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Cell Sorting Market 2020 to Witness Exponential Growth. Top Growing Companies are Breathalyzers, Akers Biosciences Inc., Alcohol Countermeasure…

Posted: March 31, 2020 at 3:43 am

In this Cell Sorting market report, breakdown and estimations of important industry trends, market drivers, market restraints, market size, market share and sales volume have been explained very well. This global market report gives CAGR value fluctuation during the forecast period of 2020-2027 for the Healthcare industry that helps in estimating investment and costing. To take decisions of growing or lessening the production of goods depending on the general market conditions and demand, plentiful information accompanied with deep Cell Sorting market insights plays a supportive role. Most recent and established tools and techniques are utilized exceptionally to make the report outstanding.

Cell sorting market is expected to experience market growth at a rate of 7.87% in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 502.27 million by 2027. Due to the wide-scale acceptance of cell sorting techniques as a method of increasing the understanding of tissues and cell samples, market players have developed specialized reagents designed for each individual application of cell sorting methods.

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The major players covered in the Cell Sorting Market report are Abcam plc, Sepmag, BD, Beckman Coulter, Inc., Bio-Rad Laboratories, Inc., Sony Biotechnology Inc., Miltenyi Biotec, Thermo Fisher Scientific Inc., Sysmex Partec GmbH, On-chip Biotechnologies. Co., Ltd., Cytonome/ST, LLC, Union Biometrica, Inc., Luminex Corporation, pluriSelect Life Science UG (haftungsbeschrnkt) & Co. KG, STEMCELL Technologies Inc., TERUMO BCT, INC., Cellular Highways, Abgenex, among other players domestic and global. Market Share data is available for Global, North America, Europe, Asia-Pacific, Middle East & Africa and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Market Analysis and Insights:Global Cell Sorting Market

In February of 2019, Institute of Life Sciences announced that they had developed a modernized magnetic cell separation kit designed for its application in various research-based and medical applications. This kit termed as QuikSort has been developed to improve the cost-effectiveness of the cell sorting instruments and kits currently commercialized in the market where Abgenex will be responsible for its commercialization. The kit has been based on the patented technology and will be responsible for the separation of only specific cells

Cell sorting is defined as that technology field which enables isolation of cells from the tissue sample based on their type. This technology invokes differentiation of cells based on the different size, shape, surface protein expression amongst various others. This technology results in the growth of these cells in a clump that does not consist of any adhesion.

There has been a renewed level of focus from the healthcare industry on furthering their understanding of human tissues and cells, this focus has essentially given rise to an increased level of consumption for different varieties of research based products, solutions and technologies consisting of cell sorting techniques of research. Along with the growing volume of research activities, the significant growth witnessed by the pharmaceutical and biotechnology organizations resulting in enhanced consumption rate for research based products and solutions are all factors expected to drive the growth of cell sorting market in the forecast period of 2020 to 2027.

This market report provides details of market share, new developments, product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Briefour team will help you create a revenue impact solution to achieve your desired goal.

Global Cell Sorting Market Scope and Market Size

Cell sorting market is segmented on the basis of technology, product & service, application and end user. Each individual segments growth is analysed and these insights are subsequently considered before providing you with the market overview which can help you in understanding and identification of your core applications in the broad market.

Based on technology, cell sorting market consists of gradient centrifugation, cell markers-based and sorting on microchips. Cell markers-based segment is further segmented as fluorescence-based droplet cell sorting, magnetic-activated cell sorting (MACS) and micro-electromechanical systems (MEMS)-Microfluidics. Fluorescence-based droplet cell sorting is further sub segmented into jet-in-air cell sorting and cuvette-based cell sorting.

Cell sorting market has been segmented based on product & service into cell sorters, cell sorting reagents & consumables and cell sorting services. Cell sorters have been sub-segmented on the basis of price range into high-range cell sorters (above USD 300,000), mid-range cell sorters (USD 200,000-USD 300,000) and low-range cell sorters (below USD 200,000).

On the basis of applications, cell sorting market has been segmented as research applications and clinical applications. Research applications segment consists of immunology & cancer research, stem cell research, drug discovery and others.

Cell sorting market has also been categorized into research institutes, medical schools & academic institutions, pharmaceutical & biotechnology companies and hospitals & clinical testing laboratories on the basis of end user.

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Cell Sorting Market Country Level Analysis

Global cell sorting market is analysed and market size information is provided by country, technology, product & service, applications and end user as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific in the Asia-Pacific, Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa as a part of Middle East & Africa, Brazil, Argentina and Rest of South America as part of South America.

North America will be responsible for having the largest market share in the cell sorting market, whereas Asia-Pacific will hold the highest growth rate. This position of North America is due to the availability of advanced healthcare infrastructure, focus of the market players in the region to advance the levels of cancer research and improvements in therapeutics development processes. Whereas, Asia-Pacific is experiencing high prevalence of chronic diseases such as HIV, cancer and other applicable disorders resulting in lucrative opportunities for market growth in the forthcoming period.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, disease epidemiology and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands impact of sales channels are considered while provided forecast analysis of the country data.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Cell sorting market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for cell sorting market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the cell sorting market. The data is available for historic period 2010 to 2018.

Competitive Landscape and Cell Sorting Market Share Analysis

Cell sorting market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, clinical trials pipelines, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companies focus related to cell sorting market.

TTP plc in April 2019 announced that they had invested approximately USD 2.2 million to improve the pace of commercialization for their Highway 1, companys bench-top cell sorting instrument. The instrument is developed to meet the various requirements such as improvements in cell sorting operations of different applications such as cell therapies, liquid biopsy diagnostics and high-throughput drug discovery amongst various others. The instrument has been based on the companys Vortex-Actuated Cell Sorting technology and will be commercialized by Cellular Highways which has been established as a spin-off of TTP plc

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Cell Sorting Market 2020 to Witness Exponential Growth. Top Growing Companies are Breathalyzers, Akers Biosciences Inc., Alcohol Countermeasure...

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Navy Preventive Medicine Teams Embark Ships in 7th Fleet to Combat COVID-19 – HSToday

Posted: March 31, 2020 at 3:41 am

Members of Navy Forward-Deployed Preventive Medicine Units (FDPMU) and Naval Medical Research Center (NMRC) embarked several 7th Fleet ships March 14 to help combat the risk of and provide laboratory batch testing for COVID-19 onboard the ships.

Teams are embarked on the amphibious assault ship USS America (LHA 6), the aircraft carrier USS Theodore Roosevelt (CVN 71), and the U.S. 7th Fleet flagship USS Blue Ridge (LCC 19) and have the ability to batch test Sailors onboard who present with influenza-like illness symptoms, instead of only sending samples to be tested ashore.

This capability provides early-warning surveillance for the medical teams to be able to identify if a COVID-19 case is onboard a ship, but does not individually diagnose sailors. If a batch were to test positive for COVID-19, the medical teams would take additional measures, such as isolating the Sailors whose samples were in the batch, and depending on the Sailors symptoms, potentially medically evacuating them off the ship to a shore facility for testing.

To date, no cases of COVID-19 have been diagnosed aboard any U.S. 7th Fleet Navy vessel.

The team here in 7th Fleet has taken COVID-19 seriously from the beginning and has many public health measures already in place, said Capt. Christine Sears, U.S. 7th Fleet Surgeon. The FDPMU and NMRC augmentation teams provide additional depth in our ability to combat this virus.

Teams embarked the ships to provide at-sea testing and to ensure the U.S. 7th Fleet operating forces are ready to combat a possible outbreak while maintaining mission readiness. The teams provide additional capabilities in addition to the U.S. 7th Fleets isolation procedures.

The teams are comprised of a variety of specialized Navy Medicine personnel to ensure force health protection of the fleet, and may include: a microbiologist, medical laboratory technician, preventive medicine officer, preventive medicine technician.

As a medical service corps microbiology officer, this embark gives us the chance to demonstrate some of our skillsets to the fleet, and what we bring to the fight, said Lt. Cmdr. Rebecca Pavlicek, Blue Ridge COVID-19 testing team lead. This capability allows us, the Navy, to protect mission readiness and protection of our Sailors.

To ensuring force health protection of the fleet, other medical specialties or logistical components can be scaled up or down to meet mission specific requirements in the mitigation, health surveillance, and casualty prevention.

The 4-person team aboard America was the first to bring COVID-19 testing capability to a U.S. Navy ship.

This is the most advanced laboratory capability that Navy Medicine has placed forward deployed, said Cmdr. Brian Legendre, team lead and preventative medicine officer for the preventative medicine team aboard America.

We can make force health protection decisions in real time, enhancing the health of the crew while minimizing any potential outbreak of COVID-19, added Lt. Cmdr. Danett Bishop, team microbiologist.

The FDPMU teams aboard the USS America and the USS Blue Ridge are from Navy Environmental Preventative Medicine Unit Six based out of Pearl Harbor, Hawaii, and work to facilitate and educate using preventive medicine practices and provide additional laboratory capabilities. The team embarked with USS Theodore Roosevelt is assigned to the Naval Medical Research Center based in Silver Spring, Maryland.

Currently, the teams are only authorized to perform surveillance testing and not individual testing. This means that the results cannot be linked to a particular patient for diagnostics, but would enable the team to detect COVID-19s presence on the ship based off of the results.

Since we are performing surveillance testing, the results of COVID-19 present, or not present can help inform the force health protection posture and provide valuable insight for the senior medical officer and outbreak response team, said Pavlicek.

The teams are equipped with two testing capabilities, including the BioFire Film Array and the Step One RT-PCR System. The BioFire Film Array will test for a dozen different respiratory diseases, while the Step One RT-PCR System allow for complex COVID-19 tests at sea, if necessary.

