COVID-19 coronavirus could cost the US billions in medical expenses

Study shows hospitalizations, ventilators, and other health resources that patients would require could cost $654 billion if a majority of the population gets infected
CUNY GRADUATE SCHOOL OF PUBLIC HEALTH AND HEALTH POLICY

ESTIMATED COVID-19 CORONAVIRUS HEALTH CARE COSTS BASED ON PERCENT OF US POPULATION INFECTED view more CREDIT: CUNY SPH
One of the major concerns about the COVID-19 coronavirus pandemic has been the burden that cases will place on the health care system. A new study published April 23 in the journal Health Affairs found that the spread of the virus could cost hundreds of billions of dollars in direct medical expenses alone and require resources such as hospital beds and ventilators that may exceed what is currently available. The findings demonstrate how these costs and resources can be cut substantially if the spread of COVID-19 coronavirus can be reduced to different degrees.

The study was led by the Public Health Informatics, Computational, and Operations Research (PHICOR) team at the City University of New York (CUNY) Graduate School of Public Health and Health Policy (CUNY SPH) along with the Infectious Disease Clinical Outcomes Research Unit (ID-CORE) at the Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center and Torrance Memorial Medical Center. The team developed a computer simulation model of the entire U.S. that could then simulate what would happen if different proportions of the population end up getting infected with the COVID-19 coronavirus. In the model, each infected person would develop different symptoms over time and, depending upon the severity of those symptoms, visit clinics, emergency departments, or hospitals. The resources each patient would require such as health care personnel time, medication, hospital beds, and ventilators would then be based on the health status of each patient. The model then tracks the resources invovled, the associated costs, and the outcomes for each patient.

For example, if 20 percent of the U.S. population were to become infected with the COVID-19 coronavirus, there would be an average of 11.2 million hospitalizations and 1.6 million ventilators used, costing an average of $163.4 billion in direct medical costs during the course of the infection. The study shows the factors that could push this amount up to 13.4 million hospitalizations and 2.3 million ventilators used, costing an average of $214.5 billion. If 50 percent of the U.S. population were to get infected with the COVID-19 coronavirus, there would be 27.9 million hospitalizations, 4.1 million ventilators used and 156.2 million hospital bed days accrued, costing an average of $408.8 billion in direct medical costs during the course of the infection. This increases to 44.6 million hospitalizations, 6.5 million ventilators used and 249.5 million hospital bed days (general ward plus ICU bed days) incurred, costing an average of $654 billion during the course of the infection if 80 percent of the U.S. population were to get infected. The significant difference in medical costs when various proportions of the population get infected show the value of any strategies that could reduce infections and, conversely, the potential cost of simply letting the virus run its course.

"Some have suggested herd immunity strategies for this pandemic," explained Sarah Bartsch, project director at PHICOR and the study's lead author. "These strategies consist of allowing people to get infected until herd immunity thresholds are reached and the virus can no longer spread. However, our study shows that such strategies could come at a tremendous cost."

"This also shows what may occur if social distancing measures were relaxed and the country were to be 're-opened' too early," said CUNY SPH Professor Bruce Y. Lee, executive director of PHICOR and the study's senior author. "If the virus is still circulating and the infection rates surge as a result, we have to consider the resulting health care costs. Such costs will affect the economy as well because someone will have to pay for them. Any economic argument for re-opening the country needs to factor in health care costs."

The study shows how costly the COVID-19 coronavirus is compared to other common infectious diseases. For example, a single symptomatic COVID-19 coronavirus infection costs an average of $3,045 in direct medical costs during the course of the infection alone. This is four times higher than a symptomatic influenza case and 5.5 times higher than a symptomatic pertussis case. Factoring in the costs from longer lasting effects of the infection such as lung damage and other organ damage increased the average cost to $3,994.

"This is more evidence that the COVID-19 coronavirus is very different from the flu," said Bartsch. "The burden on the health care system and the resources needed are very different."

"Factoring in the costs incurred after the infection is over also adds to the costs. It is important to remember that for a proportion of the people who get infected, health care costs don't end when the active infection ends," Lee warned. "This pandemic will have its lasting effects and taking care of those who will suffer contuing problems is one of them."






A continuing concern is that the U.S. health care system will become overloaded with the surge of COVID-19 coronavirus cases and will subsequently not have enough person-power, ventilators, and hospital beds to accommodate the influx of patients. This study shows that even when only 20 percent of the population gets infected, the current number of available ventilators and ICU beds will not be suffient. According to the Society of Critical Care Medicine, there are approximately 96,596 ICU beds and 62,000 full-featured mechanical ventilators in U.S., substantially lower than what would be needed when only 20 percent of the population gets infected.

"Of course, the actual capacity used will depend on the timing of when patients need them," said Bartsch. "But showing that there are orders of magnitude differences between what is currently available and what may be needed is concerning."

While health care professionals and public health officials have expressed concerns about ventilator and hospital bed shortages, the model can quantify in a more detailed manner what specifically will be required at different phases of the pandemic and what to expect when more people are infected.


"The Potential Health Care Costs and Resource Use Associated with COVID-19 Coronavirus in the United States" was written by Sarah M. Bartsch, Marie C. Ferguson, James A. McKinnell, Kelly J. O'Shea, Patrick T. Wedlock, Sheryl S. Siegmund and Bruce Y. Lee.

This work was supported in part by CUNY SPH, the Agency for Health care Research and Quality (AHRQ) via grant R01HS023317, United States Agency for International Development (USAID) under agreement number AID-OAA-A-15-00064, Global Obesity Prevention Center (GOPC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Office of the Director, National Institutes of Health (OD) under award number U54HD070725. It was also supported by NICHD via grant U01HD086861 and 5R01HD086013-02 and by National Institute of General Medical Sciences (NIGMS) via the Models of Infectious Disease Agent Study (MIDAS) network under grant 1 R01 GM127512-01A1. The funders did not have any role in the study design, collection, analysis and interpretation of data, writing the report, and the decision to submit the report for publication. The authors of this manuscript are responsible for its content, including data analysis. Statements in the manuscript do not necessarily represent the official views of, or imply endorsement by, National Institute of Health, AHRQ or HHS.

About CUNY SPH

The CUNY Graduate School of Public Health and Health Policy is committed to teaching, research, and service that creates a healthier New York City and helps promote equitable, efficient, and evidence-based solutions to pressing health problems facing cities around the world.

About PHICOR

Since 2007, PHICOR has been developing computational methods, models, and tools to help decision makers better understand and address complex systems in health and public health. Follow @PHICORTeam for updates.

