Doctors warn on rise in French COVID-19 intensive care patients

 The number of COVID-19 patients in France's intensive care units has risen to a new high for this year, health ministry data showed on Sunday, as doctors warned a third wave of infections could soon overwhelm hospitals.

There were 4,872 ICU patients being treated for COVID-19, close to a November peak during France's second wave of the virus, though well below a high of about 7,000 in April last year. The number of new infections fell, however, by around 5,600 to 37,014.

A group of 41 hospital doctors in the Paris region signed an article in the newspaper Le Journal du Dimanche warning that they might soon have to start choosing between patients for emergency treatment.

Scientists have argued that the government's partial lockdown measures targeting high-infection zones like Paris are inadequate faced with fast-spreading coronavirus variants.

French President Emmanuel Macron this week defended his decision to not impose a third full lockdown and to keep schools open, but said further restrictions would probably be needed.

The government is also trying to speed up a lagging vaccination campaign, part of a troubled EU effort marred by shortfalls of AstraZeneca doses that have created tensions with former EU member Britain.

Junior European affairs minister Clement Beaune told France 2 television on Sunday that France would receive 2 million doses out of a batch of 16 million AstraZeneca vaccines held by the Italian authorities amid the EU's row with the pharmaceutical group.

As of Sunday, nearly 7.8 million people had received a first dose of vaccine in France, the health ministry said.

It also reported a further 131 hospital deaths linked to the virus, taking the country's toll including nursing homes to nearly 95,000, the eighth-highest in the world.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-Doctors-issue-warning-over-rise-in-French-COVID-19-intensive-care-patients-32821335/

EU's Breton hopes vaccine push can boost Europe's summer tourist season

 European Internal Market Commissioner Thierry Breton said on Sunday that he hoped Europe will have a summer tourist season this year, supported by a ramp-up in its COVID-19 vaccination efforts.

Breton, who heads the European Union's executive's vaccine task force, reiterated on RTL radio and TV channel LCI that the European Union should deliver 420 million doses of COVID-19 vaccines by mid-July, enough to allow the bloc to reach collective immunity.

"We have to shift to the next gear," he said of the EU's vaccination campaign.

"This will be the price for having a tourist season that I hope will be comparable to last year's, which in the end wasn't so bad in the context we're in."

The planned introduction of a common EU vaccine certificate in June would support the resumption of travel, he added.

The tourism and travel sectors have been hammered by the year-old coronavirus pandemic, despite a partial revival last summer between the first and second waves of the virus in Europe.

The EU has blamed big shortfalls of AstraZeneca doses for its slow vaccine roll-out, in a dispute that has created tensions with former EU member Britain.

Breton reiterated that the EU will ensure that coronavirus vaccines produced by AstraZeneca within the bloc stay there until the company returns to fulfilling its delivery commitments.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-nbsp-EU-s-Breton-hopes-vaccine-push-can-boost-Europe-s-summer-tourist-season-32821028/

Identification of antiviral antihistamines for COVID-19 repurposing

 Leah R.Reznikova1Michael H.Norrisb1RohitVashishtcAndrew P.BluhmbDanmengLidYan-Shin J.LiaoaAshleyBrowneAtul J.ButtecDavid A.Ostrovd

https://doi.org/10.1016/j.bbrc.2020.11.095

Abstract

There is an urgent need to identify therapies that prevent SARS-CoV-2 infection and improve the outcome of COVID-19 patients. Although repurposed drugs with favorable safety profiles could have significant benefit, widely available prevention or treatment options for COVID-19 have yet to be identified. Efforts to identify approved drugs with in vitro activity against SARS-CoV-2 resulted in identification of antiviral sigma-1 receptor ligands, including antihistamines in the histamine-1 receptor binding class. We identified antihistamine candidates for repurposing by mining electronic health records of usage in population of more than 219,000 subjects tested for SARS-CoV-2. Usage of diphenhydramine, hydroxyzine and azelastine was associated with reduced incidence of SARS-CoV-2 positivity in subjects greater than age 61. We found diphenhydramine, hydroxyzine and azelastine to exhibit direct antiviral activity against SARS-CoV-2 in vitro. Although mechanisms by which specific antihistamines exert antiviral effects is not clear, hydroxyzine, and possibly azelastine, bind Angiotensin Converting Enzyme-2 (ACE2) and the sigma-1 receptor as off-targets. Clinical studies are needed to measure the effectiveness of diphenhydramine, hydroxyzine and azelastine for disease prevention, for early intervention, or as adjuvant therapy for severe COVID-19.