As the U.S. Navys largest forward-deployed fleet, 7th Fleet operates roughly 50-70 ships and submarines and 140 aircraft with approximately 20,000 Sailors.

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Ohio Valley Facing Pandemic With A Health System Hollowed Out By Hospital Closures – WKU Public Radio

Posted: March 31, 2020 at 3:41 am

As new cases of coronavirus mount in the Ohio Valley, health officials are bracing for an onslaught of patients and what could be unprecedented demand for beds, medical staff and specialized equipment.

Kentucky, Ohio and West Virginia have disproportionately high rates of people vulnerable to serious illness from COVID-19. But the regions capacity to treat them has been sharply reduced by the closure of some 21 hospitals over the past 15 years. An analysis by the Ohio Valley ReSource shows some of the communities where hospitals have closed have some of the nations poorest health outcomes, making them especially vulnerable.

Still more hospitals in the region are being closed now, even as the pandemic unfolds.

Click to hear Liam's story about how Ohio Valley health care systems are handling the coronavirus pandemic.

Tiffany Wilburn-Meeks has lived in eastern Kentucky's Greenup County for most of her 38 years. And the hospital her family has always relied on is only a five-minute drive away.

Our Lady of Bellefonte Hospital is where she would go if she was sick growing up, and its where she was considering taking her 23-month-old daughter Darian for speech therapy. Its also where her mom, Judy, would go if an asthma attack turned for the worst.

But I think if she'd had to go to Kings Daughters [Hospital], I don't know that she would have survived the drive because it's 10 or 15 more minutes down the road.

But by May, her family wont be able to rely on Our Lady of Bellefonte anymore. The 220-bed hospital with more than 1,000 employees started by a congregation of Catholic sisters in 1953 with the blessing of the pope via telegram will close its doors.

That would leave 35,000 people in Greenup County without a hospital, forcing those who need intensive medical care to drive to Kings Daughters Hospital in Ashland. This comes as many Ohio Valley public health officials are bracing for the coronavirus to reach their communities.

While the number of confirmed cases in her region have not reached levels in larger cities, she knows the number will grow.

If it does, there's no way that Kings Daughters is going to be able to handle that, she said. It is terrifying, and I'm afraid that people will die as a consequence of the hospital closing.

In a statement, a spokesperson for Kings Daughters Hospital said they were working daily with Our Lady of Bellefonte to potentially expand the capacity of Kings Daughters if patient needs surge due to coronavirus.

Wilburn-Meek started an online petition to try to call attention to the situation and save the hospital, but she isnt optimistic shell be successful. And more than a dozen communities across the Ohio Valley are facing a similar situation.

Our Lady of Bellefonte will join at least 21 other hospital closures in the Ohio Valley within the past 15 years. The Ohio Valley Resource estimates those 21 closures represented more than 1,000 hospital beds in total.

Some shuttered hospital sites are now vacant parking lots. Some have been turned into addiction rehab facilities or urgent care facilities, but those often have limited or no in-patient services.

These closures have left a hollowed out healthcare infrastructure in the Ohio Valley, and leading healthcare professionals worry that the loss of hospital beds, skilled staff and equipment combined with a population that is especially vulnerable to COVID-19 disease could hinder how well the region can respond to the coronavirus.

Running Out

For 15 years, Marlene Moore was lead nurse of the intensive care unit at Ohio Valley Medical Center in downtown Wheeling, West Virginia. She would make determinations about who would be admitted and who would be discharged, who would be transferred to other departments and hospitals, and helping younger nurses with questions and assistance.

That time came to an end when the company that owned OVMC and another hospital in nearby Martins Ferry, Ohio, announced last year both hospitals would close. Along with Belmont Community Hospital also closing, three hospitals in total last year shuttered in the Wheeling metropolitan area.

It was just devastating, because especially at our smaller hospitals, the employees know everybody. I mean, from housekeeping, to dietary to the lab, to all the departments, Moore said. It affected the whole valley.

Moore started working last month at what is now the only hospital in town, Wheeling Hospital, where a coronavirus patient is currently being treated.

She said because Wheeling Hospital often has many beds filled with patients having other needs, those needing a bed for coronavirus treatment may have to travel a half-hour or more to hospitals in Steubenville, Ohio, Columbus or Pittsburgh.

And its the kind of people her hospital tends to serve that has her particularly worried.

We have such an older population here. And if you get several that come in at the same time with severe respiratory distress, you're going to run out of ICU beds, you're going to run out of ventilators, you're actually going to run out of places to treat these people, she said.

A recent Kaiser Family Foundation study found West Virginia led the nation in how vulnerable its population is to coronavirus because of old age and preexisting conditions. More than half of all adults in West Virginia and more than 45% of all adults in Kentucky were at high risk of serious illness from coronavirus because of advanced age, pre-existing conditions, or both.

A report from Kaiser Health News also found there are only 325 ICU beds for more than 12,000 people over the age of 60 in Ohio County, where Wheeling is located. People over the age of 60 make up 28% of the countys population.

According to an Ohio Valley Resource data analysis, 4 of the 18 counties that lost hospitals over the past 15 years also have some of the worst health outcomes in the nation. Those counties have some of the countrys highest rates of chronic respiratory disease deaths, cardiovascular disease deaths and diabetes prevalence.

Amid closures, remaining Ohio Valley hospitals are reinforcing their capacity for beds, equipment and personal protective equipment for worst case scenarios.

A statement from the West Virginia Hospital Association said hospitals are canceling or rescheduling elective surgeries to free up more beds, in compliance with a state emergency order. Hospitals are converting different departments into infectious disease units, and developing alternative treatment sites. One hospital in Athens, Ohio, has now set up a triage tent to treat potential patients outside.

Rising Costs

Even if Ohio Valley hospitals are able to accommodate a surge of coronavirus patients, the financial toll it could take could devastate rural healthcare providers.

A report last year from Navigant Consulting showed that 16 rural hospitals in Kentucky about a quarter of all rural hospitals in the state were at high risk of closing due to unstable financial situations. Some of the reasons cited for financial struggles include population loss with fewer people to serve, and more patients insured through Medicare and Medicaid, which often undercompensates hospitals for treatment.

Those ongoing challenges will only be made worse by the pandemic.

The payment mechanism for treating these patients is not clear at this point. The unusually long length of stay I think is a concern with the very sick of these patients who typically end up, or have ended up, on ventilator care, which is very expensive and resource intensive to deliver, said Bud Warman, Kentucky Hospital Association Vice President and former CEO of Highlands Regional Medical Center in east Kentucky. They haven't always had potentially this much volume of wants to deal with.

The American Hospital Association is asking for $100 billion from Congress to offset anticipated coronavirus costs, while some rural hospitals struggle to ration protective medical supplies. A bill being considered by the Kentucky Senate would also provide a loan program for struggling rural hospitals.

Warman also said when hospitals have closed in Appalachia, there are often few options remaining for the people the provider served.

In some cases, they just don't have adequate transportation to get them that longer distance, Warman said. If they're deciding between food on the table or traveling 50 miles to see a doctor or to seek health care, oftentimes, they make the choice for food on the table. It sounds dire, but the fact is in many parts of our state, many parts of Appalachia, that is the case.

Whats Left

In central West Virginia, Michael Brumage is leading one of the remaining options for those without easy access to a hospital.

As Chief Medical Officer of Cabin Creek Health Systems, he directs several Federally Qualified Health Centers that provide preventative care and substance abuse treatment, often for people who are low-income or uninsured. His experience also extends across multiple organizations: Brumage serves as director of the Preventative Medicine Residency Program in the WVU School of Public Health, was former executive director of the Kanawha-Charleston Health Department, and former health officer for Kanawha County and Putnam County, West Virginia.

His staff is preparing to treat patients who have respiratory symptoms outside of the centers in order to prevent the spread of the virus inside their buildings, and theyll also have curbside service for those with respiratory symptoms.

Our public health system has been underfunded for many, many years, at the federal, state and local levels, Brumage said. So we're fortunate, I think that there are federally qualified health centers, that there are free and charitable clinics that are able to pick up the slack.

But even with his centers, there are still intensive, in-patient services that he cant provide, that a hollowed out healthcare infrastructure has left lacking.

Brumage was born in Fairmont Regional Medical Center in Fairmont, West Virginia. So was his sister. Hes had several relatives whove been hospitalized there over the years. The hospital is set to close this week.

It's befuddling to me how they can close this hospital during a pandemic, when there are going to be so many more beds that need to be filled. It staggers the imagination, Brumage said.

While a hospital is being built to replace Fairmont Regional, Brumage is worried that it will be too late for the demand for hospital beds, ventilators and skilled staff needed to respond to the pandemic.

There will be many competing economic priorities once this clears to restore the American economy, Brumage said. But shame on us if we don't invest in our public health infrastructure, and if we don't invest in our overall health infrastructure, and if we don't look for ways to make health care equitable for all Americans.

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Coronavirus symptoms: A list and when to seek help – WKTV

Posted: March 31, 2020 at 3:41 am

What are the telling signs that you may have the novel coronavirus which causes Covid-19?

The main list of acute symptoms at this time is actually quite short and can appear anywhere from two to 14 days after exposure to the virus, according to the US Centers for Disease Control and Prevention.

"We're emphasizing fever plus a notable lower respiratory tract symptom -- cough or trouble breathing," said infectious disease expert Dr. William Schaffner, a professor of preventative medicine and infectious disease at Vanderbilt University School of Medicine in Nashville.

Being able to identify those symptoms and act upon them when necessary is critical.

Here's what you need to know.

Fever is a key symptom, experts say. Don't fixate on a number, but know it's really not a fever until your temperature reaches at least 100 degrees Fahrenheit (37.7 degrees Celsius) for children and adults.