Falling visibility shows African cities suffering major air pollution increases -- study

UNIVERSITY OF BIRMINGHAM 

Falling visibility in three major African cities reveals that air pollution has increased significantly over the last 45 years - leaving citizens facing further short-term increases in man-made pollution due to increasing urbanization and economic development, a new study reveals.

Africa is not well-equipped with air quality monitoring, so scientists have used visibility data for capital cities in Ethiopia, Kenya and Uganda as a substitute measurement.

They discovered a significant reduction in visibility since the 1970s, where Nairobi shows the greatest loss (60%), compared to Kampala (56%) and Addis Ababa (34%) - due to increased particulate matter (PM) emissions from vehicles and energy generation.

Correspondingly, PM pollution levels in the three cities are estimated to have increased by 182%, 162% and 62% respectively since the 1970s to the current period.

University of Birmingham experts published their findings in Environmental Research Letters. They are now calling for a systematic approach to understand the causes and effects of air pollution in urban East Africa - allowing improvements in air quality to co-exist with sustainable future economic development.

Report co-author Dr. Ajit Singh commented: "Evidence indicates that ambient air quality in urban African locations is often poor, because of high rates of urbanisation and population growth leading to large-scale construction, increased energy use, vehicle emissions and industrialisation.

"PM air pollution is a major concern in East Africa because of its impact on human health. There are few air quality monitoring networks, resulting in little long-term air quality data, but visibility measured at major cities can be used as a proxy for PM pollution.

"We're tremendously proud of our work in East Africa and the analysis techniques we developed to study Nairobi, Kampala and Addis Ababa are translatable to other parts of the world where air quality data is limited."

The Birmingham team's work is funded by the UK Department for International Development (DFID) through the East Africa Research Fund (EARF) grant 'A Systems Approach to Air Pollution (ASAP) East Africa' and Digital Air Quality (DAQ) - East Africa funded via EPSRC Global Challenges Research Fund.

Co-author Dr. William Avis commented: "Air pollution poses a major health, economic and social threat to cities around the world - inextricably linked to how we plan, manage and live in urban areas. East Africa is no exception to this, but lacks robust air quality data."

Co-author and ASAP lead Professor Francis Pope said: "We need to understand the causes and effects of air pollution in these three cities, which are rapidly developing and will likely experience further increases in PM. Poor air quality acts as a brake on development through increasing expenditure on health, loss of labour productivity, and the impact of illness on education.

"To date, no studies have been able to assess the role of socio-economic factors upon the evolution of air pollution in East Africa. Our work provides data that helps us understand this relationship and provides a much needed baseline for East African urban air quality that can help assess future air quality improvement interventions in the region."

The researchers compared changes in pollution to population growth and GDP statistics - finding increased PM levels linked to increases in national GDP and populations in all three study cities.

They also discovered distinct variations in seasonal visibility, which are largely explained by changing PM sources and sinks in rainy and dry seasons. Visibility was lowest during the dry months and highest in wet months. At all study sites, visibility was higher on Sundays - due to reduced traffic and industrial emissions.

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* 'Visibility as a proxy for air quality in East Africa' - Ajit Singh, William R. Avis and Francis D. Pope is published in Environmental Research Letters. A copy of the research paper can be downloaded at https://iopscience.iop.org/article/10.1088/1748-9326/ab8b12 - please feel free to include this link to the paper in any online article.

New study takes the pulse of a sleeping supervolcano



UPPSALA UNIVERSITY

THE LLAMAS OF THE ANDES' HIGH PLATEAU ARE UNAWARE OF THE ENORMOUS AMOUNT OF MAGMA BELOW THEIR HOOVES. view more  CREDIT: OSVALDO GONZÁLEZ-MAUREL
Under the volcanoes in the Andes where Chile, Argentina and Bolivia meet, there is a gigantic reservoir of molten magma. For several million years, it has been there without fully solidifying or causing a supervolcanic eruption. Geologists have long wondered how this is possible. Researchers from Uppsala University, among others, have now discovered that the secret may be hidden tributaries of hot magma from inside the Earth.

The study is published in the journal Scientific Reports.

"Huge volcanic eruptions from so-called supervolcanoes are very unusual, but when they happen they are extremely devastating. It's incredibly important for volcanologists to clarify what keeps this sleeping giant alive and what can cause it to awaken," says Valentin Troll, Professor of Petrology at the Department of Earth Sciences at Uppsala University.

The giant so-called Altiplano-Puna magma body is estimated to contain 500,000 cubic kilometers of molten and semimolten magma. In order to provide a picture of how much volume is involved, it can be said that the entire island of Gran Canaria would fit inside - more than ten times over. The last really large volcanic eruption here occurred 4 million years ago and was the last in a series of very large explosive eruptions that began 10 million years ago. Some of them can be classified as supervolcanic eruptions.

In order to look for answers as to how the magma could stay molten for millions of years, the researchers studied lavas that were ejected from the magma reservoir during smaller volcanic eruptions after the last major eruption. The chemical composition of such material can provide an indication of how a magma reservoir works, how far down from inside the Earth the material originates, how long it remained in the reservoir and what different processes the magma underwent before it was ejected by the volcano.

In this case, the researchers wants to find out if new magma forces its way into the reservoir and therefore needed to find material that, after forming in the Earth's mantle, was not affected by interaction with the magma that was already in the reservoir.

"This was a demanding task. Under these particular volcanoes in the Central Andes is the Earth's thickest crust, 70 kilometers thick, which means that the magma is given many chances to change and react with the material it comes into contact with when it forces its way up to the surface," says Frances Deegan, a researcher at Uppsala University.

The researchers therefore searched several years for lava that was as "original" as possible. Finally, they found what they were looking for. They have now analyzed the composition of the oxygen isotopes in their samples to find out how lavas were formed and where they originate from. The results showed that the lavas came from deep within the Earth and that they represent the material that feeds the volcanoes of the Central Andes, keeping them alive.

This new knowledge is important to understanding how large, complex volcanoes work.

"Supervolcanic eruptions can cause gigantic disasters. The last one that happened on the Earth was Toba's super eruption in Indonesia 73,000 years ago and it is considered to have almost led to the extinction of mankind. Even if we can't prevent a super eruption from happening, it would be smart to use the time until the next eruption to learn as much as possible to increase the chances for our communities to survive such an event," says Valentin Troll.

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For further information, please contact:

Valentin Troll, professor at Department of Earth Sciences, Natural Resources and Sustainable Development
Phone: +46 18 471 25 70
Email: Valentin.Troll@geo.uu.se

Hummingbirds show up when tropical trees fall down



UNIVERSITY OF ILLINOIS COLLEGE OF AGRICULTURAL, CONSUMER AND ENVIRONMENTAL SCIENCES

HUMMINGBIRDS LIKE THIS ONE APPEARED IN DROVES AFTER A TREEFALL GAP OPENED UP IN THE PANAMANIAN FOREST. view more CREDIT: PHOTO BY HENRY POLLOCK, UNIVERSITY OF ILLINOIS.

