With supplies of covid-19 vaccines scarce, a federal advisory panel recommends first putting shots into the arms of health care workers, who keep the nation’s medical system running, and long-term care residents most likely to die from the coronavirus.
Nowhere on the list of prioritized recipients are public officials’ spouses.
Yet the first ladies of Kentucky and West Virginia; Republican Vice President Mike Pence’s wife, Karen Pence; Democratic President-elect Joe Biden’s wife, Jill Biden; and Vice President-elect Kamala Harris’ husband, Doug Emhoff, were among the first Americans to get the potentially lifesaving shots.
Kentucky also vaccinated six former governors and four former first ladies, including current Democratic Gov. Andy Beshear’s parents.
The early vaccinations of political spouses spurred outrage on social media, with several Twitter users saying they should not be able to “jump the line” ahead of doctors, nurses and older people.
In most of the 29 states that responded to KHN inquiries of all 50 governors’ offices, top elected officials said they — and their spouses — will be vaccinated but have chosen to wait their turn behind more vulnerable constituents. Some Congress members from both parties said much the same when they refused early doses offered in the name of keeping the government running. Those weren’t offered to their spouses.
Governors who got the shots along with their spouses, and the vice president’s office, said they wanted to set an example for residents, build trust, bridge ideological divides and show that the vaccine is safe and effective.
But that’s a rationale some critics don’t buy.
“It looks more like cutting in line than it does securing trust. The politicians can get the hospitals to give it to them under this illusion of building trust. But it’s a façade,” said Arthur Caplan, a bioethics professor and founding head of the medical ethics division at New York University Grossman School of Medicine. “People might say: ‘Yup, typical rich people. They can’t be trusted.’ This undermines what they set out to do.”
Besides, Caplan said, the public doesn’t trust politicians all that much anyway, so inoculating celebrities, religious leaders or sports figures would likely do more to boost confidence in the vaccine. Rock ’n’ roll king Elvis Presley famously got the polio vaccine in 1956 to help win over those who were skeptical; the actions of governors’ wives from that period are less remembered.
Dr. José Romero, chairperson of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, said in an email to KHN that while his group provides an outline for distributing limited vaccine doses, “jurisdictions have the flexibility to do what’s appropriate for their population.” Kentucky and Texas officials pointed out that CDC Director Dr. Robert Redfield encouraged governors to publicly get the vaccine.
No one mentioned medical reasons for their spouses to get vaccines; hospitals are generally not vaccinating the spouses of medical professionals who have gotten the shot. (It’s unclear whether vaccinated people can still spread the virus, so it’s possible that a vaccinated person could pass the virus to their spouse or have to quarantine if an unvaccinated spouse were to get covid.)
The office of West Virginia’s governor, Republican Jim Justice, released pictures of him, his wife, Cathy Justice, and other officials receiving shots. He also showed his own vaccination on YouTube.
Beshear’s office in Kentucky also released photos of him getting the vaccine in December on the same day as his wife, Britainy Beshear, and other state officials.
“There is no question that there is vaccine hesitancy out there,” Beshear said at a coronavirus briefing on Monday, the day former Kentucky governors and their spouses were vaccinated. He alluded to a future program involving faith leaders and others. “Validators are incredibly important to building that confidence.”
His father, Democratic former Gov. Steve Beshear, posted photos of his vaccination on his Facebook page, saying that he and his wife, Jane Beshear, along with other former Kentucky governors of both parties and their spouses, stepped up partly to show residents the vaccine is safe and encourage them to get it when it’s available to them.
Kentucky is currently in the first stage of vaccine distribution, which targets health care workers and residents of long-term care and assisted living facilities. Fewer than 15,000 of the 58,500 doses received for long-term care had been given out when the former governors and their spouses were vaccinated.
Tres Watson, a former communications director for the Republican Party of Kentucky who founded a political consulting firm, was skeptical about the intentions behind the event. He said it seemed to be a public relations effort created so the governor could vaccinate his parents.
“I understand the continuity of government, but first ladies have no part in the continuity of government,” he said. “You need to stick with the priorities. Once you start making exceptions, that’s when you run into problems.”
Officials representing the Biden-Harris transition team and three other states where governors got vaccinated — Republican-led West Virginia and Texas, and Democratic-led Kansas — either didn’t respond to KHN or didn’t answer questions about spouses. Alabama’s Republican governor, Kay Ivey, got the vaccine and is divorced.
Politicians in other states have taken the opposite tack.
In Arkansas, Republican Gov. Asa Hutchinson is focused on ensuring high-priority groups such as health care workers, long-term care staffers and residents are vaccinated, said spokesperson LaConda Watson. “He and his wife will receive the vaccination when it’s their turn,” she said.
In Missouri, Kelli Jones, communications director for Republican Gov. Mike Parson, said in an email that he and the first lady fully intend to get the vaccine. Like governors from Colorado, Nevada and elsewhere, they’ve both recovered from covid-19, Jones said, and will “wait until their age group is eligible” under the state plan. Doctors recommend vaccinations even for people who have already had covid.
Cissy Sanders, 52, an events manager who lives in Austin, Texas, said she understands why lawmakers would need to get the vaccine. Her own governor, Republican Greg Abbott, received it on live television to instill confidence, said his press secretary, Renae Eze, who wouldn’t address whether Abbott’s wife was vaccinated.
But Sanders said politicians’ spouses should not be vaccinated before nursing home residents like her 71-year-old mom. Sanders’ mother received the vaccine in late December — after some public officials’ spouses — but she said far too many nursing home residents across America are still waiting.
“Why is a non-high-risk group — i.e., these spouses — going before the most high-risk group? Who makes these decisions? Who thinks this is a good, responsible, safe decision to make?” she said. “Political spouses have not been at ground zero for the virus. Nursing home residents have been.”
