Risk of new lockdowns rises with fear of second COVID-19 wave

LONDON/BRUSSELS (Reuters) – Fears of a second wave of COVID-19 infections shut six major food markets in Beijing on Friday, while India, which opened up this week, recorded a record daily increase and half a dozen U.S. states said their hospital beds were filling up fast.

FILE PHOTO: People wearing face masks queue to enter a reopened Primark store as Madrid eases lockdown restrictions following the coronavirus disease (COVID-19) outbreak, in Madrid, Spain, June 11, 2020. REUTERS/Susana Vera/

Health officials worldwide have expressed concerns in recent days that some countries grappling with the devastating economic impact of lockdowns may lift restrictions too swiftly, and that the coronavirus could spread during mass anti-racism protests.

“We must be ready to roll back relaxation of measures if needed,” the European Union’s health commissioner Stella Kyriakides said after urging its 27 members to plough ahead with testing the population as they reopen schools and businesses.

In China, where the new coronavirus originated, two new cases of COVID-19, the disease it causes, were recorded in the capital. Authorities closed part or all of six big wholesale food markets which the two men had recently visited but it was not known how they had become infected.

India opened most public transport, offices and malls this week after nearly 70 days even though health officials said it was weeks away from flattening the rising infection curve.

The official death toll, at 8,498, is relatively small, but the health ministry said registered cases rose by 10,956 on Friday, a record, with many in Delhi, Mumbai and Chennai.

Syed Ahmed Bukhari, the head of Delhi’s Jama Masjid, one of India’s biggest mosques, ordered a halt to congregations until the end of the month.

“What is the point of visiting mosques at a time when the virus is spreading so fast?” he said.


In Turkey, the top medical association said the easing of restrictions on June 1 had come too soon, although the daily death toll as fallen in recent weeks to about 20.

“There is talk of when the second wave will hit, but we have not yet been able to overcome the first wave,” Cavit Isik Yavuz, part of the coronavirus research team at the Turkish Medics Association said.

While new infections are slowing in most of Europe, health experts see a moderate to high risk that post-lockdown rises may warrant new restrictions.

The European Centre for Disease Prevention and Control (ECDC) predicted a moderate acceleration across Europe in coming weeks, which could place healthcare systems under stress if not checked rapidly. Government control measures could check and reverse upward trends within two to three weeks, it said.

Andrea Ammon, director of the ECDC, stressed the importance of maintaining physical distancing, hand hygiene and what she called “respiratory etiquette”.

Officials have expressed concern the virus could spread among the tens of thousands who have crowded together in Europe’s big cities to demonstrate against racism after the death in U.S. police custody of George Floyd.

“Mass events could be a major route of transmission,” said Martin Seychell, a health official at the EU Commission.


World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus said late on Thursday that the threat of a resurgence remained very real.

“We must also remember that, although the situation is improving here in Europe, globally it’s getting worse … We will continue to need global solidarity to defeat this pandemic fully,” he said.

Of 5,347 new deaths recorded worldwide, 3,681 were in the Americas, the WHO said on Thursday.

In about half a dozen U.S. states including Texas and Arizona, the number of coronavirus patients filling hospital beds is rising, fanning concerns that the reopening of the U.S. economy may unleash a second wave of infections. Alabama, Florida, North Carolina, South Carolina, Oregon and Nebraska all had a record number of new cases on Thursday.

“I want the reopening to be successful,” Harris County Judge Lina Hidalgo, the top executive for the county that encompasses Houston, Texas, told reporters. “But I’m growing increasingly concerned that we may be approaching the precipice of a disaster.”

More hospitalisations inevitably mean more deaths ahead, said Spencer Fox, research associate at the University of Texas at Austin.

“We are starting to see very worrying signs about the course the pandemic is taking in cities and states in the U.S. and around the world,” he said. “When you start seeing those signs, you need to act fairly quickly.”

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Wall Street’s main indexes opened sharply higher on Friday, a day after the biggest one-day dive in about three months on fears of a resurgence in infections. Global stocks .MIWD00000PUS were up 1.3% after four days of consecutive losses.