URBANA, Ill. - When the tree fell that October in 2015, the tropical giant didn't go down alone. Hundreds of neighboring trees went with it, opening a massive 2.5-acre gap in the Panamanian rainforest.

Treefalls happen all the time, but this one just happened to occur in the exact spot where a decades-long ecological study was in progress, giving University of Illinois researchers a rare look into tropical forest dynamics.

"I've been walking around that tree for 30 years now. It was just humongous," says Jeff Brawn, Professor and Stuart L. and Nancy J. Levenick Chair in Sustainability in the Department of Natural Resources and Environmental Sciences at Illinois. "Here we are, running around on this plot for years and all of a sudden I couldn't even find my way around. We just lucked into it."

What's lucky is that Brawn and his colleagues had amassed decades of data on the bird community in that exact spot, meaning they had a clear before-and-after view of what a treefall could mean for tropical birds.

This particular gap meant hummingbirds. Lots and lots of hummingbirds.

"After the treefall, we saw a very large spike in the total number of hummingbird species," says Henry Pollock, a postdoctoral scholar working with Brawn and lead author on a study published in the Journal of Field Ornithology. "Within the previous 25 years of the study, we had only documented three or four hummingbird species, and they were usually present in low numbers. There was one species, the snowy-bellied hummingbird, which we had never captured on either of our two plots in 25 years of sampling. The year after the treefall happened, we got 16 unique individuals of this one species, and total diversity of hummingbirds more than doubled."

The gap also attracted fruit-eating birds. The researchers documented a doubling of this group compared to pre-treefall numbers, with certain species being more than three times as abundant. Other species, including the thick-billed seed-finch, which typically inhabits grasslands, appeared as if out of thin air.

"They just swooped in," Brawn says. "It's analogous to a backyard bird feeder. As soon as you put one in, you'll see species you've never seen before."

And then, almost as quickly, the birds disappeared.

Within one to four years, depending on the species, the birds returned to pre-treefall numbers or were not detected again.

"What that suggests is these birds are incredibly mobile and opportunistic," Pollock says. "They are probably just cruising around the landscape prospecting for their preferred food sources and habitats. Given the sheer size of this gap, it acted as a sort of magnet, pulling in species from potentially kilometers away. I mean, 16 snowy-bellied hummingbirds and we've never caught one before? It's pretty astounding."

Treefalls are a common and necessary occurrence in forests all over the world. As sunshine streams in from above, trees hunkered down in the understory finally get their chance to rise. Basking in the suddenly resource-rich environment, tropical trees and other plants produce nectar-filled flowers and fruit, important food sources for birds and other animals.

Previous research has hinted at how important these food sources are for tropical birds, but no one had documented before-and-after differences until now. Instead, researchers typically compared treefall gaps with intact forest areas at a single time point. That approach has its uses, but it can't capture what Brawn and Pollock found: just how quickly the birds arrived on the scene, and how quickly they left.

"I was just really just astonished at how quickly and how efficiently these birds seem to be able to find and exploit a new source of food," Brawn says.

Gaps don't stay open long in the tropics. Understory trees shoot up, elbowing each other out of the way to take the top spot. Soon, there's no evidence a gap - or its riotous array of feathered occupants - was there at all.

As short-lived as they may be, treefall gaps represent critical opportunities for species turnover, especially in the tropics where forest fires are comparatively rare.

"This kind of periodic disturbance is probably necessary for these birds to persist in the landscape matrix," Pollock says. "That's true for many organisms and ecosystems; our study provides evidence to back that up in these birds."


The article, "Rapid colonization and turnover of birds in a tropical forest treefall gap," is published in the Journal of Field Ornithology [DOI: 10.1111/jofo.12328]. Authors include Henry Pollock, Todd Jones, Corey Tarwater, Elise Nishikawa, and Jeffrey Brawn. The Smithsonian Tropical Research Institute supported this research. The Department of Natural Resources and Environmental Sciences is in the College of Agricultural, Consumer and Environmental Sciences at the University of Illinois.

Nursing homes prepared for pandemics, but COVID-19 reveals gaps

Survey of Michigan nursing homes at start of current pandemic suggests great improvement since just before the H1N1 pandemic

MICHIGAN MEDICINE - UNIVERSITY OF MICHIGAN

The COVID-19 pandemic has hit some nursing homes especially hard - including in the hotspot state of Michigan. Hundreds of deaths of residents in homes from Seattle to Boston have raised concerns about how well facilities are protecting the 1.3 million older Americans who live in them. Those concerns have prompted new federal and state requirements about testing and transparency.

But it might have been worse.

New data suggests that at least in Michigan, nursing homes that responded to a survey were far better prepared for this pandemic than they were for the last one. The study includes responses from 130 nursing homes to a survey performed during the week the state announced its first documented case of COVID-19.

It shows that nearly all had a pandemic plan in place. That's compared with just over half of the 280 nursing homes that answered the same survey in 2007. Nearly all said they now have at least one staff member in charge of pandemic preparedness.

The findings are reported in the Journal of the American Geriatrics Society by a team from the University of Michigan that has studied and worked to improve nursing home infection prevention for years.

Members of the team have several other recent publications with direct or indirect relevance to the COVID-19 pandemic, including putting forth recommendations for nursing homes and other housing facilities for older adults to use in planning how they will respond to pandemics such as COVID-19.

Lona Mody, M.D., M.Sc., a geriatrician at Michigan Medicine, U-M's academic medical center, and the VA Ann Arbor Healthcare System, is senior author of both of the new publications. She's a professor of internal medicine, the associate director for clinical and translational research at the U-M Geriatrics Center, and director of the Infection Prevention in Aging research group.

"Our nursing homes house some of the most vulnerable in our society," says Mody. "This virus unfortunately is very contagious, the disease it causes has incredibly poor outcomes in older adults with comorbidities, and nursing homes are communal settings with shared spaces and resource limitations. This creates a perfect storm of sorts. Being novel, we learn as go and have to learn really quickly."

Mody heads the PRIISM, or Preventing Resistance and Infection by Integrating Systems in Michigan, project, which partners with skilled nursing facilities, hospitals and public health agencies across the state to perform research and create and test education and training materials for nursing home staff. The program's website has many free materials for use by nursing homes everywhere.