KHN Montana correspondent Katheryn Houghton, California Healthline correspondent Angela Hart and KHN senior correspondents Markian Hawryluk and JoNel Aleccia contributed to this report.
The approval is a 10-year "experiment." Instead of the open-ended federal funding that rises with higher enrollment and health costs, Tennessee will instead get an annual block grant.
This article was published on Friday, January 8, 2021 in Kaiser Health News.
With just a dozen days left in power, the Trump administration on Friday approved a radically different Medicaid financing system in Tennessee that for the first time would give the state broad authority in running the health insurance program for the poor in exchange for capping its annual federal funding.
The approval is a 10-year “experiment.” Instead of the open-ended federal funding that rises with higher enrollment and health costs, Tennessee will instead get an annual block grant. The approach has been pushed for decades by conservatives who say states too often chafe under strict federal guidelines about enrollment and coverage and can find ways to provide care more efficiently.
The approval, however, faces an uncertain future because the incoming Biden administration is likely to oppose such a move. But to unravel it, officials would need to set up a review that includes a public hearing.
Meanwhile, the changes in Tennessee will take months to implement because they need final legislative approval, and state officials must negotiate quality of care targets with the administration.
TennCare, the state’s Medicaid program, said the block grant system would give it unprecedented flexibility to decide who is covered and what services it will pay for.
It said the new arrangement would allow the state to keep part of the money it saves from operating the program more efficiently. Trump administration officials said the approach adds incentive for the state to save money, unlike the current system, in which increased state spending is matched with more federal dollars. If Medicaid enrollment grows, the state can secure additional federal funding. If enrollment drops, it will get less money.
“This groundbreaking waiver puts guardrails in place to ensure appropriate oversight and protections for beneficiaries, while also creating incentives for states to manage costs while holding them accountable for improving access, quality and health outcomes,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services. “It’s no exaggeration to say that this carefully crafted demonstration could be a national model moving forward.”
Opponents, including most advocates for low-income Americans, say the approach will threaten care for the 1.4 million people in TennCare, which includes children, pregnant women and the disabled. Federal funding covers two-thirds of the cost of the program.
Michele Johnson, executive director of the Tennessee Justice Center, said the block grant approval is a step backward for the state’s Medicaid program.
“No other state has sought a block grant, and for good reason. It gives state officials a blank check and creates financial incentives to cut health care to vulnerable families,” she said.
Democrats have fought back block grant Medicaid proposals since the Reagan administration and most recently in 2018 as part of Republicans’ failed effort to repeal and replace major parts of the Affordable Care Act. Even some key Republicans opposed the idea because it would cut billions in funding to states that would make it harder to help the poor.
Implementing block grants via an executive branch action rather than getting Congress to amend Medicaid law is also likely to be met with court challenges.
The block grant approval comes as Medicaid enrollment is at its highest ever level.
More than 76 million Americans are covered by the state-federal health program, a million more than when the Trump administration took charge in 2017. Enrollment has jumped by more than 5 million in the past year as the economy slumped with the pandemic.
Medicaid, part of President Lyndon B. Johnson’s “Great Society” initiative of the 1960s, is an entitlement program in which the government pays each state a certain percentage of the cost of care for anyone eligible for the health coverage. As a result, the more money states spend on Medicaid, the more they get from Washington.
Under the approved demonstration, CMS will work with Tennessee to set spending targets that will increase at a fixed amount each year.
The plan includes a “safety valve” to increase federal funding due to unexpected increases in enrollment.
“The safety valve will maintain Tennessee’s commitment to enroll all eligible Tennesseans with no reduction in today’s benefits for beneficiaries,” CMS said in a statement.
Tennessee has committed to maintaining coverage for eligible beneficiaries and existing services.
In exchange for taking on this financing approach, the state will receive a range of operating flexibilities from the federal government, as well as up to 55% of the savings generated on an annual basis when spending falls below the aggregate spending cap and the state meets certain quality targets, yet to be determined.
The state can spend that money on various health programs for residents, including areas that Medicaid funding typically doesn’t cover, such as improving transportation and education and employment.
The 10-year waiver is unusual, but the Trump administration has approved such long-term experiments in recent years to give states more flexibility.
Tennessee is one of 12 states that have not approved expanding Medicaid under the Affordable Care Act that’s left tens of thousands of working adults without health insurance.
“The block grant is just another example of putting politics ahead of health care during this pandemic,” said Johnson of the Tennessee Justice Center. “Now is absolutely not the time to waste our energy and resources limiting who can access health care.”
State officials applauded the approval.
“It’s a legacy accomplishment,” said Tennessee Gov. Bill Lee, a Republican. “This new flexibility means we can work toward improving maternal health coverage and clearing the waiting list for developmentally disabled.”
“This means we will be able to make additional investments in TennCare without reduction in services and provider cuts.”
KHN chief Washington correspondent Julie Rovner contributed to this report.
In recent weeks, it’s not just the number of positive cases that has increased, overwhelming the capacity of case investigators — so has the number of contacts that each infected person has.
This article was published on Friday, January 8, 2021 in Kaiser Health News. This story also ran on NPR.
The contact tracers of Washtenaw County in Michigan have been deluged with work and, to cope, the overburdened health department has a new tactic: It is asking residents who test positive for covid-19 to do their own contact tracing.
Washtenaw is a county of nearly 350,000 residents who live in and around the city of Ann Arbor, about 45 minutes from Detroit. Until mid-October, a county team of 15 contact tracers was managing the workload. But by Thanksgiving, more than 1,000 residents were testing positive for the coronavirus every week, and the tracers could not keep pace.
In Washtenaw County, the process starts with people called case investigators, who receive lab reports of positive coronavirus tests. Their job is to call anyone who has tested positive, tell them they need to isolate and ask them for the names of people with whom they have had close contact. After creating a list of potentially exposed “contacts,” investigators pass it to a new team to start the actual contact tracing. As the number of positive cases builds, the number of calls tracers must make swells.