https://www.sciencedirect.com/science/article/pii/S0006291X20321409

Let Patients Manage More of Their Own Health Care Dollars

 An estimated 26 million people are managing some of their own health care dollars by means of a Health Savings Account (HSA). Although exact figures aren’t available, it’s possible that an equal number are managing some of their own health care spending by means of a Health Reimbursement Arrangement (HRA). Between 33 and 38 million people have a Flexible Spending Account (FSA).

These accounts allow people to make their own decisions about how to use the dollars they spend on health care, rather than conform to the rules of a health plan administered by an employer, a health insurance company or the government.

Some time ago I explained the advantages and disadvantages of these accounts at the Health Affairs Blog, an exercise I won’t repeat here. Let’s jump to the bottom line: We could have all the advantages of all three accounts and none of the disadvantages if we combined them into one, easy-to-use account, with very few restrictions.

(Interestingly, Sen Ben Sasse (R-NE) has introduced a plan that would move us in this direction.)

There are three social benefits of self-directed care. First, people are always more careful when spending their own money than when spending someone else’s money. Second, virtually all the patient-pleasing innovations that have occurred in recent years are for services people buy with their own money. For example, walk-in clinics emerged so that patients paying out-of-pocket could save on time and money. Online mail-order pharmacies came into existence to compete with local pharmacies for patients who buy their own drugs. Long before Covid hit, doctor consultations by phone, email and teleconferencing were available to millions of patients who paid for the services out-of-pocket. None of these innovations would have been likely if Blue Cross were paying all the bills.

Third, when patients are spending their own money, they get the full benefits and bear the full costs of their own decisions. That means one person’s wasteful decisions don’t impose costs on others. It also means that third-party insurance can be restricted to those activities that can’t be easily individualized. That makes third-party insurance less expensive and more efficient.

In addition to unifying the three types of medical savings accounts, there are three additional changes that are needed. They are explained in greater detail in my book, New Way to Care.

No Across-the-Board Deductible. Under current law, access to a Health Savings Account requires an across-the-board deductible. For the year 2021, for example, people must pay the first $1,400 (individual) or $2,800 (family) either out of pocket or from their HSA, before insurance kicks in. The only exceptions are certain preventive procedures.

This makes it very difficult to structure rational insurance. Say an employee is a diabetic. The employer might want to make medications available for free, since lack of compliance with drugs is a major cause of problems with many chronic patients. But if the patient is noncompliant and ends up in the emergency room, the employer might want the employee to pay for that expense himself. This kind of rational insurance design is not possible under the rigidities of the current HSA regulations.

Special Accounts for the Chronically ill. Studies show that chronic patients can often manage their own care, with minimal patient education, as well or better than relying on traditional doctor care. If they are to be allowed to manage their own care, they should be allowed to manage the dollars that pay for that care. No patient should be forced to do this, but in return for the patients’ willingness to manage their own care, health plans should be able to put money into an account controlled by the patients themselves.

One highly successful example of patient-directed care is the Medicaid Cash and Counseling Program. Started several decades ago, this program originally allowed the homebound disabled to manage their own budgets. That meant they had the right to hire and fire the people who serviced them and any money they saved could be spent in other ways that benefited the patient.

Satisfaction rates in this program were in the mid-90th percentile (something rarely seen in any health program anywhere in the world). And because of this success, the program has been expanded. Today, for example, the family of an Alzheimer’s patient can receive a budget to manage the patient’s care.

Special Accounts for Primary Care. The ability to talk with a doctor by phone or email or Skype – day or night and on weekends – used to be a privilege only the rich could afford. We used to call it “concierge care.” The benefits are obvious. The coronavirus and other medical problems don’t just crop up during working hours. And a trip to the emergency room is not only expensive, these days it has health risks as well.

Today, Atlas MD in Wichita offers all primary care – round the clock and by means of phone, email, Skype, Zoom and Facebook if needed – for $50 a month for a mother and $10 for a child. This “direct primary care,” or DPC, not only offers patients the entire range of primary care services, it helps patients make appointments with specialists, helps them get discount prices on MRI scans and other medical tests and (in the case of Atlas) provides generic drugs for less than Medicaid pays in some instances.