The United States has now recorded more than 113,000 coronavirus deaths, by far the most in the world. That figure could be over 200,000 by September, Ashish Jha, the head of Harvard’s Global Health Institute, told CNN.

additional reporting by Reuters bureax around the world, writing by Philippa Fletcher; Editing by Kevin Liffey and Toby Chopra

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Virus has multiple pathways into cells, Moderna vaccine clears safety hurdle in mouse study

(Reuters) – The following is a brief roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

FILE PHOTO: A worker checks the temperature of a client at a local store opened for pick up, as phase one of reopening after lockdown begins, during the outbreak of the coronavirus disease (COVID-19), at 5th Avenue in New York City, New York, U.S., June 12, 2020. REUTERS/Eduardo Munoz/File Photo

Coronavirus has more than one gateway into cells

Two teams of European researchers, working independently, have identified a new entryway through which the coronavirus gets into cells and infects them, suggesting another approach to stopping it. One key route – via a protein on cell surfaces called ACE2 – is well known. The newly identified gateway is a cell-surface protein called neuropilin-1, or NRP1. A “spike” on the surface of the coronavirus binds to NRP1, allowing the virus to break into the cell, similar to how a virus spike attaches itself to ACE2. Other viruses also employ NRP1 as an entry into cells, including the one that causes mononucleosis. In laboratory experiments with human cells, one of the teams found that an antibody that binds to NRP1 can block the coronavirus spike from attaching and prevent infection. Neither of the studies has been through the peer-review process. One was posted on the preprint server bioRxiv on Wednesday and the other late last week. The research groups say their findings suggest that NRP1 could be another target for drugs and vaccines against the new virus. (bit.ly/2C1nKk4; bit.ly/2UE2pDJ)

Mouse study suggests Moderna vaccine will be safe in humans

A study of Moderna Inc’s COVID-19 vaccine in mice lends some assurance that it will not increase the risk of more severe disease in humans, and that one dose may provide protection against the novel coronavirus, according to preliminary data released on Friday. Prior studies testing vaccines in similar viruses have suggested that rather than being protective, they might accidentally cause more severe disease, especially in individuals who do not produce an adequately strong immune response. Scientists see this risk as a key hurdle that must be cleared before vaccines can be safely tested in thousands of healthy people. While the data released by the U.S. National Institutes of Allergy and Infectious Disease and Moderna were encouraging, mouse data is no guarantee of what will happen in humans. Further testing also suggested that the vaccine induces potent neutralizing antibody responses – the type of response needed to block the virus from infecting cells – and that it appeared to protect against infection in the lungs and nose without evidence of toxic effects. The study, which has not yet been peer reviewed, was posted on the bioRxiv website. Moderna said on Thursday it plans to begin final-stage trials enrolling 30,000 people in July. (; reut.rs/37pvckt;bit.ly/30Br3sr)

Hydroxychloroquine affect on immune system not helpful against virus

Researchers studying how hydroxychloroquine modifies the body’s immune response have found it is unlikely to be helpful in fighting the coronavirus, in the latest evidence against use of the decades-old malaria drug promoted by U.S. President Donald Trump. The medicine, which is also used treat inflammatory conditions like lupus and rheumatoid arthritis, was shown to prevent the new coronavirus from replicating in test tube experiments. While it does reduce severe inflammation, the researchers say, it simultaneously suppresses the immune responses needed to fight off the virus and does not allow the body to develop so-called trained immunity, which facilities the defense against infections. “The fact that hydroxychloroquine averts trained immunity argues against the usefulness of this drug in clearing SARS-CoV-2 infection,” the researchers wrote in a not-yet-peer-reviewed paper posted on Tuesday on the preprint server medRxiv. (bit.ly/30CRQoe)

COVID-19 is a neurological disease too

Add problems with the brain and nervous system to the list of complications in patients with COVID-19, say doctors, providing further evidence that it is far more than a respiratory illness. For a report on Thursday in the Journal of Neurology, researchers pooled data from 41 previously published studies of the neurological effects of the coronavirus. The most common nonspecific neurological symptoms were fatigue (seen in 33.2% of patients), loss of appetite (30.0%), shortness of breath (26.9%), and general malaise (26.7%). The most common specific neurological symptoms – which occurred less often – included disorders of smell and taste, Guillain-Barré syndrome and inflammation of the brain, spinal cord, and meninges. These tallies did not include strokes that result from blood clotting disorders caused by the coronavirus. In a report published on Sunday in Annals of Neurology, a separate team of doctors called COVID-19 “a global threat to the nervous system” and said, “the number of recognized neurologic manifestations of SARS-CoV-2 infection is rapidly accumulating.” (bit.ly/2YnRuz6; bit.ly/3hgFCYp)