But in recent weeks, it’s not just the number of positive cases that has increased, overwhelming the capacity of case investigators — so has the number of contacts that each infected person has, said contact tracer Madeline Bacolor.
“There’s just so many more people that are gathering and that are exposed,” she said. “It used to be, we had a case, and maybe that person had seen two people, and now it’s a whole classroom full of day care students or a whole workplace.”
The work to keep people who have been exposed to the virus away from people who have not is crucial, said public health professor Angela Beck, because it breaks viral transmission chains and prevents the virus from spreading unchecked through a community.
Beck teaches at the University of Michigan and runs the campus program for tracing coronavirus exposures among students.
When you’re trying to contain an infectious disease, she said, running out of contact tracers is “not a situation that you want to be in.”
But it’s happening now in health departments in Michigan and around the U.S. where contact tracing workforces have grown, but not fast enough to keep pace with the pandemic’s spread.
As a result, health departments are asking some residents with covid to reach out to their contacts on their own.
Trying ‘a Compromised Strategy’
Once billed as one of the fundamental tools for stemming the spread of the virus, contact tracing has fallen apart in many regions of the country. It’s a systematic breakdown that Lawrence Gostin, a professor of global health law at Georgetown University, said hasn’t happened since the spread and stigma of HIV and AIDS in the 1980s and ’90s.
In Michigan’s rural Upper Peninsula, a public health district spanning five counties warned residents that its tracers were overwhelmed and that they might not receive a call at all, despite testing positive. Health workers would need to focus their efforts on residents 65 and older, teens and children attending school in person, and people living in group settings.
In Michigan’s southwestern corner, contact tracers in Van Buren and Cass counties can no longer keep up with their calls. It’s the same situation in Berrien County: “If you test positive, take action immediately by isolating and notifying close contacts,” the county health officer urged residents in a press release.
Health officials have taken similar actions in all regions of the country, including Oregon, North Dakota, Ohio and Virginia.
Within many health departments, the shortage of contact tracers has been exacerbated by the communications challenge of relaying a recent change in quarantine guidance from the Centers for Disease Control and Prevention — it reduced the quarantine period from 14 days to 10 for some individuals exposed to the virus.
The idea behind the change was that the risk of transmission after 10 days of quarantine was low, and shorter quarantine periods might increase people’s willingness to comply with the orders. But the shift also meant that contact tracers had to spend time learning and explaining the new procedures just when caseloads were exploding.
“It makes things more confusing,” said Bacolor, the contact tracer in Washtenaw County. “People might be hearing something different from their job or school than they are from the health department.”
Asking infected people, some of whom might be sick, to call their own friends and families — in effect, conduct their own contact-tracing operation — is far from ideal, public health experts said.
“It is a last-resort tool,” said Beck, the University of Michigan professor. “It is the best that we can do in the situation that we’re in, but it’s a compromised strategy.”
Contact tracing is more than just alerting people to a potential exposure so they can quarantine. Part of the process is to conduct carefully structured interviews with those exposed, to determine if they’ve developed symptoms of covid-19. If so, contacts of those people also need to be traced and told to quarantine, to prevent the virus from proliferating through successive chains of people in the community.
Trained contact tracers also often ask valuable questions to learn more about how the virus was transmitted from person to person so that local health officials can piece together an understanding about which settings and activities seem particularly likely to promote spread — in-person choir rehearsals and crowded bars, for example — and which are unlikely to generate outbreaks.
Contact tracing is a key part of a tried-and-true strategy known as “test, trace and isolate.” Public health professor Beck said the strategy has been used allovertheworld and it works — when there are enough people and enough time to do it properly.
And she said effective contact tracing can help mitigate the economic pain of a pandemic because it means that only people with known exposures to the virus must stay away from workplaces and school and refrain from other activities.
But success requires significant investment in public health infrastructure, something that Beck and other researchers said has been lacking for decades in the U.S.
Executive orders issued by the president can be summarily overturned by a new executive order. Agency "guidance" can similarly be written over, although the Trump administration has worked to make that more onerous.
This article was published on Friday, January 8, 2021 in Kaiser Health News.
The party split in Congress is so slim that, even with Democrats technically in the majority, passing major healthcare legislation will be extremely difficult. So speculation about President-elect Joe Biden's health agenda has focused on the things he can accomplish using executive authority. Although there is a long list of things he could do, even longer is the list of things he is being urged to undo — actions taken by President Donald Trump.
While Trump was not able to make good on his highest-profile health-related promises from his 2016 campaign — including repealing the Affordable Care Act and broadly lowering prescription drug prices — his administration did make substantial changes to the nation's healthcare system using executive branch authority. And many of those changes are anathema to Democrats, particularly those aimed at hobbling the ACA.
For example, the Trump administration made it easier for those who buy their own insurance to purchase cheaper plans that don't cover all the ACA benefits and may not cover preexisting conditions. It also eliminated protections from discrimination in healthcare to people who are transgender.
Trump's use of tools like regulations, guidance and executive orders to modify health programs "was like an attack by a thousand paper cuts," said Maura Calsyn, managing director of health policy at the Center for American Progress, a Democratic think tank. Approaching the November election, she said, "the administration was in the process of doing irreparable harm to the nation's healthcare system."
Reversing many of those changes will be a big part of Biden's health agenda, in many cases coming even before trying to act on his own campaign pledges, such as creating a government-sponsored health plan for the ACA.
Chris Jennings, a health adviser to Presidents Barack Obama and Bill Clinton, said he refers to those Trump health policies as "bird droppings. As in you have to clean up the bird droppings before you have a clean slate."
Republicans, when they take over from a Democratic administration, think of their predecessor's policies the same way.
Though changing policies made by the executive branch seems easy, that's not always the case.
