You Can See Friends and Relatives During the Pandemic Surge — But Do It Carefully

Cooped up too long, yearning for a day at the beach or a night on the town — and enticed by the easing of restrictions just as the warm weather arrived — many people have bolted from the confines of home. And who can blame them?

But Houston — and San Antonio and Phoenix and Miami and Los Angeles — we have a problem.

COVID-19 is spiking in Texas, Arizona, Florida, California and other states, forcing officials once again to shut down bars, gyms and the indoor-dining sections of restaurants.

But that does not mean we can’t spend time with the important people in our lives. Our mental health is too important to avoid them.

You can expand your social bubble beyond the household — if you heed now-familiar health guidelines and even take extra precautions: Limit the number of people you see at one time, and wear a mask if meeting indoors is the only feasible option or if you can’t stay at least 6 feet from one another outdoors. Disinfect chairs and tables, and wash your hands, before and after the visit. If food and drink are on the agenda, it’s best for all involved to bring their own, since sharing can raise the risk of infection.

Arthur Reingold, a professor of epidemiology at the University of California-Berkeley’s School of Public Health, and his wife, an epidemiologist for the Centers for Disease Control and Prevention, have begun spending time with another couple around their age who have a large patio. “They have us go around the back; they don’t have us go through the house,” says Reingold, 71. “We sit on chairs that are a good 10 to 12 feet away from each other, and we talk. We bring our food, and they bring their food.”

And they don’t wear masks. “I personally believe the risk from that situation, even without a mask, is pretty minimal,” Reingold says. “But if people wanted to try to do that and wear a mask, I don’t think that would be unreasonable.”

And while we are on the topic of masks, please remember they don’t make you impervious to infection. “Your eyes are part of the respiratory tree. You can get infected through them very easily,” says George Rutherford, a professor of epidemiology at UC-San Francisco. If you are medically vulnerable, or just want to be extra careful, consider wearing a face shield or goggles.

Most of us have wrestled with the question of how big a gathering is too big. It’s impossible to give an exact answer, but the smaller the better. And keep in mind there is no such thing as zero risk.

In the U.S. as a whole, the average infection rate is currently about 1% to 2%, which means one or two people in a group of 100 would typically be infected, says Dr. Yvonne Maldonado, a pediatrician specializing in infectious diseases at Stanford University’s School of Medicine. In any individual setting, however, these percentages don’t necessarily apply, she says. And a gathering in an area where the COVID-19 rate is surging — or already high — is more dangerous than one of the same size in a place where it’s not. So stay informed about the status of the pandemic in your area.

Be wary even of friends you’ve known and loved a long time. That may sound callous, but you need to know something about the behavior and recent whereabouts of anyone with whom you plan to visit. Don’t be shy about asking where and with whom they have been in recent weeks. If they are a close enough friend for you to want to see them, they should understand why you are asking.

A chart from the Texas Medical Association that generated controversy on Twitter in recent days listed numerous activities, ranked from lowest to highest risk. Among the riskiest behaviors: going to a bar, a movie theater or any other crowded venue — and eating at a buffet. You could ask questions based on that list, or a similar one, to determine if it’s safe to visit with someone.

With regard to play dates for your children, public health experts say you should apply the same safety precautions as for adult get-togethers. “Children can play together, especially if their families have been socially distancing, the activities do not involve physical contact, and they can engage in the activities with sufficient physical spacing,” says Stanford’s Maldonado.

Another question, never far from my mind, is whether it’s risky to let a plumber or electrician or handyman into the house. I’ve put off needed house repairs for several months because of my uncertainty about it.

I put the question to the public health experts I interviewed for this column, and they agreed: As long as you both wear masks and stay a healthy distance apart, the visit should not pose a significant threat. But ask the person what precautions he took on visits to other homes. If he works for a company, check its policies for employees who go from home to home.

Shannon Albers is hugging loved ones again – with certain COVID-inspired modifications. “After 89 days I finally got to hug my mom, and she started crying,” Albers recalls.

Because I have two large dogs, I have also wondered whether they could be potential virus spreaders — not through their respiratory droplets, but because the virus might land on their fur. When I’m out walking them in the evening and see neighbors with their canines, we usually keep our distance, but once in a while somebody wants to pet one of my dogs, and I’ve been tempted to pet theirs — but have resisted.

My experts say I shouldn’t worry. It is theoretically possible to catch the virus off a dog if somebody just sneezed on it, but that’s an unlikely scenario. The dog’s owner poses a bigger risk.

For those of us who have craved more human contact, it may come as a welcome surprise that some public health experts think it can be safe to hug people (though not dog owners you don’t know) if you follow certain guidelines: Do it outdoors; wear a mask; point your faces in opposite directions; avoid contact between your face and the other person’s body; keep it brief and wash your hands afterward.

Shannon Albers, a 35-year-old resident of Sacramento, says she started hugging people again after reading a story about how to do it safely in The New York Times.

“After 89 days I finally got to hug my mom, and she started crying,” Albers recalls. “We were standing on the driveway, and I said, ‘Do you want a hug?’ She immediately tightened her mask and started coming down the driveway, and I said, ‘Wait, Mom. There’s rules.’”

Chronically ill and elderly people may not want to risk it, says UC-Berkeley’s Reingold. “But if you are out drinking beers with somebody in a crowded room, I’m not sure the hug makes a difference, frankly.”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

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Families Of Health Workers Killed By COVID Fight For Denied Workers’ Comp Benefits

James “Mike” Anderson was a hospital employee in suburban Philadelphia with a low-profile though critical job: changing air filters in COVID patients’ rooms.

By late March, new COVID cases in Bucks County, Pennsylvania, had ramped up to as many as 90 per day. At the hospital, Anderson handled air filters and other surfaces that might have been contaminated with the deadly virus, also known to hang in the air.

In early April, Anderson, 51, came down with what he thought was a cold, according to his family’s lawyer, David Stern. On April 13 Anderson was rushed to the hospital, where he died of acute respiratory distress syndrome from COVID-19, according to the county coroner. He left behind a wife and two children, ages 5 and 9.

James “Mike” Anderson, a maintenance mechanic at St. Mary’s Medical Center outside of Philadelphia, died of COVID-19 complications on April 13.(Courtesy of Stephanie Anderson)

Anderson was exposed to the virus at work, the lawyer contends, making his family eligible for workers’ compensation death benefits paid by his employer’s insurer.

“His family deserves to have that income replaced,” Stern said. “Their husband and father certainly can’t be.”

But in a June 16 response to Stern’s death benefits claim, St. Mary Medical Center denied all allegations.

As the COVID toll climbs, sick workers and families of the dead face another daunting burden: fighting for benefits from workers’ compensation systems that, in some states, are stacked against them.

In interviews with lawyers and families across the nation, KHN found that health care workers ― including nurses’ aides, physician assistants and maintenance workers ― have faced denials or long-shot odds of getting benefits paid. In some cases, those benefits amount to an ambulance bill. In others, they would provide lifetime salary replacement for a spouse.

Legal experts say that in some states COVID-19 falls into a long-standing category of diseases like a cold or the flu — conditions not covered by workers’ compensation — with no plans to change that. Other states force workers to prove they caught the virus at work, rather than from a family member or in the community.

