Forcing companies to gear up production won't provide much-needed doses anytime soon. Expanding production lines takes time. Establishing lines in repurposed facilities can take months.
This article was published on Tuesday, January 26, 2021 in Kaiser Health News.
Americans are dying of covid-19 by the thousands, but efforts to ramp up production of potentially lifesaving vaccines are hitting a brick wall.
Vaccine makers Moderna and Pfizer-BioNTech are running their factories full tilt and are under enormous pressure to expand production or collaborate with other drug companies to set up additional assembly lines. That pressure is only growing as new viral variants of the virus threaten to launch the country into a deadlier phase of the pandemic.
President Joe Biden has said he plans to invoke the Cold War-era authority of the Defense Production Act to provide more vaccines to millions of Americans. Consumer advocates — who had called for Donald Trump to use the Defense Production Act more aggressively as president — are now asking Biden to do the same.
But even forcing companies to gear up production won't provide much-needed doses anytime soon. Expanding production lines takes time. Establishing lines in repurposed facilities can take months.
"The big problem is that even if you can get the raw material and get the infrastructure set up, how do you get a company that is already producing at maximum capacity to go beyond that maximum capacity?" said Lawrence Gostin, a professor of global health law at Georgetown University.
Ordering the companies to work 24/7 "would be a naïve solution," said Dr. Nicole Lurie, a senior adviser to the CEO of the Coalition for Epidemic Preparedness Innovations, an international group that finances vaccines for emerging diseases. "They're probably already doing that to the extent they have the raw materials."
Lurie added, "If you completely wear people out, mistakes happen. You have to balance speed with quality and safety."
The technological challenges involved are daunting, and the companies haven't been forthcoming about what's needed to overcome any supply shortfalls.
"We don't know what the holdup is. Is it capacity? Raw materials? People? Glass vials? We just don't know what the bottleneck is," said Erin Fox, senior director of drug information and support services at the University of Utah Health Hospitals.
Forcing other companies to start making the vaccines might not work either, Gostin said.
"I'm not sure if Biden could require a private company to transfer its technology to another company," Gostin said. "That is highly questionable legally. … President Biden's room for maneuvering isn't as great as people think."
Drug companies define "trade secrets" broadly, Fox said. "In general, drug companies don't have to tell me who is making their product, where it's made, the location of the factory. … That's considered proprietary."
Part of the challenge relates to how these vaccines are made. The first two authorized products use lipid nanoparticles to deliver a snippet of the coronavirus's genetic material — called messenger RNA, or mRNA — into cells. The viral genes teach our cells how to make proteins that stimulate an immune response to the novel coronavirus.
Messenger RNA is fragile and breaks down easily, so it needs to be handled with care, with specific temperatures and humidity levels.
The vaccines "are not widgets," said Lurie, who served as assistant secretary for preparedness and response at the Department of Health and Human Services during the Obama administration.
Every step, experts say, to get vaccines to market has its complexities: obtaining raw materials; building facilities to precise specifications; buying single-use products, such as tubing and plastic bags to line stainless steel bioreactors; and hiring employees with the requisite training and expertise. Companies also must pass safety and quality inspections and arrange for transportation.
The Defense Production Act, for instance, would allow the government to commandeer a plant that already has a fermenter — there are plenty in the biotech industry — to expand production. But that's just the first stage in making an mRNA vaccine and, even then, it would take about a year to get going, said Dr. George Siber, a vaccine expert who is on the advisory board of CureVac, a German mRNA vaccine company.
Companies would first have to do a breathtakingly thorough cleaning to prevent cross-contamination, Siber said. Next, they would need to set up, calibrate and test equipment, and train scientists and engineers to run it. Finally, Siber said, unlike a drug, whose components can be tested for purity, there's no way to be sure a vaccine produced in a new facility is what it claims to be without testing it on animals and people.
"Making vaccines is not like making cars, and quality control is paramount," said Dr. Stanley Plotkin, a vaccine industry consultant credited with inventing the rubella vaccine. "We are expecting other vaccines in a matter of weeks, so it might be faster to bring them into use."
However, even that will require patience. Johnson & Johnson, expected to announce clinical trial results this month, has said that it won't be able to deliver as many shots as planned because of manufacturing delays. The company did not confirm a manufacturing delay and declined to respond to questions.
AstraZeneca's vaccine, also funded in part by U.S. taxpayers, is in use already in the United Kingdom and India, but the Food and Drug Administration has raised questions about its late-stage trial, so it may not be available here until the spring.
Novavax, another U.S.-funded vaccine maker, has been plagued by delays and only recently began recruiting volunteers for its big trial. Merck, the most recent company to get federal support for covid vaccines, announced Monday it was scrapping its two candidates after they failed to produce adequate immune response in early tests.
"None of the vaccine makers are manufacturing at the volume they ultimately want to be at," Lurie said. "They all have manufacturing delays."
Pfizer, which has committed 200 million doses to the U.S. government by the end of July, said last week it expected "no interruptions" in shipments from its primary U.S. covid manufacturing plant in Kalamazoo, Michigan. Pfizer spokesperson Sharon Castillo said the company has expanded manufacturing facilities and added more suppliers and contract manufacturers. Those efforts, and the company's announcement that its five-dose vials actually contain an extra dose, mean "we can potentially deliver approximately 2 billion doses worldwide by the end of 2021."
The U.S. government also has an option to acquire another 400 million doses of the Pfizer-BioNTech vaccine, though the company declined to provide details on that option when asked.
But countries around the world are competing for the same supplies and raw materials, Gostin said.
Biden could use the Defense Production Act "to force Pfizer to prioritize U.S. contracts, but that would be politically risky," given that other countries could retaliate by hoarding supplies. Although Pfizer is an American company, it has partnered with BioNTech, of Germany, to make its covid vaccine. "That would lead to a global mess."
Trying to corner the world market on vaccine ingredients or supplies would look bad, experts say, given that the United States just this week joined Covax, an international venture to source and distribute vaccines, in an effort to ensure poor countries aren't left behind.
Paradoxically, the rush to get vaccines to market may have resulted in a less efficient manufacturing process.
Vaccine companies typically spend months making their factories run as efficiently as possible, as well as finding an ideal dose and the most effective interval between doses, Lurie said. Given the urgency of the pandemic, however, they delayed parts of this process and launched straight into mass production.
Pfizer angered European countries last week when it paused vaccine production at a Belgian plant to upgrade its capacity. Pfizer said the weeklong closure would decrease vaccine deliveries to Europe for three to four weeks before boosting supplies in February. The move doesn't affect U.S. vaccine supplies.
"The U.S can't necessarily readily access stuff that's being held for vaccines in other countries," Lurie said.
And forcing other companies to make covid vaccines could jeopardize production of other important shots, such as measles, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Routine childhood immunization rates have fallen during the pandemic, raising the risk of epidemics.
Using the act to prioritize covid vaccine manufacturing has already disrupted supplies of at least one drug, Fox noted. In December, Horizon Therapeutics warned doctors and patients to expect a shortage of a drug called Tepezza, used to treat thyroid-related eye disease, because its manufacturer was ordered to prioritize covid shots.
Moderna officials have said the intrinsic differences in the two companies' mRNA material make that technology hard to share. Besides, they say, Pfizer has declined to share data with Moderna. Pfizer has declined to comment on the issue.
Since Moderna's effort is federally funded, the government presumably has march-in rights and could take over production, said Mike Watson, former president of Moderna subsidiary Valera, in an email. "The reality is that however far you push production capacity, you sooner or later reach a bottleneck."
Experts say it's not as simple as demanding that glassmaker Corning step up and make glass vials, for example. Of course, the vials will need to meet rigorous requirements. But there's also this: The U.S. is facing a shortage of mined sand, the main component needed to make glass vials.