"These are issue-by-issue determinations that must be made, and they require process evaluation, legal evaluation, resource consideration and timeliness," said Jennings. In other words, some policies will take more time and personnel resources than others. And health policies will have to compete for White House attention with policies the new administration will want to change on anything from the environment to immigration to education.
Even within healthcare, issues as diverse as the operations of the ACA marketplaces, women's reproductive health and stem cell research will vie to be high on the list.
A Guide to Executive Actions
Some types of actions are easier to reverse than others.
Executive orders issued by the president, for example, can be summarily overturned by a new executive order. Agency "guidance" can similarly be written over, although the Trump administration has worked to make that more onerous.
Since the 1980s, for example, every time the presidency has changed parties, one of the incoming president's first actions has been to issue an executive order to either reimpose or eliminate the "Mexico City Policy" that governs funding for international family planning organizations that "perform or promote" abortion. Why do new administrations address abortion so quickly? Because the anniversary of the landmark Supreme Court abortion decision Roe v. Wade is two days after Inauguration Day, so the action is always politically timely.
Harder to change are formal regulations, such as one effectively banning Planned Parenthood from the federal family planning program, Title X. They are governed by a law, the Administrative Procedure Act, that lays out a very specific — and often time-consuming — process. "You have to cross your t's and dot your legal i's," said Nicholas Bagley, who teaches administrative law at the University of Michigan Law School.
And if you don't? Then regulations can be challenged in court — as those of the Trump administration were dozens of times. That's something Biden officials will take pains to avoid, said Calsyn. "I would expect to see very deliberate notice and comment rule-making, considering the reshaped judiciary" with so many Trump-appointed judges, she said.
What Comes First?
Undoing a previous administration's actions is an exercise in trying to push many things through a very narrow tube in a short time. Department regulations have to go not just through the leadership in each department, but also through the Office of Management and Budget "for a technical review, cost-benefit analysis and legal authority," said Bagley. "That can take time."
Complicating matters, many health regulations emanate not just from the Department of Health and Human Services, but jointly from HHS and other departments, including Labor and Treasury, which likely means more time to negotiate decisions among multiple departments.
Finally, said Bagley, "for really high-profile things, you've got to get the president's attention, and he's got limited time, too." Anything pandemic-related is likely to come first, he said.
Some items get pushed to the front of the line because of calendar considerations, as with the abortion executive orders. Others need more immediate attention because they are part of active court cases.
"You have all these court schedules and briefing schedules that will dictate the timeline where they make all these decisions," said Katie Keith, a health policy researcher and law professor at Georgetown University.
The Trump administration's efforts to allow states to set work requirements for many low-income adults who gained Medicaid coverage under the Affordable Care Act's expansion of the program is the highest-profile Trump action that falls into that latter category. The Supreme Court has agreed to hear a case challenging HHS approval of work requirements for Arkansas and New Hampshire in the next few months. Some Democrats are concerned about how the high court, with its new conservative majority, might rule, and the Biden administration will have to move fast if officials decide they want to head off that case.
But court actions also might help the Biden administration short-circuit the onerous regulatory process. If a regulation the new administration wants to rewrite or repeal has already been blocked by a court, Biden officials can simply choose not to appeal that ruling. That's what Trump did in ending insurance company subsidies for enrollees with low incomes in 2017.
Allowing a lower-court ruling to stand, however, is not a foolproof strategy. "That raises the possibility of having someone [else] intervene," said Keith. For example, Democratic attorneys general stepped in to defend the ACA in a case now pending at the Supreme Court when the Trump administration chose not to. "So, you have to be pretty strategic about not appealing," she said.
Adding On?
One other big decision for the incoming administration is whether it wants to use the opportunity to tweak or add to Trump policies rather than eliminate them. "Is it undoing and full stop?" asked Keith. "Or undoing and adding on?"
She said there is "a full slate of ideologically neutral" policies Trump put out, including ones on price transparency and prescription drugs. If Biden officials don't want to keep those as they are, they can rewrite them and advance other policies at the same time, saving a round of regulatory effort.
But none of it is easy — or fast.
One big problem is just having enough bodies available to do the work. "There was so much that undermined and hollowed out the federal workforce; there's a lot of rebuilding that needs to done," said Calsyn of the Center for American Progress. And Trump officials ran so roughshod over the regulatory process in many cases, she said, "even putting those processes back in place is going to be hard."
Incoming officials will also have other time-sensitive work to do. Writing regulations for the newly passed ban on "surprise" medical bills will almost certainly be a giant political fight between insurers and healthcare providers, who will try to re-litigate the legislation as it is implemented. Rules for insurers who sell policies under the ACA will need to be written almost immediately after Biden takes office.
Anyone waiting for a particular Trump policy to be wiped from the books will likely have to pack their patience. But law professor Bagley said he's optimistic it will all get done.
"One of the things we've grown unaccustomed to is a competent administration," he said. "When people are competent, they can do a lot of things pretty quickly."
San Francisco is on track to lose an average of nearly two people a day to drugs in 2020, compared with the 178 who had died by Dec. 20 of the coronavirus.
SAN FRANCISCO — In early 2019, Tom Wolf posted a thank-you on Twitter to the cop who had arrested him the previous spring, when he was homeless and strung out in a doorway with 103 tiny bindles of heroin and cocaine in a plastic baggie at his feet.
“You saved my life,” wrote Wolf, who had finally gotten clean after that bust and 90 days in jail, ending six months of sleeping on scraps of cardboard on the sidewalk.
Today, he joins a growing chorus of people, including the mayor, calling for the city to crack down on an increasingly deadly drug trade. But there is little agreement on how that should be done. Those who demand more arrests and stiffer penalties for dealers face powerful opposition in a city with little appetite for locking people up for drugs, especially as the Black Lives Matter and Defund the Police movements push to drastically limit the power of law enforcement to deal with social problems.