Mask-wearing significantly reduces infection risk

Of all the lifestyle changes imposed to prevent the spread of the new coronavirus, mask-wearing may be the most important, a new study suggests. Researchers say infection trends shifted dramatically when mask-wearing rules were implemented on April 6 in northern Italy and April 17 in New York City – two epicenters of the pandemic. “This protective measure alone significantly reduced the number of infections, that is, by over 78,000 in Italy from April 6 to May 9 and over 66,000 in New York City from April 17 to May 9,” they calculated in a study published on Thursday in PNAS: The Proceedings of the National Academy of Sciences of the USA. When mask-wearing went into effect in New York, the daily new infection rate fell by about 3% per day, researchers said. In the rest of the country, daily new infections continued to increase. Direct contact precautions – social distancing, quarantine and isolation, and hand sanitizing – were all in place before mask-wearing rules went into effect in Italy and New York City. But they only help minimize virus transmission by direct contact, while face covering helps prevent airborne transmission, the researchers say. “The unique function of face covering to block atomization and inhalation of virus-bearing aerosols accounts for the significantly reduced infections,” they said. That would indicate “that airborne transmission of COVID-19 represents the dominant route for infection,” they conclude. (bit.ly/3fvbabp)

(GRAPHIC: The lifeline pipeline, COVID-19 treatments, vaccines in development – here)

Reporting by Nancy Lapid and Julie Steenhuysen; Editing by Bill Berkrot

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Federal Help Falters As Nursing Homes Run Short Of Protective Equipment

Around the country, nursing homes trying to protect their residents from the coronavirus eagerly await boxes of masks, eyewear and gowns promised by the federal government. But all too often the packages deliver disappointment — if they arrive at all.

Some contain flimsy surgical masks or cloth face coverings that are explicitly not intended for medical use. Others are missing items or have far less than the full week’s worth of protective equipment the government promised to send. Instead of proper medical gowns, many packages hold large blue plastic ponchos.

“It’s like putting a trash bag on,” said Pamela Black, the administrator of Enterprise Estates Nursing Center in Enterprise, Kansas. “There’s no real place for your hands to come out.”

As nursing homes remain the pandemic’s epicenter, the federal government is failing to ensure they have all the personal protective equipment, or PPE, needed to prevent the spread of the virus, according to interviews with administrators and federal data.

Despite President Donald Trump’s pledge April 30 to “deploy every resource and power that we have” to protect older Americans, a fifth of the nation’s nursing homes — 3,213 out of more than 15,000 — reported during the last two weeks of May that they had less than a week’s supply of masks, gowns, gloves, eye protectors or hand sanitizer, according to federal records. Of those, 946 reported they had at least one confirmed COVID infection since the pandemic began.

“The federal government’s failure to nationalize the supply chain and take control of it contributed to the deaths in nursing homes,” said Scott LaRue, president and CEO of ArchCare, the health care system of the Roman Catholic Archdiocese of New York, which operates five nursing homes.

Widespread equipment shortages continue in some places as the virus rages lethally through nursing homes and other long-term care facilities. More than 217,000 short-term patients and long-term residents in nursing homes have contracted COVID-19, and 43,000 have died.

Some homes still have not received the first of two batches of supplies the Federal Emergency Management Agency said it would ship in May. Instead, some got only cloth masks that the Department of Health and Human Services commissioned through a contract with HanesBrands, the apparel company known for its underwear. An HHS webpage says the masks are not intended for caring for contagious patients but can be given to workers for their commutes or to residents when they leave their rooms.

As homes keep scrounging for supplies in a chaotic market with jacked-up prices and continued scarcity, 653 skilled nursing facilities informed the government they had completely run out of one or more types of protective supplies at some point in the last two weeks of May, according to records released last week by the Centers for Medicare & Medicaid Services, or CMS.

“The federal government has got to step up,” said Lori Smetanka, executive director of the National Consumer Voice for Quality Long-Term Care, an advocacy group based in Washington, D.C. “We’re now — what? — three months into this pandemic, and these facilities still don’t have enough PPE to protect themselves and their residents?”

A ‘Relentless Commitment’

In April, Trump pledged his administration “will never waver in its relentless commitment to America’s seniors.” But FEMA’s shipments of masks, gloves, gowns and eye protection have had a more modest goal: “to serve as a bridge between other PPE shipments.”

In written comments, FEMA defended the quality of the poncho gowns but said that because of complaints, the contractor was creating a “short instructional video about proper use of the gowns” to share with homes. FEMA officials said that, as of June 4, the agency had shipped packages to 11,287 nursing homes, starting at “the soonest possible date in the COVID-19 global supply chain climate.”

Yet 67 of the Good Samaritan Society’s 147 nursing homes have not received a FEMA shipment, including homes that are fighting the biggest outbreaks in Sioux Falls, South Dakota; Greeley, Colorado; and Omaha, Nebraska, according to Nate Schema, the Evangelical Lutheran society’s vice president of operations. “We have not received a shipment in our six or seven hot spots,” he said.

