The vaccine trial that Vice President Mike Pence kicked off in Miami on Monday gives the United States the tiniest chance of being ready to vaccinate millions of Americans just before Election Day.
It's a possibility that fills many public health experts with dread.
Among their concerns: Early evidence that any vaccine works would lead to political pressure from the administration for emergency approval by the Food and Drug Administration. That conflict between science and politics might cause some people to not trust the vaccine and refuse to take it, which would undermine the global campaign to stop the pandemic. Or it could lead to a product that is not fully protective. Confidence in routine childhood vaccinations, already shaken, could decline further.
"The fear is that you wind up doing to a vaccine what [Trump has] already done with [opening] school," said Dr. Joshua Sharfstein, a former FDA deputy commissioner and a professor at Johns Hopkins University in Baltimore. "Take an important, difficult question and politicize it. That's what you want to avoid."
On Monday at 6:45 a.m., the first volunteer in the landmark phase 3 trial for the Moderna Therapeutics vaccine received a shot at a clinic in Savannah, Georgia. Clinicians at 88 other sites, stretching from Miami to Seattle, also administered the experimental shot in a trial that aims to enroll 30,000 people.
Dr. Anthony Fauci, the country's leading infectious disease expert, told reporters he hoped 15,000 could be vaccinated by the end of the week, although he provided no information about progress toward that goal. All volunteers would receive a second shot 29 days after their first inoculation. (Half will receive a placebo containing saline solution.)
Another vaccine, produced by Pfizer with the German company BioNTech, also entered a large phase 3 U.S. trial this week. It's being tested independently of the National Institutes of Health, which is partially funding the Moderna trial as well as tests for an Oxford University/AstraZeneca vaccine trial, and others in the future. AstraZeneca has said some doses of its vaccine might be ready as early as September.
Fauci said he expects the Moderna trial to provide an answer about whether that vaccine works by the end of the year — and it's "conceivable" an answer could come in October. "I doubt that, but we are leaving an open mind that it is a possibility."
Such a fast pace worries some experts.
"I don't see how that's remotely possible unless the thing I most fear happens, a truncated phase 3 trial with just an idea of efficacy, an idea of common side effects, and then it rolls out," said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.
Pence downplayed such fears Monday, telling reporters: "There will be no shortcuts. There will be no cutting corners."
Officials are pressing for an open and transparent process.
Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight and Reform Subcommittee on Economic and Consumer Policy, is preparing to release a bill requiring the FDA to have an expert panel review any COVID vaccine and issue a recommendation before FDA Commissioner Stephen Hahn makes a decision.
With past vaccines, the FDA has generally relied on such a committee, made up mostly of vaccine experts and appointed by the FDA commissioner. They typically conduct a painstaking examination of all evidence before voting on whether the FDA should approve a vaccine. The commissioner has rarely, if ever, gone against the committee's decisions.
Hahn undercut confidence in the FDA's independence earlier in the year, many observers felt, when he issued an Emergency Authorization Use declarationfor hydroxychloroquine, a drug used to treat malaria that President Donald Trump and members of his administration have continued to tout, erroneously, as a cure for COVID-19. The FDA later revoked the authorization, which was made without consulting an independent committee.
"FDA's independence has been threatened, no question, by the hydroxychloroquine issue," said Dr. Jesse Goodman, a Georgetown University professor who led the FDA's biologics division and later was chief scientific officer.
The agency must give outside scientists and the public the opportunity to see the data and the FDA's reasoning before coming to such a decision, he said.
Concerns about political interference arose recentlywhen Trump talked excitedly about a vaccine, and Treasury Secretary Steven Mnuchin confidently told reporters there would be a vaccine by the end of the year for emergency use.
To be sure, it's unlikely the FDA would be tempted to issue an emergency release without data that showed a vaccine was working and not causing serious side effects.
The massive coronavirus outbreaks in Texas and other hard-hit areas where the Moderna vaccine is being tested should provide an answer, although exactly when is an open question.
In theory, scientists might get a handle on a vaccine's efficacy before all 30,000 people are enrolled, vaccinated and studied.
In fact, an answer could become clear after only 150 to 160 cases of disease are reported among the trial participants, Fauci said. If roughly two-thirds of those cases occurred in non-vaccinated people, it would show statisticians that the vaccine had above-60% efficacy, he said.
If the vaccine is 80% to 90% effective and the annual rate of infection in the places where it's being tested is above 4%, scientists could get a signal of efficacy in such a trial with just 50 cases, or in as little as three months, said Ira Longini, a University of Florida biostatistician who designs vaccine trials.
The Moderna vaccine trial would hit that three-month threshold on Oct. 27.
The trial's fate is partly in the hands of its 30-member Data and Safety Monitoring Board, whose members can see unblinded data about the participants in real time — pinpointing who was vaccinated with the actual vaccine and got sick, for example. The board will alert the NIH and vaccine maker if it sees surprising data — either dangerous side effects or powerful efficacy. Some fear that if the vaccine seems to work in an early review, the FDA would be pressured to stop the trial.
Offit said NIH should not accept anything less than a completed trial of 30,000 people. Fifty cases "is a very small number" to use as evidence for releasing a vaccine that could be administered to tens of millions, he said.
The public might clamor for the release of any vaccine that seemed to work. Moderna said it has already begun producing millions of doses of vaccine "at risk," banking on the vaccine's success. The FDA could release those under powers provided when the country declared a public health emergency in March.
With more than half the country deeply mistrustful of Trump, according to recent polls, any federal decision could be resisted and lead to widespread rejection of even a promising vaccine. Sharfstein worries about a "knee-jerk" reaction against the vaccine by Democrats if Trump touts it before the election.
Experts also worry about releasing a vaccine that shows some positive effects but isn't robustly protective. A slide presented by FDA deputy director Philip Krause at the World Health Organization earlier this month said a weak vaccine could fail to protect the public adequately, leading to a false sense of security in those who've received it, while making it harder to test future vaccines.
Reversing a three-year decline, the number of people covered by Medicaid nationwide rose markedly this spring as the impact of the recession caused by the outbreak of COVID-19 began to take hold.
Yet, the growth in participation in the state-federal health insurance program for low-income people was less than many analysts predicted. One possible factor tempering enrollment: People with concerns about catching the coronavirus avoided seeking care and figured they didn't need the coverage.
Program sign-ups are widely expected to accelerate through the summer, reflecting the higher number of unemployed. As people lose their jobs, many often are left without workplace coverage or the money to buy insurance on their own.
Medicaid enrollment was 72.3 million in April, up from 71.5 million in March and 71 million in February, according to the latest enrollment figures released last week by the Centers for Medicare & Medicaid Services. The increase in March was the first enrollment uptick since March 2017.
About half of the people enrolled in Medicaid are children.
The increases varied widely around the country. Kentucky had the largest jump at nearly 7% from March to April. In addition, enrollment rose to 1.4 million in April from 1.2 million in February, according to the CMS data. That has continued, and today it's up to 1.5 million, state officials said in an interview.
Kentucky has an aggressive outreach strategy using email or phone calls to contact thousands of residents who applied for state unemployment insurance, designed to make sure they know about Medicaid. "It's been very effective, and in the past few weeks we've been enrolling 8,000 to 10,000 people a week," said Eric Friedlander, secretary of the Kentucky Cabinet for Health and Family Services, which oversees Medicaid.
The Bluegrass State has also made enrollment easier by developing a one-page online form instead of having people fill out a 20-page application, he added.
"This is the right thing to do to help people get signed up for healthcare coverage and it supports the health industry in our state," Friedlander said. "The health industry would collapse without Medicaid."