Drug overdoses killed 621 people in the first 11 months of 2020, up from 441 in all of 2019 and 259 in 2018. San Francisco is on track to lose an average of nearly two people a day to drugs in 2020, compared with the 178 who had died by Dec. 20 of the coronavirus.
As in other parts of the country, most of the overdoses have been linked to fentanyl, the powerful synthetic opioid that laid waste to the eastern United States starting in 2013 but didn’t arrive in the Bay Area until about five years later. Just as the city’s drug scene was awash with the lethal new product — which is 50 times stronger than heroin and sells on the street for around $20 for a baggie weighing less than half a gram — the coronavirus pandemic hit, absorbing the attention and resources of health officials and isolating drug users, making them more likely to overdose.
The pandemic is contributing to rising overdose deaths nationwide, according to the Centers for Disease Control and Prevention, which reported last month that a record 81,000 Americans died of an overdose in the 12 months ending in May.
“This is moving very quickly in a horrific direction, and the solutions aren’t matching it,” said Supervisor Matt Haney, who represents the Tenderloin and South of Market neighborhoods, where nearly 40% of the deaths have occurred. Haney, who has hammered City Hall for what he sees as its indifference to a life-or-death crisis, is calling for a more coordinated response.
“It should be a harm reduction response, it should be a treatment response — and yes, there needs to be a law enforcement aspect of it too,” he said.
Tensions within the city’s leadership came to a head in September, when Mayor London Breed supported an effort by City Attorney Dennis Herrera to clean up the Tenderloin by legally blocking 28 known drug dealers from entering the neighborhood.
But District Attorney Chesa Boudin, a progressive elected in 2019 on a platform of police accountability and racial justice, sided with activists opposing the move. He called it a “recycled, punishment-focused” approach that would accomplish nothing.
People have died on the Tenderloin’s needle-strewn sidewalks and alone in hotel rooms where they were housed by the city to protect them from covid-19. Older Black men living alone in residential hotels are dying at particularly high rates; Blacks make up around 5% of the city’s population but account for a quarter of the 2020 overdoses. Last February, a man was found hunched over, ice-cold, in the front pew at St. Boniface Roman Catholic Church.
The only reason drug deaths aren’t in the thousands, say health officials, is the outreach that has become the mainstay of the city’s drug policy. From January to October, 2,975 deaths were prevented by naloxone, an overdose reversal drug that’s usually sprayed up the nose, according to the DOPE Project, a city-funded program that trains outreach workers, drug users, the users’ family members and others.
“If we didn’t have Narcan,” said program manager Kristen Marshall, referring to the common naloxone brand name, “there would be no room at our morgue.”
The city is also hoping that this year state lawmakers will approve safe consumption sites, where people can do drugs in a supervised setting. Other initiatives, like a 24-hour meth sobering center and an overhaul of the city’s behavioral health system, have been put on hold because of pandemic-strained resources.
Efforts like the DOPE Project, the country’s largest distributor of naloxone, reflect a seismic shift over the past few years in the way cities confront drug abuse. As more people have come to see addiction as a disease rather than a crime, there is little appetite for locking up low-level dealers, let alone drug users — policies left over from the “war on drugs” that began in 1971 under President Richard Nixon and disproportionately punished Black Americans.
In practice, San Francisco police don’t arrest people for taking drugs, certainly not in the Tenderloin. On a sunny afternoon in early December, a red-haired young woman in a beret crouched on a Hyde Street sidewalk with her eyes closed, clutching a piece of foil and a straw. A few blocks away, a man sat on the curb injecting a needle into a thigh covered with scabs and scars, while two uniformed police officers sat in a squad car across the street.
Last spring, after the pandemic prompted a citywide shutdown, police stopped arresting dealers to avoid contacts that might spread the coronavirus. Within weeks, the sidewalks of the Tenderloin were lined with transients in tents. The streets became such a narcotics free-for-all that many of the working-class and immigrant families living there felt afraid to leave their homes, according to a federal lawsuit filed by business owners and residents. It accuses City Hall of treating less wealthy ZIP codes as “containment zones” for the city’s ills.
The suit was settled a few weeks later after officials moved most of the tents to designated “safe sleeping sites.” But for many, the deterioration of the Tenderloin, juxtaposed with the gleaming headquarters of companies like Twitter and Uber just blocks away, symbolizes San Francisco’s starkest contradictions.
The Federal Initiative for the Tenderloin was one such effort, announced in 2019. It aims to “reclaim a neighborhood that is being smothered by lawlessness,” U.S. Attorney David Anderson said at a recent virtual news conference held to announce a major operation in which the feds arrested seven people and seized 10 pounds of fentanyl.
Law enforcement agencies have blamed the continued availability of cheap, potent drugs on lax prosecutions. Boudin, however, said his office files charges in 80% of felony drug cases, but most involve low-level dealers whom cartels can easily replace in a matter of hours.
He pointed to a 2019 federal sting that culminated in the arrest of 32 dealers — mostly Hondurans who were later deported — after a two-year undercover operation involving 15 agencies.
“You go walk through the Tenderloin today and tell me if it made a difference,” said Boudin.
His position reflects a growing “progressive prosecutor” movement that questions whether decades-old policies that focus on putting people behind bars are effective or just. In May, the killing of George Floyd by the Minneapolis police energized a nationwide police reform campaign. Cities around the country, including San Francisco, have promised to redirect millions of dollars from law enforcement to social programs.
“If our city leadership says in one breath that they want to defund the police and are for racial and economic justice and in the next talk about arresting drug dealers, they’re hypocrites and they’re wrong,” said Marshall, the leader of the DOPE Project.
But Wolf, 50, believes a concerted crackdown on dealers would send a message to the drug networks that San Francisco is no longer an open-air illegal drug market.