The supplies that did arrive tended to be in one size only, he said, and “the quality wasn’t quite up to the same level we’ve been receiving” through the society’s affiliation with Sanford Health, a large hospital and physician system.

The society has enough equipment, but small nursing home groups and independent homes are still struggling, particularly with obtaining N95 masks, which filter out tiny particles of the virus and are considered the best way to protect both nursing home employees and residents from transmitting it.

The CMS records show 711 nursing homes reported having run out of N95 masks, and 1,963 said they had less than a week’s worth. But FEMA is not shipping any N95 masks, and nursing homes are having trouble obtaining them from other sources. Instead, it is sending surgical masks, but more than 1,000 homes have less than a week’s supply of those.

Messiah Lifeways at Messiah Village in Mechanicsburg, Pennsylvania, received a FEMA shipment this week that had face shields and gloves, but only three days’ worth of surgical masks and “very low low-grade quality” gowns that lacked sleeves, said Katie Andreano, a Messiah communications specialist.

Only two of ArchCare’s five nursing homes have received any FEMA shipments even though it is based in New York City, the site of the nation’s biggest outbreak. The equipment for those two homes lasted less than a week. LaRue tried to procure equipment from abroad, but all of the potential suppliers turned out to be fraudulent. He said ArchCare has had to rely on sporadic supplies from the state and city emergency management offices.

“As we sit here today, I’m still not able to get more than a few days’ supply of N95 masks, and I still struggle to a certain extent with gowns,” LaRue said. “That doesn’t make you sleep at night, because you’re not sure when the next delivery comes.”

‘It’s Not Going To Work’

In addition to the supplies, the administration has dedicated $5 billion to nursing homes out of $175 billion in provider relief funds appropriated by Congress. Hospitals are getting much more. Administrators said money doesn’t solve the broken private supply chains, where the availability of PPE is spotty and the equipment is vastly overpriced.

“Too often, the only signs of FEMA’s much-hyped promise of PPE are scattershot delivery with varying amounts of ragtag supplies,” said Katie Smith Sloan, president and CEO of LeadingAge, an association of nonprofit nursing homes and other service agencies for older people.

The cloth masks from HHS have been particularly perplexing to nursing home administrators, given the caveats that accompanied them. The instructions for the masks said they could be washed up to 15 times, according to Sondra Norder, president and CEO of St. Paul Elder Services in Kaukauna, Wisconsin.

“I don’t know how we would possibly track how many times each mask has been washed,” she said. The instructions also said the masks should not be washed with disinfectants, bleach or chemicals, which is how Norder said nursing homes clean their laundry.

Norder said she laundered about 100 masks and they shrank. “The ones that have been washed are tiny, and I certainly wouldn’t want to put something on someone’s face that hasn’t been laundered,” she said. “All my colleagues [at other nursing homes] received the same thing and were also baffled by it, wondering, ‘How are we going to use these?’”

KHN senior correspondent Christina Jewett contributed to this report.

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Only French victims of faulty breast implant may claim damages, EU court says

BRUSSELS (Reuters) – German victims of defective breast implants made by French company Poly Implant Prothese (PIP) cannot claim damages from its insurer as its policy covered only French victims, Europe’s top court said on Thursday, dealing a blow to thousands of women worldwide.

The PIP scandal, in which the company filled its implants with unauthorized industrial silicone instead of medical silicone, occurred in 2010 and affected about 300,000 women in some 65 countries. The company shut down in 2010.

A German victim had sought compensation from PIP’s insurer Allianz IARD in a German court for her faulty breast implants, saying that a clause in the company’s policy which restricted coverage to French victims was against EU laws.

The Luxembourg-based Court of Justice of the European Union disagreed.

“The general prohibition of discrimination on grounds of nationality cannot be the basis for challenging a clause, contained in a contract concluded between a manufacturer of medical devices and an insurance company, that places a territorial limit on civil liability insurance coverage,” judges said.

The PIP Implant World Victims Association called for changes to EU rules for medical devices and more protection for cross-border consumers.

“The regulation favours international exchanges of products, which is a good thing, but consumer protection stops at the border,” said Olivier Aumaitre, a lawyer for the association.

“More than 10 years after the revelation of the scandal, the European authorities have still not deemed it necessary to remedy this major deficiency.”

PIP founder Jean-Claude Mas was jailed for four years and fined 75,000 euros ($85,365) in 2013 after a police investigation revealed a sophisticated fraud.

