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Friday, May 8, 2020

FDA approves Eli Lilly drug to treat three types of tumors

Eli Lilly’s (NYSE:LLY) Retevmo treatment is approved by the Food and Drug Administration for three types of tumors: non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers.
The FDA calls Retevmo (selpercatinib) “the first therapy approved specifically for cancer patients with RET gene alterations,” a mutation that occurs in ~2% of lung cancers and 10%-20% of papillary thyroid cancers.
Lilly’s drug is part of a trend of treating cancer based on a patient’s genetics rather than the location in the body where the disease originated.
Lilly will price the drug at $20,600 for 30 days of treatment, the head of the company’s oncology division tells Reuters.
https://seekingalpha.com/news/3572368-fda-approves-eli-lilly-drug-to-treat-three-types-of-tumors

Acceptability of app-based Covid-19 contact tracing: Cross-country survey

Samuel Altmann, Luke Milsom, Hannah Zillessen, Raffaele Blasone, Frederic Gerdon, Ruben Bach, Frauke Kreuter, Daniele Nosenzo, Severine Toussaert, Johannes Abeler

Abstract

Background: The COVID-19 pandemic is the greatest public health crisis of the last 100 years. Countries have responded with various levels of lockdown to save lives and stop health systems from being overwhelmed. At the same time, lockdowns entail large socio-economic costs. One exit strategy under consideration is a mobile phone app that traces close contacts of those infected with COVID- 19. Recent research has demonstrated the theoretical effectiveness of this solution in different disease settings. However, concerns have been raised about such apps because of the potential privacy implications. This could limit the acceptability of app-based contact tracing among the general population. As the effectiveness of this approach increases strongly with app take-up, it is crucial to understand public support for this intervention. Objectives: The objective of this study is to investigate user acceptability of a contact-tracing app in five countries hit by the pandemic. Methods We conducted a multi-country, large-scale (N = 5995) study to measure public support for digital contact tracing of COVID-19 infections. We ran anonymous online surveys in France, Germany, Italy, the UK and the US. We measured intentions to use a contact-tracing app across different installation regimes (voluntary installation vs. automatic installation by mobile phone providers), and studied how these intentions vary across individuals and countries. Results: We found strong support for the app under both regimes, in all countries, across all sub-groups of the population, and irrespective of regional-level COVID-19 mortality rates. We inves- tigated the main factors that may hinder or facilitate take-up and found that concerns about cyber security and privacy, together with lack of trust in government, are the main barriers to adoption. Conclusions: Epidemiological evidence shows that app-based contact-tracing can suppress the spread of COVID-19 if a high enough proportion of the population uses the app and that it can still reduce the number of infections if take-up is moderate. Our findings show that the willingness to install the app is very high. The available evidence suggests that app-based contact tracing may be a viable approach to control the diffusion of COVID-19.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

We acknowledge funding from the Economic and Social Research Council (grant ES/R011710/1), the University of Oxford and Volkswagen Foundation (grant “Consequences of Artificial Intelligence for Urban Societies”).

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https://www.medrxiv.org/content/10.1101/2020.05.05.20091587v1

Hydroxychloroquine and azithromycin plus zinc in hospitalized Covid-19 patients

Philip Carlucci, Tania Ahuja, Christopher M Petrilli, Harish Rajagopalan, Simon Jones, Joseph Rahimian

Abstract

Background: COVID-19 has rapidly emerged as a pandemic infection that has caused significant mortality and economic losses. Potential therapies and means of prophylaxis against COVID-19 are urgently needed to combat this novel infection. As a result of in vitro evidence suggesting zinc sulfate may be efficacious against COVID-19, our hospitals began using zinc sulfate as add-on therapy to hydroxychloroquine and azithromycin. We performed a retrospective observational study to compare hospital outcomes among patients who received hydroxychloroquine and azithromycin plus zinc versus hydroxychloroquine and azithromycin alone. Methods: Data was collected from electronic medical records for all patients being treated with admission dates ranging from March 2, 2020 through April 5, 2020. Initial clinical characteristics on presentation, medications given during the hospitalization, and hospital outcomes were recorded. Patients in the study were excluded if they were treated with other investigational medications. Results: The addition of zinc sulfate did not impact the length of hospitalization, duration of ventilation, or ICU duration. In univariate analyses, zinc sulfate increased the frequency of patients being discharged home, and decreased the need for ventilation, admission to the ICU, and mortality or transfer to hospice for patients who were never admitted to the ICU. After adjusting for the time at which zinc sulfate was added to our protocol, an increased frequency of being discharged home (OR 1.53, 95% CI 1.12-2.09) reduction in mortality or transfer to hospice remained significant (OR 0.449, 95% CI 0.271-0.744). Conclusion: This study provides the first in vivo evidence that zinc sulfate in combination with hydroxychloroquine may play a role in therapeutic management for COVID-19.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

this is a retrospective observational study and therefor not a clinical trial

Funding Statement

No funding was provided for this work.