Like hundreds of thousands of other Americans who’ve succumbed to opiate misuse, he began with a prescription for the painkiller oxycodone, in his case following foot surgery in 2015. When the pills ran out, he made his way from his tidy home in Daly City, just south of San Francisco, to the Tenderloin, where dealers in hoodies and backpacks loiter three or four deep on some blocks.
When he could no longer afford pills, Wolf switched to heroin, which he learned how to inject on YouTube. He soon lost his job as a caseworker for the city and his wife threw him out, so he became homeless, holding large quantities of drugs for Central American dealers, who sometimes showed him photos of the lavish houses they were having built for their families back home.
Looking back, he wishes it hadn’t taken six arrests and three months behind bars before someone finally pushed him toward treatment.
“In San Francisco, it seems like we’ve moved away from trying to urge people into treatment and instead are just trying to keep people alive,” he said. “And that’s not really working out that great.”
Illinois recently became the first state to provide public health insurance to all low-income noncitizen seniors, even if they're in the country illegally.
This article was published on Thursday, January 7, 2021 in Kaiser Health News.
As a nurse manager for one of Chicago's busiest safety-net hospitals, Raquel Prendkowski has witnessed covid-19's devastating toll on many of the city's most vulnerable residents — including people who lack health insurance because of their immigration status. Some come in so sick they go right to intensive care. Some don't survive.
"We're in a bad dream all the time," she said during a recent day treating coronavirus patients at Mount Sinai Hospital, which was founded in the early 20th century to care for the city's poorest immigrants. "I can't wait to wake up from this."
Prendkowski believes some of the death and suffering could have been avoided if more of these people had regular treatment for the types of chronic conditions — asthma, diabetes, heart disease — that can worsen covid. She now sees a new reason for hope.
Amid a deadly virus outbreak that has disproportionately stricken Latino communities, Illinois recently became the first state to provide public health insurance to all low-income noncitizen seniors, even if they're in the country illegally. Advocates for immigrants expect it will inspire other states to do the same, building on efforts to cover undocumented children and young adults. Currently, Democratic legislators in California are pushing to expand coverage to all low-income undocumented immigrants there.
"The fact that we're going to do this during the pandemic really shows our commitment to expansion and broadening healthcare access. It's an amazing first step in the door," said Graciela Guzmán, campaign director for Healthy Illinois, a group that advocates for universal coverage.
Undocumented immigrants without health insurance often skip care. That was the case for Victoria Hernandez, 68, a house cleaner who lives in West Chicago, a suburb. The Mexico City native said she had avoided going to the doctor because she didn't have coverage. Eventually, she found a charity program to help her get treatment, including for her prediabetes. She said she intends to enroll in the new state plan.
"I'm very thankful for the new program," she said through a translator who works for the DuPage Health Coalition, a nonprofit that coordinates charity care for the uninsured in DuPage County, the state's second-most populous. "I know it will help a lot of people like me."
Healthy Illinois pushed state lawmakers to offer health benefits to all low-income immigrants. But the legislature opted instead for a smaller program that covers people 65 and older who are undocumented or have been legal permanent residents, also known as green card holders, for less than five years. (These groups don't typically qualify for government health insurance.) Participants must have an income at or below the federal poverty level, which is $12,670 for an individual or $17,240 for a couple. It covers services like hospital and doctor visits, prescription drugs, and dental and vision care (though not stays in nursing facilities), at no cost to the patient.
The new policy continues a trend of expanding government health coverage to undocumented immigrants.
Illinois was the first state to cover children's care — a handful of states and the District of Columbia have since followed suit — and organ transplants for unauthorized immigrants. In 2019, California became the first to offer public coverage to adults in the country illegally when it opened eligibility for its Medi-Cal program to all low-income residents under age 26.
Under federal law, undocumented people are generally not eligible for Medicare, nonemergency Medicaid and the Affordable Care Act's health insurance marketplace. The states that do cover this population get around that by using only state funds.
An estimated 3,986 undocumented seniors live in Illinois, according to a study by Rush University Medical Center and the Chicago demographer group Rob Paral & Associates — but that number is expected to grow to 55,144 by 2030. The report also found that 16% of Illinois immigrants 55 or older live in poverty, compared with 11% of the native-born population.
Given the outgoing Trump administration's crackdown on immigration, some advocates worry that people will be afraid to enroll in the insurance because it could affect their ability to obtain residency or citizenship. Andrea Kovach, senior attorney for healthcare justice at the Shriver Center on Poverty Law in Chicago, said she and others are working to assure immigrants they don't need to worry. Because the new program is state-funded, federal guidance suggests it is not subject to the "public charge" rule designed to keep out immigrants who might end up on public assistance.
"Illinois has a legacy of being a very welcoming state and protecting immigrants' privacy," Kovach said.
The Illinois policy is initially expected to cover 4,200 to 4,600 immigrant seniors, at an approximate cost of $46 million to $50 million a year, according to John Hoffman, a spokesperson for the Illinois Department of Healthcare and Family Services. Most of them would likely be undocumented.
Some Republicans criticized the coverage expansion, saying it was reckless at a time when Illinois' finances are being shredded by the pandemic. The Illinois Republican Party deemed it "free healthcare for illegal immigrants."
But proponents contend that many unauthorized immigrants pay taxes without being eligible for programs like Medicare and Medicaid, and that spending on preventive care saves money in the long run by cutting down on more expensive treatment for emergencies.
State Rep. Delia Ramirez, a Chicago Democrat who helped shepherd the legislation, advocated for a more expansive plan. She was inspired by her uncle, a 64-year-old immigrant who has asthma, diabetes and high blood pressure but no insurance. He has been working in the country for four decades.
She wanted the policy to apply to people 55 and older, since the vast majority of those who are undocumented are not seniors (she noted that a lot of older immigrants — 2.7 million, according to government estimates — obtained legal status under the 1986 federal amnesty law).