Joan Alker, executive director of the Center for Children and Families at Georgetown University in Washington, D.C., said she expects Medicaid enrollment to keep rising this summer. "Given that there are no signs that the virus is coming under control anytime soon, job losses will become more permanent, and more folks will become eligible for Medicaid over time," she said.
One reason Medicaid numbers have not grown faster, she suggested, is because people have more immediate needs than securing health coverage, especially if they are feeling well.
Many people are worried about getting unemployment insurance or getting evicted from their home, she noted. "That's combined with the fact that many people are reluctant to go to their doctor because of safety concerns," she said. "And, as a consequence, applying for Medicaid may not be at the top of their list."
Chris Pope, a senior fellow at the Manhattan Institute for Policy Research, a conservative think tank, said the slower-than-expected growth in Medicaid could signal that people who were laid off had coverage through a spouse or a parent.
In addition, he said, "many jobs that went away did not offer health insurance," citing millions of service-sector positions in industries such as hotels and restaurants that have been lost.
Beyond the surge in unemployment, Medicaid rolls have risen because states cannot discontinue coverage to people enrolled as of March 18, 2020, as a condition of receiving higher federal Medicaid funding included in a coronavirus relief package passed by Congress.
Medicaid is a countercyclical program, meaning enrollment typically rises during an economic downturn. But that forces states to face the fiscal challenge of paying for their share of the program even as tax revenue dries up.
An exception to this rule was the jump in enrollment starting in 2014 when the Affordable Care Act allowed states to expand Medicaid to cover everyone with incomes below 138% of the federal poverty level, or about $17,609 for an individual this year.
Enrollment soared by about 15 million people from 2014 to 2017, peaking at about 75 million as nearly three dozen states expanded the program. Since then, a strong economy and steadily declining unemployment levels led to a drop in Medicaid rolls until April.
Nevada and Oklahoma posted nearly 4% enrollment growth rates between March and April's data.
Florida's Medicaid numbers jumped to 3.7 million in April from 3.6 million in March, nearly a 2.5% increase, the CMS data showed. Since then, Florida data shows enrollment has topped 4.1 million.
The Trump administration has been criticized by consumer advocates for not establishing a national campaign to promote Medicaid during the economic downturn and health crisis.
One indicator that Medicaid enrollment is still going up is the growing number of recipients in managed care plans in 16 states that reported data from March to May. Those plans have increased by a total of nearly 4%, according to a KFF report. (KHN is an editorially independent program of KFF.) Most states have shifted many of their Medicaid enrollees into these private health plans.
KFF estimated that nearly 13 million people who became uninsured after losing their jobs in March are eligible for Medicaid.
Robin Rudowitz, a KFF vice president, said there is typically a lag time of weeks or months before people who have lost their jobs and health coverage seek to enroll in Medicaid. The impact on Medicaid enrollment also lasts well after the immediate effect of a downturn, she said.
Historically, racial and ethnic miniorities have been less likely to be included in clinical trials for disease treatment.
This article was first published on Monday, July 27, 2020 in Kaiser Health News.
When U.S. scientists launch the first large-scale clinical trials for COVID-19 vaccines this summer, Antonio Cisneros wants to make sure people like him are included.
Cisneros, who is 34 and Hispanic, is part of the first wave of an expected 1.5 million volunteers willing to get the shots to help determine whether leading vaccine candidates can thwart the virus that sparked a deadly pandemic.
"If I am asked to participate, I will," said Cisneros, a Los Angeles cinematographer who has signed up for two large vaccine trial registries. "It seems part of our duty."
It will take more than duty, however, to ensure that clinical trials to establish vaccine safety and effectiveness actually include representative numbers of African Americans, Latinos and other racial minorities, as well as older people and those with underlying medical conditions, such as kidney disease.
Black and Latino people have been three times as likely as white people to become infected with COVID-19 and twice as likely to die, according to federal data obtained via a lawsuit by The New York Times. Asian Americans appear to account for fewer cases but have higher rates of death. Eight out of 10 COVID deaths reported in the U.S. have been of people ages 65 and older. And the Centers for Disease Control and Prevention warns that chronic kidney disease is among the top risk factors for serious infection.
Historically, however, those groups have been less likely to be included in clinical trials for disease treatment, despite federal rules requiring minority andelder participation and the ongoing efforts of patient advocates to diversify these crucial medical studies.
In a summer dominated by COVID-19 and protests against racial injustice, there are growing demands that drugmakers and investigators ensure that vaccine trials reflect the entire community.
"If Black people have been the victims of COVID-19, we're going to be the key to unlocking the mystery of COVID-19," said the Rev. Anthony Evans, president of the National Black Church Initiative, a coalition of 150,000 African American churches.
Evans and his team met in mid-July with officials from Moderna, the Massachusetts biotech firm that launched thefirst COVID vaccine trial in the U.S., to discuss a collaboration in which NBCI would supply African American participants. But that was less than two weeks before the start of a phase 3 trial expected to enroll 30,000 people, and Evans said the meeting was his idea.
"It's not that the industry came to me," he said. "I went to the industry."
Blacks make up about 13% of the U.S. population but on average 5% of clinical trial participants, research shows. For Hispanics, trial participation is about 1% on average, though they account for about 18% of the population.
When it comes to trials for drug treatments and vaccines, diversity matters. For reasons not always fully understood, people of different races and ethnicities can respond differently to drugs or therapies, research shows. Immune response wanes with age, so there's a high-dose flu shot for people 65 and older.
Still, the pressure to produce an effective vaccine quickly during a pandemic could sideline efforts to ensure diversity, said Dr. Kathryn Stephenson, director of the clinical trials unit in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.
"One of the questions that has come up is, What do you do if you're a site investigator and you have 250 people banging on your door — and they're all white?" she said.
Do you enroll those people, reasoning that the faster the trial progresses, the faster a vaccine will be available for everyone? Or do you turn away people and slow down the study?
"You're accelerating development of a vaccine, and if you hit a milestone, what is the meaning of that milestone if you don't know if it's very safe or effective in [a given] population? Is that really hitting the milestone for everyone?" she said.
Including people who are elderly or have underlying medical conditions is vital to the science of vaccines and other treatments, even if it's more difficult to recruit patients otherwise healthy enough to participate, advocates said.
"We have to admit that older adults are the ones who are likely to develop side effects" to treatments and vaccines, said Dr. Sharon Inouye, director of the Aging Brain Center and a professor of medicine at Harvard Medical School. "On the other hand, that is the population that will be using it."
People with kidney disease, which affects 1 in 7 U.S. adults, have been left out of clinical research for decades, said Richard Knight, a transplant recipient and president of the American Association of Kidney Patients. Nearly 70% of more than 400 kidney disease patients the organization surveyed in July said they'd never been asked to join a clinical trial.
Excluding from the vaccine trial such a large population vulnerable to COVID doesn't make sense, Knight contended. "If you're trying to manage this from a public health standpoint, you want to make sure you're inoculating your highest-risk populations," he said.
New guidance from the federal Food and Drug Administration, which regulates vaccines, "strongly encourages" the inclusion of diverse populations in clinical vaccine development. That includes racial and ethnic minorities, elderly people and those with underlying medical problems, as well as pregnant women.
But the FDA does not require drugmakers and researchers to meet those goals, and will not refuse trial data that doesn't comply. And while the federal government is rushing billions of dollars to fast-track more than a half-dozen leading candidates for COVID vaccines, the pharmaceutical firms producing them are not required to publicly disclose their demographic goals.
"This is business as usual," said Marjorie Speers, executive director of Clinical Research Pathways, a nonprofit group in Atlanta that works to increase diversity in research. "It's very likely these [COVID] trials will not include minorities because there's not a strong statement to do that."