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https://www.medrxiv.org/content/10.1101/2020.05.02.20080036v1

Kids without computers left behind with schools closed by coronavirus


Not all kids have computers – and they're being left behind with schools closed by the coronavirus
Since 2014, the Dornsife Center for Economic and Social Research, located at the University of Southern California, has been tracking trends in health economic well-being, attitudes and behaviors through a nationwide survey for its Understanding America Study, asking the same individuals questions over time.
The nationally representative survey is now assessing how COVID-19 is affecting U.S. families. This includes their health, economic status and, for the first time, educational experiences. With two other education researchers Amie Rapaport and Marshall Garland, we analyzed the educational experience data that have recently been added to the study.
What we did
We worked with the broader Understanding America Study team to ask Americans about the effects the pandemic is having on students and their families.
About 1,450 families with children answered these questions between April 1 and April 15.
We found that nearly all—about 85% – of families with at least one child between kindergarten and their senior year of high have and a computer they can use for distance learning while school buildings are shuttered.
However, we found large disparities in technology access based on income. Among the 20% of American households who make US$25,000 or less a year, just 63% of schoolchildren have access to a computer and the internet. In comparison, essentially all students from the most affluent families—those whose parents make $150,000 annually or more—do.
To be sure, that doesn’t mean a third of poor kids are being locked out of getting an online education. Many of those students are also using tablets and smartphones to participate in educational activities. However, the types of educational activities a can easily engage in with a computer and wireless internet –such as writing long essays—are broader than the types possible on a tablet or an even smaller screen and with just a cellular connection.
These inequities can leave low-income families scrambling for wireless access. Some of the limited options available can include include working from a car parked outside a local library or a McDonald’s parking lot.
Why it matters
There’s a big gap between how much access rich and poor children have to technology. This is known as the “digital divide.”
This disparity contributes to the achievement gaps between students based largely on their .
These findings show that the digital divide is playing out in real time during this pandemic in ways that are sure to lead to unequal negative effects on already disadvantaged students.
What’s next?
Most schools in the country are likely to remain closed for months – long after we collected this initial data. We believe that it’s possible that this divide will narrow once more districts distribute computers, tablets and other hardware, more communities take steps to expand broadband access to those who can’t afford it and teachers get better at educating kids online.
There’s a chance that federal help could arrive, should Congress pass the Emergency Educational Connections Act of 2020, a measure authored and backed by House Democrats aimed at narrowing the . It would normally be states—which provide the largest share of funding for —that would address issues like technology in schools, but with states facing mounting budget constraints that’s going to be a big challenge. A similar bill is pending in the Senate.
https://phys.org/news/2020-05-kids-left-schools-coronavirus.html#