Diminished testing capacity could lead to longer waits for appointments, which means infected people could potentially expose others for a longer time before learning they have the virus.
This article was published on Monday, January 25, 2021 in Kaiser Health News.
California Gov. Gavin Newsom, under growing pressure to jump-start a faltering covid-19 vaccine rollout, jetted to Los Angeles on Jan. 15 to unveil a massive new vaccination site at Dodger Stadium that is expected eventually to inoculate 12,000 people a day.
The city-run venue had been the biggest covid testing site in the U.S., administering over 1 million tests in its nearly eight months of operation — and over 10,000 a day during the recent surge. Its redeployment to the cause of vaccination, Newsom declared, provides "an extraordinary world-class site for a world-class logistics operation."
That effort came with a trade-off: When the city of Los Angeles ended covid tests at Dodger Stadium and closed another testing site to help staff the new vaccination center, it removed, at least temporarily, about one-third of all government-run testing in Los Angeles County — the nation's largest county, with a population of 10 million, and one of the biggest covid hot spots.
Sites operated by the city, county or state account for just over one-third of all covid tests in L.A. County, said Dr. Clemens Hong, who heads the county's testing operations.
Diminished testing capacity could lead to longer waits for appointments, which means infected people could potentially expose others for a longer time before learning they have the virus.
But L.A. Mayor Eric Garcetti said that has not happened so far. In what he called an instance of "perfect timing," infection rates in L.A. County have declined since Dodger Stadium switched to vaccinations, and demand for tests has dropped by half to two-thirds, the mayor said Thursday. "We are meeting the need — actually exceeding the need."
Still, he acknowledged that converting the stadium had been a risk – one the city took because "the vaccines will prevent and heal and finally resolve this."
Many health experts agree that prioritizing vaccination over testing is the right move.
"The best way out of our current crisis is masks, few contacts per day and vaccines, so it makes sense to create lots more access points for vaccinations even if it means a bit less testing," said Dr. Bob Kocher, a senior fellow at the University of Southern California's Schaeffer Center for Health Policy & Economics and a former member of the state's COVID-19 Testing Task Force.
But with covid caseloads still high despite their recent decline from peak levels, and mutant strains of the virus threatening to fuel new outbreaks, some senior public health officials say testing remains an equally vital part of the effort to contain — and ultimately suppress — the pandemic.
And it could become even more important in the coming months, as the inoculation campaign gains steam, since the tests could prove a valuable tool for assessing how well the vaccines are working.
"It's hard to say right now, given how many people are sick with covid, that vaccine is more important," said Hong. "It's hard to balance those two against each other, because we really just need a lot of both."
Balancing vaccinations with testing and other covid-related tasks is a significant challenge for public health officials across California and the nation, because those functions draw on many of the same resources — especially the staff needed for administration and record-keeping.
At vaccination sites, keeping good records is essential for planning from day to day how many doses to pull out of the freezer. "It's got to be done right, or else you screw up when the second dose is," said Dr. George Rutherford, an epidemiologist at the University of California-San Francisco.
Sara Bosse, public health director of Madera County, noted that counties across the state have asked Newsom for $400 million in the current budget year to help defray the costs of setting up vaccination sites, including facility costs, security, data entry staffers and clinicians to give the shots and watch for adverse side effects. They are also seeking $280 million for covid testing and $440 million for contact tracing and non-group housing to protect covid-vulnerable residents.
"I think that many counties are prioritizing vaccination, and based on the resources they have, they may pull from various parts of the covid response such as contact tracing or testing," Bosse said. The funding, she said, would help county health officials avoid "those difficult decisions where we have to pull from one part of the covid response to prop up the next."
In Madera County, a poor rural area of 160,000 people that stretches from the Central Valley into the Sierra Nevada, the state has largely taken over covid testing, allowing the county to focus its resources on vaccinations, Bosse said.
The big challenge on that front, she said, is having enough trained health personnel to run the vaccination sites. The county recently heard from 85 trained clinicians willing to volunteer for the vaccine effort, "which is going to be a game changer for us," Bosse said.
In Los Angeles, the city has the means to add testing capacity elsewhere and beef up mobile testing, Garcetti said. It had been considering a testing site at Pierce College in the San Fernando Valley, "which it looks like we won't need to open," the mayor said.
The city, county and state are also discussing the possibility of a partnership to expand testing at Exposition Park in South L.A.
In San Diego County, health officials expect to face a challenge due to the competition for staffing between vaccination and testing, and they are hiring to meet the need, said Sarah Sweeney, a spokesperson for the county's Health and Human Services Agency. The county hasn't yet converted testing venues to vaccination sites but expects to do so after vaccine supplies increase, she said.
San Bernardino County health officials are committed to maintaining testing at current volumes even as they ramp up vaccinations, said Corwin Porter, the director of public health. But he conceded that doing both at the same time "is a struggle" because "we don't have enough vaccine and we don't have enough staff."
The county is holding hiring events every week and working with multiple partners to find additional resources, "because we are trying not to pull anything out of testing or contact tracing," Porter said.
Beyond the resource question, another big challenge confronts health officials: "There is an issue of divided attention," said L.A. County's Hong. "Now we have two big things to deal with — three if you include contact tracing. I think we will have to be thoughtful about our strategy."
Once a broad swath of the population has been vaccinated, which could take many months, testing volume will likely drop off sharply, said UCSF's Rutherford.
"I don't see hundreds of thousands of tests a day anymore once we get well up on vaccinations," he said. "You'll be testing thousands of people to find tens of cases."
In the meantime, L.A. County will likely add questions to its testing appointment website asking people about their vaccination status, Hong said. "That way we can track what's happening in people who are vaccinated."
Ongoing covid outbreaks may require increased testing, particularly in poorer communities of color, which have been hit hardest by the pandemic — and where hesitancy to be vaccinated is likely to be more widespread, said Hong. "So the bottom line is that testing is not going away."
The pandemic highlights licensing barriers that predate covid, but many believe it can serve as a wake-up call for state legislatures to address the issue for this crisis and beyond.
This article was published on Monday, January 25, 2021 in Kaiser Health News.
As hospitals nationwide struggle with the latest covid-19 surge, it's not so much beds or ventilators in short supply. It's the people to care for the sick.
Yet a large, highly skilled workforce of foreign-educated doctors, nurses and other health practitioners is going largely untapped due to licensing and credentialing barriers. According to the Migration Policy Institute think tank in Washington, D.C., some 165,000 foreign-trained immigrants in the U.S. hold degrees in health-related fields but are unemployed or underemployed in the midst of the health crisis.
Many of these workers have invaluable experience dealing with infectious disease epidemics such as SARS, Ebola or HIV in other countries yet must sit out the covid pandemic.
The pandemic highlights licensing barriers that predate covid, but many believe it can serve as a wake-up call for state legislatures to address the issue for this crisis and beyond. Already, five states — Colorado, Massachusetts, Nevada, New Jersey and New York — have adapted their licensing guidelines to allow foreign-trained health care workers to lend their lifesaving skills amid pandemic-induced staff shortages.
"These really are the cabdrivers, the clerks, the people who walk your dog," said Jina Krause-Vilmar, CEO of Upwardly Global, a nonprofit that helps immigrant professionals enter the U.S. workforce. "They also happen to be doctors and nurses in their home countries, and they're just not able to plug and play into the system as it's set up."
That's left doctors such as Sussy Obando, a 29-year-old from Colombia, jumping through hoops to become physicians in the U.S. In 2013, she graduated after six years of medical school in Colombia, then spent a year treating patients in underserved communities. But when Obando arrived in the U.S., her credentials and experience weren't enough.