The vaccine trials are being coordinated through the COVID-19 Prevention Network, or CoVPN, based at the Fred Hutchinson Cancer Research Center in Seattle. It draws on four long-standing federally funded clinical trial networks, including three that target HIV and AIDS.
Those trial networks were chosen in large part because they have rich relationships in Black, Latino and other minority communities, said Stephaun Wallace, director of external relations for CoVPN. The hope is to leverage existing connections based on trust and collaboration.
"Our clinical trial sites are prepped and ready to engage diverse people," Wallace said.
Wallace acknowledged, however, that attracting a diverse population requires investigators to be flexible and innovative. There can be practical problems. Clinic hours may be limited or transportation may be an issue. Older people may have problems with sight or hearing and require extra help to follow protocols.
Distrust of the medical establishment also can be a barrier. African Americans, for instance, have a well-founded wariness of medical experiments after the infamous Tuskegee Study and the exploitation of Henrietta Lacks. That extends to suspicion about recommended vaccines, said Wallace.
"Part of the consideration for many groups is not wanting to feel like a guinea pig or feel like they're being experimented on," he said.
Moderna, which plans to launch its phase 3 trial Monday, said the company is working to ensure participants "are representative of the communities at highest risk for COVID-19 and of our diverse society."
However, results of the company's phase 1 trial, released in mid-July, showed that of 45 people included in that safety test, six were Hispanic, two were Black, one was Asian and one was Native American. Forty were white.
Phase 1 and phase 2 clinical trials aim to test the best dose and safety of vaccines in small groups of people. Phase 3 trials assess the efficacy of the drug in tens of thousands of people.
Investigators at nearly 90 sites across the U.S. are preparing now to recruit participants for Moderna's phase 3 trial. Dr. Carlos del Rio, executive associate dean at the Emory University School of Medicine, will seek 750 volunteers at three Atlanta-area sites. Half will receive the vaccine; half, placebo injections.
Del Rio has had marked success recruiting minorities for HIV trials and expects similar results with the vaccine trial. "We're trying to do our best to get out to the communities that are most at risk," he said.
Meanwhile, vaccine volunteers like Cisneros just want the advanced trials to start. He signed up for the CoVPN trials. But earlier, he also signed up for 1 Day Sooner, an effort to launch human challenge trials, which aim to speed up vaccine development by deliberately infecting participants with the virus. Such trials can be completed in weeks rather than months but risk exposing volunteers to severe illness or death, and federal officials remain leery.
Cisneros is willing to take that risk to help halt COVID-19, which has killed 143,000 Americans. He said it's a way to take action at a time when the U.S. government has failed to protect minorities, the elderly and other vulnerable people.
"Government is supposed to help those who can't protect themselves," he said. "It appears to me the only thing they want to protect is people with money, people with guns — and not brown people like me."
Changes to health plan networks occur all the time as doctors retire, relocate or leave networks. And patients may be the last to find out because providers and insurers are not always required to inform them.
This article was first published on Monday, July 27, 2020 inKaiser Health News.
NEW YORK — As the coronavirus spread silently through New York City early this year, Deborah Koeppel had an appointment with her cardiologist and two visits with her primary care doctor. Both physicians are members of Concorde Medical Group, a practice in Manhattan with an office conveniently located a few blocks from where Koeppel works.
She soon received notices telling her — after the fact — that those doctors were not in her health plan's network of providers. According to the notices, she was on the hook for $849 in out-of-network cost sharing for three visits, which typically would cost her nothing from in-network providers.
Changes to health plan networks occur all the time as doctors retire, relocate or leave networks. And patients may be the last to find out about such changes because providers or insurers are not always required to inform them.
Koeppel also faced the loss of low-cost access to her in-network gynecologist and dermatologist.
"I felt sickened," said Koeppel, 62, a senior social worker who kept working even as New York was hit by a brutal COVID-19 outbreak, with more than 1,000 deaths a day at its peak. "To me, it feels like physician abandonment. In the middle of something like this, you're left without your doctors."
Legislators, regulators and insurers have enacted special policies during the coronavirus pandemic, including paying for more virtual visits and eliminating copays for COVID-related testing and care. But long-standing issues, such as ever-shifting networks — often unbeknownst to patients — persist unchanged. And blindsiding patients with such changes is particularly hazardous at a time when many offices are partly closed, and patients are vulnerable and more likely than usual to need medical advice or attention.
That's not how it should work, experts say. "Both parties should have responsibility for notifying their members," said Sabrina Corlette, a research professor at Georgetown University's Center on Health Insurance Reforms who co-authored a recent report examining state protections for patients who lose access to their doctors and other providers during contract disputes between providers and health plans.
The paper highlighted published examples of contract disputes that potentially affected hundreds of thousands of members, including 100,000 UnitedHealthcare members who lost access to eight Houston hospitals because of a contract dispute last year and the long-running feud in Pennsylvania between Highmark Health and the University of Pittsburgh Medical Center over in-network access to at least 11 hospitals.
Network changes that affect only a small number of patients or are the result of amicable negotiations between providers and insurers happen too, but they rarely make the news.
Healthcare experts agree that maintaining regular relationships with providers over time can help people manage chronic conditions and stay healthy. But patient protections from disruptions caused by network changes are scant. Most states have laws that permit health plan members to continue to see their doctors for a time after they leave the network, but only under certain limited circumstances, such as if they are pregnant or have a terminal illness. And some states require insurers to notify members in advance of network changes, Corlette said.
But state laws don't protect the majority of people who have coverage through health plans that are self-insured, meaning they pay members' claims directly rather than buy insurance for that purpose. Those plans operate under federal guidelines and generally aren't subject to state insurance regulation.
Koeppel is a member of 1199SEIU, the Service Employees International Union's largest local, representing nearly 450,000 healthcare workers on the East Coast. She receives healthcare through the National Benefit Fund, a self-insured plan funded by contributions from the union members' employers.
Koeppel has gone to doctors at Concorde for eight years. Until January, Concorde doctors participated in plans offered through the Independent Practice Association at NYU Langone Health, a large private health system. Eleven Concorde doctors treated members of the National Benefit Fund for 1199SEIU. In January, the physicians group joined Northwell Health, another large private health system in New York. Koeppel and 162 other 1199SEIU patients lost in-network access to their Concorde doctors as a result, said Terry Lynam, a Northwell spokesperson.
The National Benefit Fund wasn't notified of the change either, according to a statement from the fund. A staff member for the fund brought it to their attention.
Koeppel said she knows there are other doctors she can see — there are tens of thousands in network in the New York City area. But she was distraught to lose those with whom she's developed a trusting relationship.
Her primary care physician "has been incredibly available by phone, just a really committed person who's caring, warm and very reassuring," she said.
After Koeppel complained to Northwell, administrators offered to write off any charges for her visits to Concorde physicians during the pandemic, she said.
And after a reporter contacted Northwell and the union's National Benefit Fund about the network changes, the health system and the union agreed to a temporary contract extension from January 2020 through the end of August that allows 1199SEIU members to continue to see their Concorde doctors without cost sharing. The two parties are in negotiations for a new agreement that would give National Benefit Fund members in-network access to Concorde and other Northwell physicians after that date.
Northwell's Lynam said that since there was no interruption in patient care, the timing of patients' discovering the change is immaterial.
"Whether they found out in December that they had to find a new provider or they found out in June that they had to do so, the end result would be the same," he said. "No patient was abandoned or harmed because they didn't know earlier, and they would have been equally upset by the news whether they found out now or in December."
Koeppel disagreed. If she had been informed of the upcoming change in October when Northwell put out its press release, Koeppel said, she would still have been upset. But she would have been better positioned to switch providers before January and would have had new physicians in place before the pandemic hit.
Trump could enact a policy, even one judged illegal by the courts, and the person who follows him into office would need to jump through a number of hoops to undo it.