This type of care needs to be an option for people spending from an HSA. Under current law it is not.

Roth Accounts for Seniors. The payment of health insurance premiums and deposits to Health Savings Accounts for young people with employer plans are made with pre-tax dollars. That means the choice between third-party insurance and individual self-insurance is made on a level playing field under the tax law. People are free to make these choices without regard to the tax consequences. Something similar needs to happen for seniors.

Senior premiums for Medicare Part B, C and D and for Medigap insurance are all paid with after-tax money. So, senior deposits to an HSA also need to be made after-tax. The accounts that allow this are called Roth Health Savings Accounts. Deposits are made with after-tax dollars, and withdrawals (for any purpose) are tax-free.

Roth HSAs, therefore, are a way of using the tax law to encourage health insurance for the elderly and the disabled without distorting any important decisions.

The choice between self-insurance and third-party insurance would be made on a level playing field under the tax law. The choice between spending out of the account on health care or on non-health goods and services would also be made on a level playing field. And the choice between spending from the account on anything in the current period and spending on health and non-health in all future periods would also be unimpeded by tax-law distortions.

https://www.forbes.com/sites/johngoodman/2021/02/08/let-patients-manage-more-of-their-own-health-care-dollars/

Vaccines haven't cured loneliness in NY nursing homes

Vaccines have begun saving lives in New York's nursing homes, but they haven't yet cured another crisis caused by the pandemic: loneliness.

Persistently high rates of COVID-19 have left the majority of the state's nursing homes off limits to visitors, despite relaxed guidance meant to help reopen them.

Until this week, under state and federal rules, they could admit visitors only if they had no new infections among either patients or staff for 14 days.

That mark proved too hard for most to reach. A little more than half of the state’s 616 nursing homes were ineligible for indoor visits in mid-March, according to an Associated Press analysis of data from the U.S. Centers for Medicaid and Medicare. That’s the highest percentage of any state.

New York updated its visitation rules Thursday in a way that will now allow visits to resume under certain conditions, even if a resident or staffer has recently tested positive. But that relaxed standard might not clear the way for visitation in many homes having trouble keeping the virus out.

The lack of visits has frustrated people like Debbie Barbano, who has been able to see her 69-year-old mother at a central New York nursing home only through a window.

“When this hit last year, it was like a bullet to your chest,” Barbano said. “She didn’t understand why I wasn’t coming. It was like I was abandoning her.”

Under New York’s new guidelines, homes would still have to halt visits after any resident or staffer tested positive, but they could potentially resume for some patients if a thorough round of further testing revealed the outbreak was confined to just one part of the facility.

It’s unclear, though, exactly how that guidance will be applied and whether the change would mostly affect large homes with multiple buildings, floors or units with little mingling of staff or residents between units.

State Health Commissioner Howard Zucker has justified restrictions on visits by pointing to a winter surge that infected 15,000 nursing home residents, killing at least 3,000.

The federal program to vaccinate nursing home residents has helped drive down COVID-19 outbreaks and deaths in nursing homes nationwide. In New York, 41 nursing home residents died of COVID-19 in the second week in March, down from 382 for the week ending Jan. 17.

Decreased infections nationwide have allowed 80% of nursing homes nationally eligible to open doors by mid-March, including the vast majority of nearly 1,200 facilities in California.

Infections in New York are dropping more quickly among nursing home residents than among staffers. Some workers have been hesitant to take the vaccine. And as parts of New York City and its suburbs see an uptick in cases, the state’s data shows just 68% of nursing home residents and 51% of staffers in New York City have been vaccinated.

“Nursing homes have finally started to see the light at the end of the tunnel,” said Christopher Laxton, executive director of the Society for Post-Acute and Long-Term Care Medicine, whose group is seeking clarity on the new rules from the U.S. Centers for Medicare and Medicaid Services. “But we’re not out of the tunnel. We’re seeing the end of it.”

Meanwhile, some relatives are fighting to see loved ones.

Family members in New York and nationwide who have organized on Facebook groups say their loved ones are losing weight, falling, declining cognitively, dying alone and suffering from lack of attention. Federal and state guidance allows compassionate care visits, but families in New York and elsewhere say nursing homes don’t always allow them.