“We are asking people to risk their lives every single day — not just doctors, nurses and first responders, but also nurses’ aides and grocery store clerks,” said Laurie Pohutsky, a Democratic Michigan lawmaker who proposed a bill to help essential workers get coverage more easily. “These people are heroes, but we have to actually back those words up with actions.”

In at least 16 states and Puerto Rico, officials have passed measures to make it easier for workers infected with the coronavirus to qualify for benefits for lost wages, hospital bills or death. Similar bills are pending in other states, but some face opposition from business groups over costs.

Many of the proposed actions would turn the tables on the status quo, forcing employers to prove workers did not catch the virus at work. Bills vary in the scope of workers they cover. Some protect all who left home to work during stay-at-home orders. Others are limited to first responders and health care workers. Some would cover only workers who get sick during states of emergency, while others would cover a longer period.

An early glimpse of data shows that health care workers and first responders, two groups hit hard by the virus, make up the majority of those seeking benefits. Data from the Centers for Disease Control and Prevention shows that more than 95,000 health care workers have been infected, a figure the agency acknowledges is an undercount. KHN and The Guardian U.S. have identified more than 700 who have died and told the story of 139 of them. For these workers’ families, the stakes of the pending laws are enormous.

In Virginia, attorney Michele Lewane is representing a nurse and a physician assistant who contracted the coronavirus while working at the same urgent care center. The physician assistant, who administered COVID tests, was hospitalized with COVID-19 and pneumonia for about a week. He missed five weeks of work.

When the physician assistant asked the urgent care center for paperwork to file a workers’ compensation claim to cover his hospital bill, an administrator refused to hand it over, saying coronavirus treatment wouldn’t be covered, Lewane said. He was laid off days later and left with a $60,000 hospital bill.

Lewane said the law in Virginia will likely consider COVID-19 an “ordinary disease of life,” akin to a cold or the flu. She said she’d have to prove by “clear and convincing evidence” that he caught the coronavirus at work.

The bar is so high, she said, that she’s waiting to file a claim in hopes that Virginia joins many other states passing laws that make it easier for health workers to prove their cases.

Craig Davis, president-elect of the Virginia Trial Lawyers Association, said he took on a test case and received a quick denial of workers’ compensation benefits for a COVID-positive physician assistant.

“We think there’s an infinitesimal possibility of prevailing under our laws as currently written,” he said. His group is pushing for a legislative change.

In Montana, which has largely been spared by the pandemic, workers face even longer odds. A 64-year-old nurse at a small hospital there was hospitalized for eight days with COVID-19 in April, according to her Great Falls lawyer, Thomas Murphy. She remains at home on oxygen, unable to work.

The woman filed a workers’ compensation claim, which could qualify her for up to $800 a week in lost wages plus lifetime coverage of medical bills related to her condition. Instead of agreeing to those benefits, Murphy said, the insurer offered to settle for $17,000, which she declined because it would not cover her medical bills.

Murphy said the employer, which he did not name to protect his client from retaliation, is arguing that she was the first person at the hospital to contract the virus, so she likely didn’t get it at work. However, he noted that two other hospital employees and six patients tested positive within the next two weeks and his client went few places other than work.

In Montana law, the burden of proof lies on the employee to show an illness was work-related.

“We’re going to have to try to piece together all of the sources” that might have infected her — “and prove that it’s more probable than not that she got it at work,” Murphy said. “Women like this woman are going to have a hard road ahead of them.”

The Montana Legislature isn’t set to meet until January, and an executive order appears unlikely.

In New Jersey, attorney Rick Rubenstein is representing the widow of a man who worked as a housekeeper at a nursing home, doing laundry and occasional patient care. Not given protective gear by his employer, the man caught COVID-19 and had a lengthy stay in the intensive care unit before he died.

His wife has the virus now and was faced with a default — no answer in 35 days — after seeking benefits in New Jersey’s workers’ compensation system. They would cover her husband’s $188,000 hospital bill and survivor’s pay of $308 per week.

“She’s isolated, doesn’t know what her own health future holds and doesn’t have an explanation of why this stuff is happening,” Rubenstein said. “It’s terrible.”

A bill proposed in New Jersey would make it easier for essential workers who got COVID-19 during the state of emergency to prove that they got it on the job. The bill was passed by the state Senate and is pending before the General Assembly.

The New Jersey Business & Industry Association has opposed the bill, saying it would push higher workers’ compensation insurance rates onto businesses that are “struggling to survive.”

“Our concerns are primarily that the cost of these claims can overwhelm the system, which was not designed to handle claims during a worldwide pandemic,” NJBIA Chief Government Affairs Officer Chrissy Buteas said in a statement.

While there are no national estimates of how many are filing claims for workers’ compensation ― or getting approvals ― Massachusetts provided KHN with a summary of its coronavirus reports from March, April and May.

During those months, employers filed 3,482 “first reports of injury” regarding a worker with COVID-19 ― 2,915 were for health care workers. Insurers denied benefits to 216 health care workers, according to Massachusetts records.

Florida posted similar data, showing a higher rate of denied claims for health care workers. While 1,740 health care workers sought benefits related to COVID-19, about 30%, or 521 claims, were fully denied. Among the 1,200 who were paid benefits, the amount paid added up to $1.3 million.

The cost of covering 9.6 million first responders and health workers nationally could range from $1 billion to $16 billion, according to the National Council on Compensation Insurance, which provides insurance rate recommendations for 38 states. The bill is paid by employers who buy workers’ compensation insurance, employers that self-insure and taxpayers, who support government agencies.

Those estimates do not include New York or California, where Gov. Gavin Newsom’s executive order broadening coverage through July 5 is projected to add about $1.2 billion to California’s costs.

In many states, business associations consider proposals to expand workers’ compensation too costly and too broad.

A proposed California bill would extend Newsom’s executive order and put the burden on employers to prove that “critical workers,” including those in retail, warehousing and delivery, who got the coronavirus did not get it at work. The bill has critics.

“California employers have been significantly impacted by this crisis and simply cannot be the safety net for this pandemic by providing workers’ compensation benefits for all employees, even when they are not injured at work,” according to a letter of concern signed by the California Chamber of Commerce, California Hospital Association and others.

A federal backstop may become available. Sen. Tammy Duckworth (D-Ill.) and a bipartisan group of lawmakers introduced a bill that would create a federal fund for essential workers, including health care personnel, who get sick or die from the coronavirus. The Pandemic Heroes Compensation Act would be modeled after the September 11th Victim Compensation Fund.

In Pennsylvania, there is no presumption that COVID-19 is acquired on the job.

Stern, the lawyer for Anderson’s family, filed a “fatal claim” in May with the state workers’ compensation board, which passed it on to the employer.

A St. Mary Medical Center spokesperson confirmed in an email that Anderson worked there for 23 years and was a maintenance mechanic. She would not discuss his case. “We are extremely saddened by his death,” she wrote. “We are not able to provide additional information out of respect for his and his family’s privacy.”

Mark Banchi volunteers with hospital chaplains and knew Anderson for over 30 years. He said co-workers are reeling from the death of a man who “was enthusiastic, gregarious, friendly.”

“His loss to the hospital is real,” Banchi said. “Some people lift spirits, some people make you glad you came that day, and Mike was one of those people.”