This article was first published on Friday, July 24, 2020 in Kaiser Health News.
President Donald Trump came into office vowing to repeal and replace Obamacare. While he successfully neutralized the healthcare law's requirement that everyone carry insurance, the law remains in effect.
When Fox News host Chris Wallace noted that Trump has yet to put forward a replacement plan, Trump told him to stay tuned.
"We're signing a healthcare plan within two weeks, a full and complete healthcare plan that the Supreme Court decision on DACA gave me the right to do," Trump said July 19 on "Fox News Sunday."
"The Supreme Court gave the president of the United States powers that nobody thought the president had."
Trump said he would "do things on immigration, on healthcare, on other things that we've never done before."
We wanted to know if the Supreme Court really did that. So we ran the president's words by a number of people who study constitutional and administrative law. We heard several reasons why the Supreme Court might not have said what Trump thinks it said.
The Likely Source
We asked the White House press office for the basis of Trump's assertion and never heard back. Several law professors pointed to a National Review article by University of California-Berkeley law professor John Yoo, best known as authoring a legal justification that led to waterboarding enemy combatants during the George W. Bush administration.
In the article, Yoo argues that when the Supreme Court ruled against the administration's rollback of Deferred Action for Childhood Arrivals, or DACA, the court made it more difficult for new presidents to unwind the policies of their predecessors.
How might this give Trump new power?
In theory, Trump could enact a policy, even one judged illegal by the courts, and the person who follows him into office would need to jump through a number of hoops to undo it.
Yoo wasn't sure if Trump could use the argument to make sweeping changes in healthcare, saying it "depends on what the administration policy actually says."
But as Yoo sees it, should Trump establish a new program, the ruling "requires his successor to follow a burdensome process, which could take a year or more, to repeal it."
Many legal experts disagree with Yoo's interpretation. Before we go there, we need to recap the court's DACA decision.
Court Sends DHS Back to the Drawing Table
President Barack Obama created DACA on the grounds that every administration has to allocate limited prosecution resources. Obama argued that it was more important to deport violent criminals, drug dealers and thieves than people who had come into the country illegally when they were little. So long as they had committed no serious offenses and met other criteria, they could apply to avoid deportation.
Under Trump, the Department of Homeland Security moved to end DACA. Supporters of the program sued, saying that under the Administrative Procedure Act, that action was arbitrary. In its June 18 ruling, a 5-4 majority on the Supreme Court agreed.
The ruling describes how Homeland Security Secretary Kirstjen Nielsen got in a procedural bind when she inherited the decision of her predecessor (Acting Secretary Elaine Duke) to end the program. She erred, Chief Justice John Roberts wrote, because instead of making the case for ending DACA as her own decision, she came up with new reasons to justify the earlier move.
"Because Nielsen chose not to take new action, she was limited to elaborating on the agency's original reasons," Roberts wrote. "But her reasoning bears little relationship to that of her predecessor and consists primarily of impermissible 'post hoc rationalization.'"
The court didn't say Homeland Security couldn't change the policy. It said the Administrative Procedure Act requires an agency to consider the key options it faces and explain why it chose the one it picked. With DACA, it said the change needed to show a fuller vetting of its choices.
No New Power Created
So while Trump technically lost that case, he is using the ruling (and Yoo's theory) to voice confidence that he can do things no one thought possible.
Legal scholars give several reasons that might be off the mark. Broadly, they say the court's ruling changed nothing.
"It's a straightforward application of long-standing administrative law doctrine that dates back at least to President Ronald Reagan," said Cary Coglianese, director of the Penn Program on Regulation and a professor of law at the University of Pennsylvania. "Agencies have to explain why they are doing something. They have to look at the plausible alternatives and give a reason for the one they selected."
Justice Brett Kavanaugh also did not see a new take on an old law. In his dissenting opinion, he called the ruling on the Administrative Procedure Act "narrow."
In a similar vein, the court left intact the specific power behind DACA of selective enforcement of the law.
"That's an ordinary part of executive branch practice, and nothing in the Supreme Court's DACA decision should be read to authorize anything beyond that simple practice," said Yale University law professor Cristina Rodríguez.
The path to undoing this sort of executive action may not be as long as Yoo described. The court spelled out how Nielsen could have ended DACA without much delay, said Eric Freedman, professor of constitutional law at Hofstra University Law School.
"If she had considered other possible solutions, what she did would have been fine," Freedman said. "She would have complied with the Administrative Procedure Act and no one would have enjoined her."
There is also something unusual about DACA itself that makes it less of a model for other steps Trump might take.
The program was in place for quite a while before Trump tried to end it. As a result, about 700,000 people ultimately counted on it. The court said that reliance on the program should have factored into the decision to end it.
A new policy from Trump wouldn't have time to accumulate that critical mass.
"Anything Trump does now will be enjoined tomorrow," said Josh Blackman at the South Texas College of Law. "So there will be no reliance, and the next administration could do what it wanted."
Blackman said the court's ruling did create some murkiness around challenging the legality of an unwanted policy. But he said an agency could justify a change strictly for reasons of policy, not law.
Lastly, the DACA decision was about a policy not to enforce the law in certain circumstances. Robert Chesney at the University of Texas Law School said that focus also limits the scope of the ruling.
"If Trump wants to create new rules, the example does not fit in the first place," Chesney said.
A "full and complete healthcare plan" and major immigration changes would likely require new government actions. Without new laws from Congress, that would be out of reach.
Family gatherings on Zoom and FaceTime. Online orders from grocery stores and pharmacies. Telehealth appointments with physicians.
These have been lifesavers for many older adults staying at home during the coronavirus pandemic. But an unprecedented shift to virtual interactions has a downside: Large numbers of seniors are unable to participate.
Among them are older adults with dementia (14% of those 71 and older), hearing loss (nearly two-thirds of those 70 and older) and impaired vision (13.5% of those 65 and older), who can have a hard time using digital devices and programs designed without their needs in mind. (Think small icons, difficult-to-read typefaces, inadequate captioning among the hurdles.)
Many older adults with limited financial resources also may not be able to afford devices or the associated internet service fees. (Half of seniors living alone and 23% of those in two-person households are unable to afford basic necessities.) Others are not adept at using technology and lack the assistance to learn.
During the pandemic, which has hit older adults especially hard, this divide between technology "haves" and "have-nots" has serious consequences.
Older adults in the "haves" group have more access to virtual social interactions and telehealth services, and more opportunities to secure essential supplies online. Meanwhile, the "have-nots" are at greater risk of social isolation, forgoing medical care and being without food or other necessary items.
Dr. Charlotte Yeh, chief medical officer for AARP Services, observed difficulties associated with technology this year when trying to remotely teach her 92-year-old father how to use an iPhone. She lives in Boston; her father lives in Pittsburgh.
Yeh's mother had always handled communication for the couple, but she was in a nursing home after being hospitalized for pneumonia. Because of the pandemic, the home had closed to visitors. To talk to her and other family members, Yeh's father had to resort to technology.
But various impairments got in the way: Yeh's father is blind in one eye, with severe hearing loss and a cochlear implant, and he had trouble hearing conversations over the iPhone. And it was more difficult than Yeh expected to find an easy-to-use iPhone app that accurately translates speech into captions.
Often, family members would try to arrange Zoom meetings. For these, Yeh's father used a computer but still had problems because he could not read the very small captions on Zoom. A tech-savvy granddaughter solved that problem by connecting a tablet with a separate transcription program.
When Yeh's mother, who was 90, came home in early April, physicians treating her for metastatic lung cancer wanted to arrange telehealth visits. But this could not occur via cellphone (the screen was too small) or her computer (too hard to move it around). Physicians could examine lesions around the older woman's mouth only when a tablet was held at just the right angle, with a phone's flashlight aimed at it for extra light.