While licensure guidelines vary by state, foreign-trained doctors typically must pass a medical licensing exam costing more than $3,500, and then complete at least a year of on-the-job training, known as a residency, in the U.S. For many, including Obando, that means brushing up on their English and learning the relevant medical terminology. She also needed U.S. clinical experience to qualify for a residency, something U.S.-trained doctors achieve through rotations during medical school.
"If you don't know anyone in this field, you have to go door to door to find somebody to give you the opportunity to rotate," Obando said.
She tried emailing Hispanic doctors she found online to ask if she could complete a rotation with one of them. She ended up paying $750 to enter a psychiatry rotation at the University of Texas McGovern Medical School in Houston.
"I tried to go into internal medicine," Obando said. "But because psychiatry was less expensive, I have to go for that."
She also worked for almost a year as a volunteer at Houston's MD Anderson Cancer Center, and is now assisting with clinical trials for covid vaccines at the Texas Center for Drug Development. She's applied for a residency through a national program that matches medical school graduates with residency slots. But it's difficult for foreign-trained physicians to secure a spot, because many are earmarked for U.S. med school graduates. And many residency programs are open only to recent graduates, not those who finished medical school years ago.
"It's competitive for people who trained in the United States to get into a residency program. If you're trained outside the United States, it's even harder," said Jacki Esposito, director of U.S. policy and advocacy for World Education Services, a nonprofit that helps immigrants find jobs in the U.S. and Canada.
That's why states such as Colorado have eased the requirement for a residency during the pandemic. Early on, Colorado officials realized they couldn't license doctors and other health workers because covid lockdowns had canceled required licensing exams. Under an executive order from Democratic Gov. Jared Polis in April, state officials created a temporary licensing program allowing medical school graduates to begin practicing under supervision for six months, and then extended it through June 2021.
Officials created a similar pathway to temporary licensure for foreign medical school graduates who lacked the minimum year of residency.
Colorado also created temporary licenses for foreign-trained nurses, certified nurse's aides, physician assistants and many other health professionals. All of those licenses require supervision from a licensed professional and are valid only as long as the governor's public health emergency declaration remains in effect.
The state relaxed the scope-of-practice rules for those health workers, too, allowing them to perform any task their supervisors assign to them.
"So if you're an occupational therapist, you can give vaccinations as long as they are delegating to you and they're confident you have the skill and knowledge," said Karen McGovern, deputy director of legal affairs for the professions and occupations division at the Colorado Department of Regulatory Agencies. "You can exceed your statutory skill and practice to what needs to be done during the pandemic."
Through mid-December, the state had received 36 applications from foreign-trained doctors seeking temporary licenses, although only one applicant met all the criteria. New Jersey, on the other hand, received more than 1,100 applications for temporary medical licenses last year. (Michigan also issued an executive order allowing temporary licenses, but it was later rescinded.)
Many of the medical professionals stuck on the sidelines have unique skills and experience that would be invaluable during the pandemic. Victor Ladele, 44, finished medical school in Nigeria and treated patients during a drought in Niger in 2005, in the midst of the Darfur genocide in Sudan in 2007 and after a civil war in Liberia in 2010. His family moved to the U.S. a few years later, but Ladele was recruited to help with the Ebola outbreak in West Africa in 2014. What he thought would be a three-month stay turned into a two-year mission.
Now back in Edmond, Oklahoma, working with a U.N. program that helps new business ventures get off the ground, Ladele has found that the challenges of the covid pandemic parallel many of his past experiences. He saw how a program for Ebola contact tracing told people with a cough or fever to call a hotline, which would direct them to a care center. But as soon as the initiative went live, rumors began to spread on social media that European doctors at the care centers were harvesting organs. It took months of outreach to tribal and religious leaders to instill confidence in the system.
He's seen similar misinformation spread about covid and masks.
"If, in Oklahoma, the public health officials had done outreach to all the pastors in the churches and gained their support for masking, would there be more people using masks?" Ladele said.
Ideally, he said, he would like to spend about half his time seeing patients, but the licensing process remains a challenge.
"It's not unsurmountable," he said. But "when I think of all the hurdles to credentialing here, I'm not really sure it's worth the effort."
Upwardly Global helps health professionals navigate that unfamiliar application and credentialing system. Many foreign-trained health workers have never had to write résumés or interview for jobs.
While the pandemic has temporarily eased entry in five states, Krause-Vilmar and others believe it could be a model to address workforce shortages in underserved areas across the country. As of September, the federal Health Resources and Services Administration had designated more than 7,300 health care shortage areas, requiring an additional 15,000 health care practitioners.
"We've had a crisis in access to health care, especially in rural areas, in this country for a long time," she said. "How do we start imagining what that would look like in terms of more permanent licenses for these folks who are helping us recover and rebuild?"
Anti-vaxxers are blaming patients' coincidental medical problems on covid shots, even when it's clear that age or underlying health conditions are to blame.
This article was published on Monday, January 25, 2021 in Kaiser Health News.
Anti-vaccine groups are exploiting the suffering and death of people who happen to fall ill after receiving a covid shot, threatening to undermine the largest vaccination campaign in U.S. history.
"This is exactly what anti-vaccine groups do," said Dr. Peter Hotez, an infectious diseases specialist and author of "Preventing the Next Pandemic: Vaccine Diplomacy in a Time of Anti-Science."
Anti-vaccine groups have falsely claimed for decades that childhood vaccines cause autism, weaving fantastic conspiracy theories involving government, Big Business and the media.
Now, the same groups are blaming patients' coincidental medical problems on covid shots, even when it's clear that age or underlying health conditions are to blame, Hotez said. "They will sensationalize anything that happens after someone gets a vaccine and attribute it to the vaccine," Hotez said.
As more seniors receive their first covid shots, many will inevitably suffer from unrelated heart attacks, strokes and other serious medical problems — not because of the vaccine but, rather, their age and declining health, said epidemiologist Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy.
For example, in a group of 10 million people — about the number of Americans who have been vaccinated so far — nearly 800 people ages 55 to 64 typically die of heart attacks or coronary disease in one week, Osterholm said. Public health officials "are not ready" for the onslaught of news and social media stories to come, he cautioned.
"The media will write a story that John Doe got his vaccine at 8 a.m. and at 4 p.m. he had a heart attack," Osterholm said on his weekly podcast. "They will make assumptions that it's cause and effect."
Public health officials need to do a better job communicating the risks — real and imagined — from vaccines, said Osterholm, who has been advising President Joe Biden on the pandemic since his election.
"You get one chance to make a first impression," Osterholm said. "Even if we come back later and say, "No, [the deaths] had nothing to do with vaccination, it was coronary artery disease,' the damage has already been done."
In a blog post, Kennedy scoffed at autopsy results that concluded a Portuguese woman's death was unrelated to a vaccine. He cast doubt on statements by medical authorities in Denmark who said the deaths of two people there after vaccination were due to old age and chronic lung disease. In an interview, Kennedy said the post-vaccination deaths of some very frail and terminally ill nursing home patients in Norway are a danger sign. Norwegian officials have said the elderly patients died of their underlying illnesses, not from the vaccine.
"Coincidence is turning out to be quite lethal to COVID vaccine recipients," Kennedy wrote. Kennedy described the deaths as suspicious, accusing medical officials of following an "all-too-familiar vaccine propaganda playbook" and "strategic chicanery."
Here in the U.S., vaccine opponents have pounced on the tragedy of Dr. Gregory Michael, a 56-year-old Florida obstetrician-gynecologist, to sow doubts about vaccine safety and government oversight. Michael died Jan. 5 after suffering a catastrophic drop in platelets — elements in the blood that control bleeding — suggesting he may have developed immune thrombocytopenia.