In addition to working at St. Mary for $22 an hour, Anderson had a cleaning job at a car dealership. Stern said Anderson was unlikely to be exposed to the virus there. If Stern prevails, the family would receive two-thirds of Anderson’s combined pay, capped at $1,081 a week.

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As COVID Testing Soars, Wait Times For Results Jump To A Week — Or More

Elliot Truslow went to a CVS drugstore on June 15 in Tucson, Arizona, to get tested for the coronavirus. The drive-thru nasal swab test took less than 15 minutes.

More than 22 days later, the University of Arizona graduate student was still waiting for results.

Elliot Truslow had a drive-thru COVID test at a CVS in Tucson, Arizona, on June 15. CVS told Truslow to expect results in two to four days, but 22 days later, still nothing. (Courtesy of Elliot Truslow)

Truslow was initially told it would take two to four days. Then CVS said five or six days. On the sixth day, the pharmacy estimated it would take 10 days.

“This is outrageous,” said Truslow, 30, who has been quarantining at home since attending a large rally at the school to demonstrate support of Black Lives Matter. Truslow has never had any symptoms. At this point, the test findings hardly matter anymore.

Truslow’s experience is an extreme example of the growing and often excruciating waits for COVID-19 test results in the United States.

While hospital patients can get the findings back within a day, people getting tested at urgent care centres, community health centres, pharmacies and government-run drive-thru or walk-up sites are often waiting a week or more. In the spring, it was generally three or four days.

The problems mean patients and their physicians don’t have the information necessary to know whether to change their behaviour. Health experts advise people to act as if they have COVID-19 while waiting — meaning to self-quarantine and limit exposure to others. But they acknowledge that’s not realistic if people have to wait a week or more.

Atlanta Mayor Keisha Lance Bottoms, who announced Monday that she had tested positive for the virus, complained she waited eight days for her results in an interview on MSNBC Wednesday. During that time, she held a number of meetings with city officials and constituents — “things that I personally would have done differently had I known there was a positive test result in my house,” she said on “Morning Joe.”

“We’ve been testing for months now in America,” she added. “The fact that we can’t quickly get results back so that other people are not unintentionally exposed is the reason we are continuing in this spiral with COVID-19.”

The slow turnaround for results could also delay students’ return to school campuses this fall. It’s already keeping some professional baseball teams from training for a late July start of the season. The lag times could even foil Hawaii’s plan to welcome more tourists. The state had been requiring visitors to quarantine for 14 days, but it announced last month that starting Aug. 1 that mandate would be lifted for people who could show they tested negative within three days before arriving in the islands.

In California, Gov. Gavin Newsom noted the problem when addressing reporters Wednesday. “We were really making progress as a nation, not just as a state, and now you’re starting to see, because of backlogs with [the lab company] Quest and others, that we’re experiencing multi-day delays,” he said.

The delays even apply to people in high-risk, vulnerable populations, he said, citing a massive outbreak at San Quentin State Prison, which has been sending its tests to Quest. The state is now looking at partnering with local labs, hoping they can provide faster turnaround.

Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said the long waits spell trouble for individuals and complicate the national response to the pandemic.

“It defeats the usefulness of the test,” he said. “We need to find a way to make testing more robust so people can function and know if they can resume normal activities or go back to work.”

The problem is that labs running the tests are overwhelmed as demand has soared in the past month.

Azza Altiraifi of Vienna, Virginia, got her COVID test at CVS on July 1. She still has symptoms, including fatigue — but as of July 7, she was still awaiting the result.(Courtesy of Azza Altiraifi)

“We recognize that these test results contain actionable information necessary to guide treatment and inform public health efforts,” said Julie Khani, president of the American Clinical Laboratory Association, a trade group. “As laboratories respond to unprecedented spikes in demand for testing, we recognize our continued responsibility to deliver accurate and reliable results as quickly as possible.”

Dr Temple Robinson, CEO of Bond Community Health Center in Tallahassee, Florida, said test results have gone from a three-day turnaround to 10 days in the past several weeks. Many poor patients don’t have the ability to easily isolate from others because they live in smaller homes with other people. “People are trying to play by the rules, but you are not giving them the tools to help them if they do not know if they tested positive or negative,” she said.

“If we are not getting people results for at least seven or eight days, it’s an exercise in futility because either people are much worse or they are better” by then, she said.

Given the lag in testing results from big lab companies, Robinson said her health centre this month bought a rapid test machine. She held off buying the machine due to concerns the tests produced a high number of false-negative results but went ahead earlier this month in order to curtail the long waits, she said.

Robinson doesn’t blame the large labs and points instead to the surge in testing. “We are all drinking through a firehose, and none of the labs was prepared for this volume of testing,” she said. “It’s a very scary time.”

Azza Altiraifi, 26, of Vienna, Virginia, knows that all too well. She started feeling sick with respiratory symptoms and had trouble breathing on June 28. Within a few days, she had chills, aches and joint pain and then a needling sensation in her feet. She went to her local CVS to get tested on July 1. She was still awaiting the result of July 8.

What is most frustrating about her situation is that her husband is a paramedic, and his employer won’t let him work because he may have been exposed to the virus. He was tested July 6 and is still awaiting news.

“This is completely absurd,” Altiraifi said. She also worries that her husband may have unknowingly passed on the virus on one of his ambulance calls to nursing homes and other care facilities before he began isolating at home. He has not shown any symptoms.

Altiraifi, who still has symptoms including fatigue, said she was initially told she would have resulted in two to four days, but she was suspicious because after using a nasal swab to give herself the test, the box to put it in was so full it was hard to close.

Charlie Rice-Minoso, a spokesperson for CVS Health, said patients are waiting five to seven days on average for test results. “As demand for tests has increased, we’ve seen test result turnaround times vary due to temporary processing capacity limitations with our lab partners, which they are working to address,” he said.

In South Florida, the Health Care District of Palm Beach County, which has tested tens of thousands of patients since March, said findings are taking seven to nine days, several days longer than in the spring.

CityMD, a large urgent care chain in the New York City area, said it now tells patients they will likely wait at least seven days for results because of delays at Quest Diagnostics.

Quest Diagnostics, one of the largest lab companies in the United States, said average turnaround time has increased from three to five days to four to six days in the past two weeks. The company has performed nearly 7 million COVID tests this year.

“Quest is doing everything it can to add testing capacity to reduce turnaround times for patients and providers amid this crisis and the unprecedented demands it places on lab providers,” said spokesperson Kimberly Gorode.

At Treasure Coast Community Health in Vero Beach, Florida, officials are advising patients of a 10- to 12-day wait for results.

CEO Vicki Soule said Treasure Coast is deluged with calls every day from patients wanting to know where their test results are.

“The anxiety on the calls is way up,” she said.

Julie Hall, 48, of Chantilly, Virginia, got tested June 27 at an urgent care centre after learning that her husband had tested positive for COVID-19 as he prepared for hip replacement surgery. She was dismayed to have to wait until July 3 to get an answer.

“I was thrilled to be negative, but by that point, it likely did not matter,” she said, noting that neither she nor her husband, Chris, showed any symptoms.

“It was awful and terrible because of the unknowns and not knowing if you exposed someone else,” she said of being quarantined at home awaiting results. “Whenever you would sneeze, someone would say ‘COVID’ even though you feel completely fine.”