"It was like a three-ring circus," Yeh said. Her family had the resources needed to solve these problems; many do not, she noted. Yeh's mother passed away in July; her father is now living alone, making him more dependent on technology than ever.
When SCAN Health Plan, a Medicare Advantage plan with 215,000 members in California, surveyed its most vulnerable members after the pandemic hit, it discovered that about one-third did not have access to the technology needed for a telehealth appointment. The Centers for Medicare & Medicaid Services had expanded the use of telehealth in March.
Other barriers also stood in the way of serving SCAN's members remotely. Many people needed translation services, which are difficult to arrange for telehealth visits. "We realized language barriers are a big thing," said Eve Gelb, SCAN's senior vice president of healthcare services.
Nearly 40% of the plan's members have vision issues that interfere with their ability to use digital devices; 28% have a clinically significant hearing impairment.
"We need to target interventions to help these people," Gelb said. SCAN is considering sending community health workers into the homes of vulnerable members to help them conduct telehealth visits. Also, it may give members easy-to-use devices, with essential functions already set up, to keep at home, Gelb said.
Landmark Health serves a highly vulnerable group of 42,000 people in 14 states, bringing services into patients' homes. Its average patient is nearly 80 years old, with eight medical conditions. After the first few weeks of the pandemic, Landmark halted in-person visits to homes because personal protective equipment, or PPE, was in short supply.
Instead, Landmark tried to deliver care remotely. It soon discovered that fewer than 25% of patients had appropriate technology and knew how to use it, according to Nick Loporcaro, the chief executive officer. "Telehealth is not the panacea, especially for this population," he said.
Landmark plans to experiment with what he calls "facilitated telehealth": nonmedical staff members bringing devices to patients' homes and managing telehealth visits. (It now has enough PPE to make this possible.) And it, too, is looking at technology that it can give to members.
One alternative gaining attention is GrandPad, a tablet loaded with senior-friendly apps designed for adults 75 and older. In July, the National PACE Association, whose members run programs providing comprehensive services to frail seniors who live at home, announced a partnership with GrandPad to encourage adoption of this technology.
"Everyone is scrambling to move to this new remote care model and looking for options," said Scott Lien, the company's co-founder and chief executive officer.
PACE Southeast Michigan purchased 125 GrandPads for highly vulnerable members after closing five centers in March where seniors receive services. The devices have been "remarkably successful" in facilitating video-streamed social and telehealth interactions and allowing nurses and social workers to address emerging needs, said Roger Anderson, senior director of operational support and innovation.
Another alternative is technology from iN2L (an acronym for It's Never Too Late), a company that specializes in serving people with dementia. In Florida, under a new program sponsored by the state's Department of Elder Affairs, iN2L tablets loaded with dementia-specific content have been distributed to 300 nursing homes and assisted living centers.
The goal is to help seniors with cognitive impairment connect virtually with friends and family and engage in online activities that ease social isolation, said Sam Fazio, senior director of quality care and psychosocial research at the Alzheimer's Association, a partner in the effort. But because of budget constraints, only two tablets are being sent to each long-term care community.
Families report it can be difficult to schedule adequate time with loved ones when only a few devices are available. This happened to Maitely Weismann's 77-year-old mother after she moved into a short-staffed Los Angeles memory care facility in March. After seeing how hard it was to connect, Weismann, who lives in Los Angeles, gave her mother an iPad and hired an aide to ensure that mother and daughter were able to talk each night.
Without the aide's assistance, Weismann's mother would end up accidentally pausing the video or turning off the device. "She probably wanted to reach out and touch me, and when she touched the screen it would go blank and she'd panic," Weismann said.
What's needed going forward? Laurie Orlov, founder of the blog Aging in Place Technology Watch, said nursing homes, assisted living centers and senior communities need to install communitywide Wi-Fi services — something that many lack.
"We need to enable Zoom get-togethers. We need the ability to put voice technology in individual rooms, so people can access Amazon Alexa or Google products," she said. "We need more group activities that enable multiple residents to communicate with each other virtually. And we need vendors to bundle connectivity, devices, training and service in packages designed for older adults."
The predictions were dire: Coronavirus lockdowns would put millions of Americans out of work, stripping them of their health insurance and pushing them into Medicaid, the health insurance program for low-income people.
In California, Gov. Gavin Newsom's administration projected that the pandemic would force about 2 million additional people to sign up for the state's Medicaid program, called Medi-Cal, by July, raising enrollment to an all-time high of 14.5 million Californians — more than one-third of the state's population.
But July is almost over, and Medi-Cal enrollment has hovered around 12.5 million since March, when the pandemic shut down much of the economy — though enrollment ticked up in May and June, according to the latest data from the state Department of Healthcare Services, which administers the program.
Essentially, enrollment hasn't budged even though nearly 3 million Californians are newly unemployed.
"It's a mystery," said Anthony Wright, executive director of Health Access California, an advocacy group for health consumers. "We have lots of plausible explanations, but they don't seem to add up."
Even the state is stumped. The enrollment data is preliminary, and Medi-Cal officials expect the numbers to grow as eligibility appeals and other "unusual cases" are resolved, but not by 2 million people, said Norman Williams, spokesperson for the Department of Healthcare Services.
The department based its projections on the state's experience with the Great Recession a decade ago, a comparison that it now acknowledges was misguided because the pandemic did not spur a purely economic crisis. The state failed to predict people would avoid care at clinics and hospitals during this public health crisis, and thus be less likely to need coverage immediately.
"The current situation is far more complex because it involves both economic and health decisions, creating a more complicated picture more closely related to that seen during the 1918 influenza pandemic," Williams said in a prepared statement.
Even with the faulty comparison, it's not clear why more Californians haven't enrolled, he said.
"The state prepared an estimate based on the best data available, during an unprecedented and rapidly evolving situation," he said.
The miscalculation meant the state likely allocated more money to Medi-Cal than the program now needs, even as lawmakers struggled to find ways to prevent deep healthcare cuts and close a massive $54 billion budget deficit as they negotiated the 2020-21 state budget in May and June.
And a more accurate estimate could have potentially funded new programs, such as expanding Medi-Cal to unauthorized immigrants age 65 and up, some state lawmakers and advocacy groups said.
Newsom backed that expansion of Medi-Cal, estimated to cost $80.5 million in the first year, in his January budget proposal but abandoned it in May, citing California's financial crisis spurred by the pandemic.
"We are talking about life-or-death services, so to say I'm frustrated is putting it mildly," said state Sen. Holly Mitchell (D-Los Angeles), who chairs the Senate budget committee and leads budget negotiations in the upper house. "It's irritating to me that they can be so off."
The new state budget puts Medi-Cal's overall cost at $115 billion, of which $2.4 billion in state money has been earmarked for caseload growth. Yet it's unclear how much of that could have been available to fund other programs or stave off cuts had the caseload projection been more accurate, department officials acknowledged.
Most states predicted their Medicaid enrollment would rise due to the pandemic, though many are seeing similar delays in Medicaid sign-ups, said Cindy Mann, a partner at the legal and consulting firm Manatt Health who served as federal Medicaid director for the Centers for Medicare & Medicaid Services during the Obama administration.
Washington state, like California, hasn't seen its Medicaid caseload grow as expected, said MaryAnne Lindeblad, its Medicaid director. It projected up to 95,000 people would join the program by now, yet it has seen 80,000 new enrollees since March.
"It's been a little bit surprising," she said. "There's so much going on in people's lives right now and signing up for Medicaid doesn't seem to be one of them."
Yet a record number of Americans have lost health insurance as a result of the COVID-19 pandemic and corresponding economic crash, according to a new report from Families USA, a national health advocacy group. California experienced the largest increase in newly uninsured residents of any state so far when an estimated 689,000 people lost coverage between February and May this year, the study shows.