According to a Facebook post by his wife, Heidi Neckelmann, doctors tried a variety of treatments to save her husband, but none worked.
A spokesperson for the Centers for Disease Control and Prevention said the agency is investigating Michael's death, as it does for all suspected vaccine-related health problems. California authorities have recommended pausing vaccinations with a particular batch of covid vaccines made by Moderna because of a high rate of allergic reactions.
"We're going to see these events happen, and we have to follow up on every one of these cases," Osterholm said. "I don't want people to think that we're sweeping them under the rug."
Many Americans were already nervous about covid vaccines, with 27% saying they "probably or definitely" would not get a shot, even if the shots were free and deemed safe by scientists, according to a December survey by KFF. (KHN is an editorially independent program of KFF.)
These people may be particularly susceptible to vaccine misinformation, said Rory Smith, an investigator at First Draft News, a nonprofit that reports on misinformation online.
A Rare Condition
Seven experts in blood disorders interviewed by KHN said there's not enough information available to blame Michael's decline on a vaccine and that the demonstrated benefits of covid vaccinations vastly outweigh any potential risk of bleeding. Even if investigators conclude that Michael's vaccine caused his death, it would still be an incredibly rare event, given that more than 12 million doses have been administered.
"It shouldn't give anyone pause about whether the vaccine is safe or not," said Dr. James Zehnder, a hematologist and director of clinical pathology at Stanford Medicine.
Michael's bleeding disorder could have been developing silently for some time, said Dr. Adam Cuker, director of the Penn Blood Disorders Center at the Hospital of the University of Pennsylvania. It could be a coincidence that Michael started showing symptoms shortly after vaccination, he said. About 30 Americans are diagnosed with immune thrombocytopenia every day.
The timing of Michael's illness suggests it had another cause, doctors said. According to his wife's Facebook post, his bleeding problems began three days after his first covid shot. It takes the body 10 to 14 days after vaccination to generate antibodies, which would be needed to cause immune thrombocytopenia, said Dr. Cindy Neunert, a pediatric hematologist at the Columbia University Irving Medical Center in New York City.
In most cases, the cause of thrombocytopenia is never known, said Dr. Deepak Bhatt, executive director of interventional cardiovascular programs at Brigham and Women's Hospital in Boston.
But it can also be caused by viruses themselves, including measles and the novel coronavirus, said Dr. Sven Olson, an assistant professor of hematology-medical oncology at Oregon Health & Science University's school of medicine.
Many patients with immune thrombocytopenia are now wondering if they should be vaccinated against covid, Cuker said. Cuker said he urges nervous patients to be vaccinated, noting that any problems could be managed by closely monitoring their platelet levels and adjusting medication if needed.
Even in patients with underlying bleeding conditions, "it's still safer to get vaccinated than to get covid," Zehnder said.
"If you give a vaccine to a large enough number of people, there are going to be rare adverse events but there are also going to be coincidental events unrelated to the vaccine," Cuker said. "If an anti-vaccine group uses a single case, where no link has been proven, to discourage people from vaccination, that's terrible."
Barbara Loe Fisher, president of the National Vaccine Information Center, said her site provides balanced information from reputable news sources, including CNN, CBS and the Miami Herald, as well as Pfizer and the CDC.
In an interview with KHN, Kennedy said he questions why government officials have been so quick to dismiss connections between vaccinations and deaths. "How in the world do they know if it's a vaccine injury or not?" he asked.
"We don't discourage anybody from getting vaccinated," Kennedy said. "All we're doing is conveying the data, which is what the government should be doing. … We print the truth, which is what the medical agencies ought to do."
"They have come out against every public health measure to control the pandemic," Carpiano said. "They have said public health is public enemy No. 1."
Recently, anti-vaccine activists have been so eager to discredit immunizations that they have blamed covid for the deaths of people who are very much alive.
Social media users selectively edited a video of a Tennessee nurse, Tiffany Dover to make it appear as if she dropped dead after being vaccinated, when in fact she simply fainted, said Dorit Reiss, a professor at the UC Hastings College of Law in San Francisco. Although Dover quickly recovered, social media users posted a fake death certificate and obituary. Anti-vaccine activists also harassed Dover and her family online, said Reiss, who chronicled Dover's ordeal in a blog post.
Anti-vaccine activists are adept at manipulating video, Smith said.
"They are notorious for using videos and images purportedly showing the adverse effects of vaccines, such as autism in children and seizures in other vaccine recipients," Smith said. "The more emotive and graphic the videos and images — irrespective of whether it's actually linked at all to vaccines or not — the better."
In December, multipleFacebookpostsfalsely claimed that an Alabama nurse died after receiving one of the state's first covid vaccines. One Twitter user went so far as to identify the nurse as Jennifer McClung, who worked at Helen Keller Hospital in Sheffield, Alabama. In fact, McClung died of covid. Social media posts spread so widely that Alabama health department officials contacted every hospital in the state to confirm that no vaccinated staff member had died.
Anti-vaccine groups often build fables around "a tiny, tiny grain of truth," Smith said. "This is why misinformation, specifically vaccine misinformation, can be so convincing. … But this information is almost always taken completely out of context, creating claims that are either misleading or outright false."
The Ron Paul Institute for Peace and Prosperity twisted a news story about the deaths of 24 people at an upstate New York nursing home, incorrectly blaming their deaths on covid vaccinations. The original article noted, however, that a covid outbreak at the nursing home began in late December, before residents received any vaccines. Covid vaccines, which require two doses for full protection, did not arrive in time to save the residents' lives.
Kennedy repeated the misinformation — again incorrectly blaming the residents' deaths on vaccines — in his blog, although he linked to a local news station that reported the information correctly.
Distorting facts to discourage vaccination, Cuker said, is "very irresponsible and damaging to public health."
The list of some 200 Trump pardons or commutations, most issued as he vacated the White House this week, included at least seven doctors or health care entrepreneurs who ran discredited health care enterprises, from nursing homes to pain clinics.
This article was published on Friday, January 22, 2021 in Kaiser Health News.
At the last minute, President Donald Trump granted pardons to several individuals convicted in huge Medicare swindles that prosecutors alleged often harmed or endangered elderly and infirm patients while fleecing taxpayers.
“These aren’t just technical financial crimes. These were major, major crimes,” said Louis Saccoccio, chief executive officer of the National Health Care Anti-Fraud Association, an advocacy group.
The list of some 200 Trump pardons or commutations, most issued as he vacated the White House this week, included at least seven doctors or health care entrepreneurs who ran discredited health care enterprises, from nursing homes to pain clinics. One is a former doctor and California hospital owner embroiled in a massive workers’ compensation kickback scheme that prosecutors alleged prompted more than 14,000 dubious spinal surgeries. Another was in prison after prosecutors accused him of ripping off more than $1 billion from Medicare and Medicaid through nursing homes and other senior care facilities, among the largest frauds in U.S. history.
“All of us are shaking our heads with these insurance fraud criminals just walking free,” said Matthew Smith, executive director of the Coalition Against Insurance Fraud. The White House argued all deserved a second chance. One man was said to have devoted himself to prayer, while another planned to resume charity work or other community service. Others won clemency at the request of prominent Republican ex-attorneys general or others who argued their crimes were victimless or said critical errors by prosecutors had led to improper convictions.
Trump commuted the sentence of former nursing home magnate Philip Esformes in late December. He was serving a 20-year sentence for bilking $1 billion from Medicare and Medicaid. An FBI agent called him “a man driven by almost unbounded greed.” Prosecutors said that Esformes used proceeds from his crimes to make a series of “extravagant purchases, including luxury automobiles and a $360,000 watch.”