U.S. COVID-19 death rate is 1.3% – study

Among detected cases of COVID-19 in the United States, 1.3% of patients will die from the illness, according to a new calculation. But that rate could increase if current precautions and health care capacities change, the study’s author said.
The 1.3% rate calculation is based on cumulative deaths and detected cases across the United States, but it does not account for undetected cases, where a person is infected but shows few or no symptoms, according to researcher Anirban Basu.
If those cases were added into the equation, the overall death rate might drop closer to 1%, Basu said.
He directs the department of pharmacy at the University of Washington in Seattle.
Basu stressed that the apply “under the assumption that the current supply [as of April 20] of health care services, including hospital beds, ventilators, and access to health care providers, would continue in the future.” Declines in the availability of could increase COVID-19 death rates.
Most crucially, social distancing and other preventive measures will help keep the U.S. COVID-19 death rate down, Basu said. Accordingly, recent White House COVID-19 Taskforce projections of 100,000 to 200,000 deaths this year from COVID-19 are made with assumptions about the effectiveness of measures that are currently in place, he said.
Many states are already moving to relax restrictions on “shelter in place” rules, with businesses, beaches and parks reopening.
The estimated COVID-19 death rate of 1.3% is still much higher than the U.S. death rate for seasonal flu for 2018-2019, which was just 0.1% of cases, according to the U.S. Centers for Disease Control and Prevention.
On the other hand, the new estimate is much lower than prior death rate calculations. For example, China’s COVID-19 death rate was initially reported to be 5.6%, falling to 3.8% by Feb. 20. But that could be due to timing: As in China, U.S. rates were much higher in the early stages of the pandemic, Basu noted.
The new study’s findings are based on 40,835 confirmed COVID-19 cases and 1,620 confirmed deaths in 116 counties across 33 states through April 20. Death rates varied widely across locales, with some counties recording a death rate of just 0.5% while others went as high as 3.6%.
According to Basu, determining the COVID-19 death rate is crucial in the fight against the pandemic.
“When used with other estimating approaches, our model and our estimates can help disease and policy modelers to obtain more accurate predictions for the epidemiology of the disease and the impact of alternative policy levers to contain this pandemic,” he wrote in the report published online May 7 in Health Affairs.
“The CDC reports a significant variation in fatality rates by age groups. Further work is required on this front,” Basu added in a journal news release.
The estimate of the U.S. COVID-19 rate is “not outside the ballpark” of estimated rates available from other countries, but lower, he concluded.
https://medicalxpress.com/news/2020-05-covid-death.html

7 questions about Covid-19 testing and what it means for reopening the country

Pressure to perform widespread Covid-19 testing is growing as public health experts and ordinary citizens question the safety of reopening schools and businesses across the U.S. without better information about who is infected and at risk of spreading the virus. That is only adding to the strain on the nation’s testing capacity, and raising questions about who should get priority.
The Infectious Diseases Society of America, which represents the nation’s infectious disease experts, issued guidelines Wednesday about who should be tested, how they should be tested, when they should be tested, and then what to make of the results.
Some answers aren’t known with any certainty yet, leading to knowledge gaps future research might fill, but not before many states begin to relax social distancing, two co-authors of the guidelines said in a call with reporters Friday. Meanwhile, tests and chemicals needed by labs to interpret them are still in short supply.
“Something that we’re all concerned about right now is in some locations in this country, they don’t have adequate [supplies] to test symptomatic patients,” said Angela Caliendo, an infectious disease specialist and professor of medicine at Brown University. “It remains a substantial challenge for all of us to be able to get enough people tested and having enough reagents to do that.”
Shortages go beyond tests and reagents when community surveillance is proposed as a way to judge how the coronavirus is spreading, said Kimberly Hanson, an associate professor of medicine at the University of Utah School of Medicine.
“It’s all sorts of resources around the testing,” she said. “We need more support for public health in our area to really deploy testing and contact tracing in the community. We need to train and get more epidemiologists and contact tracers to do that.”
Here’s what else Caliendo and Hanson had to say about testing:

Who should get tested?

Policies about testing all people with possible coronavirus infections have varied from state to state. But the IDSA guidelines state that all patients who have clinical signs or symptoms that could be consistent with Covid-19, as defined by the CDC, should be tested. Knowing if a patient is infected with the virus starts a cascade of decision-making for clinicians: Do they need to be hospitalized and separated from other patients? If they can go home, how should they isolate themselves?
Another reason to test patients is to see if they would consider being enrolled in a clinical trial of a Covid-19 treatment, Hanson said.

What about people who don’t have symptoms?

If there aren’t enough tests, symptomatic patients should get them, but there are three situations that argue for a test in asymptomatic patients. If a patient is already in the hospital and Covid-19 is widespread in the area, do the test. If a patient has a compromised immune system owing to a disease or a transplant, that patient should be tested because Covid-19 leads to poor outcomes in these people. And if a patient is going to have surgery, do a test for the patient’s sake and for the protection of health care workers.

What kind of test is best?

A nasal swab or a nasopharyngeal swab got the group’s recommendation, based on a review of the medical literature. Throat swabs and saliva specimens did not, but that could change as more studies are published, particularly about saliva.
The group did not find enough research to differentiate the effectiveness of rapid testing  — results within an hour — from standard testing that takes up to five hours.
Most of the information about various tests is based on limited lab experiments comparing an individual test to what are called contrived samples, such as a nasal swab that doesn’t have any virus on it. The Food and Drug Administration approved tests using relaxed standards, so evaluations of tests as they’re used in the field, or comparisons among tests, have not been done.
“We don’t know yet what test is best or really how the emergency use authorization tests in the U.S. that are commercially available really compare to each other,” Caliendo said.