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Shingles Vaccination Rate Soars But Leaves Many Behind

Worried about the high cost of the copayment for the shingles vaccine, Jacky Felder, a Medicare beneficiary, opted against getting immunized last year.

Last month, the Green Bay, Wisconsin, woman developed the disease, which left a painful, itchy rash across her abdomen. “Luckily, I’ve had a relatively mild case, but it’s been a week and half with a lot of pain,” said Felder, 69.

Felder is far from alone. Nationally, about 35% of people 60 and older were vaccinated for shingles by 2018, up from about 7% in 2008, according to a report released Thursday by the federal Centers for Disease Control and Prevention.

The report also shows low-income adults and those who are Black or Hispanic are far less likely to get vaccinated than whites. About 39% of non-Hispanic white adults were vaccinated for shingles by 2018, compared with about 19% of Hispanic and Black adults, the report found.

Those findings are consistent with disparities for other adult vaccines.

Adults with incomes under the federal poverty level ($12,760 for an individual) were only half as likely to get immunized as those with annual incomes of more than $25,000, the report said.

Cara James, CEO of the nonprofit Grantmakers in Health and former director of the Office of Minority Health at the Centers for Medicare & Medicaid Services, said Blacks and Hispanics are more likely than whites not to have health insurance or a regular health provider, which may help account for their lower vaccination rates. They are also likely to have less income to afford the shot.

The lower vaccination rates for Blacks and Hispanics have implications for when and if a vaccine is developed for COVID-19, she said. Even though they are more likely to have the coronavirus and experience more severe cases of COVID-19, Blacks and Hispanics may not be at the front of the line to get vaccinated because of costs and other factors.

Shingles is caused by the same virus that causes chickenpox, which can remain in the body inactive for years. For about a third of adults, it can reactivate as shingles, often presenting as a painful rash anywhere on the body.

The drugmaker Merck offered the first shingles vaccine, Zostavax, in the U.S. in 2006. In late 2017, a newer and more effective vaccine, Shingrix, was approved by the Food and Drug Administration, and this month Merck stopped selling its product.

Shingrix, made by GlaxoSmithKline, is 97% effective in preventing the disease in adults ages 50 to 69, compared with about 51% for Zostavax. The CDC recommends that everyone over 50 — including those who were vaccinated with Zostavax — get Shingrix. No prescription is required.

The Affordable Care Act required that preventive health services, including vaccines, be provided to people with private health insurance with no out-of-pocket costs. But people with Medicare were excluded.

While Medicare beneficiaries get free vaccinations for the flu and pneumonia, they often have to pay for other vaccines, including the shingle shots. The payments are set by their Medicare drug plan.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University in Nashville, said he recommends his patients get the Shingrix vaccine before they turn 65 and enroll in Medicare. He faults Congress for adding costs for Medicare enrollees to get vaccinated.

“We’ve seen a substantial portion of the population receive the vaccine, but it is far from the goal of 100%,” Schaffner said.

GlaxoSmithKline said the average Medicare enrollee pays $50 for each of two doses of the vaccine, which are typically given a few months apart.

For people without insurance, Shingrix costs about $300 for the two doses.

Besides cost, another factor that may play into the low rate of vaccinations is access. Demand for Shingrix led to a shortage of the vaccine shortly after its launch, but GlaxoSmithKline officials say they now have plenty to distribute.

About 17 million people have received at least one dose of Shingrix, although the shots are recommended for more than 100 million people, spokesperson Sean Clements said. In comparison, he said between 20 million and 25 million people received Zostavax after 14 years on the market.

Dr. Anjali Mahoney, a family physician in Los Angeles and vice chair for clinical affairs at the University of Southern California’s Keck School of Medicine, said she was pleased to hear about the big increase in people getting the vaccine.

“About 1 in 3 people get shingles in their lifetime, and that is not something you want to get,” she said. Complications and pain from shingles, she added, can last for years, long after the rash has disappeared.

But she said that the cost barriers to vaccination for Medicare beneficiaries are keeping the numbers lower than they should be.

Felder, whose income is limited to her Social Security payments, said even $50 per dose would be too much for her to pay for the shingles vaccine. She hopes to get vaccinated if she receives another federal stimulus check.

“It isn’t right that people on Medicare have to pay for this, because for a lot of people, shingles can make them very sick,” Felder said.
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Analysis: How A COVID-19 Vaccine Could Cost Americans Dearly

Yes, of course, Americans’ health is priceless and reining in a deadly virus that has trashed the economy would be invaluable.

But a COVID-19 vaccine will have an actual price tag. And given the prevailing business-centric model of American drug pricing, it could well be budget-breaking, perhaps making it unavailable to many.

The last vaccine to quell a global viral scourge was the polio inoculation, which ended outbreaks that killed thousands and paralyzed tens of thousands each year in the United States. The March of Dimes Foundation covered the nominal drug cost for a free national vaccination program.

It came in the mid-1950s before health insurance for outpatient care was common before new drugs were protected by multiple patents before medical research was regarded as a way to become rich. It was not patented because it was not considered patentable under the standards at the time.

Now we are looking for viral deliverance when drug development is one of the world’s most lucrative businesses, ownership of drug patents is disputed in endless court battles, and monopoly power often lets manufacturers set any price, no matter how extraordinary. New cancer treatment can cost a half-million dollars, and old staples like insulin have risen manifold in price to thousands of dollars annually.

And the American government has no effective way to fight back.

Recent vaccines targeting more limited populations, such as a meningitis B vaccine for college students and the shingles vaccine for older adults, have a retail cost of $300 to $400 for a full course.

If a COVID-19 vaccine yields a price of, say, $500 a course, vaccinating the entire population would bring a company over $150 billion, almost all of it profit.

Dr. Kevin Schulman, a physician-economist at the Stanford Graduate School of Business, called that amount “staggering.” But Katherine Baicker, dean of the University of Chicago Harris School of Public Policy, said that from society’s perspective “$150 billion might not be an unreasonable sum” to pay to tame an epidemic that has left millions unemployed and cost the economy trillions.

Every other developed country has evolved schemes to set or negotiate prices, while balancing cost, efficacy and social good. The United States instead has let business calculations drive drug price tags, forcing us to accept and absorb ever higher costs. That feels particularly galling for treatments and vaccines against COVID-19, whose development and production is being subsidized and incentivized with billions in federal investment.

When AZT, the first effective drug for combating the virus that causes AIDS, was introduced in 1992, it was priced at up to $10,000 a year or about $800 a month. It was the most expensive prescription drug in history, at that time. The price was widely denounced as “inhuman.” Today that price gets you some drugs for toenail fungus.

Investors already smell big money for a COVID-19 vaccine.

The market cap of Moderna, a small Boston-area company that has partnered with the National Institutes of Health in the vaccine race, has tripled since Feb. 20, to $23 billion from $7 billion, turning its chief executive into an overnight billionaire. While Moderna’s vaccine is regarded as a strong contender, the company has never brought a successful drug to market.

Manufacturers have traditionally claimed that only the lure of windfall profits would encourage them to take the necessary risks, since drug development is expensive and there’s no way of knowing whether they’re putting their money on a horse that will finish first, or scratch.