Pandemic planning

The new survey data show Michigan's nursing homes have done a lot to prepare for pandemics since the last time the U-M team performed the survey. That previous survey was taken before the H1N1 influenza pandemic of 2009, but after the H5N1 "bird flu" pandemic of 2005 raised national awareness of the importance of pandemic preparedness. Mody and colleagues published pandemic preparedness guidance for nursing homes at that time.

In mid-March of this year, 85% of nursing homes said they had stockpiled supplies before COVID-19 hit, compared with 57% after the H5N1 pandemic. Most of those that had stockpiled supplies had focused on surgical masks, gloves and hand sanitizer. Less than half had stockpiled N95 respirator masks, which are recommended by national and global health authorities for health care workers performing certain types of care on a COVID-19 patient.

Still, 42% of the nursing homes that answered a question about COVID-19-specific concerns said they were worried about running short of personal protective gear.

"Although the size and severity of COVID-19 outbreaks in some nursing homes have taken everyone by surprise, just as so much about this pandemic has, in general nursing homes knew exactly what their challenges were going to be in a pandemic - PPE shortages, staff shortages and worries that they did not have the capacity to care for COVID patients after their hospital stay."

Nearly all now said they had trained staff on how their facility would respond in a pandemic, up from 42% in 2007. But only one-third had conducted a pandemic drill. And Mody notes that nursing homes have a much higher rate of staff turnover than hospitals - meaning that training on infection prevention and pandemic response has to be offered whenever a new person joins the organization.

Michigan's nursing homes appear to have gotten better connected to the broader health care system in the past decade, with significantly more saying they now have communication lines established with local hospitals and public health departments.

Many also said they were drawing COVID-19 guidance not just from the Centers for Disease Control and Prevention, but also from state and local health departments. Half also received guidance from their home's corporate parent.

And while half of the nursing homes surveyed this year said they expected significant staff shortages due to COVID-19, most of them said they had a plan to deal with that. Most planned to ask existing clinical staff to work more hours, and to redeploy non-clinical staff. Two-thirds expected they'd need to require staff to work overtime.

The survey also explored the potential for nursing homes to relieve the burden on hospitals. In all, 82% said they'd be willing to take non-pandemic patients from overburdened hospitals now, compared with 53% in 2007. But the percent that said they'd be able to accept patients with the pandemic disease stayed the same, at one-third of responding homes.

Additional guidance

Mody and her colleagues John P. Mills, M.D. and Keith Kaye, M.D. from the U-M Division of Infectious Diseases recently published some recommendations regarding COVID-19 and older adults in the journal JCI Insight. Mody and Kaye are members of the U-M Institute for Healthcare Policy and Innovation.

They note that it's not just nursing homes with long-term residents that need to be ready to care for vulnerable older adults during pandemics.

In fact, the trend over the past decade to use nursing homes more often for short-term stays by patients who have been discharged from a hospital, and to create state and local programs that allow older adults to 'age in place' instead of moving to nursing homes for the long-term, have led to potential gaps for pandemic responses to help older adults.

They call for policymakers to address those gaps, by creating pandemic-specific plans for community-dwelling older adults, especially those with health needs.

As for nursing homes, they recommend that in areas where COVID-19 is spreading widely in the community, facilities should take these steps, and others:

• place patients with known or suspected disease in the same area of the facility, away from others
• perform rapid COVID-19 tests on all patients, both short-stay and long-stay
• screen healthcare workers and other staff for symptoms including checking temperatures
• limit visitors and group activities
• require everyone wear a surgical mask
• require additional protective gear for clinical staff

The limits on group activities tie in to other research by Mody and her colleagues, published in JAGS in December.

That study sampled surfaces, and the hands of patients and staff, in the common areas and rehabilitation gyms with in nursing homes, and looked for drug-resistant bacteria that can cause dangerous infections. Though the team didn't look for the presence of viruses in these areas, they did find that half of the samples taken in rehab gyms contained at least one type of bacteria that was resistant to several types of antibiotics.

In addition to stockpiling PPE and cleaning supplies, the team recommends that nursing homes should use "burn calculators" to predict how quickly they'll use those supplies based on their patient population.

If nursing homes and other residential facilities for older adults haven't already done so, they should establish lines of communication with local health departments in advance of any outbreak of COVID-19 in their facility. They should also focus on staff retention, including providing for generous sick leave policies so that staff can stay home when ill, and hazard pay for those who can come to work.

And, the team says, nursing homes should make sure they have an infection prevention plan in place for staff when a patient has died of COVID-19.

Another gap in preparedness that the COVID-19 pandemic is revealing, Mody says, is a gap in communication with patients and their families. Keeping families informed, and enabling them to connect virtually with their loved ones when they can't visit in person, is crucial, she says.

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Open access hardware & 3D printing can help tackle demand for health supplies

Local communities could use open access hardware to help alleviate the burden of COVID-19 on global health systems, according to Sussex scientists
UNIVERSITY OF SUSSEX

AN EXAMPLE FACE SHIELD MADE USING A LASER CUTTER view more
CREDIT: ANDRÉ CHAGAS, UNIVERSITY OF SUSSEX

Free open source hardware and 3D printing could help to alleviate the burden of Covid-19 on global health systems, according to scientists at the University of Sussex.

Free and open source hardware (FOSH) follows an ethos where blueprints for a tool are made freely available so that anyone can study, learn, modify, customize and commercialize them.

In a study published by PLoS Biology, Professor Tom Baden and Andre Chagas at the University of Sussex have suggested that this could be a viable option to provide our health services with the tools and equipment they so desperately need.

The study provides an overview of the blueprints which are currently available for free online and which could be used to help in the fight against coronavirus, focusing on personal protective equipment, ventilators and test kits.

Although some of the designs still need to be tested, many others have already received suitable verification, having been published in peer reviewed papers. The authors therefore believe that FOSH should be seriously considered as a method of quickly providing equipment where it's needed.

Tom Baden, Professor of Neuroscience, said: "Now is the time that Open Hardware could really shine and it's so important that we get on board quickly.

"Previous studies and experiences have shown that free and open source hardware is a brilliant option in disaster situations. Designs can be shared globally, it has typically lower implementation costs than mass manufacturing and it can be easily adapted to meet local resources.

"But the real power - and the way this could really help to tackle Covid-19 - is that once a tool has been designed and tested, anyone can build it. This bypasses the traditional manufacturing and distribution routes and means that it can become a community driven endeavour where anyone with the capacity to do so can help to produce much-needed equipment and supplies for the healthcare services.

"Anyone with the necessary knowhow, tools and time can build on this knowledge to meaningfully support their community. At a time when global health systems are facing immense pressure and becoming increasingly overburdened, we need a response not just from frontline workers such as medical staff and scientists, but from skilled members of the public who have the time, facilities and knowledge to meaningfully contribute."