"It's a different kind of downturn and that might explain some of the reason we're seeing lags across the country," Mann said. "But unless unemployment numbers turn around dramatically, which is not the prediction, I think we will see the number of uninsured people continuing to grow and turn to the program."
There are several theories about why Californians who have lost their jobs during the pandemic have not yet enrolled in Medi-Cal.
For one, signing up for food and housing assistance appears "more urgent" than signing up for Medi-Cal, Williams said.
The pandemic has also created new sign-up hurdles. With libraries, schools, community centers and county healthcare offices largely closed during lockdowns, uninsured residents have had fewer places to enroll. Hospitals and clinics also frequently enroll uninsured people into the program, but many healthy people are avoiding treatment for fear of being infected with COVID-19.
And those who have lost jobs may still have work-based coverage because employers planned to rehire them and kept them on job-based insurance plans, or because they've signed up for COBRA insurance temporarily.
Enrollment could also be lagging because the service industry has been hit hard, and many low-income workers in restaurants, bars or salons were already enrolled in Medi-Cal.
"About a quarter who were at risk of losing jobs were already enrolled when the crisis started," said Laurel Lucia, director of healthcare programs at the Center for Labor Research and Education at the University of California-Berkeley.
Vanessa Poveda, 28, wasn't among the service workers already enrolled in Medi-Cal when the crisis hit. Instead, she had health insurance through her job as a server at Bartlett Hall, an upscale gastropub near San Francisco's Union Square.
When Poveda was laid off during the first round of coronavirus closures in March, the restaurant extended her health coverage for 30 days before it expired, she said. Now unemployed and uninsured, she thinks she probably qualifies for Medi-Cal but hasn't signed up.
"I haven't really gotten around to it," she said.
Because Poveda is relatively healthy, she said, enrolling in coverage isn't as urgent as some of her other needs.
"Medical insurance is definitely a top priority for me," she said, "but I also need a roof over my head."
In California, another factor may be at play. The Trump administration's "public charge" policy may be having an outsize impact on Medi-Cal enrollment because of the state's large immigrant population, said Hamutal Bernstein, a researcher at the Urban Institute. The rule allows federal immigration officials to more easily deny permanent residency status to those who depend on certain public benefits such as Medicaid.
"A lot of immigrant families are being disproportionately impacted by economic and health hardship and are increasingly needing some of this assistance," Bernstein said. But "a lot of people are afraid of getting any kind of help."
Federal rules also prevent the state from kicking anyone off Medicaid during the pandemic, which means people who normally would have fallen off the program will stay enrolled, contributing to the state's inflated projections, Williams said.
The department said it is working to get out the word that Medi-Cal is available, but Mitchell is urging the state to do more.
"I'm concerned not enough outreach is being done," she said. "We expect people to magically know they may qualify for Medi-Cal and they should go online and apply."
HELENA, Montana — States frustrated by private laboratories' increasingly long turnarounds for COVID-19 test results are scrambling to find ways to salvage their testing programs.
Montana said Wednesday that it is dropping Quest Diagnostics, one of the nation's largest diagnostic testing companies. The Secaucus, New Jersey-based company had done all the state's surveillance COVID-19 testing — drive-thru testing that moves from community to community to help track COVID's spread. But it told state officials last week that it was at capacity and would be unable to accommodate more tests for two or three weeks.
"We don't want to be left high and dry again in the event that the national demand for testing puts a state like ours onto the back burner," Democratic Gov. Steve Bullock said.
Instead, he said, the state is enlisting Montana State University's lab to process up to 500 tests a day and has finalized a contract with a new private lab, North Carolina-based Mako Medical, for an additional 1,000 tests a day.
California, Florida and other states that work with Quest have started experimenting with separate, expedited lines for people who have symptoms of the disease. Some states are contracting with other private labs. And CVS, which uses Quest for COVID tests at many of its sites nationwide, said it is looking for more lab partners to reduce wait times for results.
Quest, LabCorp and other private labs have struggled to expand quickly enough to meet demand as states expand their testing and cases soar across the nation. Officials for Quest, which handles about 130,000 tests daily in 20 laboratories, said its ability to expand has been limited by a global shortage of the machines and chemical reagents needed to perform COVID-19 testing.
On Monday, Quest announced that turnaround times had slowed to a week or more, up from three or four days in June. It also said some patients may face wait times of up to two weeks. Quest officials warned this week that could get worse as flu season starts this fall.
A wait of a week or more for results can make the tests moot, since few people, especially those without symptoms, are likely to remain quarantined that long — and if the test comes back positive, they may already be over the disease.
"We are working with a number of different organizations to provide as much testing as possible, but some of these constraints are out of our control," Quest spokesperson Wendy Bost said. "We've taken the step of asking our clients to modulate the testing demand by focusing on patients who are most in need at this time."
The Trump administration is also trying to speed up turnaround times by allowing some labs to use an approach known as pooled testing, which combines samples from multiple people and then screens the individual samples only if the batch comes back positive for the virus. But public health experts worry it may be too late to try pool testing, as the percentage of positive results has doubled or tripled in many parts of the country.
States grappling with rising caseloads amid the testing slowdown have grown exasperated. Colorado Gov. Jared Polis, a Democrat, told NBC's "Meet the Press" on Sunday that it can take up to nine days to get test results from Quest and LabCorp.
"Almost useless from an epidemiological or even diagnostic perspective," Polis said.
LabCorp officials say turnaround times are improving.
Those who worry they have COVID-19 are also frustrated. In San Francisco, Mark Mackler, a 71-year-old retired law librarian, went with his husband to get a free test at the Bernal Heights Recreation Center on June 28 for peace of mind. He expected results after five days, but the test, processed by Quest, took 16 days — it came back negative for COVID-19.
"I was just annoyed and concerned the taxpayers were getting taken for a ride on something expensive and useless to a lot of people," Mackler said.
In California, Democratic Gov. Gavin Newsom acknowledged Quest's slow turnaround times at a press conference Wednesday.
"It's rather preposterous that you get a test and 13, 14 days later you get the results," Newsom said, adding that the results in those cases are "utterly meaningless."
But, he added, "We're not going to abandon Quest. We need them as one of our partners."
California is partnering with other private and university labs to expedite test results, ramping up from 2,000 tests a day early in the pandemic to an average of more than 125,000 a day, Newsom said. Test results now average between five and seven days, and state health officials said they have told all labs to first process from high-risk groups, such as people with COVID symptoms, those in hospitals and those in long-term care facilities.
In Florida, Quest has performed more than 600,000 COVID tests, the most of any lab. After reports of labs taking seven to 10 days to turn around test results, health officials created special lanes at four testing sites for symptomatic people that will allow them to receive their results faster. If that program goes well, Florida officials said, it will be expanded to all 50 state-run sites.
Pennsylvania health officials plan to cut the number of drive-thru testing sites it runs with Quest and Walmart from 19 to 13. They also are relocating some site locations that have seen low testing numbers to more populated areas with higher positivity rates.
Weeklong waits for COVID tests are not the norm everywhere. In Texas, state-run mobile test sites are providing results within two to three days because the state has "spread the load" of testing among many lab companies, said Seth Christensen, spokesperson for the Texas Division of Emergency Management. The state does not use Quest but instead uses more than 10 other lab companies, including LabCorp, another of the nation's largest lab chains.
Return times vary widely by company. LabCorp said turnaround time for outpatient test results improved to three to five days this week from four to six last week. BioReference Laboratories, another big lab chain, said it has improved turnaround time from about six days in June to three or fewer this month. Walmart, which has used Quest and eTrueNorth for more than 150,000 COVID tests, said on its website that Quest results take a week, compared with three to five days with eTrueNorth.