Should people get repeat tests?

Tests can have up to a 30% false negative rate, meaning they miss that proportion of people with actual infections. The IDSA said the need for retesting people with negative results  depends on how sick the person seems to be. “If you have a low clinical suspicion and the test is negative, our recommendation was to not retest. But if you have a high clinical suspicion, you should retest people who are ill, who are in the hospital, who are in the ICU,” Caliendo said.

What about antibody testing?

Antibody tests don’t detect an active infection, but rather look for signs that a person was previously infected, as shown by antibodies their immune system produced to fight the coronavirus. With other diseases, the presence of antibodies often means you have acquired immunity against re-infection, for at least some period of time, but that is not known yet in the case of Covid-19.
“We don’t have enough information about the performance of these tests to know ideally how to use them,” Caliendo said. “We need to understand, if the test is accurate and you have antibodies, what does that mean? Does it mean you’re protected from future infection? We don’t know that. We don’t know if it means you’re no longer infectious.”
Her advice to patients who get the antibody test anyway: “If you test positive, do not assume you’re immune from the attack, do not assume that you don’t have to abide by distancing, wearing masks, washing your hands, and doing all of that.”

How much testing is enough testing? Is there a percentage of the population we should shoot for?

“I think in general more is better. But I do think resources are not limitless and there still are places in the country that really don’t have sustained access to testing,” Hanson said. But “we need to really understand at a given location how much asymptomatic infection is present.”

What’s next?

Crunch time for labs.
People who have been able to manage their non-Covid-19 medical problems over the past few months will eventually come back to the hospital, Caliendo predicted, for the elective surgeries they may have postponed. When they do, that will strain hospital labs.
“The clinical labs are going to get really busy again,” she said. “And they won’t have as many resources to devote to Covid-19 when surgery opens up and we get back to what we would call our previous normal.”
7 questions about Covid-19 testing and what it means for reopening the country

Routine child vaccinations have plummeted during the Covid-19 pandemic

Routine vaccination of children in the United States appeared to have declined dramatically in March and April, in the weeks after Covid-19 was declared a pandemic and the United States government declared a national emergency, a new study published Friday shows.
The authors, from the Centers for Disease Control and Prevention and other institutions, used vaccine ordering data from pediatricians who administer vaccines through the Vaccines for Children Program, which provides government-purchased vaccines to about half of the children in the United States. The study, published by the CDC in its Morbidity and Mortality Weekly Report, compared orders for the period from Jan. 7 through April 21 this year to the same period last year.
The findings suggest childhood vaccination efforts nearly ground to a halt between March 13 — when the national emergency was declared — and April 19.
There was a 2.5 million-dose decline in orders of regular childhood vaccines — not counting influenza vaccines — and a 250,000-dose decline in vaccines containing measles protection in that period, the authors reported.
Doctors and public health experts have worried that a vast number of regular health care needs — including preventive care interventions like vaccinations — have gone unmet in the past few months as people shy away from interacting with a health system that has, at least in some places, been overwhelmed by caring for Covid-19 patients.
Pediatricians in particular have been concerned that children may be missing critical vaccinations, which the new data confirm has happened.
“Routine immunizations in young children are critical to maintain during the pandemic,” said Kathryn Edwards, a pediatrician and scientific director of the Vanderbilt Vaccine Research Program in Nashville, Tenn. “The usual childhood diseases are still around and we need to protect our children from them.”
Paul Offit, a pediatrician and vaccines expert at the Children’s Hospital of Philadelphia, said his institution had urged all pediatricians to continue to hold well-child appointments for children under the age of 2 to ensure they got their vaccinations on schedule.
“I think that didn’t happen,” Offit said. “I think there were a number of practices that didn’t do that because they were too scared. And so this is the result. You have this dramatic decline.”
Neither Edwards nor Offit was involved in this study.
The research suggests that the drop-off in vaccinations was less acute — though still sharp — in children under the age of 2 than in those aged 2 to 18 years old. It also points to a gradual uptick in administration of measles-containing vaccines in children under the age of 2 from about the end of March. But weekly numbers administered to children aged 2 to 18 remained a fraction of the previous weekly total through the end of the study period.
“The identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases,” the authors warned.
Routine vaccinations for U.S. children have plummeted during the Covid-19 pandemic