The paper describes existing FOSH designs from simple tools like DIY facemasks to 3D printed valves which can regulate airflow in ventilator tubes. Others are far more complex including state-of-the-art scientific instruments for diagnosis, such as an automated pipetting robot, plate readers and a range of other medical tools and supplies.

Some blueprints are already being used to provide support to the NHS. A company in Portslade which produce face visors have recently removed their patent and license and asked for support from anyone with a 3D printer in order to produce more to meet demand and provide protection to NHS staff.

But for those unverified designs, testing and approval can be a lengthy process.

Andre Chagas said: "One thing governments could do right now, is to figure out a process in which we can legitimately fast track the testing and certification of tools which are in short supply."

"For instance, in Spain a group is already testing their ventilator designs with support from the government. While each country will have different rules and certifications to meet, this is a crucial moment for us to get together and figure out a single set of certification so that implementation can move faster."

Prof. Tom Baden added: "If governments can support this through financial support to ramp up production of the best tools, that would be incredibly useful right now.

"But asides from financial support, we also need support from those who actually know about the use of these tools, rather than just their design. To make this equipment properly and safely, we don't just need tech-savvy people building it. We need people in the healthcare sector who know how these tools should work and can actually test them. These people should contact ongoing products to see if they can help."

A team at the University of Sussex team recently finished creating 100 face shields which are to be tested within the NHS. Once the design is approved the University will launch a full-scale production operation, hoping to produce 1000 face shields a day by early May.

Early high school start times adversely affect attendance

NORTH CAROLINA STATE UNIVERSITY

A new study finds that earlier high school start times can have significant adverse consequences for students, including increased rates of tardiness and absenteeism.

"The American Academy of Pediatrics recommends that high schools begin class after 8:30 a.m., but we know that most schools start much earlier," says Melinda Morrill, an associate professor of economics at North Carolina State University and corresponding author of a paper on the work. "We were able to look at five high schools that moved start times from 8:05 a.m. to 7:25 a.m. in order to examine the effect that the change had on students."

The researchers looked at data on seven cohorts of students, with graduation years ranging from 2013 to 2019. Specifically, researchers looked at data from the freshman, sophomore and junior years of each cohort. The change in start times was implemented in the 2012-13 school year. As an additional control group, the researchers also looked at data from 14 other high schools in the same school district that had already adopted a 7:25 a.m. start time.

"There's a growing body of research that suggests earlier start times can hurt test scores," Morrill says. "We looked at that, but the numbers weren't statistically significant one way or the other."

"However, the move to the earlier start times caused a small increase in the number of students who did not advance to 12th grade on time," says John Westall, a Ph.D. candidate at NC State and co-author of the paper. "Specifically, the move from 8:05 to 7:25 was associated with students being 8% more likely not to advance to 12th grade on schedule."

"We also wanted to look beyond testing to see if there were effects on other measures of academic engagement," Morrill says. "And we found a significant increase in both absences and tardiness."

"The change to an earlier start time led to an increase of about one additional absence per year and just over three additional tardy arrivals per year for students," Westall says. "So students were definitely missing more school."

"Looking at all 19 of the schools, we found that historically, the five schools that started at 8:05 had significantly lower rates of absenteeism and tardiness than the 14 schools that started at 7:25," Morrill says. "But once those five schools moved their start time to 7:25, those advantages disappeared.

"The take-home message here is that we need to look at more than just test scores if we want to understand all of the ways that early start times can affect high school students," Morrill says. "We know that school districts have to consider a wide range of issues, such as transportation logistics, student safety, extracurricular activities and school finances. But the more we look, the more the findings suggest that there are significant consequences of early start times for students."

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The paper, "High School Start Times and Student Achievement: Looking Beyond Test Scores," is published in the journal Economics of Education Review. The paper was co-authored by Matthew Lenard, a graduate student at the Harvard Graduate School of Edu

Urban slums are uniquely vulnerable to COVID-19. Here's how to help.

Report provides eight urgent recommendations for reducing the impact of COVID-19 on people living in poverty
UNIVERSITY OF CALIFORNIA - BERKELEY

PEOPLE DWELLING IN URBAN SLUMS ARE UNIQUELY VULNERABLE TO COVID-19, BUT SUFFER UNDER SHELTER-IN-PLACE RESTRICTIONS THAT CAN OFTEN LIMIT THEIR ACCESS TO BASIC NEEDS LIKE FOOD AND WATER.... view more  CREDIT: PHOTO BY JASON CORBURN

Berkeley -- Government-enforced social isolation may help relatively affluent populations limit the spread of COVID-19, but these measures can be devasting for the nearly 1 billion people around the globe currently dwelling in urban slums, where physical space is scarce, and many rely on daily wage labor for survival.

To help the urban poor weather the COVID-19 pandemic, governments should instead prioritize providing basic needs, including fresh water, sanitation and a moratorium on evictions, and support existing community leadership in delivering health care and emergency preparedness, argues a new report published April 24 in the Journal of Urban Health.

The report, authored by a team of public health experts and epidemiologists working in collaboration with community leaders and non-governmental organizations (NGOs) from urban slums around the world, provides eight urgent recommendations for reducing the impact of COVID-19 on people living in poverty.

These recommendations are crucial not just for people living in urban slums in the global south, but for other vulnerable populations, such as migrant farm workers and those living in refugee camps and homeless encampments and on Native American reservations in the United States, the authors say. Evidence now suggests that the coronavirus is disproportionately affecting black Americans in some U.S. cities, possibly due to similar structural factors, such as the inability to take time off of work.

"The political and economic shocks and instability that are happening now and are likely to follow from this epidemic will likely kill more and lead to more disability in this population than the coronavirus itself," said Jason Corburn, a professor of public health and of city and regional planning at the University of California, Berkeley, and lead author of the paper. "We felt we needed a strategy that recognized the unique needs of the urban poor at the front."

Close living conditions and lack of basic sanitation make urban slum dwellers particularly vulnerable to contracting and spreading the coronavirus, said study co-author Lee Riley, a professor of epidemiology and infectious diseases at UC Berkeley. Many also have pre-existing medical conditions and lack access to health care, putting them at high risk of dying or developing serious complications if they do get sick with the virus.

Simply staying home is rarely an option for them, as it often means giving up work and even basic necessities like food, water and sanitation. In some countries, like Kenya and South Africa, people even face government violence for not obeying curfews and other restrictions.

"Shelter-in-place is a luxury of the wealthy," Riley said. "In many slums, people need to walk a long distance to collect water to use at home. Most people living in slums also have no choice but to participate in the informal economy, which will disappear under lockdowns."