In Montana, the Quest delays forced the state to pause its community testing program, which aims to serve as an alert system for how the virus is spreading. Officials plan to resume next week once it has Montana State and the North Carolina lab in place, Bullock said.
Montana, with 2,813 confirmed cases as of Tuesday, has one of the lowest per-capita rates in the nation. But the average daily caseload in the state has risen 112% in the past two weeks — the country's third-highest rate increase, according to an analysis by NPR.
Quest started running the state's mass-testing events in the spring, with promised turnaround times of two or three days. But that started to stretch into a week or longer, Bullock said.
Bost, the Quest spokesperson, described the delay in community testing as a temporary agreement with state officials.
"We mutually agreed to postpone some community events for the general population in order to ensure testing is available for the patients who are most in need, such as those who are symptomatic and ill in the hospital," she said.
Montana hasn't canceled its contract with Quest, but state officials said they are unsure whether the state will resume using the company.
"We can meet the need that we have in Montana with these two solutions," Bullock said, referring to the Montana State University and North Carolina laboratories. "But that doesn't mean that we won't be returning to Quest at some point."
KHN correspondent Rachel Bluth contributed to this report.
Research already shows that germicidal UV can effectively inactivate airborne microbes that transmit measles, tuberculosis and SARS-CoV-1, a close relative of the novel coronavirus.
This article was first published on Wednesday, July 22, 2020 in Kaiser Health News.
High up near the ceiling, in the dining room of his Seattle-area restaurant, Musa Firat recently installed a "killing zone" — a place where swaths of invisible electromagnetic energy penetrate the air, ready to disarm the coronavirus and other dangerous pathogens that drift upward in tiny, airborne particles.
Firat's new system draws on a century-old technology forfending off infectious diseases: Energetic waves of ultraviolet light — known as germicidal UV, or GUV — are delivered in the right dose to wipe out viruses, bacteria and other microorganisms.
Research already shows that germicidal UV can effectively inactivate airborne microbes that transmit measles, tuberculosis and SARS-CoV-1, a close relative of the novel coronavirus. Now, with concern mounting that the coronavirus that causes COVID-19 may be easily transmittedthrough microscopic floating particles known as aerosols, some researchers and physicians hope the technology can be recruited yet again to help disinfect high-risk indoor settings.
"I thought it was a great idea, and I want my customers to be safe," said Firat whose casual eatery, Marlaina's Mediterranean Kitchen, is 20 minutes south of downtown Seattle.
As the U.S. grapples with how to interrupt the spread of the highly infectious virus, UV is being used to decontaminate surfaces on public transit and in hospitals where infectious droplets may have landed, as well as to disinfectN95 masks for reuse. But so far using this technology to provide continuous air disinfection has remained outside of most mainstream, policy-setting conversations about the coronavirus.
Experts attribute this to a combination of factors: misconceptions about UV's safety, a lack of public awareness and technical know-how, concerns about the costs of installing the technology, and a general reluctance to consider the role of aerosols in the spread of the coronavirus.
Aerosols are microdroplets expelled when someone exhales, speaks or coughs. Unlike the larger and heavier respiratory droplets that fall quickly to the ground, aerosols can linger in the air a long time and travel through indoor spaces. When someone catches a virus this way, the process is called "airborne transmission."
It's already recognized that the coronavirus can spread by means of aerosols during medical procedures, which is why healthcare workers are advised to wear respirators, such as N95 masks, that filter out these tiny particles. Yet there is still considerable debate over how likely the virus is to spread in other settings via aerosols.
Recently, the question of airborne transmission gained new urgency when a group of 239 scientistscalled on the World Health Organization to take the threat of infectious aerosols more seriously, arguing that the "lack of clear recommendations on the control measures against the airborne virus will have significant consequences."
WHO officials conceded that more research is needed but maintained that most infections do not happen this way.
As the science continues to evolve, UV could emerge as an attractive safeguard against airborne transmission — one with a track record against pathogens — that can be deployed to reduce the risk of infectious aerosols accumulating in indoor settings such as schools and businesses.
Welcome to the 'Killing Zone'
At Marlaina's restaurant, there are just two visible clues of the new UV disinfection system — a subtle glow of blue light above the black grates of the drop ceiling, and a hand-chalked sign at the door, proudly announcing to diners: "Coronavirus Disinfected Here!"
The system was installed while the restaurant was closed during Washington state's lockdown. The setup is known as "upper-room germicidal UV" because the UV fixtures are mounted high and angled away from humans below.
Ceiling fans circulate the air, eventually pushing any suspended viral particles that have accumulated in the dining space through the grated drop ceiling, to the area where UV lights, positioned horizontally, blast them with radiant energy.
The inspiration and technical assistance for Marlaina's owner came from customer Bruce Davidson, a pulmonary physician who was Philadelphia's "tuberculosis czar" in the mid-'90s. Back then, the U.S. was grappling with a new outbreak of TB that included strains resistant to existing drugs.
"Preventing transmission was the most important part, because we had no drugs, no vaccine," recalled Davidson, who now lives outside Seattle. UV light proved to be a key strategy back then, and Davidson thinks it can help again: "It really ought to be in most indoor public spaces now."
To demonstrate the concept, Davidson lit a cigar inside Marlaina's and showed how the smoke danced upward, collecting in the ceiling space with the UV fixtures.
"If somebody has undetected coronavirus and doesn't eat with a mask and is talking and so on, the vast majority of their particles are going to get pulled up there into the killing zone and circulate and bounce around," Davidson said. "Statistically, the risk to other people is going to be very low."
Research shows close to 90% of airborne particles from a previous coronavirus (SARS-CoV-1) can be inactivated in about 16 seconds when exposed to the same strength of UV as in the restaurant's ceiling. Other viruses, such as the adenovirus, are more resistant and require a higher dose of UV.
"Although it's not perfect, it probably offers the best solution for direct air disinfection" in the current pandemic, said David Sliney, a faculty member at Johns Hopkins University and longtime researcher on germicidal UV.
When used with proper ventilation, upper-room GUV is about 80% effective against the spread of airborne tuberculosis,according to several studies. This is equivalent to replacing the air in a room up to 24 times an hour.
But widespread adoption of UV systems could be an uphill battle, Sliney said, because in the U.S., interest in using UV for air disinfection has waned in recent decades as scientists focused their attention on powerful vaccines and drugs to deal with infectious diseases.
Understanding Aerosols and Airborne Transmission
UV can be a powerful weapon against an airborne virus, but it can go only so far toward preventing infection. People can still get sick from the larger, heavier droplets ejected via coughs and sneezes. They can directly inhale those droplets or touch a surface contaminated with them, and then touch their eyes, nose or mouth.
UV also does not prevent someone from being exposed to infectious aerosols that have just emerged from an infected person — and are lingering quite near his or her body — what researcher Richard Corsi called the "near field."
"In that scenario, you're inhaling a very concentrated cloud of these tiny particles that you can't see," said Corsi, dean of the Maseeh College of Engineering & Computer Science at Portland State University. "You're getting a pretty significant dose in your respiratory system."
So, even if there is upper-room UV in a building, Corsi said, face masks and social distancing are still necessary to block larger respiratory droplets and remove some of the aerosols in the near field. But Corsi said there's now enough evidenceto show that coronavirus aerosols can hang in the air and spread throughout a room ("the far field"), and it's time to take that airborne spread seriously.
One example of far-field transmission is documented in a study of a restaurant in China at which some diners seated at neighboring tables contracted the COVID-19 virus despite never coming into close contact with the "index case-patient." Another piece of evidencecame from a March 10 choir practice in Mount Vernon, Washington, after which the majority of singers contracted the coronavirus, even though members of the group took precautions to use hand sanitizer and avoid hugs and handshakes.