Laura Corridi, a 56-year-old senior programmer analyst in Hamlin, New York, has driven an hour and a half on the weekends to stand outside her 93-year-old mother’s nursing home and shout to her through a window throughout the past year.

“She gets very upset sometimes,” Corridi said. “She’ll say: ‘It’s cold out. You can’t be out there.’ She starts to cry, ‘Why don’t they let you in?’ She doesn’t want me standing out in the cold.”

State lawmakers passed a bill this year that would allow nursing home residents to designate as many as two caregivers who can visit them even if general visitation isn’t allowed, as long as they get tested and follow other infection protocols.

Gov. Andrew Cuomo hasn’t yet signed the legislation, however, and his office didn’t respond to a request for comment on whether he intended to do so. His counsel Beth Garvey told reporters Monday that the administration wants to make sure the bill is in line with federal guidance.

Cuomo has taken political heat over recent revelations that his administration did not disclose the full number of nursing home residents who died during the pandemic's peak.

New York is one of at least 17 states where lawmakers are considering similar legislation, according to the AP review.

But many New Yorkers with relatives in nursing homes say their loved ones can’t wait for companionship.

“They’re dying now,” Karen Costner, of Greece, New York, said. “My mother’s losing her will to live every week. And I need to get in there now.”

Zucker told lawmakers last month he’s “very empathetic” to family members, but claimed the state's hands are “tied” by federal guidance.

“Too many elderly have been isolated, lonely, frightened,” said Arthur Caplan, director of the division of medical ethics at the New York University Grossman School of Medicine. “Many people with cognitive disabilities have been frightened with seeing everybody in masks and not seeing familiar people.”

But Caplan, whose mother died at a Massachusetts nursing home last year, said he still worries not enough is being done to protect vulnerable residents. Staffers should be required to be vaccinated, and visitors must be tested, he urged.

“If the staff isn’t vaccinated I think people who have family members in there should be screaming for them to get vaccinated,” Caplan said.

https://www.sfgate.com/news/article/Vaccines-haven-t-cured-loneliness-in-New-York-16057651.php 

Comic-Con Plans In-Person Convention Thanksgiving Weekend 2021

 

Christy Radecic/Invision/AP

San Diego Comic-Con is returning in 2021 as a “special edition” gathering. Despite recent news that the massive, pop culture convention would be going virtual in July, plans for the fall gathering have moved forward. Comic-Con International has announced their plans to hold an in-person convention in 2021.

The three-day event titled, “Comic-Con Special Edition” will take place over Thanksgiving weekend Friday, Saturday and Sunday, November 26 through the 28 at the San Diego Convention Center.

“It is our hope that by Fall conditions will permit larger public gatherings,” the announcement said. “Comic-Con Special Edition will be the first in-person convention produced by the organization since Comic-Con 2019, and the first since the onset of the global pandemic COVID-19. The Fall event will allow the organization to highlight all the great elements that make Comic-Con such a popular event each year, as well as generate much needed revenue not only for the organization but also for local businesses and the community.”

Spokesperson for the organization David Glanzer noted the impact the quarantine has had on small businesses in the statement as well. “Hopefully this event will shore up our financial reserves and mark a slow return to larger in-person gatherings in 2022.”

This additional convention was announced earlier in the year on the heels of the 2021 virtual announcement. The massive, 100,00 plus attendee convention of Comic-Con proper has been officially moved to 2022. This fall offering will be an entirely separate convention but will be held in the same place and backed by the same company.

There are no additional details on badge costs or attendance capacity.

https://variety.com/2021/film/news/comic-con-november-2021-sdcc-1234939610/

Consumers filed 106 injury claims from COVID vax, ventilators, drugs; none paid

 A federal program charged with compensating people for serious side effects from COVID-19 drugs and vaccines did not pay or reject any claims during the first year of the pandemic.

The 106 injury claims for vaccines, hydroxychloroquine and other COVID-19 treatments remained under medical review as of March 15, according to figures from the U.S. Department of Health and Human Services.

The Health Resources and Services Administration, the agency within HHS that runs the Countermeasures Injury Compensation Program, provided data to USA TODAY showing injury claims for 20 types of COVID-19 treatments. 