Topping the list of recommendations is a call for governments to partner with existing community leadership and NGOs to form emergency planning committees that can consider the unique social, economic and cultural needs of the community in charting the appropriate response, rather than relying on top-down directives.

Similarly, as many communities lack easy access to health care, community and informal health workers should be deployed to monitor individuals for early symptoms and educate them about how to avoid transmitting the disease. Plans should be also be enacted for emergency transport into and out of settlements, which often lack adequate transportation infrastructure.

"The worst thing you can do in an emergency, particularly in an infectious disease outbreak, is to give everybody the same advice, because it doesn't recognize that not everybody starts in the same position," Corburn said. "Community health workers are uniquely positioned to know the preexisting conditions and the constraints that a group faces."

Finally, governments should ensure that people in slums have their basic needs for shelter and food met by enacting a moratorium on evictions and by providing payments for lost work, fresh water and food, and solid waste removal.

"COVID-19 became a pandemic because of the global spread of the virus by those people who can afford to travel on airplanes and cruise ships," Riley said. "As we are now seeing, inevitably, the disease has ended up in vulnerable communities of the world."

"We want to be bold in calling for actions that don't just tinker around the edges," Corburn added. "It's not just about getting people some more care or better care. We're really calling for a more holistic approach to public health."

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Co-authors of the paper include David Vlahov of the Yale School of Nursing; Blessing Mberu of the African Population and Health Research Center in Kenya; Waleska Teixeira Caiaffa of the Federal University of Minas Gerais School of Medicine in Brazil; Sabina Faiz Rashid of BRAC University in Bangladesh; Albert Ko of the Yale School of Public Health; Sheela Patel and Smurti Jukur of the Society for the Promotion of Area Resource Centers (SPARC) in India; Eliana Martínez-Herrera of the University of Antioquia in Colombia; Saroj Jayasinghe of the University of Colombo in Sri Lanka; Siddharth Agarwal of the Urban Health Resource Centre in India; Blaise Nguendo-Yongsi of the University of Yaoundé II in Cameroon; Jane Weru of the Akiba Mashinani Trust (AMT) in Kenya; Smith Ouma of Cardiff Law and Global Justice at Cardiff University in Kenya; Katia Edmundo of Centro de Promoçâo da Saúde in Brazil; Tolullah Oni of the University of Cape Town, South Africa; and Hany Ayad of Alexandria University in Egypt.

Survey: Most Americans want government commitment to reduce inequality

New national survey shows a majority of Americans want the federal government to reduce inequality amid the Covid-19 economic crisis. Most say the US is increasingly divided between 'haves' and 'have-nots'
LEHIGH UNIVERSITY


A new poll finds that a majority of Americans say that the federal government should commit to reducing economic inequality in this country over the next year, considering the spread of coronavirus in the United States and its impact on the economy and the American people.

A national survey conducted by The Harris Poll on behalf of Lehigh University of 2,018 Americans, conducted between April 7-9, 2020, finds that 78 percent of Americans agree that "considering the spread of coronavirus in the United States and its impact on the economy and the American people," it is "somewhat" or "very important" that "the U.S. government commit to reducing economic inequality" over the next year, through things like "raising the minimum wage" and "taxing households making more than $250,000 a year to guarantee health care coverage to all Americans who lack access." Only 22 percent feel reducing inequality through these actions is "not very important" or "not at all important."

As the polling data show, public attitudes on inequality reduction vary by income, age, and between renters and homeowners. Support for inequality reduction is highest among Americans, age 35-44 (88%, compared to 82% of 18-34, 80% of 45-54 ,74% of 55-64 and 67% of 65+), individuals with household incomes of less than $100,000 a year (81% compared to 73% of those with HHI of $100K+), and renters (84%, compared to 76% of homeowners).

Opinions about the inequality divide are divided. Fifty-seven percent of Americans agree that "in a time of growing economic instability and rising unemployment claims, the U.S. is increasingly divided between the 'haves' and 'have-nots.'" By comparison, 43 percent agree that "recent economic troubles are only temporary, and the economy will soon bounce back, so it makes little sense to speak of 'haves' and 'have-nots.'" Groups that are most likely to agree that the U.S. is divided include younger Americans, aged 18-34 (64%, compared to 54% of 35-54, and 51% of 65+), individuals with household incomes of less than $50,000 a year (61%, compared to 53% of those with HHI of $100k+), and women (60%, compared to 54% of men).

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Methodology This survey was conducted online within the United States by The Harris Poll on behalf of Lehigh University from April 7 - 9, 2020 among 2,018 U.S. adults ages 18 and older. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated. For complete survey methodology, including weighting variables and subgroup sample sizes, please contact:

Dr. Anthony DiMaggio
Associate Professor, Lehigh University
Department of Political Science
Email: Ard416@lehigh.edu

Experimental Biology press materials available now

Explore exciting research findings published in The FASEB Journal

EXPERIMENTAL BIOLOGY

 

Though the Experimental Biology (EB) 2020 meeting was canceled in response to the COVID-19 outbreak, EB research abstracts are being published in the April 2020 issue of The FASEB Journal.

Explore the journal for the latest findings in anatomy, biochemistry, molecular biology, investigative pathology, pharmacology and physiology. Discover exciting research highlights below and in our Virtual Newsroom.

Vaping

Is It Safe to Vape While Breastfeeding?
Animal study suggests maternal nicotine exposure during breast feeding can affect offspring

Can Vaping Scar Your Lungs? New Insights and a Possible Remedy
E-cigarette liquid found to affect lung tissue repair process; inhibiting nicotine receptors may help

Say No to Vaping: Blood Pressure, Heart Rate Rises in Healthy, Young Nonsmokers

Infectious Disease

"Dirty" Mice Could Help Make a More Effective Flu Vaccine
Study suggests standard laboratory mice may lead scientists to overestimate vaccine efficacy

Scientists Uncover How Zika Virus Can Spread through Sexual Contact
Virus finds hospitable environment in the cells that line the vagina

Treatment Innovations

Light Helps Arthritis Treatments Target Joints
New drug delivery method could reduce side effects from rheumatoid arthritis drugs

Earbud-like Nerve Stimulator Shows Promise for Relieving Indigestion
Non-invasive vagus nerve stimulation helps stomach expand and empty properly

CBD

CBD Shows Promise for Fighting Aggressive Brain Cancer
Study shows that CBD isolate and extract can slow growth and kill cancer cells

What's the Best Way to Identify Male Hemp Seedlings?
More accurate sex determination could increase yields and lower price of CBD