"There are many misconceptions about fever. Average daily temperature is 98.6 degrees Fahrenheit (37 degrees Celsius), but we all actually go up and down quite a bit during the day as much as half of a degree or a degree," said Dr. John Williams, chief of the division of pediatric infectious diseases at the University of Pittsburgh Medical Center Children's Hospital of Pittsburgh.

"So 99.0 degrees or 99.5 degrees Fahrenheit is not a fever," he stressed.

When you check for fever, don't rely on a temperature taken in the morning. Instead take your temp in the late afternoon and early evening.

"Our temperature is not the same during the day. If you take it at eight o'clock in the morning, it may be normal," Schaffner explained.

"One of the most common presentations of fever is that your temperature goes up in the late afternoon and early evening -- it's a common way that viruses produce fever."

Coughing is another key symptom, but it's not just any cough, said Schaffner. It should be a dry cough that you feel in your chest.

"It's not a tickle in your throat. You're not just clearing your throat. It's not just irritated. You're not putting anything out, you're not coughing anything up," Schaffner said.

"The cough is bothersome, it's coming from your breastbone or sternum. and you can tell that your bronchial tubes are inflamed or irritated," he added.

Shortness of breath can be a third -- and very serious -- manifestation of Covid-19, and it can occur on its own, without a cough. If your chest becomes tight or you begin to feel as if you cannot breathe deeply enough to get a good breath, that's a sign to act, experts say.

"If there's any shortness of breath immediately call your health care provider, a local urgent care or the emergency department," said American Medical Association president Dr. Patrice Harris.

"If the shortness of breath is severe enough, you should call 911," Harris added.

In addition to difficulty breathing or shortness of breath, the CDC lists emergency warning signs for Covid-19 as a "persistent pain or pressure in the chest," "bluish lips or face" -- which indicates a lack of oxygen -- and any sudden mental confusion or lethargy and inability to rouse.

Get medical attention immediately, the CDC says.

This trifecta of symptoms -- fever, cough and shortness of breath -- are not the only signs of sickness that have been seen in cases of Covid-19.

Many other symptoms can resemble the flu, including headaches, digestive issues, body aches and fatigue, which can be severe. Still other symptoms can resemble a cold or allergies, such as a runny nose, sore throat and sneezing.

Most likely, experts say, you simply have a cold or the flu -- after all they can cause fever and cough too. One possible sign that you might have Covid-19 is if your symptoms, especially shortness of breath, don't improve after a week or so but actually worsen.

An odd symptom that might flag a Covid-19 infection in its early stages was recently identified by the American Academy of Otolaryngology-Head and Neck Surgery.

In a statement on their website, they said symptoms of anosmia, or lack of sense of smell, and dysgeusia, or lack of taste, should be used to identify possible Covid-19 infections.

"Anosmia, in particular, has been seen in patients ultimately testing positive for the coronavirus with no other symptoms," the statement says.

It has long been known in medical literature that a sudden loss of smell may be associated with respiratory infections caused by other types of coronaviruses.

The same applies to conjunctivitis, a highly contagious condition also known as pink eye. Conjunctivitis is an inflammation of the thin, transparent layer of tissue, called conjunctiva, that covers the white part of the eye and the inside of the eyelid.

Reports from China and around the world are showing that about 1% to 3% of people with Covid-19 also had conjunctivitis.

But this novel coronavirus, also called SARS-CoV-2, is just one of many viruses that can cause conjunctivitis, so it came as no real surprise to scientists that this newly discovered virus would do the same.

Still, a pink or red eye could be one more sign that you should call your doctor if you also have other tell-tale symptoms of Covid-19, such as fever, cough or shortness of breath.

Overall, "I think we're getting a little bit more insight into the types of symptoms that patients might have," said CNN Chief Medical Correspondent Dr. Sanjay Gupta on the CNN's New Day news program.

"In a study out of China where they looked at some of the earliest patients, some 200 patients, they found that digestive or stomach GI (gastrointestinal) symptoms were actually there in about half the patients," Gupta said, adding that "fever and cough and shortness of breath" still appear to be the prevailing symptoms of Covid-19.

"At this moment, the current guidance -- and this may change -- is that if you have symptoms that are similar to the cold and the flu and these are mild symptoms to moderate symptoms, stay at home and try to manage them," Harris said, with rest, hydration and the use of fever-reducing medications.

That advice does not apply if you are over age 60, since immune systems weaken as we age, or if you are pregnant -- anyone with concerns about coronavirus should call their healthcare provider, according to the CDC.

It's unclear whether pregnant women have a greater chance of getting severely ill from coronavirus, but the CDC has said that women experience changes in their bodies during pregnancy that may increase their risk of some infections.

In general, Covid-19 infections are riskier if you have underlying health conditions such as diabetes, chronic lung disease or asthma, heart failure or heart disease, sickle cell anemia, cancer (or are undergoing chemotherapy), kidney disease with dialysis, a body mass index (BMI) over 40 (extremely obese) or an autoimmune disorder.

"Older patients and individuals who have underlying medical conditions or are immunocompromised should contact their physician early in the course of even mild illness," the CDC advises.

To be clear, you are at higher risk -- even if you are young -- if you have underlying health issues.

"People under 60 with underlying illnesses, with diabetes, heart disease, immunocompromised or have any kind of lung disease previously, those people are more vulnerable despite their younger age," Schaffner said.

A history of travel to an area where the novel coronavirus is widespread (and those parts of the world, including the US, are going up each day) is obviously another key factor in deciding if your symptoms may be Covid-19 or not.

If you have no symptoms, please do not ask for testing or add to backlog of calls at testing centers, clinics, hospitals and the like, experts say.

"We do not test people with no symptoms because it's a resource issue," Schaffner said about the assessment center at Vanderbilt.

"However, we are emphasizing that people who have this small cluster of important symptoms -- fever and anything related to the lower respiratory tract such as cough and difficulty breathing -- reach out to be evaluated."

If you do have those three signs, where should you go?

"If you have insurance and you're looking for a provider or someone to call or connect with, there's always a number on the back of your insurance card; or if you go online, there is information for patients," Harris said.

"If you don't have insurance, you can start with the state health department or the local community health centers, those are officially known as federally qualified health centers," Harris advised, adding that some states have a 1-800 hotline number to call.

"If there is a testing and assessment center near you, you can go there directly," Schaffer said. "It's always good to notify them that you're coming. Otherwise, you need to call your healthcare provider and they will direct you what to do."

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New coronavirus symptoms to look for and when to seek help – WDAF FOX4 Kansas City

Posted: March 31, 2020 at 3:41 am

Please enable Javascript to watch this video

NASHVILLE -- What are the telling signs that you may have the novel coronavirus, also known as COVID-19?

The main list of acute symptoms at this time is actually quite short andcan appear anywhere from two to 14 days after exposure to the virus,according to the US Centers for Disease Control and Prevention.

"We're emphasizing fever plus a notable lower respiratory tract symptom -- cough or trouble breathing," said infectious disease expert Dr. William Schaffner, a professor of preventative medicine and infectious disease at Vanderbilt University School of Medicine in Nashville.

Being able to identify those symptoms and act upon them when necessary is critical. Here's what you need to know.

Fever is a key symptom, experts say. Don't fixate on a number, but know it's really not a fever until your temperature reaches at least 100 degrees Fahrenheit (37.7 degrees Celsius) for children and adults.

"There are many misconceptions about fever. Average daily temperature is 98.6 degrees Fahrenheit (37 degrees Celsius), but we all actually go up and down quite a bit during the day as much as half of a degree or a degree," said Dr. John Williams, chief of the division of pediatric infectious diseases at the University of Pittsburgh Medical Center Children's Hospital of Pittsburgh.

"So 99.0 degrees or 99.5 degrees Fahrenheit is not a fever," he stressed.

When you check for fever, don't rely on a temperature taken in the morning. Instead take your temp in the late afternoon and early evening.

"Our temperature is not the same during the day. If you take it at eight o'clock in the morning, it may be normal," Schaffner explained.

"One of the most common presentations of fever is that your temperature goes up in the late afternoon and early evening -- it's a common way that viruses produce fever."

Coughing is another key symptom, but it's not just any cough, said Schaffner. It should be a dry cough that you feel in your chest.

"It's not a tickle in your throat. You're not just clearing your throat. It's not just irritated. You're not putting anything out, you're not coughing anything up," Schaffner said.

"The cough is bothersome, it's coming from your breastbone or sternum. and you can tell that your bronchial tubes are inflamed or irritated," he added.

Shortness of breath can be a third -- and very serious -- manifestation of CoOVID-19, and it can occur on its own, without a cough. If your chest becomes tight or you begin to feel as if you cannot breathe deeply enough to get a good breath, that's a sign to act, experts say.

"If there's any shortness of breath immediately call your health care provider, a local urgent care or the emergency department," said American Medical Association president Dr. Patrice Harris.

"If the shortness of breath is severe enough, you should call 911," Harris added.

In addition to difficulty breathing or shortness of breath, the CDC lists emergency warning signs for COVID-19 as a "persistent pain or pressure in the chest," "bluish lips or face" -- which indicates a lack of oxygen -- and any sudden mental confusion or lethargy and inability to rouse.

Get medical attention immediately, the CDC says.

This trifecta of symptoms -- fever, cough and shortness of breath -- are not the only signs of sickness that have been seen in cases of Covid-19.

Many other symptoms can resemble the flu, including headaches, digestive issues, body aches and fatigue, which can be severe. Still other symptoms can resemble a cold or allergies, such as a runny nose, sore throat and sneezing.

Most likely, experts say, you simply have a cold or the flu -- after all they can cause fever and cough too. One possible sign that you might have COVID-19 is if your symptoms, especially shortness of breath, don't improve after a week or so but actually worsen.