The case is C-581/18 TÜV Rheinland LGA Products et Allianz IARD (DE).

($1 = 0.88 euros)

Reporting by Foo Yun Chee, additional reporting by Myriam Rivet in Paris; Editing by Angus MacSwan

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Retracted COVID-19 studies expose holes in vetting of data firms

(This story corrects UnitedHealth executive’s title)

FILE PHOTO: The ultrastructural morphology exhibited by the 2019 Novel Coronavirus (2019-nCoV), which was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China, is seen in an illustration released by the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, U.S. January 29, 2020. Alissa Eckert, MS; Dan Higgins, MAM/CDC/Handout via REUTERS/File Photo

By Caroline Humer and Marisa Taylor

NEW YORK (Reuters) – The scramble to research the novel coronavirus has exposed weaknesses in the vetting of healthcare data being supplied by a growing number of U.S. firms, a flaw that forced two of the most respected medical journals to pull studies last week.

The Lancet and the New England Journal of Medicine (NEJM) retracted COVID-19 studies over questionable patient health data supplied by a small company called Surgisphere.

U.S. researchers say they are routinely peppered with pitches from similar firms, with no widespread standard of how to verify their datasets.

“Whenever you don’t know where data comes from, and precisely how it was managed, then the number of incorrect conclusions you can draw is large,” said Kenneth Mandl, director of the Computational Health Informatics Program at Boston Children’s Hospital. “The field is young enough that those best practices may not be well established across the scientific community.”

The Lancet study, which concluded treating COVID-19 with hydroxychloroquine increased the risk of death, drew scrutiny from scientists worldwide. They suggested that patient outcomes data from several countries did not add up.

Mandeep Mehra, a Harvard Medical School professor and researcher with Brigham and Women’s Hospital in Boston, and his co-authors retracted the Lancet study and a second study in NEJM, saying they could not vouch for the veracity of the data and that Surgisphere would not provide its underlying data to independent auditors.

The retractions “are great examples of why science needs more of a ‘In God We Trust, everyone else needs to show their data’ approach,” said Ivan Oransky, vice president of editorial at Medscape and co-founder of the Retraction Watch blog.

Over the years, more than 1,500 studies have made it into Retraction Watch’s database because of data concerns such as data falsification by the authors, Oransky said. There have been about 15 medical paper retractions related to COVID-19, according to the website.

For years, U.S. healthcare data was concentrated in medical claims compiled by large insurers such as UnitedHealth Group Inc and the government. As hospitals have moved to electronic health records, independent analytics firms are buying hospital data sold without patient names.

The U.S. Food and Drug Administration now allows data gathered outside of clinical trials to be considered in its reviews of new drugs, providing another boost to the healthcare analytics industry.


It is not clear how Surgisphere accessed the data used in the two studies. Surgisphere did not return requests for comment.

At a time when researchers are scrambling to find a cure for COVID-19, data sets like those used in the now retracted studies can appear to be a “goldmine,” Mandl said.

A spokesman for Lancet publisher Elsevier said it will re-assess about 20 additional published articles that contain Surgisphere data.

A spokesman for Brigham and Women’s Hospital said its data oversight mechanisms “were not applicable” to the Lancet and NEJM studies, adding it only provides “support, guidance and oversight on all agreements that involve the use of our institutional resources, including our patient data.”

Harvard Medical School would not comment on its role in vetting the data. Harvard and the Brigham declined to say whether further steps would be taken regarding the researchers’ handling of the matter.

While the NEJM and Lancet articles had external peer review, they relied on the authors to vouch for the data.

“We are reviewing our procedures, including how we assess research analyzing large datasets based on electronic medical record data,” said NEJM spokeswoman Jennifer Zeis.

After the retraction, the Lancet said it was conducting a review, and that serious scientific questions had been raised.

Dr. Deneen Vojta, executive vice president of UnitedHealth’s global research and development division, said it is important to ask questions about how a group obtained their data, and that it must be made available for scrutiny.

Dr. Peter Bach, from Memorial Sloan Kettering in New York, said his research team regularly assesses data offered by these new firms to make sure it jibes with its own knowledge, such as ages of people having a certain surgery or the number of prescriptions the firm says were dispensed.

“We do lots of tire kicking,” Bach said.