The real impact of this plan will likely be felt in years to come. At Esperanza Health Centers, one of Chicago's largest providers of healthcare to immigrants, 31% of patients 65 and older lack coverage, compared with 47% of those 60 to 64, according to Jeffrey McInnes, who oversees patient access there.
Ramirez said her uncle called her after seeing news of the legislation on Spanish-language TV.
"And I said to him, 'Tío, not yet. But when you turn 65, you'll finally have healthcare, if we still can't help you legalize,'" Ramirez recalled, choking up during a recent phone interview.
"So it is a reminder to me that, one, it was a major victory for us and it has meant life or a second chance at life for many people," she said. "But it is also a reminder to me that we still have a long way to go in making healthcare truly a human right in the state and, furthermore, the nation."
As Los Angeles hospitals give record numbers of covid patients oxygen, the systems and equipment needed to deliver the life-sustaining gas are faltering.
It's gotten so bad that Los Angeles County officials are warning paramedics to conserve it. Some hospitals are having to delay releasing patients as they don't have enough oxygen equipment to send home with them.
"Everybody is worried about what's going to happen in the next week or so," said Cathy Chidester, director of the L.A. County Emergency Medical Services Agency.
Oxygen, which makes up 21% of the Earth's air, isn't running short. But covid damages the lungs, and the crush of patients in hot spots such as Los Angeles, the Navajo Nation, El Paso, Texas, and in New York last spring have needed high concentrations of it. That has stressed the infrastructure for delivering the gas to hospitals and their patients.
The strain in those areas is caused by multiple weak links in the pandemic supply chain. In some hospitals that pipe oxygen to patients' rooms, the massive volume of cold liquid oxygen is freezing the equipment needed to deliver it, which can block the system.
"You can completely — literally, completely — shut down the entire hospital supply if that happens," said Rich Branson, a respiratory therapist with the University of Cincinnati and editor-in-chief of the journal Respiratory Care.
There is also pressure on the availability of both the portable cylinders that hold oxygen and the concentrators that pull oxygen from the air. And in some cases, vendors that supply the oxygen have struggled to get enough of the gas to hospitals. Even nasal cannulas, the tubing used to deliver oxygen, are now running low.
"It's been nuts, absolutely nuts," said Esteban Trejo, general manager of Syoxsa, an industrial and medical gas distributor based in El Paso. He provides oxygen to several temporary hospitals set up specifically to treat people with covid.
In November, he said, he was answering calls in the middle of the night from customers worried about oxygen supplies. At one point, when the company's usual supplier fell through, they were hauling oxygen from Houston, more than a 10-hour drive each way.
Branson has been sounding the alarm about logistical limitations on critical care since the SARS pandemic nearly 20 years ago, when he and others surveyed experts about the specific equipment and infrastructure needed during a future pandemic. Oxygen was near the top of the list.
Oxygen as Cold as Neptune
Last spring, New York, New Jersey and Connecticut faced a challenge similar to what is now unfolding in Los Angeles, said Robert Karcher, a vice president of contract services for Acurity, a group purchasing organization that worked with many hospitals during that surge.
To take up less space, oxygen is often stored as a liquid around minus 300 degrees Fahrenheit, about as cold as the surface of Neptune. But as covid patients filling ICUs were given oxygen through ventilators or nasal tubes, some hospitals began to see ice form over the equipment that converts liquid oxygen into a gas.
When a hospital draws more and more liquid oxygen from those tanks, the super-cold liquid can seep further into the vaporizing coils where liquid oxygen turns to gas.
Branson said some ice is normal, but a lot of ice can cause valves on the device to freeze in place. And the ice can restrict airflow in the pipes sending the oxygen into patients' rooms, Karcher said. To combat this, hospitals could switch to a backup vaporizer if they had one, hose down iced vaporizers or move patients to cylinder-delivered oxygen. But that puts additional strain on the hospitals' cylinder oxygen supply, as well as the medical gas supplier, Karcher said.
Hospitals in New York began to panic in the spring because the icing of the vaporizer was much greater than they had seen before, he added. It got so bad, he said, that some hospitals worried they'd have to close their ICUs.
"They thought they were in imminent danger of their tank piping shutting down," he said. "We came pretty close in a couple of our hospitals. It was a rough few weeks."
The strain on Los Angeles healthcare infrastructure could be worse given the now-common treatment of putting patients on oxygen using high-flow nasal cannulas. That requires more of the gas pumped at a higher rate than with ventilators.
"I don't know of any system that is really set to triple patient volumes — or 10 times the oxygen delivery," Chidester said of the L.A. County hospitals. "They're having a hard time keeping up."
The Oxygen Shortage Doom Loop
In and around Los Angeles, the Army Corps of Engineers has so far surveyed 11 hospitals for freezing oxygen pipe issues. The hospitals are a mix of older facilities and smaller suburban hospitals seeing such high demand amid skyrocketing cases in the area, said Mike Petersen, a Corps spokesperson.
One of the worst examples he saw included pipes that looked like a home freezer that had not been defrosted in some time.
The problem gets worse for hospitals that have had to convert regular hospital rooms to intensive care units. ICU pipes are bigger than those leading to other parts of a hospital. When rooms get repurposed as pop-up ICUs, the pipes can simply be too narrow to deliver the oxygen that covid patients need. And so, Chidester said, the hospitals switch to large cylinders of oxygen. But vendors are having a hard time refilling those quickly enough.
Even smaller cylinders and oxygen concentrators are in short supply amid the surge, she said. Those patients who could be sent home with an oxygen cylinder are left stuck in a hospital waiting for one, taking up a much-needed bed.
'Extreme Rurality'
In early December, doctors serving the Navajo Nation said they needed more of everything: the oxygen itself and the equipment to get oxygen to patients both in the hospital and recovering at home.