An odd symptom that mightflag a Covid-19 infection in its early stageswas recently identified by the American Academy of Otolaryngology-Head and Neck Surgery.

In a statement on their website, they said symptoms of anosmia, or lack of sense of smell, and dysgeusia, or lack of taste,should be used to identify possible COVID-19 infections.

"Anosmia, in particular, has been seen in patients ultimately testing positive for the coronavirus with no other symptoms," the statement says.

It has long been known in medical literature that a sudden loss of smell may be associated with respiratory infections caused by other types of coronaviruses.

Overall, "I think we're getting a little bit more insight into the types of symptoms that patients might have," said CNN Chief Medical Correspondent Dr. Sanjay Gupta on the CNN's New Day news program.

"In a study out of China where they looked at some of the earliest patients, some 200 patients, they found that digestive or stomach GI (gastrointestinal) symptoms were actually there in about half the patients," Gupta said, adding that "fever and cough and shortness of breath" still appear to be the prevailing symptoms of COVID-19.

"At this moment, the current guidance -- and this may change -- is that if you have symptoms that are similar to the cold and the flu and these are mild symptoms to moderate symptoms, stay at home and try to manage them with rest, hydration and the use of Tylenol," Harris said.

That advice does not apply if you are over age 60, since immune systems weaken as we age, or if you are pregnant -- anyone with concerns about coronavirus should call their healthcare provider,according to the CDC.

It's unclear whether pregnant women have a greater chance of getting severely ill from coronavirus, but theCDC has said that women experience changesin their bodies during pregnancy that may increase their risk of some infections.

In general, COVID-19 infections are riskier if you have underlying health conditions such as diabetes, chronic lung disease or asthma, heart failure or heart disease, sickle cell anemia, cancer (or are undergoing chemotherapy), kidney disease with dialysis, a body mass index(BMI)over 40 (extremely obese) or an autoimmune disorder.

"Older patients and individuals who have underlying medical conditions or are immunocompromised should contact their physician early in the course of even mild illness," theCDC advises.

To be clear, you are at higher risk -- even if you are young -- if you have underlying health issues.

"People under 60 with underlying illnesses, with diabetes, heart disease, immunocompromised or have any kind of lung disease previously, those people are more vulnerable despite their younger age," Schaffner said.

A history of travel to an area where the novel coronavirus is widespread (and those parts of the world, including the US, are going up each day) is obviously another key factor in deciding if your symptoms may be Covid-19 or not.

If you have no symptoms, please do not ask for testing or add to backlog of calls at testing centers, clinics, hospitals and the like, experts say.

"We do not test people with no symptoms because it's a resource issue," Schaffner said about the assessment center at Vanderbilt.

"However, we are emphasizing that people who have this small cluster of important symptoms -- fever and anything related to the lower respiratory tract such as cough and difficulty breathing -- reach out to be evaluated."

If you do have those three signs, where should you go?

"If you have insurance and you're looking for a provider or someone to call or connect with, there's always a number on the back of your insurance card; or if you go online, there is information for patients," Harris said.

"If you don't have insurance, you can start with the state health department or the local community health centers, those are officially known as federally qualified health centers," Harris advised, adding that some states have a 1-800 hotline number to call.

"If there is a testing and assessment center near you, you can go there directly," Schaffer said. "It's always good to notify them that you're coming. Otherwise, you need to call your healthcare provider and they will direct you what to do."

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Seattle researchers to study malaria drug treatment of coronavirus – KUOW News and Information

Posted: March 31, 2020 at 3:41 am

A decades-old malaria drug -- that has recently prompted debate and confusion -- will be tested in Seattle and New York to see if it could treat coronavirus patients.

Chloroquine and hydroxychloroquine are used to treat malaria (and sometimes other ailments such as lupus or arthritis). It is among potential treatments that UW Medicine is studying in response to the coronavirus pandemic.

"We currently dont know if hydroxychloroquine works, but we will learn in as short a timeframe as possible what the outcome is, said principal investigator Ruanne Barnabas in a statement.

Barnabas is an associate professor of global health in the University of Washington schools of Medicine and Public Health.

The hypothesis around hydroxychloroquine is that it could prevent a virus from entering a cell. That hypothesis has not yet been proven. Evidence that the drug could help fight the virus has so far been anecdotal. Only a couple small studies have touched on it.

UW's study aims to gauge the effectiveness of known drugs on the virus both as a preventative measure and as a treatment after a person is infected. It's budgeted for $9.5 million, drawn from funds provided by the Bill & Melinda Gates Foundation.

UW is asking anyone within western Washington or New York who has been in close contact with a COVID-19 case to contact their health care provider to see about participating. Researchers are seeking 2,000 people.

More information on the study can be found here.

Chloroquine was invented in the 1930s to treat malaria, which is a parasite and not a virus like coronavirus.

President Trump reportedly said Monday that the federal government will know whether the malaria drug is an effective coronavirus treatment within three days. Chloroquine is reportedly being used to treat about 1,100 COVID-19 cases in New York.

I think were going to have a good idea over the next three days because its been used now in New York at my request -- 1,100 people," Trump said. "Its been used. I think thats better than testing it in a laboratory. But the doctors tell me no.

UW Medicine says its study will take eight weeks, however. Results are expected by summer.

Hydroxychloroquine grabbed headlines in recent weeks after Trump called the drug a game-changer. That statement has been walked back by medical experts on the White House's own Coronavirus Task Force. Still, the information coming from the White House has concerned medical officials and other experts who warn about making promises that have not been tested.

After hearing such comments, however, some doctors reportedly started hoarding the drug. Others say that chloroquine or hydroxychloroquine should be used earlier when treating COVID-19 patients.

The CDC has warned against using forms chloroquine to treat coronavirus after an Arizona man died and his wife was hospitalized after the two consumed chloroquine phosphate. The wife told NBC they were afraid of getting sick and took the chemical after hearing the president talk about it.

"We saw his press conference, it was on a lot actually," the woman told NBC.

While the chemical the couple consumed had chloroquine in it, it differed from the drug meant for humans. Rather, it was intended to be used to kill parasites in fish tanks.

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Lessons we can learn from the Spanish Flu outbreak of 1918 – Ladders

Posted: March 31, 2020 at 3:41 am

Often overlooked today in favor of World War II, the first World War was a global conflict the scale of which had never been seen at the time. Millions of French, German, British, and Russian soldiers passed away during the fighting, as well as over 100,000 Americans.

Foolishly, when the war first started in the summer of 1914 most of the nations involved promised their citizens that it would be a quick and decisive contest, and predicted victory parades by Christmas. In reality, the vast majority of Europe was in store for four years of bloody and brutal warfare. By the time the Great War finally ended in 1918 all of the nations involved were ready for peace and a return to normalcy. Unfortunately, nature had other ideas.

Just as the carnage finally came to an end, the most lethal modern strain of influenza reared its viral head. The Spanish flus origins are still debated to this day. Ironically, however, its universally agreed upon that it certainly didnt come from Spain. The Spanish flu received its name simply because neutral Spain was the only country willing to openly report on the new deadly disease at the time.

Wherever it came from, the Spanish flu wreaked havoc on an even larger scale than the war had, infecting an estimated one-fifth to one-third of the planets population and killing as many as 50 million people. World War I killed 17 million for comparisons sake.

All of this just goes to show that while the current COVID-19 pandemic is definitely a new challenge for todays generation, it isnt all that unique within the context of human history. From the black death in the middle ages to the cholera pandemic exactly 200 years ago, mankind has periodically been faced with such challenges.

Fast forward to now, and weve all begun to self-isolate and hunker down in our homes for the foreseeable future. These social-distancing measures arent fun, theres no getting around that, but a new analysis of Spanish flu mortality rates and statistics conducted by the Loyola University Health System has some reassuring news. These policies worked 100 years ago during the Spanish flu outbreak in the United States, and theres no reason why they shouldnt work again this time around.

Dr. Stefan E. Pambuccian, a Loyola Medicine cytologist, surgical pathologist, and professor & vice-chair of the Department of Pathology and Laboratory Medicine at Loyola University Chicago Stritch School of Medicine, analyzed three research projects from over 100 years ago that focused on the spread of the Spanish flu in the US.

According to his analysis, cities that quickly responded to the Spanish flu and enacted sweeping isolation and prevention measures saw much lower disease and mortality rates. Preventative strategies like school and church closures, mandatory mask-wearing in public, a ban on all mass gatherings and events, and strict hygiene practices were incredibly effective then, providing all the more reason to have faith were taking the right approach today. Cities that acted quickly, such as Kansas City, St. Louis, San Francisco, and Milwaukee, had 30-50% lower infection and mortality rates than other US cities that didnt act in a timely manner.

Conversely, the city of Philadelphia failed to take swift action at the time and ended up suffering the highest death rate of any US city. Just 10 days after Philadelphia recorded its first case of Spanish flu, the city held a World War I victory parade that saw 200,000 residents gathered in close quarters on the street. In retrospect, that decision cost thousands of lives.

Theres a great deal of talk these days about flattening the curve, or the idea that social distancing isnt going to completely stop COVID-19 but it will slow its spread enough for hospitals not to be overrun with new patients. Legitimizing this idea, Dr. Pambuccians work found that proactive cities during the Spanish flu pandemic saw a much greater delay before hitting peak mortality. These delays ultimately helped lower the overall mortality numbers in said cities.

The stricter the isolation policies, the lower the mortality rate, Dr. Pambuccian comments.

Its estimated that 675,000 Americans died due to the Spanish flu, and just like today, there were a number of citizens at the time who were skeptical about the effectiveness of social distancing measures.

There was skepticism that these policies were actually working, Dr. Pambuccian adds. But they obviously did make a difference.