Esformes also bribed the basketball coach at the University of Pennsylvania “in exchange for his assistance in gaining admission for his son into the university,” according to prosecutors.
Fraud investigators had cheered the conviction. In 2019, the National Health Care Anti-Fraud Association gave its annual award to the team responsible for making the case. Saccoccio said that such cases are complex and that investigators sometimes spend years and put their “heart and soul” into them. “They get a conviction and then they see this happen. It has to be somewhat demoralizing.”
Tim McCormack, a Maine lawyer who represented a whistleblower in a 2007 kickback case involving Esformes, said these cases “are not just about stealing money.”
“This is about betraying their duty to their patients. This is about using their vulnerable, sick and trusting patients as an ATM to line their already rich pockets,” he said. He added: “These pardons send the message that if you are rich and connected and powerful enough, then you are above the law.”
The Trump White House saw things much differently.
“While in prison, Mr. Esformes, who is 52, has been devoted to prayer and repentance and is in declining health,” the White House pardon statement said.
The White House said the action was backed by former Attorneys General Edwin Meese and Michael Mukasey, while Ken Starr, one of Trump’s lawyers in his first impeachment trial, filed briefs in support of his appeal claiming prosecutorial misconduct related to violating attorney-client privilege.
Trump also commuted the sentence of Salomon Melgen, a Florida eye doctor who had served four years in federal prison for fraud. That case also ensnared U.S. Sen. Robert Menendez (D-N.J.), who was acquitted in the case and helped seek the action for his friend, according to the White House.
Prosecutors had accused Melgen of endangering patients with needless injections to treat macular degeneration and other unnecessary medical care, describing his actions as “truly horrific” and “barbaric and inhumane,” according to a court filing.
Melgen “not only defrauded the Medicare program of tens of millions of dollars, but he abused his patients — who were elderly, infirm, and often disabled — in the process,” prosecutors wrote.
These treatments “involved sticking needles in their eyes, burning their retinas with a laser, and injecting dyes into their bloodstream.”
Prosecutors said the scheme raked in “a staggering amount of money.” Between 2008 and 2013, Medicare paid the solo practitioner about $100 million. He took in an additional $10 million from Medicaid, the government health care program for low-income people, $62 million from private insurance, and approximately $3 million in patients’ payments, prosecutors said.
In commuting Melgen’s sentence, Trump cited support from Menendez and U.S. Rep. Mario Diaz-Balart (R-Fla.). “Numerous patients and friends testify to his generosity in treating all patients, especially those unable to pay or unable to afford healthcare insurance,” the statement said.
In a statement, Melgen, 66, thanked Trump and said his decision ended “a serious miscarriage of justice.”
“Throughout this ordeal, I have come to realize the very deep flaws in our justice system and how people are at the complete mercy of prosecutors and judges. As of today, I am committed to fighting for unjustly incarcerated people,” Melgen said. He denied harming any patients.
Faustino Bernadett, a former California anesthesiologist and hospital owner, received a full pardon. He had been sentenced to 15 months in prison in connection with a scheme that paid kickbacks to doctors for admitting patients to Pacific Hospital of Long Beach for spinal surgery and other treatments.
“As a physician himself, defendant knew that exchanging thousands of dollars in kickbacks in return for spinal surgery services was illegal and unethical,” prosecutors wrote.
Many of the spinal surgery patients “were injured workers covered by workers’ compensation insurance. Those patient-victims were often blue-collar workers who were especially vulnerable as a result of their injuries,” according to prosecutors.
The White House said the conviction “was the only major blemish” on the doctor’s record. While Bernadett failed to report the kickback scheme, “he was not part of the underlying scheme itself,” according to the White House.
The White House also said Bernadett was involved in numerous charitable activities, including “helping protect his community from COVID-19.” “President Trump determined that it is in the interests of justice and Dr. Bernadett’s community that he may continue his volunteer and charitable work,” the White House statement read.
Others who received pardons or commutations included Sholam Weiss, who was said to have been issued the longest sentence ever for a white collar crime — 835 years. “Mr. Weiss was convicted of racketeering, wire fraud, money laundering, and obstruction of justice, for which he has already served over 18 years and paid substantial restitution. He is 66 years old and suffers from chronic health conditions,” according to the White House.
John Davis, the former CEO of Comprehensive Pain Specialists, the Tennessee-based chain of pain management clinics, had spent four months in prison. Federal prosecutors charged Davis with accepting more than $750,000 in illegal bribes and kickbacks in a scheme that billed Medicare $4.6 million for durable medical equipment.
Trump’s pardon statement cited support from country singer Luke Bryan, said to be a friend of Davis’.
“Notably, no one suffered financially as a result of his crime and he has no other criminal record,” the White House statement reads.
“Prior to his conviction, Mr. Davis was well known in his community as an active supporter of local charities. He is described as hardworking and deeply committed to his family and country. Mr. Davis and his wife have been married for 15 years, and he is the father of three young children.”
CPS was the subject of a November 2017 investigation by KHN that scrutinized its Medicare billings for urine drug testing. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS’ medical professionals stood among the nation’s top such Medicare billers.
Joe Biden ran on an expansive healthcare platform during his 2020 presidential campaign, with a broad array of promises such as adding a government-sponsored health plan to the Affordable Care Act and lowering prescription drug prices. Perhaps most significantly, he pledged to get control of the covid pandemic that claimed more than 400,000 American lives by Inauguration Day.
President Biden now faces major challenges in accomplishing his healthcare agenda; among the biggest will be bridging partisan divides in both Congress and the nation at large.
The Biden Promise Tracker monitors the 100 most important campaign promises of President Joseph R. Biden, elected in November 2020.
Even with the Democrats' newfound majority in the Senate — the result of victories by the Rev. Raphael Warnock and Jon Ossoff in Georgia's runoff elections — differences in health policy between the party's moderate and progressive wings will persist.
"With razor-thin Democratic majorities in both the House and the Senate and many other priorities in addition to healthcare, Biden is unlikely to succeed in accomplishing all of his health agenda," said Larry Levitt, executive vice president for health policy at the KFF. (KHN is an editorially independent program of KFF.)
Still, Democratic control of the Senate will allow Biden to pursue some of his healthcare priorities "using a two-pronged strategy of legislation and executive actions," Levitt said.
PolitiFact and KHN teamed up to analyze Biden's promises during the 2020 presidential campaign and will monitor his policies over the next four years to see which ones materialize. But, for now, as Biden settles into the West Wing, what are his chances of making progress on healthcare?
The Covid Pandemic
In his first 100 days in office, Biden has promised to get 100 million doses of covid vaccine in the arms of Americans and — if Congress provides the funds to do so — get all kids back into schools safely. He asked people to wear face masks in public for those 100 days. He also has repeatedly promised he would get the covid pandemic under control.
Other covid promises include a pledge to double the number of drive-thru testing sites and create a national pandemic testing board. He said he wants to invest $25 billion in covid vaccine distribution and to ensure that every American has access to the vaccine at no cost. He's also promised to use the Defense Production Act to ramp up personal protective equipment supplies and restore national stockpiles.
During his first two days in office, Biden took steps to accomplish these goals, using executive orders to put in place masking mandates regarding federal buildings and interstate travel — for example, in airports and on commercial aircraft, trains, ferries and intercity bus services — and re-engaging the United States with the World Health Organization. He also issued orders to create a covid response coordinator who will lead the federal government's efforts for providing vaccination, testing and supplies, set up a national pandemic testing board, establish international travel protocols, use the Defense Production Act to provide necessary supplies and ensure minority communities are provided resources to combat the disease. The White House released a 200-page plan on Thursday that outlines the Biden administration's strategy to address the covid-19 pandemic.