Reporting by Caroline Humer in New York and Marisa Taylor in Washington D.C.; Additional reporting by Julie Steenhuysen in Chicago and Nancy Lapid in New York; Editing by Bill Berkrot

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U.S. coronavirus cases now over 2 million: Reuters tally

FILE PHOTO: Gavin Roberts wears his father’s police hat as he looks at the flag-draped casket of his father, Glen Ridge Police Department officer Charles Roberts, at his funeral service, after the 45-year-old father of three died of the coronavirus disease (COVID-19) in Glen Ridge, New Jersey, U.S., May 14, 2020. REUTERS/Mike Segar/File Photo

(Reuters) – Total U.S. coronavirus cases surpassed 2 million on Wednesday, according to a Reuters tally, as health officials urge anyone who took part in massive protests for racial justice to get tested.

Nationally, new infections are rising slightly after five weeks of declines, according to a Reuters analysis. Part of the increase is due to more testing, which hit a record high on June 5 of 545,690 tests in a single day but has since fallen, according to the COVID-Tracking Project https://covidtracking.com.

Recent increases in cases are likely a result of more people moving about and resuming some business and pleasure activities as all 50 states gradually reopen. Huge nationwide protests with no social distancing after the May 25 the death of George Floyd at the hands of Minneapolis police could lead to another spike in cases in coming weeks.

Health officials believe the first U.S. coronavirus cases appeared in January, and the nation recorded 1 million cases by April 28. So far in June, there have been an average of 21,000 new cases a day compared with an average of 30,000 a day in April and 23,000 a day in May, according to a Reuters tally.

Total U.S. coronavirus-related deaths have surpassed 112,000, also the most in the world.

On May 12, the World Health Organization (WHO) advised governments that before reopening, the rate of people testing positive for the coronavirus should remain at 5% or lower for at least 14 days.

U.S. rates of positive test results have fluctuated between 4% and 7% nationally and have not met those guidelines, although many individual states have. (Open tmsnrt.rs/2WTOZDR in an external browser for a Reuters interactive)

Some states were still reporting positive rates above the WHO threshold last week, with Maryland at 8%, Utah at 9%, Nebraska at 9%, Virginia at 9%, Massachusetts at 11% and Arizona at 12%.

At the peak of the outbreak in April, 25% to 50% of tests came back positive.

Writing by Lisa Shumaker; Editing by Bill Berkrot

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Exclusive: Lilly COVID-19 treatment could be authorized for use as soon as September – chief scientist

(Reuters) – Eli Lilly and Co could have a drug specifically designed to treat COVID-19 authorized for use as early as September if all goes well with either of two antibody therapies it is testing, its chief scientist told Reuters on Wednesday.

Lilly is also doing preclinical studies of a third antibody treatment for the illness caused by the new coronavirus that could enter human clinical trials in the coming weeks, Chief Scientific Officer Daniel Skovronsky said in an interview.

Lilly has already launched human trials with two of the experimental therapies.

The drugs belong to a class of biotech medicines called monoclonal antibodies widely used to treat cancer, rheumatoid arthritis and many other conditions. A monoclonal antibody drug developed against COVID-19 is likely to be more effective than repurposed medicines currently being tested against the virus.

Skovronsky said the therapies – which may also be used to prevent the disease – could beat a vaccine to widespread use as a COVID-19 treatment, if they prove effective.

“For the treatment indication, particularly, this could go pretty fast,” he said in an interview. “If in August or September we’re seeing the people who got treated are not progressing to hospitalization, that would be powerful data and could lead to emergency use authorization.”

“So that puts you in the fall time: September, October, November is not unreasonable,” he said.

Coronavirus vaccines being developed and tested at unprecedented speed are not likely to be ready before the end of the year at the earliest.

Earlier this month, Lilly announced it had initiated patient testing for two separate antibody treatments. One currently designated LY-CoV555 is being developed in partnership with Canadian biotech AbCellera. The other, JS016, it being developed with Chinese drugmaker Shanghai Junshi Biosciences.

Both work by blocking part of the virus’ so-called spike protein that it uses to enter human cells and replicate.

Lilly’s third antibody treatment candidate acts on a different part of the virus and will most likely be tested in combination with one or both of the others, Skovronsky said.

The drugmaker, however, said it has a strong preference to develop a treatment that can work well in COVID-19 patients as a stand alone, as manufacturing these type of drugs, which are typically administered by infusion, is a complex process and capacity is limited.

“It’s good to have two antibodies. The downside is that manufacturing is precious. We have limited manufacturing capacity. If two antibodies are required, half as many people will get treated,” Skovronsky said. “So our goal is to see if we can do one antibody at as low a dose as possible.”

Lilly is continuing to screen for antibodies through its partnership with AbCellera, which is working with the U.S. National Institutes of Health to identify promising compounds, he added.