The US, and the rest of the world for that matter, are in a much better position today than we were 100 years ago to deal with a pandemic. Thanks to modern technology, an advanced understanding of viral diseases, and higher overall living quality, there are reasons to be optimistic. Nonetheless, however, social distancing is going to be key to beating this virus.

Although the world is a much different place than it was 100 years ago, the efficacy of the measures instituted during the 1918-19 pandemic gives us hope that the current measures will also limit the impact of the COVID-19 pandemic, Dr. Pambuccian concludes.

You probably heard it countless times from your history teachers growing up: those who do not learn history are doomed to repeat it. Well, history is telling all of us to stay home for the next few weeks, and its in all of our interests to heed its warning.

The full study can be found here, published in the Journal of the American Society of Cytopathology.

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CARES Act Summary of Provisions that Support Americas Health Care System – JD Supra

Posted: March 31, 2020 at 3:41 am

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The CARES Act is the third phase of the federal governments response to the coronavirus following two other laws to support American families and address health sector needs that were approved on March 6, 2020 (Phase I here) and March 18, 2020 (Phase II here).

The CARES Act includes provisions which provide cash payments and other resources to help individuals, small businesses, state and local governments and hospitals/healthcare providers. The CARES Act includes four sections (called Titles) and each title addresses a different topic. This e-update summarizes Title III of the CARES Act titled Supporting Americas Health Care System in the Fight Against the Coronavirus. Title III provides much needed financial assistance to the health care industry, as well as additional guidance and other provisions which provide information on waivers and other benefits to help hospitals and others who are on the front lines of fighting the COVID-19 pandemic. The following is a summary of the major provisions of Title III, organized in order by section numbers under the CARES Act but does not address subtitle B Education Provisions and subtitle C Labor Provisions. We will provide links to summaries of other provisions in the CARES Act prepared by our colleagues throughout the firm as they become available.

TITLE III SUPPORTING AMERICAS HEALTH CARE SYSTEM IN THE FIGHT AGAINST THE CORONAVIRUS

SUBTITLE A HEALTH PROVISIONS

PART I ADDRESSING SUPPLY SHORTAGES

SUBPART A MEDICAL PRODUCT SUPPLIES

Section 3101. National academies report on Americas medical product supply chain security.

Not later than 60 days after the enactment of the CARES Act, the Secretary of Health and Human Services is required to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to examine and report on the security of the United States medical product supply chain, considering input from various federal agencies and consulting with relevant stakeholders. The report will (1) assess and evaluate the dependence of the United States on critical drugs and devices that are sourced or manufactured outside of the United States; and (2) provide recommendations, which may include a plan to improve the resiliency of the supply chain for critical drugs and devices and to address any supply vulnerabilities or potential disruptions of such products that would significantly affect or pose a threat to public health security or national security.

Section 3102. Requiring the strategic national stockpile to include certain types of medical supplies.

The law adds the following items to the strategic national stockpile that the Secretary of Health and Human Services is required to maintain in the event of a bioterrorist attack or other public health emergency: personal protective equipment, ancillary medical supplies and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests.

Section 3103. Treatment of Respiratory Protective Devices as Covered Countermeasures.

The law provides for respiratory protective devices approved by the National Institute for Occupational Safety and Health. The law also states that the Secretary of Health and Human Services determines these devices to be a priority for use during a public health emergency qualify as covered countermeasures under Section 42 U.S. Code Section 247d-6d which provides targeted liability protection for pandemic and epidemic products and security countermeasures.

SUBPART B MITIGATING EMERGENCY DRUG SHORTAGES

Section 3111 Prioritize reviews of drug applications; incentives.

The Secretary is now required to expedite certain new drug applications to prevent drug shortages, when previously, expediting applications was optional.

Section 3112 Additional manufacturer reporting requirements in response to drug shortages.Drugs that are deemed critical during a public health emergency are added to the list of drugs that manufacturers must report to the FDA in the case of discontinuation or interruption. Additionally, this provision expands reporting requirements, including requiring manufacturers of these drugs to develop and implement a redundancy risk management plan that must be submitted to the Secretary of Health and Human Services in the event of an inspection or request.

SUBPART C PREVENTING MEDICAL DEVICE SHORTAGES

Section 3121 Discontinuance or interruption in the production of medical devices.

Manufacturers of life-sustaining devices that are deemed critical to public health during a public health emergency must notify the Secretary of Health and Human Services six months prior to any discontinuance or interruption. If appropriate, the Secretary of Health and Human Services may distribute this information to entities the discontinuance or interruption could affect. The Secretary of Health and Human Services is to maintain a list of drug devices of which there is a shortage.

PART IIACCESS TO HEALTH CARE FOR COVID-19 PATIENTS

SUBPART A COVERAGE OF TESTING AND PREVENTIVE SERVICES

Section 3201 Coverage of diagnostic testing for COVID-19.

The Families First Coronavirus Response Act which was signed into law on March 18, 2020 requires that a group health plan or a health insurance issuer offering group or individual health insurance coverage provide coverage and not impose any cost sharing (including deductibles, copayment and co-insurance) or prior authorization or other medical management requirements for an in vitro diagnostic test for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 and the administration of such a test. This section provides more specificity regarding the definition of a COVID-19 diagnostic test under the Families First Coronavirus Response Act by expanding the definition to include an in vitro diagnostic product that

Section 3202 Pricing of diagnostic testing.

A group health plan or a health insurance issuer providing coverage of items and services described in section 6001(a) of division F of the Families First Coronavirus Response Act (which provides for coverage of testing for COVID-19) with respect to an enrollee shall reimburse the provider of the diagnostic testing provider as follows:

During the emergency period described under the Families First Coronavirus Response Act, each provider of a diagnostic test for COVID-10 shall make public the cash price for such test on a public internet website of such provider. The Secretary of Health and Human Services may impose a civil monetary penalty on any provider that is not in compliance and has not completed a corrective action plan to comply in an amount not to exceed $300 per day that the violation is going on.

Section 3203 Rapid coverage of preventive services and vaccines for coronavirus.

The law requires full insurance coverage of yet to be created immunizations and preventive services for COVID-19. Specifically, the Secretary of Health and Human Services, the Secretary of Labor and the Secretary of Treasurer shall require group health plans and health insurance issuers offering group or individual health insurance to cover (without cost-sharing) a qualifying coronavirus preventive service. A qualifying coronavirus preventive service means an item, service or immunization that is intended to prevent or mitigate coronavirus disease 2019 that is:

The requirements shall take effect on the date that is 15 business days after the date on which a recommendation is made relating to the qualifying coronavirus preventive service as described in such paragraph.

SUBPART B SUPPORT FOR HEALTH CARE PROVIDERS

Section 3211 - Supplemental awards for health centers.

$1.32 billion is appropriated for grants to health centers in medically underserved areas working towards the detection of SARS-CoV-2 or the prevention, diagnosis, and treatment of COVID-19.

Section 3212 Telehealth network and telehealth resource centers grant programs.

This provision amends the National Telehealth Strategy and Data Advancement Act to include services for substance use disorders and to serve rural areas in addition to medically underserved areas.

Section 3213 Rural health care services outreach, rural health network development, and small health care provider quality improvement grant programs.

Awards under the National Telehealth Strategy and Data Advancement Act are granted for basic health care services, not only essential health care services.

Sec. 3214 - United States Public Health Service Modernization.

This section amends the Public Health Service Act (42 U.S.C. 204) with respect to Commissioned and Reserve Corps members. The amendments remove references to the Ready Reserve Corps and permit the Regular Corps to be deployed for service in time of a public health emergency, along with other technical amendments.

Section 3215 Limitation on liability for volunteer health care professionals during COVID-19 emergency response.

With limited exceptions, a health care professional shall not be liable under Federal or State law for any harm caused by an act or omission of the professional in the provision of health care services during the public health emergency with respect to COVID-19 if (1) the professional is providing health care services in response to such public health emergency as a volunteer; and (2) the act of omission occurs:

For this purpose, harm includes physical, non-physical, economic and noneconomic losses and health care services means any services provided by a health care professional, or by any individual working under the supervision of a health care professional that relate to (A) the diagnosis, prevention, or treatment of COVID-19; or (B) the assessment or care of the health of a human being related to an actual or suspected case of COVID-19. A volunteer means a health care professional who, with respect to the health care services rendered, does not receive compensation or any other thing of value in lieu of compensation, which compensation (A) includes a payment under any insurance policy or health plan, or any Federal or State health benefits programs; and (B) excludes (i) receipt of items to be used exclusively for rendering health care services in the health care professionals capacity as a volunteer; and (ii) any reimbursement for travel to the site where the volunteer services are rendered and any payments in cash or kind to cover room and board, if the services are being rendered more than 75 miles from the volunteers principal place of residence.

This limitation on liability does not apply if the harm was caused by an act or omission constituting willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious flagrant indifference to the rights or safety of the individual harmed by the health care professional or the health care professional rendered the health care services under the influence (as determined pursuant to applicable State law) of alcohol or an intoxicating drug.

The law clarifies that this section preempts the laws of a State or any political subdivision of a State to the extent that such laws are inconsistent with this section, unless such laws provide greater protection from liability and protections afforded by this section are in addition to those provided by the Volunteer Protection Act of 1997.

This section takes effect upon the date of enactment of the CARES Act and applies to a claim for harm only if the act or omission that caused such harm occurred on or after the date of enactment.

Sec. 3216 - Flexibility for members of National Health Service Corps during emergency period.

This section permits the Secretary of Health and Human Services to assign members of the National Health Service Corps, with voluntary agreement of such corps members, to deploy and provide health services as needed to respond to a public health emergency.

SUBPART C MISCELLANEOUS PROVISIONS

Section 3221 Confidentiality and disclosure of records relating to substance use disorder.