Some members of his covid leadership team — such as Jeff Zients, tapped to coordinate the White House's covid response, and Dr. Rochelle Walensky, who will lead the Centers for Disease Control and Prevention — don't require Senate confirmation, meaning they can get to work right away. But Biden's pick for Health and Human Services secretary, Xavier Becerra, will need approval by the Senate, a step that will likely be eased because of Democrats' Georgia victories. Still, how his nomination plays out — as well as Biden's other selections for posts that require confirmation — could be an early sign of whether the new administration will face strong partisan resistance.
While the executive orders are strong signals of what Biden hopes to accomplish, he will need Congress to fund his plans to expand testing and vaccine distribution. Biden outlined the week before his inauguration in a $1.9 trillion proposal to address covid and the economy. However, the president could face difficulty in getting bipartisan agreement on this plan, with some Republicans criticizing it as too expensive. It took Congress seven months to pass a second covid relief bill in December.
Other limiting factors include whether the supply of vaccine is adequate to reach 100 million doses and whether organized efforts are put in place to increase testing and ramp up production, said Dr. Georges Benjamin, executive director of the American Public Health Association.
One area in which Biden could face pushback: mask-wearing. Even though he has already issued executive orders regarding mask use in federal buildings, for instance, broader mask mandates fall under individual governors' authority, and some Republican state executives remain resistant.
Even if Biden makes inroads on that front, Americans will have to accept this step as part of their daily lives. A December KFF survey showed that while most Americans, regardless of party, wear a mask whenever they leave their house, there is still a lag among Republicans.
"I think Biden's biggest challenges in fulfilling his covid goals are in bringing a divided country together with the bully pulpit of the presidency," said Levitt. "If testing and the vaccine and mask-wearing are successful in only blue America, then it will be hard to succeed overall."
Health Insurance
As Barack Obama's vice president, Biden was instrumental in the enactment of the Affordable Care Act, which expanded health insurance coverage to millions of people but has drawn fierce Republican opposition.
Biden's health agenda promises to expand the ACA and undo many of the steps taken by President Donald Trump to dismantle it.
"I'll not only restore Obamacare, I'll build on it. You can keep your private insurance. If you like it, you can choose a Medicare-like public option," Biden said during a campaign event in Pittsburgh on Nov. 2.
Adding a government-run public option to other ACA healthcare plans is one of Biden's most ambitious pledges. It's a controversial idea even within the Democratic caucus, where some members want instead to move to a single-payer health plan like "Medicare for All." Remember the debates during the Democratic presidential primary?
Health policy experts we consulted said implementing a public option seems extremely unlikely in the current environment. So does lowering the Medicare eligibility age from 65 to 60, another divisive idea among Democrats. But both moderates and progressives — even lawmakers across the aisle — might be able to come together on initiatives that could shore up the ACA and make coverage more affordable, such as expanding eligibility for premium subsidies.
Biden doesn't need Congress to restore parts of the ACA that were changed via regulations issued by the Trump administration. He can instruct agencies to issue new rules that would reverse such Trump initiatives as allowing states to implement work requirements for some adults who gained Medicaid coverage in the ACA expansion of that program. Still, regulatory changes take time. And, in some cases, altering them can be complicated.
Take, for instance, the Trump administration's rules promoting short-term or association health plans. That metaphorical cat is already out of the bag, said Joseph Antos, a healthcare scholar at the American Enterprise Institute.
"There are a lot of people insured through those plans and so [changing that policy is] a very tricky thing," said Antos. "I don't think it would be wise for him to do anything to reverse that [rule] even though there has been a lot of noise from the left."
In Antos' view, the main advantage in gaining Senate control will be helping speed confirmation for key nominations, "which opens the door to new thinking on regulations."
Drug Prices
On the campaign trail, Biden made clear his intent to bring down prescription drug prices. He promised to lower costs by 60%. Among the related policy ideas he floated: repealing the law that bars Medicare from negotiating lower drug prices and allowing the importation of prescription drugs from other countries.
But details of these proposals aren't yet available, leaving some experts to question their feasibility.
Of course, the pharmaceutical lobby won't be enthusiastic about any drug pricing legislation and would likely mount an aggressive campaign to defeat it. And just as with any other proposal, there will be the hurdle of getting Congress to agree on what to include in a drug pricing bill. Plus, given the rapid development of covid vaccines, Capitol Hill may be more sympathetic to the drug industry.
But Stacie Dusetzina, an associate professor of health policy at Vanderbilt University, said it's possible Biden could succeed in lowering drug prices by limiting drug price increases to the rate of inflation and capping out-of-pocket spending for seniors covered by Medicare.
Both the House and Senate included similar proposals in past drug pricing bills, she said, and "those are both things I think could legitimately move forward, if anything moves forward."
Over a month into a massive vaccination program, most older Americans report they don't know where or when they can get inoculated for covid-19, according to a poll released Friday.
Nearly 6 in 10 people 65 and older who have not yet gotten a shot said they don't have enough information about how to get vaccinated, according to the KFF survey. (KHN is an editorially independent program of KFF.)
Older Americans are not the only ones in the dark about the inoculation process. About 55% of essential workers —designated by public health officials as being near the front of the line for vaccinations — also don't know when they can get the shots, the survey found. Surprisingly, 21% of health workers said they are unsure about when they will get vaccinated.
Black and Hispanic adults, as well as those in low-income households, are among the groups struggling most to find vaccine information. Within each of those groups, at least two-thirds said they do not have enough information about when they can get vaccinated, the survey found.
The covid vaccines, which were first distributed in mid-December to health care workers and people living in nursing homes or assisted living centers, are now available for other older adults in most states, though age restrictions vary. Ohio, for example, opened up vaccinations to all residents 80 and older. In Virginia, the minimum age for the second wave of shots is 65. In Indiana, it's 70; Maryland, 75. Some states, such as Florida and Texas, started vaccinating anyone 65 and up in December, though many states did not begin vaccinating all seniors until January.
Limited doses have left many seniors scrambling to get an inoculation appointment.
For example, at 9 a.m. Thursday, Washington, D.C., opened 2,200 covid vaccine appointment slots for people 65 and older in several hard-hit neighborhoods. Within 20 minutes, they were all filled.
To date, more than 15 million Americans have been vaccinated for covid, which has infected 24 million and killed more than 400,000. The two covid vaccines authorized for emergency use by the Food and Drug Administration require two doses either three or four weeks apart.
Despite the rocky rollout of vaccines, two-thirds of respondents were "optimistic" that things will get better.
Sixty-five percent of adults said they believe the distribution of the vaccines is being done fairly, but half of Black adults said they were concerned that the efforts are not adequately considering the needs of the Black community.
The KFF survey of 1,563 adults was conducted Jan. 11-18. The margin of sampling error is plus or minus 3 percentage points.
In recent months, many cities and states have imposed a raft of restrictions on indoor dining, given the high risk of spreading the virus in these crowded settings.
This article was published on Thursday, January 21, 2021 in Kaiser Health News.
With the arrival of winter and the U.S. coronavirus outbreak in full swing, the restaurant industry — looking at losses of $235 billion in 2020 — is clinging to techniques for sustaining outdoor dining even through the cold and vagaries of a U.S. winter.
Yurts, greenhouses, igloos, tents and all kinds of partly open outdoor structures have popped up at restaurants around the country. Owners have turned to these as a lifeline to help fill some tables by offering the possibility at least of a safer dining experience.
“We’re trying to do everything we can to expand the outdoor dining season for as long as possible,” said Mike Whatley with the National Restaurant Association.