In their letter to WHO, scientists note that the coronavirus that causes MERS can spread through aerosols, and "there is every reason to expect that [the COVID virus] behaves similarly."
Understanding the Technology and Safety
Germicidal UV harnesses a portion of the electromagnetic spectrum that contains short waves of radiant energy, called UV-C. This wavelength is further away from the visible spectrum than other forms of UV light.
Think of it as giving the virus a lethal sunburn.
"We have very little practical experience to show how effective it can be [in a pandemic] since it's been out of use in this country and in Western Europe," said Sliney of Johns Hopkins, who chairs a committee with the Illuminating Engineering Society, which recently released new guidance on GUV.
Sliney recommends installing UV in big-box stores, restaurants and grocery stores, which typically have high ceilings. "There needs to be vertical air exchange," he said, as with ceiling fans, so "it's not just sterilizing the air in the upper space of the room."
"No one doubts the efficacy of germicidal UV in killing small microorganisms and pathogens. I think the bigger controversy, if there is any, is misperceptions around safety," said Dr. Edward Nardell, a professor at Harvard Medical School who researches GUV.
Low-dose germicidal UV can damage the eyes and skin, but Nardell said those risks can be avoided by following the appropriate guidelines. While international guidelines warn against directly exposing humans to UV-C, the risks of skin cancer are considered negligible, especially compared with longer wavelengths of UV that can penetrate more deeply.
Could UV Make a Comeback?
With interest in UV climbing, there is concern about shoddy products on the market and exaggerated claims about their effectiveness against the virus, said Jim Malley, a professor at the University of New Hampshire who studies public health and disinfection.
Consumers should be wary of marketing claims about "UV wands" that can be waved quickly over surfaces or special "portals" that people walk through, he said, because those are probably not correctly calibrated to inactivate the virus and could be dangerous.
Malley said he does not think there's much of a viable market for upper-room GUV outside healthcare settings, but he supports installing the technology in the most high-risk settings, such as meatpacking plants and nursing facilities.
"My gut feeling is we should do anything we can in those places, because we have a horrendous fatality record" with the coronavirus, he said.
At Marlaina's restaurant, the installation was relatively straightforward.
The owner, Firat, purchased four UV fixtures (at $165 each), hired an electrician to install the fans and bought black gridded plastic panels to enclose the ceiling space where the UV is mounted.
Firat still encourages his customers to wear masks and maintain social distance. But he said the UV has become part of the ambiance.
"It's more modern and clean, and the response is great, absolutely great," he said.
This story is part of a partnership that includes NPR and Kaiser Health News.
NIH researchers are trying to get a better sense of how socioeconomic factors like income, family structure, diet and access to health care affect COVID infections and outcomes.
This article was first published on Tuesday, July 21, 2020 in Kaiser Health News.
While the disproportionate impact of COVID-19 on Black and Hispanic Americans is no secret, federal officials have launched studies of the disparity that they hope will better prepare the country for the next great epidemic.
The National Institutes of Health began the ambitious “All of Us” research project in 2018 with the goal of enrolling at least a million people in the world’s most diverse health database. Officials saw it as an antidote to medical research that traditionally has skewed heavily white, well-off and male.
Amid a wavering federal response that has allowed staggering levels of disease to sweep the country, the NIH program is a potential bright spot. About 350,000 people have consented to be part of the project, and more than 270,000 of them have shared their electronic health records and submitted blood or DNA samples. Of the latter, more than half are members of minority groups, and 81% are from traditionally underrepresented groups in terms of socioeconomic background, sexual identity or other categories, according to NIH.
NIH researchers are trying to get a better sense of how socioeconomic factors like income, family structure, diet and access to health care affect COVID infections and outcomes. The hope is to come up with insights that will better prepare the country, especially its Black and Hispanic communities, for the next pandemic.
The participants’ blood and DNA samples, and access to their electronic health records, offer researchers a trove of data about the pandemic’s effect on minorities. As part of the program, NIH has promised to return research results to all participants in plain language.
In a sense, “All of Us was designed for COVID-19,” said Hugo Campos, a program participant and ambassador who lives in Oakland, California. “If we can’t deliver value to participants now, we might as well just forget it.”
The NIH constructed All of Us with the expectation “that something like COVID-19 could come,” said Josh Denny, the project’s chief executive officer.
All of Us, started by NIH Director Francis Collins under President Barack Obama, aims to answer questions that will allow health care to be tailored to individuals based on their unique genetics, environmental exposures, socioeconomics and other determinants of health. Now, scientists are tapping into its database to ask how factors like isolation, mental health, insurance coverage and work status affect COVID-19 infections and outcomes.
The first NIH study employing the database, already underway, will conduct antibody testing on the blood of at least 10,000 program volunteers, starting with those who joined most recently and going back in time to determine when COVID-19 entered the U.S.
Beginning in early May, All of Us has distributed monthly surveys to participants, via email or text, inquiring about stress levels associated with social distancing, work habits and environments, mask-wearing and hand-washing. It’s also asking whether participants have had COVID-19 symptoms or have been tested, and includes queries about insurance coverage, drug use and mental health status.
Another study will provide researchers with de-identified data, including antibody test results and digital health information, to study whether symptoms vary among people who have tested positive for COVID-19 depending on their ethnicity, socioeconomic status and other categories.
Federal data shows that Black seniors have been four times as likely, and Latino seniors twice as likely, to be hospitalized with COVID-19 as white seniors. It’s understood that structural racism and socioeconomic differences contribute to this gap, but All of Us hopes to help pinpoint reasons and potential solutions.
The minorities who’ve experienced the poorest COVID-19 outcomes are well represented in the All of Us research cohort, said Denny. “We will really be able to layer a number of kinds of information on what’s happening to different populations and try to drive at some of that ‘Why?’ Are there genetic differences, differences in prior medical history, timing of testing?”
One of the precepts of All of Us is to share the results of its studies with participants as well as involve them in study designs. NIH hired leaders of churches, community organizations and other grassroots groups to spread the word on the program.
The largely Spanish-speaking clientele at San Ysidro Health, a federally qualified health center based in San Diego, has been eager to participate in the COVID-19 research, said Fatima Muñoz, the health system’s director of research and health promotion. Most of the All of Us participants she helped recruit prefer in-person interactions, but they are adapting to the pandemic’s online requirements, she said.
“There is historically a well-founded mistrust amongst some diverse populations and communities of color in biomedical research,” said Denny. “We can’t control history but can try to engage authentically going forward.”
The Black Lives Matter protest movement has pushed the program’s leaders to do more for its diverse participants, Denny said.
“It’s caused us to think more of how we can promote diversity in researchers, which had not been as much of a focus,” he said. “It has heightened some of the urgency and importance of what we’re doing. It’s a great call to action.”
The All of Us program is funded with $1.5 billion over 10 years through the 21st Century Cures Act of 2016. Denny said he expects results from the antibody testing, an $850,000 project that was contracted out to Quest Diagnostics, to be published this year, with insights from the surveys published after that.
The All of Us database provides unparalleled access to information on research groups whose level of harm by the virus would have been hard to predict, said Dr. Elizabeth Cohn, a professor of nursing at Hunter College in New York. Cohn is a community engagement lead for All of Us and chairs its publications committee.
“This is the demonstration of why we built this platform,” said Cohn. “This is a big moment for All of Us because this is what it was built to do.”
The pandemic has made it even clearer why it’s necessary to have a multicultural base for health research, said Dr. Randall Morgan, executive director of the W. Montague Cobb/National Medical Association Health Institute, an All of Us partner.
“When we get to 1 million, we hope to still have that level of representation,” he said.