This section revises certain provisions found at 42 U.S.C. 290dd-d concerning confidentiality and disclosure of records relating to substance use disorders. First, outdated references to substance abuse are replaced with the term substance use disorder. Second, the provisions regarding consent and use of the content found in such records was overhauled to explicitly allow use not only specifically consented to by a patient but also as permitted by the HIPAA regulations. The consent and use provisions now also make clear that prior written consent applies for all such future uses or disclosures for purposes of treatment, payment, and health care operations. Third, disclosure of the de-identified record to a public health authority was added to the list of allowable disclosures. Fourth, a list of relevant definitions was added to the statute to be consistent with HIPAA. Fifth, in addition to criminal contexts, administrative and civil contexts were added as situations under which such records may not be disclosed, for example in an application for a warrant. Sixth, general anti-discrimination language was added to protect fair treatment of individuals with such records. Seventh, breach notification language in line with the HITECH Act was added. Finally, this section calls for the Department of Health and Human Services to issue additional regulations to appropriately implement the changes described above and require covered entities to update their notices of privacy practices to account for such records.

Sec. 3222 - Nutrition services.

This section grants the Secretary of Health and Human Services the right to allow state agencies to transfer funds for the provision of nutrition services without the prior approval of the Secretary of Health and Human Services during a public health emergency.

Sec. 3223 - Continuity of service and opportunities for participants in community service activities under title V of the Older Americans Act of 1965.

This section grants the Secretary of Labor the ability to permit participants in community service activities under Title V of the Older Americans Act of 1965 to extend such participation and to increase the average participation cap as set forth therein.

Section 3224 Guidance on protected health information.

No later than 180 days after enactment, the Department of Health and Human Services must issue guidance regarding the sharing of patients protected health information during a public health emergency. The guidance must include information on compliance with regulations promulgated pursuant to HIPAA and applicable policies, including policies that may come into effect during such emergencies.

Section 3225. Reauthorization of healthy start program.

Section 3225 reauthorizes the healthy start program and appropriates $125,500,000 for each of the fiscal years 2021 through 2025. Among other things, the section requires that the Secretary of Health and Human Services ensure that the program is coordinated with other programs and activities related to the reduction of the rate of infant mortality and improved perinatal and infant health outcomes supported by the department.

Section 3226 Importance of the blood supply.

The Secretary of Health and Human Services shall carry out a national campaign to improve awareness of, and support outreach to, the public and healthcare providers about the importance and safety of blood donation and the need for donations for the blood supply during the public health emergency declared by the Secretary of Health and Human Services. The Secretary of Health and Human Services may enter into contracts to establish a national blood donation awareness campaign. The Secretary of Health and Human Services is required to consult with the Commissioner of Food and Drugs, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, and the heads of other relevant Federal agencies, and relevant accrediting bodies and representative organizations. Not later than 2 years after the date of enactment, the Secretary of Health and Human Services shall submit to the Senate and House a report which will include a description of the activities carried out, a description of trends in blood supply donations, and an evaluation of the impact of the public awareness campaign.

PART III INNOVATION

Section 3301. Removing the cap on OTA during public health emergencies.

Section 3301 amends the provisions that govern the Biomedical Advanced Research and Development Authority (BARDA) to remove the cap on other transactions authority (OTA) during a public emergency. Currently, the law authorizes the Secretary of Health and Human Services to enter into other transactions for a project that is expected to cost the Department of Health and Human Services in excess of $100 million only upon the written determination by the Assistant Secretary for Financial Resources that the use of such authority is essential to promoting the success of the project. The amendment removes the foregoing approval for transactions necessary during a public health emergency. Notwithstanding the foregoing, the Secretary of Health and Human Services, to the maximum extent practicable, is required to use competitive procedures when entering into transactions to carry out projects for the purposes of a public health emergency. Any transaction entered into during such public health emergency shall not be terminated solely due to the expiration of the public health emergency if the public health emergency ends before the completion of the terms of such agreement.

Section 3302. Priority zoonotic animal drugs.

Section 3302 amends Chapter V of the Federal Food, Drug, and Cosmetic Act by adding a new section 512A which provides a process for the Secretary of Health and Human Services to expedite the development and review of a new animal drug if preliminary clinical evidence indicates that the new animal drug, alone or in combination with 1 or more other animal drugs, has the potential to prevent or treat a zoonotic disease in animals, including a vector borne-disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.

PART IV HEALTH CARE WORKFORCE

Section 3401 Reauthorization of health professions workforce programs.

Section 3401 makes significant amendments to Title VII of the Public Health Service Act to add additional appropriations of $23,711,000 for each of fiscal years 2021 through 2025 as well as extending funding for various programs.

In addition, under this section, the Secretary of Health and Human Services may award grants or contracts to eligible entities to increase the number of individuals in the public health workforce, to enhance the quality of such workforce, and to enhance the ability of the workforce to meet national, State, and local health care needs. The law authorizes the Secretary of Health and Human Services to give priority to qualified applicants that train residents in rural areas, including for Tribes or Tribal Organizations in such areas.

Section 3402 Health workforce coordination.

Within one year after the date of enactment of the CARES Act, the Secretary of Health and Human Services in consultation with the Advisory Committee on Training in Primary Care Medicine and Dentistry and the Advisory Council on GME, shall develop a comprehensive and coordinated plan with respect to the health care workforce development programs of the Department of Health and Human Services including education and training programs. The plan will include performance measures to determine the extent to which the programs are strengthening the nations health care system, identify any gaps that exist between the outcomes of programs and projected health care workforce needs identified in workforce production reports conducted by the Health Resources and Services Administration, identify actions and barriers and coordinate with other agencies and provide a report to the Senate and House not later than 2 years after the date of enactment of the CARES Act.

Sec. 3403 - Education and training relating to geriatrics.

This section provides that the Secretary of Health and Human Services shall award grants, contracts, or cooperative agreements to certain entities or other health professions schools for the establishment or operation of Geriatrics Workforce Enhancement Programs. These programs are designed to support the training of health professionals in geriatrics, including traineeships and fellowships, with an emphasis on patient and family engagement in an effort to address gaps in health care for older adults. The section sets forth permitted activities, duration of such programs, application requirements, program requirements, and reporting requirements. The section provides the Secretary of Health and Human Services with the authority to grant special consideration and priority to those entities and health professions schools operating in areas with a shortage of geriatric workforce professionals or who can otherwise demonstrate need.

The section further establishes the Geriatric Academic Career Awards program to promote the career development of such individuals as academic geriatricians or other academic geriatric health professionals.

Section 3404 Nursing workforce development.

This section establishes clinics to address national nursing needs including addressing challenges related to the distribution of the nursing workforce and existing or projected nursing workforce shortages in geographic areas that have been identified as having, or that are projected to have, nursing shortage increase access to and the quality of health services, including by supporting the training of professional registered nurses, APRNs, and advanced education nurses within community based settings and in a variety of health delivery system settings or addressing the strategic goals and priorities. No later than September 30, 2020 and biennially thereafter, the Secretary of Health and Human Services will provide a report that contains an assessment of the programs and activities related to enhancing the nursing workforce.

This section also amends Section 296(j) which provides grants to projects that support the enhancement of advanced nursing education and practice to strike the requirements of masters degree program and adding graduate and by inserting clinical nurse leaders after nurse administrators in the list of nurses that qualify for the grants. The law also adds a clinical nurse specialist programs which are education programs that provide registered nurses with full-time clinical nurse specialist education, and have as their objective the education of clinical nurse specialists who will, upon completion of such a program, be qualified to effectively provide care through the wellness and illness continuum to inpatients and outpatients experiencing acute and chronic illness.

In addition, this section expands quality grants to make the quality and retention grants and expanding the high-risk groups to include mental health or substance use disorders in addition to those that are already listed.

Finally, this section adds an additional amount by amending 298(d) to strike $338,000,000 for fiscal years 2011 through 2016 and to insert $137,837,000 for each of the years 2021 through 2025 and to appropriate an additional $117,135,000 for each of the fiscal years 2021 through 2025.

The Comptroller General will conduct an evaluation of the nurse loan repayment program administrated by the Health Resources and Services Administration. The evaluation will focus on the manner in which payments are made under such programs, the existing oversight functions necessary to ensure the proper use of such programs (including payments made as part of such programs), the identification of gaps, if any, in oversight functions and information on the number of nurses assigned to facilities pursuant to such programs (including the type of facility to which nurses are assigned and the impact of modifying the eligibility requirements for programs under the Public Health Services Act). Not later than 18 months after the enactment of the CARES Act, the Comptroller General shall submit a report to the House and Senate on the evaluation which may include recommendations to improve relevant nursing workforce loan repayment program.

SUBTITLE DFINANCING COMMITTEE

Section 3701 Exemption for telehealth services.

This section creates a temporary telehealth-related safe harbor for high deductible health plans. For plan years beginning on or before December 31, 2021, a high deductible health plan does not need to have a deductible for telehealth and other remote care services. In addition, coverage for telehealth and other remote care during such plan years will not be considered in determining whether someone is an eligible individual under a high deductible health plan.

Section 3702 Inclusion of certain over-the-counter medical products as qualifiedmedical expenses.

This section adds the costs of menstrual care products as qualified medical expenses for purposes of health savings accounts, Archer MSAs, health flexible spending arrangements, and health reimbursement arrangements for amounts paid after December 31, 2019.

Section 3703 Increasing Medicare telehealth flexibilities during emergency period.

Federal law at 42 U.S.C. 1320b-5 provides authority to the Secretary of Health and Human Services to waive health care related requirements during a national emergency to ensure that there are sufficient health care items and services to meet patient need and to ensure that health care providers may be reimbursed and may be exempted from sanctions for noncompliance. The CARES Act improves upon Congress recent efforts to enhance the availability of telehealth services for Medicare and Medicaid beneficiaries during this emergency period.