Dire times have forced the industry to find ways to survive. Whatley said more than 100,000 restaurants are either “completely closed or not open for business in any capacity.”
“It’s going to be a hard and tough winter,” Whatley said. “As you see outdoor dining not being feasible from a cold-weather perspective or, unfortunately, from a government regulations perspective, you are going to see more operators going out of business.”
In recent months, many cities and states have imposed a raft of restrictions on indoor dining, given the high risk of spreading the virus in these crowded settings.
Many have capped occupancy for dine-in restaurants. Some halted indoor dining altogether, including Michigan and Illinois. Others have gone even further. Los Angeles and Baltimore have halted indoor and outdoor dining. Only carryout is allowed.
Those who can serve customers outdoors, on patios or sidewalks, are coming up with creative adaptations that can make dining possible in the frigid depths of winter.
Embrace the ‘Yurtiness’
Washington state shut down indoor dining in mid-November and has kept that ban in place as coronavirus cases continue to surge.
On a blustery December evening, servers at the high-end Seattle restaurant Canlis huddled together in the parking lot, clad in flannel and puffy vests, while their boss Mark Canlis gave a pep talk ahead of a busy night.
“The hospitality out here is exactly the same as it is in there,” Canlis said, gesturing to his restaurant, which overlooks Lake Union. “But that looks really different, so try to invite them into the ‘yurtiness’ of what we are doing.”
Canlis has erected an elaborate yurt village in the parking lot next to his family’s storied restaurant.
It includes an outdoor fireplace and wood-paneled walkways winding between small pine trees and the circular tents. The assemblage of yurts, with their open window flaps, is the Canlis family’s best effort to keep fine dining alive during the pandemic and a typically long and wet Seattle winter (referred to locally as the “Big Dark”).
Arriving guests are greeted with a forehead thermometer to take their temperature and a cup of hot cider.
“It gives us an excuse to think differently,” Canlis said of the outdoor dining restrictions.
The yurts are meant to shield diners from the elements and from infectious airborne particles that might otherwise spread from table to table.
Dining inside such structures is not risk free: Guests could still catch the virus from a dining companion as they sit near each other, without masks, for a prolonged period. But Canlis said there is no easy way to determine whether every member of a dining group is from the same household.
“I’m not the governor or the CDC,” he said. “I’m assuming if you are there at the table, you’re taking your health into your own hands.”
New rules for outdoor dining structures in Washington require Canlis to consider issues such as how to ventilate the yurts properly and sanitize the expensive furniture.
“What is the square inch of yurt volume space? What is the size of the door and the windows? How many minutes will we allow the yurt to ‘breathe?'” Canlis said.
The structures get cleaned after each dining party finishes a meal and leaves; during the meal service the waiters enter and leave quickly, wearing N95 masks.
Igloos, Domes, Tents: Just How Safe Are They?
Another, more modern-looking take on outdoor dining involves transparent igloos and other domelike structures that have become popular with restaurant owners all over the country.
Tim Baker, who owns the Italian restaurant San Fermo in Seattle, had to order his igloos from Lithuania and assemble them with the help of his son.
His restaurant’s policy is that only two people are allowed in an igloo at a time, to cut down on the risk of those from different households gathering together.
“You’re completely enclosed in your own space with somebody in your own household. These domes protect you from all the people walking by on the sidewalk, and the server doesn’t go in with you,” he said.
Baker said he consulted with experts in airflow and decided to use an industrial hot air cannon after each party of diners leaves the igloo and before the next set enters — aiming to clear the air inside the structure of any lingering infectious particles.
“You fire this cannon up, and it just pushes the air through really aggressively,” quickly dispersing the particles, Baker said.
His restaurant’s igloos have become a big attraction.
“I’m particularly proud of anything that we can do to get people excited right now, because we need it,” he said. “We’re all getting crushed by this emotionally.”
Not all outdoor dining structures are created equally, said Richard Corsi, an air quality expert and dean of engineering and computer science at Portland State University in Oregon.
“There’s a wide spectrum,” Corsi said. “The safest that we’re talking about is no walls — a roof. And then the worst is fully enclosed — which is essentially an indoor tent — especially if it doesn’t have really good ventilation and good physical distancing.”
In fact, Corsi said, some outdoor dining structures that are enclosed and have lots of tables near each other end up being more dangerous than being indoors, because the ventilation is worse.
Dining that is truly outdoors, with no temporary shelter at all, is much safer because there are “higher air speeds, more dispersion and more mixing than indoors,” Corsi said, which means respiratory droplets harboring the virus don’t accumulate and are less concentrated when people are close to one another.
“If they have heaters, then you’re going to actually have pretty good ventilation,” Corsi said. “The air will rise up when it’s heated, and then cool air will come in.”
He said private “pods” or “domes” can be fairly safe if they are properly ventilated and cleaned between diners. That also assumes that everyone eating inside the structure lives together, so they have already been exposed to one another’s germs.
But Corsi said he is still not going out for a meal in one of the many new outdoor dining creations — “even though I know they’ve got a much lower risk” of spreading covid-19 than most indoor alternatives.
This story comes from NPR’s health reporting partnership with Kaiser Health News.
A number of social and economic reasons make it difficult for some Miamians to get tested or treated, or isolate themselves if they are sick with covid.
Little Havana is a neighborhood in Miami that, until the pandemic, was known for its active street life along Calle Ocho, including live music venues, ventanitas serving Cuban coffee and a historic park where men gather to play dominoes.
But during the pandemic, a group called Healthy Little Havana is zeroing in on this area with a very specific assignment: persuading residents to get a coronavirus test.
The nonprofit has lots of outreach experience. It helped with the 2020 census, for example, and because of the pandemic did most of that work by phone. But this new challenge, community leaders say, needs a face-to-face approach.
The group’s outreach workers have been heading out almost daily to walk the quiet residential streets, to persuade as many people as possible to get tested for covid-19. On a recent afternoon, a group of three — Elvis Mendes, María Elena González and Alejandro Díaz — knocked on door after door at a two-story apartment building. Many people here have jobs in the service industry, retail or construction; most of them aren’t home when visitors come calling.
Lisette Mejía did answer her door, holding a baby in her arms and flanked by two small children.
“Not everyone has easy access to the internet or the ability to look for appointments,” Mejía replied, after being asked why she hadn’t gotten a test. She added that she hasn’t had any symptoms, either.
The Healthy Little Havana team gave her some cotton masks and told her about pop-up testing planned for that weekend at an elementary school just a short walk away. They explained that people might lack symptoms but still have the virus.
Testing Is Still Too Difficult
The nonprofit organization is one of several receiving funding from the Health Foundation of South Florida. The foundation is spending $1.5 million on these outreach efforts, in part to help make coronavirus testing as accessible and convenient as possible.
A number of social and economic reasons make it difficult for some Miamians to get tested or treated, or isolate themselves if they are sick with covid. One big problem is that many people say they can’t afford to stay home when they’re sick.
“People usually rather go to work than actually treat themselves — because they have to pay rent, they have to pay school expenses, food,” said Mendes.
This part of Miami is home to many Cuban exiles, as well as people from all over Latin America. Some lack health insurance, while others are undocumented immigrants.
So Mendes and his team try to spread the word among residents here about programs like Ready Responders, a group of paramedics that now has foundation funding to give free coronavirus tests at home in areas like this one, regardless of immigration status.
“Our mission is for all these people to get tested — regardless if they have a symptom or not — so we can diminish the level of people getting covid-19,” Mendes said. According to the Centers for Disease Control and Prevention, people who are infected but presymptomatic or asymptomatic account for more than 50% of transmissions.