More than half the claims alleged injury from COVID-19 immunizations. However, with just 58 claims out of 120 million-plus doses administered by mid-March, experts say the data adds to growing evidence of COVID-19 vaccine safety.

The next most common type of claim, with 15 cases, alleged ventilator injuries. Ventilators, mechanical devices that push air into the lungs of COVID-19 patients, were aggressively used during last spring's outbreak in New York. Since then, doctors have been more careful about using ventilators and have turned to less-invasive oxygen delivery methods. They've also learned about cheap and effective treatments such as the steroid dexamethasone.

Ten claims were classified as “unknown” cause. Other claims cited injuries from the anti-malaria drug hydroxychloroquine, the antiviral remdesivir and convalescent plasma. 

HRSA officials defended the pace of payouts, noting it takes months to process cases because individuals or families need to submit documents, including medical records, to support claims. The first case, filed in September, alleged injury from convalescent plasma but the agency still does not have all needed medical records, HRSA Director of Communications Martin Kramer said in an email.

“The most significant factor in the processing time for CICP claims is the time it takes for CICP to receive all required medical records from the requester,” Kramer said.

'Exactly the wrong way'

Last March, former Health and Human Services Secretary Alex Azar declared all claims of injury from COVID-19 vaccines would be handled through the countermeasures program. 

The program, established in 2010, handles injury claims from vaccines and other treatments authorized during a public health emergency.

Countermeasures has rejected 90% of injury claims over the past decade. In contrast, the federal government's "vaccine court," which handles claims mainly involving routine childhood vaccines, has paid about 70% of claims from 2006 through 2018. 

Unlike vaccine court, the countermeasures program limits claims to one year after a person gets a treatment, doesn't pay attorneys' fees or expert testimony and does not conduct hearings.

HRSA provides little public information about countermeasures' cases and outcomes. On its website, HRSA lists the total number of cases since the program began in 2010, the number of cases paid and the total amount of awards. The website does not separate COVID claims.

Because the countermeasures program is being used to handle COVID-related injuries during the pandemic, some critics say the program should share more information about claims with the public. 

Peter Meyers is former director of George Washington University Law School's Vaccine Injury Clinic. He filed a Freedom of Information Act request and obtained details of 48 cases filed as of Feb. 16. Of those COVID-related cases, 26 involved deaths and 22 other injuries. Most of the harms from vaccine claims cited allergic reactions; only three cases alleged death after immunization.

The types of claims vary widely. One case tied use of an N-95 mask to a shoulder injury. Another claim connected the stay-at-home order and mask use to attempted murder and assault. More details about the cases, including names of claimants, dates or location, were not provided under the records request.

Meyers said the federal agency should be more forthcoming about cases and outcomes.

“To the extent the Biden administration is trying to build trust and confidence in the American public, deal with all the misinformation that’s out there, deal with all the vaccine hesitancy of so many people, it seems to me they are going about it in exactly the wrong way,” Meyers said. 

Meyers said the relatively small number of vaccine-injury claims could provide more evidence of "how incredibly safe these vaccines really are," but the agency has not posted this information on its website.

Katharine Van Tassel, a visiting professor of law at Case Western Reserve School of Law in Cleveland, said limited information about COVID claims is an "unforced error that could have a serious negative impact on public trust of vaccine programs moving forward."

"Full transparency over vaccine injury claims made during a public health emergency will build the kind of trust that we as a country need as we face future public health disasters together," Van Tassel said.

But others not involved in the program say public reporting about vaccine safety is so open and widespread that more details about the relatively small numbers of countermeasures claims will make little difference in swaying public opinion.

Dr. Cody Meissner, a pediatric infectious disease expert at Tufts Children's Hospital, said the three FDA-authorized vaccines made by Moderna, Pfizer-BioNTech and Johnson & Johnson have undergone rigorous clinical trials to demonstrate they are safe and effective.

Even after vaccines hit the market, safety data is tracked through a database that collects "adverse events" reports from doctors and patients, ongoing monitoring of medical records and a voluntary program that allows immunized people to report side effects via a phone app.

"Everything is very public," Meissner said. “There’s ‘s never been any vaccine that has been placed under such careful scrutiny as these COVID-19 vaccines are going through."

https://www.usatoday.com/story/news/health/2021/03/28/covid-19-vaccines-hydroxychloroquine-generate-dozens-injury-claims/6995509002/