Reporting by Michael Erman and Carl O’Donnell; Editing by Bill Berkrot

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When A Doctor No Longer Accepts Medicare, Patients Left Holding The Bag

Pneumonia. Heart problems. High cholesterol. Betsy Carrier, 71, and her husband, Don Resnikoff, 79, relied on their primary care doctor in Montgomery County, Maryland, for help managing their ailments.

But after seven years, the couple was surprised when the doctor informed them she was opting out of Medicare, the couple’s insurer.

“It’s a serious loss,” Resnikoff said of their doctor.

Patients can lose doctors for a variety of reasons, including a physician’s retirement or when either patient or doctor moves away. But economic forces are also at play. Many primary care doctors have long argued that Medicare, the federal health insurance program for seniors and people with disabilities, doesn’t reimburse them adequately and requires too much paperwork to get paid.

These frustrations have prompted some physicians to experiment with converting their practices to more lucrative payment models, such as concierge medicine, in which patients pay a fee upfront to retain the doctor. Patients who cannot afford that arrangement may have to search for a new physician.

The exact number of physicians with concierge practices is unknown, health care experts said. One physician consulting company, Concierge Choice Physicians, estimates that roughly 10,000 doctors practice some form of membership medicine, although it may not strictly apply to Medicare patients.

Shawn Martin, senior vice president of the American Academy of Family Physicians, estimated that fewer than 3% of their 134,000 members use this model but the number is slowly growing.

The move to concierge medicine may be more prevalent in wealthier areas.

Travis Singleton, executive vice president for the medical staffing company Merritt Hawkins, said doctors switching to other payment systems or those charging Medicare patients a higher price for care are likely “in more affluent, well-to-do areas where, frankly, they can get fees.”

It is far easier for physicians than hospitals to opt out of taking Medicare patients. Most hospitals have to accept them since they rely on Medicare payments to fund inpatient stays, doctor training and other functions.

The majority of physicians do still accept Medicare, and most people insured by the federal program for seniors and people with disabilities have no problem finding another health care provider. But that transition can be tough, particularly for older adults with multiple medical conditions.

“When transition of care happens, from one provider to another, that trust is often lost and it takes time to build that trust again,” said Dr. Fatima Sheikh, a geriatrician and the chief medical officer of FutureCare, which operates 15 rehabilitation and skilled nursing centers in Maryland.

Shuffling doctors also heightens the risk of mishaps.

A study of at least 2,200 older adults published in 2016 found that nearly 4 in 10 were taking at least five medications at the same time. Fifteen percent of them were at risk of drug-to-drug interaction.

Primary care providers mitigate this risk by coordinating among doctors on behalf of the patient, said Dr. Kellie Flood, a geriatrician at the University of Alabama-Birmingham.

“You really need the primary care physicians to serve as the quarterback of the health care team,” said Flood. “If that’s suddenly lost, there’s really not a written document that can sum all that up and just be sent” to the new doctor.

Finding a physician who accepts Medicare depends partly on workforce demographics. From 2010 to 2017, doctors providing primary care services to Medicare beneficiaries increased by 13%, according to the Medicare Payment Advisory Commission (MedPAC), a nonpartisan group that advises Congress.

However, the swell of seniors who qualify for Medicare has outpaced the number of doctors available to treat them. Every day, an estimated 10,000 Americans turn 65 and become eligible for the government program, the Census Bureau reported.

The impact: In 2010, MedPAC reported, there were 3.8 primary care doctors for every 1,000 Medicare enrollees. In 2017, it was 3.5.

Authors of a MedPAC report out last June suggested that the number of available primary care providers could be an overestimate. Their calculation assumed all internal medicine doctors provided these services when, in reality, many specialize in certain medical conditions, or accept only a limited number of Medicare patients into their practices.

But MedPAC concluded seniors are not at a disadvantage finding a doctor.

“We found that beneficiaries have access to clinician services that is largely comparable with (or in some cases better) access for privately insured individuals, although a small number of beneficiaries report problems finding a new primary care doctor,” the MedPAC researchers wrote.

The coronavirus outbreak has complicated the ability for many Americans to access care, regardless of their insurer. However, many older patients now have an opportunity to connect with their doctors virtually after the Centers for Medicare & Medicaid Services (CMS) broadened access to telemedicine services under Medicare.

Experts said the long-term effects of the virus on doctors and Medicare remain unknown. But Martin said the shortage of cash that many doctors are experiencing because of the coronavirus epidemic has revealed the shortcomings of how primary care doctors are paid.

“The COVID crisis really brought to life the challenges of fee for service,” said Martin.
Despite these challenges, the number of doctors choosing to opt out of Medicare has been on the decline, according to data from CMS.