The Health Foundation of South Florida’s coronavirus-related grants have ranged from $35,000 to $160,000; other recipients include the South Florida chapter of the National Medical Association, Centro Campesino and the YMCA of South Florida.
The foundation is focusing on low-income neighborhoods where some residents might not have access to a car or be able to afford a coronavirus test at a pharmacy. Their focus includes residential areas near agriculture work sites. In Miami-Dade County, the foundation is working with county officials directly to increase testing. In neighboring Broward County, the foundation is collaborating with public housing authorities to bring more testing into people’s homes.
Soothing Fears, Offering Options in Spanish
It’s time-consuming to go door to door, but worthwhile: Residents respond when outreach teams speak their language and make a personal connection.
Little Havana resident Gloria Carvajal told the outreach group that she felt anxious about whether the PCR test is painful.
“What about that stick they put all the way up?” Carvajal asked, laughing nervously.
González jumped in to reassure her it’s not so bad: “I’ve done it many times, because obviously we’re out and about in public and so we have to get the test done.”
Another outreach effort is happening at Faith Community Baptist Church in Miami. The church hosted a day of free testing back in October, with help from the foundation.
“You know us. You know who we are,” said pastor Richard Dunn II. “You know we wouldn’t allow anybody to do anything to hurt you.”
Dunn spoke recently in nearby Liberty City, a historically Black neighborhood, at an outdoor memorial service for Black residents who have died of covid. To convey the magnitude of the community’s losses, hundreds of white plastic tombstones were set up behind the podium. They filled an entire field in the park.
“Thousands upon thousands have died, and so we’re saying to the Lord here today, we’re not going to let their deaths be in vain,” Dunn said.
Dunn is also helping with a newly launched effort to build trust in the covid vaccines among Black residents, by participating in online meetings during which Black church members can hear directly from Black medical experts. The message of the meetings is that the vaccines are safe and vital.
“It’s taken over 300,000 lives in the United States of America,” Dunn said at the end of the meeting. “And I believe to do nothing would be more of a tragedy than to at least try to do something to prevent it and to stop the spreading of the coronavirus.”
Churches will play a big role in the ongoing outreach efforts, and Dunn is committed to doing his part. He knows covid is an extremely contagious and serious disease — this past summer, he caught it himself.
Anita Baron first noticed something was wrong in August 2018, when she began to drool. Her dentist chalked it up to a problem with her jaw. Then her speech became slurred. She managed to keep her company, which offers financing to small businesses, going, but work became increasingly difficult as her speech worsened. Finally, nine months, four neurologists and countless tests later, Baron, now 66, got a diagnosis: amyotrophic lateral sclerosis.
ALS, often called Lou Gehrig’s disease after the New York Yankees first baseman who died of it in 1941, destroys motor neurons, causing people to lose control of their limbs, their speech and, ultimately, their ability to breathe. It’s usually fatal in two to five years.
People with ALS often must quit their jobs and sometimes their spouses do, too, to provide care, leaving families in financial distress. A decade-long campaign by advocates highlighting this predicament notched a victory last month when Congress passed a bill opening key support programs earlier for ALS patients.
In late December, then-President Donald Trump signed the bill into law. It eliminates for ALS patients the required five-month waiting period to begin receiving benefits under the Social Security Disability Insurance program, which replaces at least part of a disabled worker’s income. Gaining SSDI also gives these patients immediate access to Medicare health coverage.
The Muscular Dystrophy Association, an umbrella organization for people with 43 neuromuscular conditions, partnered with other ALS groups to support the bill to eliminate the SSDI waiting period.
“We’re hopeful that it can serve as a model for other conditions that may be similarly situated,” said Brittany Johnson Hernandez, senior director of policy and advocacy at MDA.
In the weeks leading up to the passage of the bill, Sen. Mike Lee (R-Utah) sought to broaden the scope of the legislation to include other conditions. He pledged to continue to work on legislation to eliminate the SSDI waiting period for additional diseases that meet certain criteria, including those with no known cure and a life expectancy of less than five years.
Eliminating the SSDI waiting period has been a top priority for ALS advocates. There is no simple, single test or scan to confirm that someone has ALS, though symptoms can escalate rapidly. By the time people finally get the diagnosis, they are often already seriously disabled and unable to work. Waiting five months longer for financial aid can be a burden, according to patients and families.
“Five months may seem like a short period of time, but for someone with ALS it matters,” said Danielle Carnival, CEO of I Am ALS, an advocacy group. “It’s a huge win and will make a huge difference for people right away.”
Eligibility for SSDI benefits generally requires people to have worked for about a quarter of their adult lives at jobs through which they paid Social Security taxes. Benefits are based on lifetime earnings; the average monthly SSDI benefit was $1,259 in June 2020, according to the Social Security Administration. (The average retirement benefit was $1,514 that month.)
The SSDI waiting period was intended to make sure the program served only people expected to have claims that would last at least a year, said Ted Norwood, chief legal officer at Integrated Benefits Inc. in Jefferson City, Missouri, who represents SSDI applicants. But it isn’t necessary, he added, because disability rules now require that people have a condition that will keep them out of work at least a year or result in death.
“The five-month waiting period serves no purpose as far as weeding out cases,” Norwood said.
Existing federal law also made special health provisions for people with ALS and end-stage renal disease. Most people with disabilities must wait two years to be eligible for Medicare, but people with either of those two diseases can qualify sooner. ALS patients are eligible as soon as SSDI benefits start.
The new law could have made a big difference for Baron, who lives in Pikesville, Maryland. She and her husband, who works part time at a funeral parlor, didn’t have comprehensive health insurance when she got sick. They were enrolled only in a supplemental medical plan that paid out limited cash benefits.
By the time she was diagnosed and her SSDI and Medicare came through, Baron and her husband had maxed out their credit cards, raided $10,000 from their IRA and gone to their family for money. They were $13,000 in debt. They sold their house and moved into a condo to save on expenses.
“It is imperative that as [people] become more and more debilitated and cannot work, that they have immediate access to SSDI,” Baron said.
Like Sen. Lee,some patient advocates say the accommodations on disability benefits and Medicare made for patients with ALS should be extended to others with similarly intractable conditions.
The Social Security Administration has identified 242 conditions that meet the agency’s standards for qualifying for disability benefits and are fast-tracked for benefit approval.
Once approved, people with these conditions still must wait five months before they receive any money. Now, under the new law, people with ALS can skip the waiting period, though no one else on the “compassionate allowances” list can.
Breast cancer advocates are hoping for similar accommodations for people with metastatic breast cancer. Legislation introduced in the House and Senate in 2019 would have eliminated the SSDI waiting period for this group, but it did not pass.
Tackling the problem one condition at a time doesn’t make sense, others argue.
“Can you imagine, one by one, people with these conditions trying to find people in the House and in the Senate to champion the bill?” said Carol Harnett, president of the Council for Disability Awareness, which represents disability insurers.
Deb McQueen-Quinn thinks it would be good if the new law sets a precedent for eliminating the SSDI waiting period. At 55, McQueen-Quinn has lived with ALS since 2009, far longer than most.
A former convenience store manager, she uses a wheelchair full time now. She knows all too well the toll of the disease. ALS runs in her family, and she’s watched several family members, including her sister, brother and a cousin die of it.
Her sister, a former quality control engineer, was diagnosed in 2006 and died the following year, a week before she would have received her first SSDI payment.
McQueen-Quinn, who lives in Wellsville, New York, with her husband, has two children in their 30s. Her son, 33, carries the familial genetic mutation that leads to ALS. So far he hasn’t developed symptoms. But it’s for people like her son and other family members that she fought for the new law.
“Now that we’ve set the precedent, I’m sure you’ll see a lot of other diseases go after this,” she said.