More recently they have justified high prices by comparing them with the costs they would prevent. Expensive hepatitis C drugs, they say, avoid the need for a $1 million liver transplant. No matter that the comparison being made is to the highly inflated costs of treating disease in American hospitals.

Such logic would be disastrous if it were applied to a successful COVID vaccine. COVID-19 has shut down countless businesses, creating record-high unemployment. And the medical consequences of severe COVID-19 mean weeks of highly expensive intensive care.

“Maybe the economic value of the COVID vaccine is a trillion — and even if the expense to the company was a billion, that’s 1,000 times return on investment,” said Schulman. “No economic theory would support that.”

In 2015, the Senate Finance Committee came up with a simpler explanation for high drug prices. After reviewing 20,000 pages of company documents, it found that Gilead Sciences had what the committee’s ranking Democratic member, Ron Wyden of Oregon, called “a calculated scheme for pricing and marketing its hepatitis C drug based on one primary goal, maximizing revenue.”

In setting prices, drugmakers rarely acknowledge the considerable federal funding and research that have helped develop their products; they have not offered taxpayer-investors financial payback.

The Biomedical Advanced Research and Development Authority, a federal agency known as BARDA, is giving Moderna up to $483 million for the late-stage development of its vaccine.

The basic science that has allowed the small company to move so rapidly was developed with a huge prior infusion of federal money to come up with a treatment for diseases like Zika.

Francis Collins, the head of the National Institutes of Health, has said the government has some intellectual property rights. Moderna seems to dispute that view, saying it is “not aware of any I.P. that would prevent us from commercializing” a COVID-19 vaccine.

Likewise, AstraZeneca, a top competitor, has received a BARDA promise of up to $1.2 billion for commercializing a product derived from research at the University of Oxford.

There is no simple, direct mechanism for regulators or legislators to control pricing. Our laws, in fact, favor business: Medicare is not allowed to engage in price negotiations for medicines covered by its Part D drug plan. The Food and Drug Administration, which will have to approve the manufacturer’s vaccine for use as “safe and effective,” is not allowed to consider proposed cost. The panels that recommend approval of new drugs generally have no idea how they will be priced.

“The idea that we would allow ourselves to be held hostage in an emergency is mind-boggling,” said David Mitchell, head of Patients for Affordable Drugs, an advocacy group.

That’s why a bipartisan coalition in the House recently proposed two new bills to prevent “price gouging” for “taxpayer-funded COVID-19 drugs” to ensure affordable pricing.

The exact mechanisms for enacting the provisions therein — such as requiring manufacturers to reveal their development costs — remain unclear. The industry has previously protected development data as a trade secret. The bills would also require “reasonable pricing clauses” to be included in agreements between drug companies and agencies funding their work. They propose waiving exclusive licenses for COVID-19 drugs, allowing competitors to sell the same products as long as they pay the patent holder royalties.

Other countries, such as Britain, take a more head-on approach: a national body does a cost-benefit analysis regarding the price at which a new drug is worth being made available to its citizens. Health authorities then use that information to negotiate with a drugmaker on price and to develop a national reimbursement plan.

We could, too, but would need to consider mechanisms outside of our current box — at least for this national emergency.

The federal government could, for example, invoke a never-before-used power called “march-in rights,” through which it can override a patent holder’s rights if it doesn’t make its medicines “available to the public on reasonable terms.” (Unfortunately, in already-signed agreements with BARDA, some drugmakers have explicitly watered down or eliminated that proviso.)

We could, alternatively, allow Medicare to negotiate drug prices — a proposal that has been raised by politicians and beaten back by industry again and again. We would then need to restrict markup for a COVID-19 vaccine for the private market. Otherwise, we’d get the kinds of results emerging from the COVID testing industry, where Medicare pays $100 for the test but some labs charge insurers over $2,000.

There is already reason to worry that our deliverance from the coronavirus will cost us plenty. BARDA paid AztraZeneca up to $1.2 billion in development, production, and delivery of its candidate vaccine, in order to secure 300 million doses in October. Britain paid the equivalent of $80 million to secure 100 million doses in September — one-fifth of what the United States government agreed to pay per dose.

Baicker, the public policy school dean, thinks public scrutiny will prevent outrageous pricing. The industry has made various pledges, trying to balance corporate citizenship against making eager investors happy: Astra Zeneca has promised 1 billion doses for low- and middle-income countries. Johnson & Johnson says it would make the COVID-19 vaccine available on a “not for profit basis” at $10 for “emergency pandemic use.”

We’ve heard such offers before. Pharmaceutical companies routinely provide coupons to cover patient copayments for expensive drugs so that we don’t squawk when they charge our insurance company tens of thousands for the medicine, driving up premiums year after year. A naloxone injector to reverse heroin overdoses is given free to some clinics but priced at thousands for the rest.

And it won’t feel like a bargain if we get free or cheap vaccines during a pandemic but pay dearly for annual COVID-19 shots thereafter.

Drug companies deserve a reasonable profit for taking on this urgent task of creating a COVID-19 vaccine. But we deserve a return, too.

So before these invaluable vaccines hit the market, we should talk about an actual price. Otherwise, we will be stuck paying dearly for shots that the rest of the world will get for much less.
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Coronavirus Crisis Disrupts Treatment For Another Epidemic: Addiction

Shawn Hayes was thankful to be holed up at a city-run hotel for people with COVID-19.

The 20-year-old wasn’t in jail. He wasn’t on the streets chasing drugs. Methadone to treat his opioid addiction was delivered to his door.

Hayes was staying at the hotel because of a coronavirus outbreak at the 270-bed Kirkbride Center addiction treatment center in Philadelphia, where he had been seeking help.

From early April to early May, 46 patients at Kirkbride tested positive for the virus and were isolated. The facility is now operating at about half-capacity because of the pandemic.

Drug rehabs around the country — including in Pennsylvania, Illinois, Indiana, Minnesota and Florida — have experienced flare-ups of the coronavirus or COVID-related financial difficulties that have forced them to close or limit operations. Centers that serve the poor have been hit particularly hard.

And that has left people who have another potentially deadly disease — addiction — with fewer opportunities for treatment while threatening to reverse their recovery gains.

“It’s hard to underestimate the effects of the pandemic on the community with opioid use disorder,” said Dr. Caleb Alexander, a professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health. “The pandemic has profoundly disrupted the drug markets. Normally that would drive more people to treatment. Yet treatment is harder to come by.”

Keeping Clients Safe

Drug rehabs aren’t as much of a COVID “tinderbox” as nursing homes, Alexander said, but both are communal settings where social distancing can be difficult.

Shared spaces, double-occupancy bedrooms, and group therapy are common in rehabs. People struggling with addiction are generally younger than nursing home residents, but both populations are vulnerable because they’re more likely to suffer from other health conditions, such as diabetes or cardiovascular disease, that leave them at risk of succumbing to COVID-19.

To keep clients safe, some addiction treatment centers employ safety precautions similar to hospitals, like testing all incoming patients for COVID-19, noted Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. But drug rehabs must avoid some strategies, such as keeping potentially intoxicating hand sanitizer on the premises.

Adalja said he hopes safety measures make people feel more comfortable about seeking addiction help.