Environment

Tube Worm Slime Displays Long-Lasting, Self-Powered Glow
Marine organism's bioluminescence could inspire new eco-friendly, long-lasting light sources

Scientists Use Bacteria to Help Plants Grow in Salty Soil
Method could be scaled up to help farmers improve crop yield in areas with increased soil salinity

Women's Health

Researchers Identify Drugs that Could Halt Preterm Labor
New approach targets problematic molecular pathway to prevent preterm labor and birth

Breathing During Exercise Is Harder for Women Than Men
With smaller airways, overcoming resistance takes more work

Heart Disease

Scientists Trace Path from PTSD to Heart Disease
Young adults with post-traumatic stress disorder show changes in small blood vessels

Researchers Weave Human Tissue into New Blood Vessels
Versatile tissue engineering approach could aid in repairing damage for many tissues and organs

Blood Test Offers Early Warning of Chemotherapy-Related Heart Problems
Accessible, cost-effective method could help doctors intervene before heart damage occurs

Insights into Why Loud Noise is Bad for Your Health
Mouse studies reveal how noise exposure affects heart health and can lead to cancer-related DNA damage

Brain Health

High-fat Diet Consequences Include Mental Fatigue, Researchers Say
Cognitive abilities were impaired in obese rats

Reducing Early Brain Inflammation Could Slow Alzheimer's Progression
Animal study targets Alzheimer's disease before symptoms are apparent

Less Addictive Form of Buprenorphine May Help Curb Cocaine Relapse
Mouse study shows buprenorphine analog is more effective with reduced potential for abuse

3D Tissue Models Provide Unprecedented Insight into Human Brain Function and Disease
Brain-region specific spheroids can be connected to study complex developmental processes

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Cancer care model could help us cope with COVID-19, says nanomedicine expert

COVID-19 should be managed more like a chronic disease

UNIVERSITY OF MANCHESTER

As the UK government looks for an exit strategy to Britain's COVID-19 lockdown a nanomedicine expert from The University of Manchester believes a care model usually applied to cancer patients could provide a constructive way forward.

Kostas Kostarelos, is Professor of Nanomedicine at The University of Manchester and is leading the Nanomedicine Lab, which is part of the National Graphene Institute and the Manchester Cancer Research Centre.

The Manchester-based expert believes more scientific research should be employed as we transform how we view the COVID-19 pandemic, or any future virus outbreak, and deal with it more like a chronic disease - an ever present issue for humanity that needs systematic management if we are ever to return to our 'normal' lives.

Professor Kostarelos makes this claim in an academic thesis entitled 'Nanoscale nights of COVID-19' that offers a nanoscience response to the COVID-19 crisis and will be published on Monday, April 27, by the journal Nature Nanotechnology.

"As for any other chronic medical condition, COVID-19 stricken societies have families, jobs, businesses and other commitments. Therefore, our aim is to cure COVID-19 if possible," says Professor Kostarelos.

"However, if no immediate cure is available, such as effective vaccination," Professor Kostarelos suggests: "We need to manage the symptoms to improve the quality of patients' lives by making sure our society can function as near as normal and simultaneously guarantee targeted protection of the ill and most vulnerable."

Professor Kostarelos says his experience in cancer research and nanotechnology suggests a model that could also be applied to a viral pandemic like COVID-19.

"There are three key principles in managing an individual cancer patient: early detection, monitoring and targeting," explains Professor Kostarelos. "These principles, if exercised simultaneously, could provide us with a way forward in the management of COVID-19 and the future pandemics.

"Early detection has improved the prognosis of many cancer patients. Similarly, early detection of individuals and groups, who are infected with COVID-19, could substantially accelerate the ability to manage and treat patients.

"All chronic conditions, such as cancer, are further managed by regular monitoring. Therefore, monitoring should be undertaken not only for patients already infected with COVID-19, to track progression and responses, but also for healthy essential workers to ensure that they remain healthy and to reduce the risk of further spreading.

Finally, says Professor Kostarelos, nanomaterials - as well as other biologicals, such as monoclonal antibodies - are often used for targeting therapeutic agents that will be most effective only against cancer cells.

The same principle of 'targeting' should be applied for the management of COVID-19 patients to be able to safely isolate them and ensure they receive prompt treatment.

Also, a safeguarding strategy should be provided to the most vulnerable segments of the population by, for example, extending social distancing protocols in elderly care homes - but with the provision of emotional and practical support to ensure the wellbeing of this group is fully supported.

"Protection of the most vulnerable and essential workers, must be guaranteed, with protective gear and monitoring continuously provided," he added. "Only if all three principles are applied can the rest of society begin to return to normal function and better support the activities in managing this and all future pandemics."

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They remember: Communities of microbes found to have working memory

Discovery draws surprising parallels between low-level organisms and sophisticated neurons; lays the groundwork for memory-capable biological systems

UNIVERSITY OF CALIFORNIA - SAN DIEGO


MEMORY IMPRINTS: RESEARCHERS USED LIGHT EXPOSURE TO IMPRESS A COMPLEX PATTERN (UC SAN DIEGO'S FORMER GEISEL LIBRARY LOGO, SPREAD ACROSS AN AREA SLIGHTLY SMALLER THAN THE THICKNESS OF A HUMAN... view more  CREDIT: SUEL LAB, UC SAN DIEGO

Biologists studying collectives of bacteria, or "biofilms," have discovered that these so-called simple organisms feature a robust capacity for memory.

Working in the laboratory of University of California San Diego Professor Gürol Süel, Chih-Yu Yang, Maja Bialecka-Fornal and their colleagues found that bacterial cells stimulated with light remembered the exposure hours after the initial stimulus. The researchers were able to manipulate the process so that memory patterns emerged.

The discovery reveals surprising parallels between low-level single-cell organisms and sophisticated neurons that process memory in the human brain.

"Even just a few years ago people didn't think bacterial cells and neurons were anything alike because they are such different cells," said Süel. "
"This finding in bacteria provides clues and a chance to understand some key features of the brain in a simpler system. If we understand how something as sophisticated as a neuron came to be--its ancient roots--we have a better chance of understanding how and why it works a certain way."

The findings, described April 27 in the journal Cell Systems, also provide a starting path for scientists to one day design basic computing systems with living organisms such as bacteria.

Following recent discoveries by the Süel lab that bacteria use ion channels to communicate with each other, new research suggested that bacteria might also have the ability to store information about their past states. In the new study, the researchers were able to encode complex memory patterns (video here) in bacterial biofilms with light-induced changes in the cell membrane potential of Bacillus subtilis bacteria. The optical imprints, they found, lasted for hours after the initial stimulus, leading to a direct, controllable single-cell resolution depiction of memory.