On March 6, 2020, Congress enacted the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, available here, which amended 1320b-5(b) by adding paragraph (b)(8) to permit the Secretary of Health and Human Services to waive certain restrictions on telehealth provided to Medicare, Medicaid and SCHIP beneficiaries starting on March 6, 2020 (the January law). The January law allowed a waiver which would permit payment for telehealth services such as office visits, mental health counseling and preventative health screenings even if a patient was not in a rural area and if the patient was at home. Medicare had historically not paid for telehealth if a patient was at their home when they received the telehealth services, and also did not pay for telehealth for patients in urban areas. The January law, which allowed a waiver to be granted during an emergency period, to permit such payments for Medicare beneficiaries in urban areas and in their homes was a very substantial leap forward for Medicare.

However, the January law still limited the Secretary of Health and Human Services ability to waive certain telehealth payment restrictions. Specifically, the January law did not permit the Secretary of Health and Human Services to waive the limitation on the payment of facility fees, which are only permitted if the patient is located at one of a specific list of originating sites (such as a physician office or a hospital, and notably, NOT at home) and the originating site is located in a rural area.

This new law removes the limitation on the Secretary of Health and Human Services waiver authority for facilities fees related to telehealth. Now, the Secretary of Health and Human Services may determine that during an emergency period, facility fees can be paid for telehealth providers even if the patient is not in a rural area and even if the patient is at home during the telehealth visit.

The January law also included restrictions on the Secretary of Health and Human Services ability to waive requirements for the types of telecommunications services used in telehealth. The Secretary was not permitted to waive telecommunications requirements if the communication did not have both audio and video capabilities. Under this new law, the Secretary now will have the authority to waive all of the requirements regarding the type of telecommunications services that can be used for telehealth.

Further, the January law included a definition of qualified provider which highlighted the fact that telehealth is only allowed for a Medicare or Medicaid beneficiary who is already an established patient of the provider or the providers practice. Despite this continued requirement, the Department of Health and Human Services stated in guidance documents, available here, that it would not conduct audits to ensure that such prior relationship existed for claims submitted during the public health emergency. This new law will go farther than a no audit statement by the Department of Health and Human Services. Instead, this new law will remove the definition of qualified provider, which means that the Secretary of Health and Human Services will have the authority to waive the established patient requirement during the emergency period.

In summary, under this new law the Secretary of Health and Human Services will now have the authority to waive all laws governing payment for telehealth services under Medicare, Medicaid and SCHIP. There are no more limitations to the Secretary of Health and Human Services waiver authority pertaining to payment for telehealth services.

In particular, the Secretary of Health and Human Services now has the authority to waive: (1) the restrictions on the payment of a facility fee even if the patient is at home and not in a rural area during the telehealth visit; (2) all requirements for the type of telecommunications services that can be used- even if the telecommunications service only has audio capabilities; and (3) the requirement that telehealth services can only be provided to a providers established patients.

Section 3704 Enhancing Medicare telehealth services for Federally qualified health centers and rural health clinics during emergency period.

The Act provides that during the currently designated emergency period Medicare shall pay for telehealth services that are furnished via a telecommunications system by a Federally qualified health center (FQHC) or a rural health clinic (RHC) to an eligible telehealth individual who is an enrolled beneficiary notwithstanding that the FQHC or RHC providing the telehealth service is not at the same location as the beneficiary. The Secretary of Health and Human Services shall develop and implement payment methods for such telehealth services, which shall be based on payment rates that are similar to the national average payment rates for comparable telehealth services under the Medicare physician fee schedule. Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement such payment methods through program instruction or otherwise. Costs associated with the telehealth services would not be included in other reimbursement methods for the FQHC and RHC.

Section 3705 - Temporary waiver of requirement for face-to-face visits between home dialysis patients and physicians.

During the currently designated emergency period, the Secretary of Health and Human Services may waive the requirement for face-to-face clinical assessments between home dialysis patients and their physicians. This would allow Medicare beneficiaries determined to have end stage renal disease receiving home dialysis to choose to receive monthly end stage renal disease-related clinical assessments via telehealth.

Section 3706 - Use of telehealth to conduct face-to-face encounter prior to recertification of eligibility for hospice care during emergency period.

For purposes of recertifying a Medicare beneficiary for hospice care, during the currently designated emergency period a hospice physician or nurse practitioner may conduct the required face-to-face encounters via telehealth, as determined appropriate by the Secretary of Health and Human Services.

Section 3707 - Encouraging use of telecommunications systems for home health services furnished during emergency period.

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CARES Act Summary of Provisions that Support Americas Health Care System - JD Supra

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What’s Genetic Engineering? | Live Science

Posted: March 29, 2020 at 6:58 pm

Genetic engineering is the process of using technology to change the genetic makeup of an organism - be it an animal, plant or a bacterium.

This can be achieved by using recombinant DNA (rDNA), or DNA that has been isolated from two or more different organisms and then incorporated into a single molecule, according to the National Human Genome Research Institute (NHGRI).

Recombinant DNA technology was first developed in the early 1970s, and the first genetic engineering company, Genentech, was founded in 1976. The company isolated the genes for human insulin into E. coli bacteria, which allowed the bacteria to produce human insulin.

After approval by the Food and Drug Administration (FDA), Genentech produced the first recombinant DNA drug, human insulin, in 1982. The first genetically engineered vaccine for humans was approved by the FDA in 1987 and was for hepatitis B.

Since the 1980s, genetic engineering has been used to produce everything from a more environmentally friendly lithium-ion battery to infection-resistant crops such as the HoneySweet Plum. These organisms made by genetic engineering, called genetically modified organisms (GMOs), can be bred to be less susceptible to diseases or to withstand specific environmental conditions.

But critics say that genetic engineering is dangerous. In 1997, a photo of a mouse with what looked like a human ear growing out of its back sparked a backlash against using genetic engineering. But the mouse was not the result of genetic engineering, and the ear did not contain any human cells. It was created by implanting a mold made of biodegradable mesh in the shape of a 3-year-old's ear under the mouse's skin, according to the National Science Foundation, in order to demonstrate one way to produce cartilage tissue in a lab.

While genetic engineering involves the direct manipulation of one or more genes, DNA can also be controlled through selective breeding. Precision breeding, for example, is an organic farming technique that includes monitoring the reproduction of species members so that the resulting offspring have desirable traits.

A recent example of the use of precision breeding is the creation of a new type of rice. To address the issue of flooding wiping out rice crops in China, Pamela Ronald, a professor of plant pathology at the University of California-Davis, developed a more flood-tolerant strain of rice seed.

Using a wild species of rice that is native to Mali, Ronald identified a gene, called Sub1, and introduced it into normal rice varieties using precision breeding creating rice that can withstand being submerged in water for 17 days, rather than the usual three.

Calling the new, hardier rice the Xa21 strain, researchers hope to have it join the ranks of other GMOs currently being commercially grown worldwide, including herbicide-tolerant or insect-resistant soy, cotton and corn, within the next year, Ronald said. For farmers in China, the world's top producer and consumer of rice, being able to harvest enough of the crop to support their families is literally a matter of life and death.

Because Ronald used precision breeding rather than genetic engineering, the rice will hopefully meet with acceptance among critics of genetic engineering, Ronald said.

"The farmers experienced three to five fold increases in yield due to flood tolerance," Ronald said at a World Science Festival presentation in New York. "This rice demonstrates how genetics can be used to improve the lives of impoverished people."

Got a question? Email it to Life's Little Mysteries and we'll try to answer it. Due to the volume of questions, we unfortunately can't reply individually, but we will publish answers to the most intriguing questions, so check back soon.

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What's Genetic Engineering? | Live Science

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Genetic Engineering – humans, body, used, process, plants …

Posted: March 29, 2020 at 6:58 pm

Photo by: Gernot Krautberger

Genetic engineering is any process by which genetic material (the building blocks of heredity) is changed in such a way as to make possible the production of new substances or new functions. As an example, biologists have now learned how to transplant the gene that produces light in a firefly into tobacco plants. The function of that genethe production of lighthas been added to the normal list of functions of the tobacco plants.

Genetic engineering became possible only when scientists had discovered exactly what is a gene. Prior to the 1950s, the term gene was used to stand for a unit by which some genetic characteristic was transmitted from one generation to the next. Biologists talked about a "gene" for hair color, although they really had no idea as to what that gene was or what it looked like.

That situation changed dramatically in 1953. The English chemist Francis Crick (1916 ) and the American biologist James Watson (1928 ) determined a chemical explanation for a gene. Crick and Watson discovered the chemical structure for large, complex molecules that occur in the nuclei of all living cells, known as deoxyribonucleic acid (DNA).

DNA molecules, Crick and Watson announced, are very long chains or units made of a combination of a simple sugar and a phosphate group.

Amino acid: An organic compound from which proteins are made.

DNA (deoxyribonucleic acid): A large, complex chemical compound that makes up the core of a chromosome and whose segments consist of genes.

Gene: A segment of a DNA molecule that acts as a kind of code for the production of some specific protein. Genes carry instructions for the formation, functioning, and transmission of specific traits from one generation to another.

Gene splicing: The process by which genes are cut apart and put back together to provide them with some new function.

Genetic code: A set of nitrogen base combinations that act as a code for the production of certain amino acids.

Host cell: The cell into which a new gene is transplanted in genetic engineering.

Human gene therapy (HGT): The application of genetic engineering technology for the cure of genetic disorders.

Nitrogen base: An organic compound consisting of carbon, hydrogen, oxygen, and nitrogen arranged in a ring that plays an essential role in the structure of DNA molecules.