“There’s not going to be anything that’s zero risks, in the absence of a vaccine,” he said. “But this is in a different category than going to a birthday party. You don’t want to postpone needed medical care.”

Still, some people requiring drug or alcohol rehab have stayed away for fear of contracting COVID-19. Marvin Ventrell, CEO of the National Association of Addiction Treatment Providers, said many of its roughly 1,000 members saw their patient numbers down by much as 40% to 50% in March and April before bouncing back to 80%.

Unlike many other centers, Recovery Works, a 42-bed treatment center in Merrillville, Indiana, has seen more clients than normal during the pandemic. The facility had to close for a few days early on after a suspected COVID-19 case, but reopened after the person tested negative. It has since split its therapy sessions into three groups, staggered mealtimes and banned visitors, CEO Thomas Delegatto said. It then had an influx of patients.

“I think there are a variety of reasons why,” Delegatto said. “A person who was struggling with a substance use disorder, and who was laid off and a nonessential worker, might have seen this as an opportunity to go to treatment without having to explain to their employer why they’re taking two, three, four weeks off.”

He also noted that alcohol sales went up at the beginning of the pandemic as anxiety and isolation rose, and sheltering in place may have made some families realize that a loved one needed help for an addiction.

Kirkbride Center, an addiction treatment center in Philadelphia, is running at about half-capacity after a recent COVID-19 outbreak.
Dr. Fred Baurer, Kirkbride’s medical director, says, “I’m starting to feel more confident we’re past the worst of this, at least for now.” (Courtesy of Dr. Fred Baurer)

Centers Serving The Poor Hit Hard

Homeless and poor Americans, because they often live in close quarters, have been particularly prone to catching COVID-19 — leaving drug rehabs dedicated to this population especially vulnerable.

Haymarket Center, a 380-bed treatment and sober living facility in Chicago’s West Loop that serves many people who are homeless, recently had an outbreak of 55 coronavirus cases among clients and staff members.

Two employees there tested positive for COVID-19 in late February, but testing was available then only for people showing symptoms, said Haymarket president and CEO Dan Lustig.

Haymarket worked with nearby Rush University Medical Center to test its clients. Twenty-six men, though asymptomatic, were found to be positive for COVID-19.

The center isolated those patients and eventually went from double- to single-occupancy rooms, improved its air filtration system and changed the way it served food. It now tests all new admissions.

“What we found was by doing serial testing we could tamp down the epidemic, not just at Haymarket but the whole city,” said Dr. David Ansell, senior vice president for community health equity at Rush, which partnered with the city and other health systems on a COVID-19 response for Chicago’s homeless population.

The pandemic’s economic fallout has also forced some facilities to scale back. The Salvation Army is shuttering a handful of its roughly 100 adult rehabilitation centers nationwide due to COVID-related revenue losses. Those rehabs were funded by the organization’s resale shops, which were forced to close during stay-at-home orders.

“A lot of what we do relies on donations or items that were donated and then sold in our stores,” said Alberto Rapley, who oversees business development for the Salvation Army’s rehab facilities in the Midwest. “When financially we struggle, that is then felt on the other side.”

For instance, the Salvation Army drug rehab in Gary, Indiana, which is set to close in September, treated as many as 80 men at a time in its free, abstinence-based program. The next closest facility will be in Chicago, more than 30 miles away.

Outbreak Contained, But Beds Still Limited

Philadelphia’s Kirkbride Center also serves a mostly homeless and low-income population. Dr. Fred Baurer, the facility’s medical director, said Kirkbride was “flying blind” early in the pandemic, with little testing capacity and personal protective equipment.

On April 8, the first COVID-19 case appeared on Kirkbride’s long-term men’s wing. Over the next week, six more men on the unit showed symptoms and tested positive, as did 12 of the remaining 22. All quarantined at a local Holiday Inn Express.

Kirkbride started requiring face masks, testing all new clients for COVID-19 and prohibiting people in its various units from mingling.

The rehab has been about half-full lately — it’s usually closer to 90% occupied — partly because it stopped taking walk-in clients and confined new admissions to single rooms.

“I’m starting to feel more confident we’re past the worst of this, at least for now,” Baurer said.

Hayes, who has recovered from COVID-19 without experiencing any symptoms, was discharged from the facility June 15 to a sober living house. He plans to attend 12-step meetings regularly. He hopes to get his GED and eventually enter the mental health field.

He recognizes the need to stay vigilant about his recovery now, at a time of increased anxiety and despair.

“Regardless of the coronavirus or not, the addiction crisis is still there,” Hayes said. “It’s bad. It’s really bad.”
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Some global reaction to the news of US mass purchase of remdesivir

Canadian physician-researcher James Brophy of McGill University read the news announcing, “US buys up world stock of key Covid-19 drug remdesivir.” Rather than reacting with shock and scorn as many observers did, Brophy celebrated the announcement as “good news for the rest of us” around the globe.

Why?

He explained in an opinion piece published by The BMJ, “US purchases world stocks of Remdesivir—why the rest of the world should be glad to be at the back of the queue.”

  • One company-sponsored remdesivir trial showed a shortened median time to recovery in the remdesivir group. There was no effect on mortality. “Moreover, there are numerous reasons why the shortened reported time to symptomatic recovery may be an over-estimate of its true value.”
  • “It has been established that company sponsored trials, prematurely stopped trials, poorly executed trials with unsuccessful blinding, and large lost to follow-up, all contribute to exaggerated, embellished and unreliable effect measures. Well, this (New England Journal of Medicine published-) remdesivir study was company sponsored, prematurely stopped, had incomplete blinding, and only about 15% of patients had their outcome determined at the specified primary endpoint of 28 days. An additional concern for some is the modification of the primary trial endpoint shortly before publication, although apparently before unblinding of any results. In contrast, a non-company sponsored trial looking at the same remdesivir doses found no benefit for either symptom duration or mortality. Hmmm, are we still convinced about the magnitude of any potential benefit?”
  • “No remdesivir study has demonstrated any reduction in hospital stay or mortality.”
  • “For this marginal and uncertain benefit, the manufacturer now proposes charging in the vicinity of $3000 USD per treatment.”
  • “The last time countries stockpiled billions of dollars of antivirals, at least $10 billion for oseltamivir (Tamiflu), could hardly be considered a success as that medication was eventually removed from the WHO list of essential medications. The aphorism “Those who don’t know history are doomed to repeat it” does seem appropriate.”
  • “In conclusion, yes, the US action may be viewed as unfriendly and is truly the apotheosis of a self-centered nation, but its course of action is potentially beneficial for other countries. Better to have the plutocratic American healthcare system dominate this market with an expenditure of $1.5 billion for such uncertain benefits. The money other countries save can surely be better spent on further research for this and other drugs as well as for public health measures, including testing, contact tracing, and maintaining universal healthcare, all notable lacunae in the American system.”

Brophy asks “Wonder why their healthcare ‘system’ has troubles?”

It sometimes helps to see the US as others see us.  This time it’s viewed as a “chilling move,” “shocking,” “disappointing…inappropriate,”or, as Dr. Brophy wrote, “the apotheosis of a self-centered nation.”

Meantime, please note a separate Los Angeles Times reported angle: How secret deals could keep a COVID-19 drug out of reach for millions.