"When we perturbed these bacteria with light they remembered and responded differently from that point on," said Süel. "So for the first time we can directly visualize which cells have the memory. That's something we can't visualize in the human brain."

The ability to encode memory in bacterial communities, the researchers say, could enable future biological computation through the imprinting of complex spatial memory patterns in biofilms.

"Bacteria are the dominant form of life on this planet," said Süel. "Being able to write memory into a bacterial system and do it in a complex way is one of the first requirements for being able to do computations using bacterial communities."

Further, as the researchers note in the study: "It may thus be possible to imprint synthetic circuits in bacterial biofilms, by activating different kinds of computations in separate areas of the biofilm... Overall, our work is likely to inspire new membrane-potential-based approaches in synthetic biology and provide a bacterial paradigm for memory-capable biological systems."

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Authors of the study included: Chih-Yu Yang, Maja Bialecka-Fornal, Colleen Weatherwax (graduate student), Joseph Larkin, Arthur Prindle, Jintao Liu, Jordi Garcia-Ojalvo and Gürol Süel.

The study was supported by the National Institute of General Medical Sciences (R01 GM121888), the Howard Hughes Medical Institute-Simons Foundation Faculty Scholars program, the Spanish Ministry of Science, Innovation and Universities and FEDER (PGC2018-101251-B-I00), Maria de Maeztu Programme for Units of Excellence in R\&D (CEX2018-000792-M) and the Generalitat de Catalunya (ICREA Academia programme).


Disclaimer: AAAS and EurekAlert! are not responsible for th

Study analyzes contamination in drug manufacturing plants

Report offers guidelines to help prevent viruses from tainting biopharmaceutical drugs

MASSACHUSETTS INSTITUTE OF TECHNOLOGY

CAMBRIDGE, MA -- Over the past few decades, there have been a handful of incidents in which manufacturing processes for making protein drugs became contaminated with viruses at manufacturing plants. These were all discovered before the drugs reached patients, but many of the incidents led to costly cleanups and in one instance a drug shortage.

A new study from an MIT-led consortium has analyzed 18 of these incidents, most of which had not been publicly reported until now. The report offers insight into the most common sources of viral contamination and makes several recommendations to help companies avoid such incidents in the future.

While the study focused on biopharmaceuticals (protein drugs produced by living cells), the findings could also help biotech companies to create safety guidelines for the manufacture of new gene therapies and cell-based therapies, many of which are now in development and could face similar contamination risks.

"As the biotech industry starts to think about manufacturing these really exciting new products, which are highly effective and even in some cases curative, we want to make sure that the viral safety aspects of manufacturing them are considered," says Stacy Springs, senior director of programs for MIT's Center for Biomedical Innovation (CBI).

Springs is the senior author of the study, which appears today in Nature Biotechnology. Paul Barone, co-director of the CBI's Biomanufacturing Program and director of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB), is the lead author. The other authors from CBI are Michael Wiebe and James Leung.

Sharing information

Many therapeutic proteins are produced using recombinant DNA technology, which allows bacterial, yeast, or mammalian cells to be engineered to produce a desired protein. While this practice has a strong safety record, there is a risk that the cultured mammalian cells can be infected with viruses. The CAACB, which performed the study, was launched in 2010 following a well-publicized contamination incident at a Genzyme manufacturing plant in Boston. The plant had to shut down for about 10 months when some of its production processes became infected with a virus in 2009.

When such incidents occur, drug companies aren't required to make them public unless the incident affects their ability to provide the drug. The CBI team assembled a group of 20 companies that were willing to share information on such incidents, on the condition that the data would be released anonymously.

"We thought it would be very valuable to have industry share their experience of viral contamination, since most companies have had none of these incidents if they're lucky, or maybe one or two at the most," Springs says. "All of that knowledge about how they discovered and managed the event, identified the virus and its source, disinfected and restarted the production facility, and took action to prevent a recurrence was all siloed within individual companies."

The study, which focused on protein drugs produced by mammalian cells, revealed 18 viral contamination incidents since 1985. These occurred at nine of the 20 biopharmaceutical companies that reported data. In 12 of the incidents, the infected cells were Chinese hamster ovary (CHO) cells, which are commonly used to produce protein drugs. The other incidents involved human or nonhuman primate cells.

The viruses that were found in the human and nonhuman primate cells included herpesvirus; human adenovirus, which causes the common cold; and reovirus, which can cause mild gastroenteritis. These viruses may have spread from workers at the plants, the researchers suggest.

In many cases, contamination incidents were first detected because cells were dying or didn't look healthy. In two cases, the cells looked normal but the viral contamination was detected by required safety testing. The most commonly used test takes at least two weeks to yield results, so the contaminating virus can spread further through the manufacturing process before it is detected.

Some companies also use a faster test based on polymerase chain reaction (PCR) technology, but this test has to be customized to look for specific DNA sequences, so it works best when the manufacturers know of specific viruses that are most likely to be found in their manufacturing processes.

New technology

Many of the CAACB member companies are exploring new technologies to inactivate or remove viruses from cell culture media before use, and from products during purification. Additionally, companies are developing rapid virus detection systems that are both sensitive and able to detect a broad spectrum of viruses.

CBI researchers are also working on several technologies that could enable more rapid tests for viral contamination. Much of this research is taking place within a new interdisciplinary research group at the Singapore-MIT Alliance for Science and Technology (SMART), called the Critical Analytics for Manufacturing Personalized Medicines. Led by Krystyn Van Vliet, MIT associate provost and a professor of biological engineering and materials science and engineering, this group, which includes several other MIT faculty members from across departments, is working on about half a dozen technologies to more rapidly detect viruses and other microbes.

"I think that there's a lot of potential for technology development to ameliorate some of the challenges we see," Barone says.

Another strategy that the report recommends, and that some companies are already using, is to reduce or eliminate the use of cell growth medium components that are derived from animal products such as bovine serum. When that isn't possible, another strategy is to perform virus removal or inactivation processes on media before use, which can prevent viruses from entering and contaminating manufacturing processes. Some companies are using a pasteurization-like process called high temperature short time (HTST) treatment, while others use ultraviolet light or nanofiltration.

The researchers hope that their study will also help guide manufacturers of new gene- and cell-therapy products. These therapies, which make use of genes or cells to either replace defective cells or produce a therapeutic molecule within the body, could face similar safety challenges as biopharmaceuticals, the researchers say, as they are often grown in media containing bovine serum or human serum.

"Having done this sharing of information in a systematic way, I think we can accelerate the dissemination of information on best practices, not only within the protein manufacturing industry but also the new industry of cell-based modalities," says James Leung.

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The research was funded by the members of the CAACB.