Plasmid: A circular form of DNA often used as a vector in genetic engineering.

Protein: Large molecules that are essential to the structure and functioning of all living cells.

Recombinant DNA research (rDNA research): Genetic engineering; a technique for adding new instructions to the DNA of a host cell by combining genes from two different sources.

Vector: An organism or chemical used to transport a gene into a new host cell.

Attached at regular positions along this chain are nitrogen bases. Nitrogen bases are chemical compounds in which carbon, hydrogen, oxygen, and nitrogen atoms are arranged in rings. Four nitrogen bases occur in DNA: adenine (A), cytosine (C), guanine (G), and thymine (T).

The way in which nitrogen bases are arranged along a DNA molecule represents a kind of genetic code for the cell in which the molecule occurs. For example, the sequence of nitrogen bases T-T-C tells a cell that it should make the amino acid known as lysine. The sequence C-C-G, on the other hand, instructs the cell to make the amino acid glycine.

A very long chain (tens of thousands of atoms long) of nitrogen bases tells a cell, therefore, what amino acids to make and in what sequence to arrange those amino acids. A very long chain of amino acids arranged in a particular sequence, however, is what we know of as a protein. The specific sequence of nitrogen bases, then, tells a cell what kind of protein it should be making.

Furthermore, the instructions stored in a DNA molecule can easily be passed on from generation to generation. When a cell divides (reproduces), the DNA within it also divides. Each DNA molecule separates into two identical parts. Each of the two parts then makes a copy of itself. Where once only one DNA molecule existed, now two identical copies of the molecule exist. That process is repeated over and over again, every time a cell divides.

This discovery gave a chemical meaning to the term gene. According to our current understanding, a specific arrangement of nitrogen bases forms a code, or set of instructions, for a cell to make a specific protein. The protein might be the protein needed to make red hair, blue eyes, or wrinkled skin (to simplify the possibilities). The sequence of bases, then, holds the code for some genetic trait.

The Crick-Watson discovery opened up unlimited possibilities for biologists. If genes are chemical compounds, then they can be manipulated just as any other kind of chemical compound can be manipulated. Since DNA molecules are very large and complex, the actual task of manipulation may be difficult. However, the principles involved in working with DNA molecule genes is no different than the research principles with which all chemists are familiar.

For example, chemists know how to cut molecules apart and put them back together again. When these procedures are used with DNA molecules, the process is known as gene splicing. Gene splicing is a process that takes place naturally all the time in cells. In the process of division or repair, cells routinely have to take genes apart, rearrange their components, and put them back together again.

Scientists have discovered that cells contain certain kinds of enzymes that take DNA molecules apart and put them back together again. Endonucleases, for example, are enzymes that cut a DNA molecule at some given location. Exonucleases are enzymes that remove one nitrogen base unit at a time. Ligases are enzymes that join two DNA segments together.

It should be obvious that enzymes such as these can be used by scientists as submicroscopic scissors and glue with which one or more DNA molecules can be cut apart, rearranged, and the put back together again.

Genetic engineering requires three elements: the gene to be transferred, a host cell into which the gene is inserted, and a vector to bring about the transfer. Suppose, for example, that one wishes to insert the gene for making insulin into a bacterial cell. Insulin is a naturally occurring protein made by cells in the pancreas in humans and other mammals. It controls the breakdown of complex carbohydrates in the blood to glucose. People whose bodies have lost the ability to make insulin become diabetic.

The first step in the genetic engineering procedure is to obtain a copy of the insulin gene. This copy can be obtained from a natural source

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(from the DNA in a pancreas, for example), or it can be manufactured in a laboratory.

The second step in the process is to insert the insulin gene into the vector. The term vector means any organism that will carry the gene from one place to another. The most common vector used in genetic engineering is a circular form of DNA known as a plasmid. Endonucleases are used to cut the plasmid molecule open at almost any point chosen by the scientist. Once the plasmid has been cut open, it is mixed with the insulin gene and a ligase enzyme. The goal is to make sure that the insulin gene attaches itself to the plasmid before the plasmid is reclosed.

The hybrid plasmid now contains the gene whose product (insulin) is desired. It can be inserted into the host cell, where it begins to function just like all the other genes that make up the cell. In this case, however, in addition to normal bacterial functions, the host cell also is producing insulin, as directed by the inserted gene.

Notice that the process described here involves nothing more in concept than taking DNA molecules apart and recombining them in a different arrangement. For that reason, the process also is referred to as recombinant DNA (rDNA) research.

The possible applications of genetic engineering are virtually limitless. For example, rDNA methods now enable scientists to produce a number of products that were previously available only in limited quantities. Until the 1980s, for example, the only source of insulin available to diabetics was from animals slaughtered for meat and other purposes. The supply was never large enough to provide a sufficient amount of affordable insulin for everyone who needed insulin. In 1982, however, the U.S. Food and Drug Administration approved insulin produced by genetically altered organisms, the first such product to become available.

Since 1982, the number of additional products produced by rDNA techniques has greatly expanded. Among these products are human growth hormone (for children whose growth is insufficient because of genetic problems), alpha interferon (for the treatment of diseases), interleukin-2 (for the treatment of cancer), factor VIII (needed by hemophiliacs for blood clotting), erythropoietin (for the treatment of anemia), tumor necrosis factor (for the treatment of tumors), and tissue plasminogen activator (used to dissolve blood clots).

Genetic engineering also promises a revolution in agriculture. Recombinant DNA techniques enable scientists to produce plants that are resistant to herbicides and freezing temperatures, that will take longer to ripen, and that will manufacture a resistance to pests, among other characteristics.

Today, scientists have tested more than two dozen kinds of plants engineered to have special properties such as these. As with other aspects of genetic engineering, however, these advances have been controversial. The development of herbicide-resistant plants, for example, means that farmers are likely to use still larger quantities of herbicides. This trend is not a particularly desirable one, according to some critics. How sure can we be, others ask, about the risk to the environment posed by the introduction of "unnatural," engineered plants?

The science and art of animal breeding also are likely to be revolutionized by genetic engineering. For example, scientists have discovered that a gene in domestic cows is responsible for the production of milk. Genetic engineering makes it possible to extract that gene from cows who produce large volumes of milk or to manufacture that gene in the laboratory. The gene can then be inserted into other cows whose milk production may increase by dramatic amounts because of the presence of the new gene.

One of the most exciting potential applications of genetic engineering involves the treatment of human genetic disorders. Medical scientists know of about 3,000 disorders that arise because of errors in an individual's DNA. Conditions such as sickle-cell anemia, Tay-Sachs disease, Duchenne muscular dystrophy, Huntington's chorea, cystic fibrosis, and Lesch-Nyhan syndrome result from the loss, mistaken insertion, or change of a single nitrogen base in a DNA molecule. Genetic engineering enables scientists to provide individuals lacking a particular gene with correct copies of that gene. If and when the correct gene begins functioning, the genetic disorder may be cured. This procedure is known as human gene therapy (HGT).

The first approved trials of HGT with human patients began in the 1980s. One of the most promising sets of experiments involved a condition known as severe combined immune deficiency (SCID). Individuals with SCID have no immune systems. Exposure to microorganisms that would be harmless to the vast majority of people will result in diseases that can cause death. Untreated infants born with SCID who are not kept in a sterile bubble become ill within months and die before their first birthday.

In 1990, a research team at the National Institutes of Health (NIH) attempted HGT on a four-year-old SCID patient. The patient received about one billion cells containing a genetically engineered copy of the gene that his body lacked. Another instance of HGT was a procedure, approved in 1993 by NIH, to introduce normal genes into the airways of cystic fibrosis patients. By the end of the 1990s, according to the NIH, more than 390 gene therapy studies had been initiated. These studies involved more than 4,000 people and more than a dozen medical conditions.

In 2000, doctors in France claimed they had used HGT to treat three babies who suffered from SCID. Just ten months after being treated, the babies exhibited normal immune systems. This marked the first time that HGT had unequivocally succeeded.

Controversy remains. Human gene therapy is the source of great controversy among scientists and nonscientists alike. Few individuals maintain that the HGT should not be used. If we could wipe out sickle cell anemia, most agree, we should certainly make the effort. But HGT raises other concerns. If scientists can cure genetic disorders, they can also design individuals in accordance with the cultural and intellectual fashions of the day. Will humans know when to say "enough" to the changes that can be made with HGT?

Photo Researchers, Inc.

Despite recent successes, most results in HGT since the first experiment was conducted in 1990 have been largely disappointing. And in 1999, research into HGT was dealt a blow when an eighteen-year-old from Tucson, Arizona, died in an experiment at the University of Pennsylvania. The young man, who suffered from a metabolic disorder, had volunteered for an experiment to test gene therapy for babies with a fatal form of that disease. Citing the spirit of this young man, researchers remain optimistic, vowing to continue work into the possible lifesaving opportunities offered by HGT.

The commercial potential of genetically engineered products was not lost on entrepreneurs in the 1970s. A few individuals believed that the impact of rDNA on American technology would be comparable to that of computers in the 1950s. In many cases, the first genetic engineering firms were founded by scientists involved in fundamental research. The American biologist Herbert Boyer, for example, teamed up with the venture capitalist Robert Swanson in 1976 to form Genentech (Genetic Engineering Technology). Other early firms like Cetus, Biogen, and Genex were formed similarly through the collaboration of scientists and businesspeople.

The structure of genetic engineering (biotechnology) firms has, in fact, long been a source of controversy. Many observers have questioned the right of a scientist to make a personal profit by running companies that benefit from research that had been carried out at publicly funded universities. The early 1990s saw the creation of formalized working relations between universities, individual researchers, and the corporations founded by these individuals. Despite these arrangements, however, many ethical issues remain unresolved.

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