, DeSantis allowed localities to reopen their beaches last week, and some, notably those in Jacksonville, were crowded.

 

 

Governor Cuomo, Bloomberg Announce Unprecedented New York COVID-19 Coronavirus Contact Tracing Program

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economy, Health Policy, Infection Control, Infectious Virus, Mortality, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, Vaccination, Vaccine • Leave a comment

https://www.forbes.com/sites/brucelee/2020/04/23/governor-cuomo-bloomberg-announce-unprecedented-new-york-covid-19-coronavirus-contact-tracing-program/?utm_source=newsletter&utm_medium=email&utm_campaign=career&cid=5d2c97df953109375e4d8b68#129e09243cd1

Coronavirus: Why are there doubts over contact-tracing apps? - BBC ...

New York is not going to let the COVID-19 coronavirus spread without a trace. Make that multiple traces. In fact, make that many, many, many traces.

New York State Governor Andrew Cuomo and former New York City Mayor Mike Bloomberg announced the launch of a massive contact tracing program in an effort to better contain the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). How massive? How about larger-than-any-contact-tracing-effort-that’s-been-attempted-before-in-the-U.S. massive?

It is a sign of the times that Cuomo had to include a slide that said: “But we can’t be stupid.” After all, there are other people out there pushing to re-open businesses without at the same time providing a specific plan on how exactly to stop the virus when social distancing measures are relaxed.

Bloomberg Philanthropies, which was founded by Bloomberg, will contribute $10.5 million as well as technical support and assistance to the program. The Johns Hopkins Bloomberg School of Public Health will develop an online training program and certification process for those doing the contact tracing. Vital Strategies, via its Resolve to Save Lives initiative, will advise and assist the New York State Health Department staff in developing protocols and processes to help the whole contact tracing process.

Speaking of vital strategies, “test-trace-isolate” is quite a vital strategy to try to contain the COVID-19 coronavirus so that social distancing measures can be relaxed and things can re-open, at least to some degree. Contact tracing is the “trace” part of that strategy. I’ve described previously for Forbes how to do contact tracing. When you’ve identified a person (an index case) infected with the SARS-Cov2 via testing, contact tracing is determining and locating every person that index case may have had contact with that was close enough to transmit the virus. This way you can isolate or quarantine all of those contacts as quickly as possible so that they can’t spread the virus any further. Essentially testing, tracing, and isolating or quarantining aims to contain the virus, to box it in, to give it no people to spread to, to surround it by nothing but toilet paper, fluffy pillows, Netflix videos, and whatever else people have in their houses and apartments.

Without a vaccine or specific treatment versus the SARS-Cov2, the virus could have spread much more widely without social distancing measures in place, because supplements, gargling salt water, Medieval chants or whatever bogus prevention measures have been offered weren’t going to stop the virus. Premature re-opening could send all of those efforts down the metaphorical toilet bowl. “While we start our work to re-open our economy we must ensure we are doing it in a way that does no harm and does not undo all of the work and sacrifice it has taken to get here,” said Cuomo in statement. “One of the most critical pieces of getting to a new normal is to ramp up testing, but states have a second big task – to put together an army of people to trace each person who tested positive, find out who they contacted and then isolate those people.”

Think about it. If you re-open places and relax social distancing measures, it could take only a small number of people spreading the virus to then cause another surge in COVID-19 cases. Therefore, a good contact tracing program needs to be in place to catch potentially infectious people quickly. Implementing large scale and coordinated contact tracing programs has been one way that Germany, Singapore and South Korea have been able to better control the COVID-19 coronavirus and its impact than the U.S. and U.K. have.

“We’re all eager to begin loosening restrictions on our daily lives and our economy,” said Bloomberg in a statement. “But in order to do that as safely as possible, we first have to put in place systems to identify people who may have been exposed to the virus and support them as they isolate.”

Putting appropriate systems in place before making a decision? Hear that sound? It’s the sound of science walking back into the ongoing “re-open America” conversation and saying, “what the heck have you been doing to the house while I’ve been away.” Deciding to re-open anything without first putting proper systems in place to monitor and contain the virus would be like going to a dinner party when you aren’t wearing any clothes. It would leave you quite exposed and basically put your butt on the line.

Although the program is launching immediately, it will take some time to recruit and train hundreds or perhaps thousands of tracers. Potential recruits will come from a variety of places such as the State Department of Health, various state agencies, the State University of New York (SUNY), and the City University of New York (CUNY). Henning indicated that the timeline for getting things in place will be in the order of “a number of weeks.”

This program will coordinate with contact tracing efforts in New Jersey and Connecticut. After all, this virus doesn’t respect borders or need an E-ZPass to spread to neighboring states. As Henning noted, “New York state has already been talking extensively with New Jersey and other states.”

If you live outside this tri-state area, try to pay attention to what’s going on here. After all, contact tracing will have to occur in other parts of the country as well. Otherwise, the virus can keep circulating in different parts of the country, which means that it could at any time readily spread to the rest of the U.S. After all, the virus is like a very bad house guest. It doesn’t respect boundaries. And it is unlikely to just disappear without a trace.