Much of the criticism within the US focused on the remdesivir pricing announcement from the drug’s manufacturer, Gilead Sciences.  For example, NPR reported:

Some advocacy organizations and members of Congress say Gilead is taking advantage of Americans during a pandemic.

Rep. Lloyd Doggett, D-Texas, called the price “outrageous.”

“Without a taxpayer investment of $99 million, this drug would have been abandoned. It would be on the scrap heap of failures,” he tells NPR. “So it’s the taxpayer who’s really taking the risk here and ought to get the reward of the angel investors that taxpayers are.”

Public Citizen, a nonprofit consumer advocacy group, echoed his remarks with a similar sentiment.

“In an offensive display of hubris and disregard for the public, Gilead has priced at several thousand dollars a drug that should be in the public domain,” Peter Maybarduk, director of Public Citizen’s Access to Medicines Program said in a written statement.

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Coronavirus Briefing: Reopening goes awry, Remdesivir’s price tag and the point-of-care pivot

When COVID-19 first announced its presence at the start of the year, even individuals with little confidence in our collective public health infrastructure figured that it would be reduced to a background noise by now. SARS, MERS, Ebola – we shut ‘em up and then we shut ‘em down, the thinking went. There wasn’t optimism so much as a sense of “yeah, we’ll figure it out.”

So it’s profoundly enraging and depressing that, in the United States and elsewhere, we enter the second half of 2020 prepared to usher in yet another unfortunate phase in our non-recovery from COVID-19: the one in which we backslide. On Tuesday, Dr. Anthony Fauci told Congress that infections could surge to 100,000 per day in the U.S. if “we don’t deal with it quickly.” Based on our actions as a global society during the last two months, what are the odds we’re able to retrench and mobilize in such an immediate manner?

This week’s Haymarket Media Coronavirus Briefing is 1,388 words and will take you seven minutes to read.


The un-reopening

For all the finger-wagging that came with the rush to reopen businesses, at least it was underpinned by a sort of risk/reward analysis. People were, and are, feeling real economic pain. If there were a way to minimize further virus spread while at the same time allowing restaurants and car washes and haberdasheries and pet salons to dust off the welcome mat and invite customers back in – well, would anyone have any real objection to that?

It’s too early to say “we blew it,” because the process is proceeding more smoothly (and safely) in some places than others. But all that enthusiastic about a V-shaped recovery seems quite pie-in-the-sky about now.

The Takeaway

There’s not much to say beyond the obvious, which is that an awful lot of factors need to line up before we can un-reverse-reopen in a safe and meaningful way. Until that day, support local businesses in any way you’re able.


Doctor's home visiting during the quarantine
Source: Getty

The science

Good things may or may not be happening on the vaccine front, depending on whom you ask. I’m choosing to focus on that, rather than the COVID data that’s easily and often terrifyingly conveyed in infographic format.

The Takeaway

We need that vaccine.


remdesivir covid-19 liquid medication background
Source: Getty

The news

Ordinarily we’d share the bigger-picture stuff up front, but three sections down feels like a more appropriate place for it this week.

  • The worst of the coronavirus pandemic is yet to come, according to the World Health Organization. It also notes that we’re about $28 billion short of the sum it believes we need to fund an initiative to fast-track development and production of COVID-19 therapeutics, vaccines and diagnostics.
  • The head of LeadingAge, the second-largest nursing home association in the United States, said it is “outrageous” that older Americans haven’t been more of a priority for the White House Coronavirus Task Force, McKnight’s Long-Term Care News’ Danielle Brown reports.
  • A PwC report concludes that employers may face increases in employee healthcare costs of between 4% and 10% in 2021, Amy Novotney notes in McKnight’s Senior Living.

The Takeaway

See? Clearly it was the right call to bury this section between the reopening/reclosing news and the marketing success stories.


jif peanut butter campaign

The market

It’s worth remembering that not every sector has been reduced to a semi-functional husk of what it was four short months ago. The business might not be great in many cases, but you can see many of the success stories without having to squint. We adapt. That’s what we do.

  • MM&M analyzes how point of care, one of healthcare marketing’s most essential channels, navigated the pandemic shutdown – and emerged stronger from it.

The Takeaway

All hail the organizations that have stuck the landing on their pivots. It’s clearly not as easy as some of them have made it look.


MacArthur Airport Debuts Face Masks And Sanitizer Wipes Vending Machine For Travelers
Source: Getty

The rest

  • Civic Science polling found that U.S. women are using hair clippers, trimmers, razors, facial cleansing devices and facial/makeup applicators with roughly the same frequency during quarantine as they did before it. Related: I’m almost certain that, at some point during the first three months of the year, I owned a comb. Civic Science research also revealed that we’re eating lots of cereal and that we won’t be ready to return to the spa or to movie theaters anytime soon.
  • If you insist on performing concerts before more than a handful of your fans, you probably shouldn’t share footage via social media – at least if you don’t want people yelling at you on the Internet, anyway.
  • I knew it! Campaign’s Oliver McAteer gets J.M. Smucker Company CMO Geoff Tanner to confirm that it prioritized production of creamy Jif during the pandemic, leaving chunky Jif fans to subsist on tier-two brands whose chunkiness might fairly be characterized as sub-standard. Have you no shame, sir? The kids are cool with it, though.

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Warning: early vaccine trial results don’t always stand test of time

“The drugmaker Moderna said on Monday that the first coronavirus vaccine to be tested in people appeared to be safe and able to stimulate an immune response against the virus.”

That’s what an early New York Times story reported yesterday.

Erick Turner, MD, reacted on Twitter:

Story strengths & weaknesses

What follows is a brief collection of some strengths and weaknesses of other stories on the early vaccine results.

A Fox News story quoted a surgeon saying that it was “great news” because “I believe that to save American lives we need American medicine and American hands, not the Chinese government leading the way and that’s what we’re doing here in America so I’m very proud.”

NBC News called it “Breaking News” and used the word ‘encouraging’ five times in a short segment.  Today Show anchorwoman Hoda Kotb actually said, “I love it when I see the word ‘encouraging’ in a script.” (Can you imagine if she had said she was excited about encouraging early poll numbers for a political candidate?)

The Wall Street Journal put important caveats up high in the fourth paragraph. (If you’re not a subscriber, you won’t get to the fourth paragraph; it’s behind a paywall.)

The vaccine still has much to prove.  The results don’t show whether it actually protects people who are exposed to the new coronavirus, a key proof point.  Many vaccines fail to pass muster even after showing positive signs in early testing.

The WSJ went on to explain that:

The phase I study data came from among the 45 people ages 18 to 55 who received three different dose levels of the vaccine.  An additional 60 people over age 55 are being enrolled in the study.

That’s an interesting note, but it could have been presented much more clearly,  So the plan is to enroll 105 people in the phase I study.  45 people have been vaccinated.  But most stories only discussed results for 8 people.

CNN explained:

While the vaccine had promising results in the lab, it’s not known if it will protect people in the real world.

The New York Times did a better job explaining what was not real world in the early vaccine results reported.

The people vaccinated in Moderna’s Phase 1 study described on Monday were healthy volunteers ages 18 to 55. Their immune systems made antibodies that were then tested in infected cells in the lab, and were able to stop the virus from replicating — the key requirement for an effective vaccine.