Singleton, of Merritt Hawkins, said concern about doctors leaving the Medicare system is part of larger workforce issues. Those include the need to recruit more medical students to concentrate on primary care.

One estimate predicts the nation will face a shortage of 23,600 primary care physicians by 2025. The majority of residents in internal medicine ― those who care for adults — are choosing a subspecialty such as cardiac care or gastroenterology, MedPAC reported.

In 2017, MedPAC reported, the median compensation for all doctors was $300,000 a year. Among primary care doctors, it was $242,000.

Creative business models can make up that difference. Under the concierge model, the doctor charges patients an annual fee — akin to a gym membership ― to access their practice. The provider still bills the insurer ― including Medicare — for all patient care.

Another model ― called direct primary care — charges the patient an annual fee for access and care; doctors do not bill health insurance plans.

Proponents say that the model enables them to take more time with their patients without dealing with the bureaucracy of getting paid by health insurers.

“I think what is most attractive to direct primary care is that they just practice medicine,” Martin said.

The size of a physician practice can also determine whether it accepts Medicare. Large practices can better offset the lower Medicare payment rates by leveraging their influence with private insurers to raise those reimbursements, said Paul Ginsburg, director of the USC-Brookings Schaeffer Initiative for Health Policy. But small, independent clinics may not have the same clout.

“If you’re a large primary care practice, private insurers are really going to want to have you in their network,” he said. “And they’re willing to pay more than they might pay an individual solo practitioner who they’re not as concerned [with] because it’s only one physician.”

Luckily, after more than a dozen calls to physicians, Carrier and Resnikoff said they found another primary care doctor. They said she accepts Medicare and impressed them during their meet-and-greet with her knowledge of their medical history. She also met their criteria for age and expertise.

“At this point in our lives, I’d be eager to find somebody who’s young enough that they might be in practice for the next 10 years,” Carrier said.

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Gilead’s remdesivir prevents lung damage in COVID-19 study on monkeys

(Reuters) – Gilead Sciences Inc’s (GILD.O) antiviral drug remdesivir prevented lung disease in macaque monkeys infected with the new coronavirus, according to a study published in the journal Nature on Tuesday.

FILE PHOTO: Two ampules of Ebola drug Remdesivir are pictured during a news conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease (COVID-19) continues. Ulrich Perrey/Pool via REUTERS/File Photo

The findings were first reported in April by the U.S. National Institutes of Health (NIH) as a “preprint,” prior to traditional academic validation provided by a medical journal.

Remdesivir is the first drug shown to be effective against COVID-19 in human trials. Other clinical studies involving the drug are being closely watched as nations look for treatments for the disease that has infected more than 7 million people and killed over 400,000 globally.

Remdesivir was approved last month in Japan under the brand name Veklury. It has been cleared for emergency use in severely-ill patients in the United States, India and South Korea. Some European nations are also using it under compassionate programs.

In the study published on Tuesday, 12 monkeys were infected with the new coronavirus, and half of them were given early treatment with remdesivir.

Macaques that received remdesivir did not show signs of respiratory disease and had reduced damage to the lungs. (go.nature.com/2Yj9xq2)

Authors of the study also said the viral load, or amount of virus, in the lungs of remdesivir-treated animals was lower.

The authors suggested that remdesivir should be considered as a treatment as early as possible to prevent progression to pneumonia in COVID-19 patients.

In a U.S.-run clinical trial released in late April, remdesivir reduced hospitalization stays by 31%, or about four days, compared to a placebo.

Gilead last week reported data from its own trial of remdesivir, showing that the drug provided a modest benefit for patients with moderate COVID-19 given a five-day course of the treatment.

Reporting by Manas Mishra in Bengaluru and Deena Beasley in Los Angeles; Editing by Saumyadeb Chakrabarty and Bill Berkrot

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U.S. CDC reports 1,956,421 coronavirus cases, 110,925 deaths

FILE PHOTO: Commuters ride the subway on the first day of New York City’s phase one reopening during the outbreak of the coronavirus disease (COVID-19) in New York City, New York, U.S., June 8, 2020. REUTERS/Mike Segar/File Photo

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday reported 1,956,421 cases of new coronavirus, an increase of 17,598 cases from its previous count, and said the number of deaths rose by 550 to 110,925.

The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by the new coronavirus, as of 4 pm ET on June 8, versus its previous report released on Monday. (bit.ly/2Uw9aYi)

The CDC figures do not necessarily reflect cases reported by individual states.

Reporting by Trisha Roy in Bengaluru; Editing by Shinjini Ganguli

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