So the meeting of antibodies and infected cells took place in the controlled setting of the lab – not in the bodies of sick people.

Still, that New York Times story was headlined, Moderna Coronavirus Vaccine Trial Shows Promising Early Results

Early results don’t always stand

That’s what a New York Times newsletter reminded readers:

In 2015, the French drug company Sanofi began selling the first vaccine for dengue. The drug had made it through multiple research trials — although some researchers believed Sanofi had ignored worrisome signs. Sure enough, as children in the Philippines began using it, some contracted an even worse form of dengue. Today, use of the vaccine is highly restricted.

In recent testimony, Dr. Anthony Fauci, the nation’s top infectious-disease expert, noted that a coronavirus vaccine could suffer from the same problem.

The larger point is that drugs that look good in small, initial studies often look less good when they’re tested in more people.

With such early trial results, you never hear much about safety or side effects.  You can’t learn much about safety in such small samples on a short-term basis.

None of this kept the manufacturer’s stock from soaring. None of it kept pundits from predicting demand and availability.

Meantime, Ed Silverman of STAT News reported on continuing “Where are the data?” questions – “Amid worldwide clamor for Covid-19 medicines and vaccines.”

Those are good questions.

As are the questions about former Moderna board member and pharma executive Moncef Slaoui – now the President’s newly appointed “vaccine czar” – first claiming he had no conflict of interest, and then announcing he would divest his equity holdings in Moderna.  But I’ll leave that to the political and financial journalists.

Addendum:

See this excellent analysis by Helen Branswell at STAT news – Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine

Also see an op-ed in the Washington Post by William Haseltine, former Harvard Medical School professor and founder of the university’s cancer and HIV/AIDS research departments. Moderna’s claim of favorable results in its vaccine trial is an example of ‘publication by press release’

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As Cases Spike, California Pauses Multimillion-Dollar Testing Expansion

In April, Gov. Gavin Newsom launched a multimillion-dollar state initiative to bring COVID-19 testing to the people and places with the least access: rural towns and disadvantaged inner-city neighborhoods.

California is now halting its expansion, citing costs, even as the state is getting walloped by record-setting spikes in new infections and double-digit increases in hospitalizations.

The state will no longer fund new testing sites despite pleas from counties for additional assistance — and it has closed some locations and moved them elsewhere. It also has threatened to pull testing out of underused sites, according to nearly two dozen interviews with county public health officials.

While it’s early, some winners and losers have emerged: El Dorado County, east of Sacramento, lost its testing site in the town of Shingle Springs in June because it couldn’t fill enough appointment slots, while Fresno County gained a site that had been pulled from elsewhere, said its health officer, Dr. Rais Vohra.

Yet San Mateo County has asked state officials three times for a second state-funded testing venue to address testing gaps in Black and farmworker neighborhoods, but has been “told no, repeatedly,” said Justin Mates, deputy county manager. So the county transformed its sole state site into a roving testing unit.

“Equity is certainly a concern for us,” Mates said. “We really need help with testing access if we’re going to reach our Latino residents and places like East Palo Alto,” a diverse city whose population is mainly Latino, African American and Asian/Pacific Islander.

California has committed up to $132 million in contracts with two private COVID-19 testing companies, Verily Life Sciences and OptumServe, to offer free coronavirus tests at more than 100 sites that the Newsom administration has identified as “testing deserts.” The expansion has dramatically increased the state’s overall testing numbers, which swelled from 16,000 tests per day in April to 105,000 on Monday.

Testing is also available at county-funded locations, private pharmacies, hospitals and community clinics.

State Health and Human Services Secretary Mark Ghaly confirmed that the state is pulling sites out of counties that aren’t generating high enough numbers and cutting off funding for new locations.

“With every asset and resource — especially when it’s scarce — you want it to go to places where it’s most needed,” Ghaly said. “It wouldn’t be prudent or wise to maintain spending in a place where resources aren’t being used.”

Newsom himself has voiced concern about the price tag, given “unprecedented” budget shortfalls. “There is a big cost associated with testing,” he said in late June.

A Newsom administration official confirmed the state wants to see counties fill at least 80% of testing slots at each location. And if testing drops below 50% for a few days or longer, counties are warned the sites could be transferred elsewhere.

Counties argue there’s a public health benefit to keeping underperforming locations open — simply to ensure that testing is available to rural and disenfranchised communities. Across the state, they are fighting to save state-funded sites even as they are being overwhelmed by rising coronavirus cases linked largely to social gatherings.

“It’s how we are able to quickly identify where the virus is and if there are hot spots,” said Dr. Olivia Kasirye, health officer for Sacramento County, where holiday celebrations and booze-fueled gatherings among family and friends are sending infection rates soaring.

Contra Costa County saw its testing numbers drop in June and was at risk of losing a state-funded site until it proved it could keep appointments near 80% of capacity, said its health officer, Dr. Chris Farnitano.

Riverside County was warned June 16 that a state-funded site north of Temecula would be “moved to another county” if it didn’t get its testing above 50%, according to an email from the state’s testing taskforce. The state told Mendocino County it could lose its state-funded site, the only free testing available within a two-hour drive for some rural residents if it didn’t push numbers up.

Alameda County grew so frustrated with state requirements that it undertook a testing expansion of its own.

“We realized we couldn’t depend on the state, especially to reach our vulnerable communities,” said Dr. Jocelyn Freeman Garrick, an emergency room doctor at Highland Hospital in Oakland, who is leading the county’s testing task force.

El Dorado County, which lost its site, so far has maintained a relatively low count of COVID-19 cases. It can’t afford to replace the site but will “make do,” said county spokesperson Carla Hass.

Ghaly said the state is working with counties in danger of losing sites to give them a chance to fill testing slots. State officials declined to say how many counties have lost sites, but as new infections have soared, testing numbers are starting to pick back up. The list of counties at risk of losing a site has dwindled from around a dozen in early June to a few last weeks.

Public health experts say focusing so intently on testing numbers, and not on adequately testing in Black and Latino neighborhoods, risks abandoning communities that already face immense barriers to health care like racism and poverty.

“If you ignore these communities, then we’ll keep seeing the kinds of surges that we’re seeing now,” said Dr. Tony Iton, formerly the top health official for Alameda County and now a senior vice president of the California Endowment, which is working with counties to expand testing in underserved neighborhoods.

Entrenched socioeconomic barriers also make it difficult to get, and keep, testing numbers up. For instance, people who want to be tested at state sites often need Internet access and an email address. Most are drive-thru, requiring access to a vehicle.

Many low-income people can’t meet those requirements, and undocumented immigrants fear that providing personal information to obtain a test could expose them to immigration officials, said Dr. Marty Fenstersheib, a former health officer of Santa Clara County who is leading its testing program.

“We can have all the tests we want, but if people are afraid to come and get tested, it’s not going to be of any benefit,” he said.

State contracts funding the testing sites were extended this month but are set to expire Aug. 31, and administration officials have not told counties whether the state will continue funding them after that, said Mimi Hall, president of the County Health Executives Association of California and director of public health for Santa Cruz County.

Counties can’t afford to keep the sites running, said Hall, who is on the state’s testing task force.

“It’s hard to plan when we don’t know how long we’ll be able to keep them,” Hall said.

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