"We've never reached capacity before — until now," said Dr. Loretta Christensen, chief medical officer for the Navajo Area Indian Health Service, in mid-December. Its hospitals serve a patient population in the southwestern U.S. that's spread across an area bigger than West Virginia.
The buildings are aging, and they aren't built to house a large number of critical patients, said Christensen. As the number of patients on high-flow oxygen climbed, several facilities started to notice their oxygen flow weaken. They thought something was broken, but when engineers took a look, Christensen said, it became clear the system was just not able to provide the amount of high-flow oxygen patients needed.
She said a hospital in Gallup, New Mexico, put in new filters to maximize oxygen flow. After delays from snowy weather, a hospital serving the northern part of the Navajo Nation managed to hook up a second oxygen tank to boost capacity.
But medical facilities in the area are always a little on edge.
"Honestly, we worry about supply a lot out here because — and I call it extreme rurality — you just can't get something tomorrow," said Christensen. "It's not like being in an urban area where you can say, 'Oh, I need this right now.'"
Because of the small size of certain hospitals and the difficulty of getting to some of them, Christensen said, Navajo facilities aren't attractive to big vendors, so they rely on local vendors, which may prove more vulnerable to supply chain hiccups.
Tséhootsooí Medical Center in Fort Defiance, Arizona, has at times had to keep patients in the hospital and transfer incoming patients to other facilities because it couldn't get the oxygen cylinders needed to send recovering patients home.
Tina James-Tafoya, covid incident commander at Fort Defiance Indian Hospital Board, which runs the center, said at-home oxygen is out of the question for some patients. Oxygen concentrators require electricity, which some patients don't have. And for patients who live in hogans, homes often heated with a wood stove, the use of oxygen cylinders is a hazard.
"It's really interesting and eye-opening for me to see that something that seems so simple like oxygen has so many different things tied to it that will hinder it getting to the patient," she said.
Healthcare — and how much it costs — is scary. But you're not alone with this stuff, and knowledge is power. "An Arm and a Leg" is a podcast about these issues, and its second season is co-produced by KHN.
This episode turns the tables: Host Dan Weissmann gets interviewed about what he learned in 2020 and what's ahead for the show — with T.K. Dutes, a radio host and podcast-maker who is also a former nurse, so she knows a thing or two about the healthcare system. She chronicled her career transition in an episode of NPR's "Life Kit."
During their conversation, Dutes shared stories about life before and after health insurance. She coins what could be a new tagline for "An Arm and a Leg": "Where there's money, there'll be scams."
Efforts to contain the spread of the novel coronavirus in the United States have led to drastic changes in the way children and teens learn, play and socialize.
This article was published on Wednesday, January 6, 2021 in Kaiser Health News.
Krissy Williams, 15, had attempted suicide before, but never with pills.
The teen was diagnosed with schizophrenia when she was 9. People with this chronic mental health condition perceive reality differently and often experience hallucinations and delusions. She learned to manage these symptoms with a variety of services offered at home and at school.
But the pandemic upended those lifelines. She lost much of the support offered at school. She also lost regular contact with her peers. Her mother lost access to respite care — which allowed her to take a break.
On a Thursday in October, the isolation and sadness came to a head. As Krissy's mother, Patricia Williams, called a mental crisis hotline for help, she said, Krissy stood on the deck of their Maryland home with a bottle of pain medication in one hand and water in the other.
Before Patricia could react, Krissy placed the pills in her mouth and swallowed.
Efforts to contain the spread of the novel coronavirus in the United States have led to drastic changes in the way children and teens learn, play and socialize. Tens of millions of students are attending school through some form of distance learning. Many extracurricular activities have been canceled. Playgrounds, zoos and other recreational spaces have closed. Kids like Krissy have struggled to cope and the toll is becoming evident.
Government figures show the proportion of children who arrived in emergency departments with mental health issues increased 24% from mid-March through mid-October, compared with the same period in 2019. Among preteens and adolescents, it rose by 31%. Anecdotally, some hospitals said they are seeing more cases of severe depression and suicidal thoughts among children, particularly attempts to overdose.
The increased demand for intensive mental healthcare that has accompanied the pandemic has worsened issues that have long plagued the system. In some hospitals, the number of children unable to immediately get a bed in the psychiatric unit rose. Others reduced the number of beds or closed psychiatric units altogether to reduce the spread of covid-19.
"It's only a matter of time before a tsunami sort of reaches the shore of our service system, and it's going to be overwhelmed with the mental health needs of kids," said Jason Williams, a psychologist and director of operations of the Pediatric Mental Health Institute at Children's Hospital Colorado.
"I think we're just starting to see the tip of the iceberg, to be honest with you."
Before covid, more than 8 million kids between ages 3 and 17 were diagnosed with a mental or behavioral health condition, according to the most recent National Survey of Children's Health. A separate survey from the Centers for Disease Control and Prevention found 1 in 3 high school students in 2019 reported feeling persistently sad and hopeless — a 40% increase from 2009.
The coronavirus pandemic appears to be adding to these difficulties. A review of 80 studies found forced isolation and loneliness among children correlated with an increased risk of depression.
"We're all social beings, but they're [teenagers] at the point in their development where their peers are their reality," said Terrie Andrews, a psychologist and administrator of behavioral health at Wolfson Children's Hospital in Florida. "Their peers are their grounding mechanism."
Children's hospitals in New York, Colorado and Missouri all reported an uptick in the number of patients who thought about or attempted suicide. Clinicians also mentioned spikes in children with severe depression and those with autism who are acting out.
The number of overdose attempts among children has caught the attention of clinicians at two facilities. Andrews from Wolfson Children's said the facility gives out lockboxes for weapons and medication to the public — including parents who come in after children attempted to take their life using medication.
Children's National Hospital in Washington, D.C., also has experienced an uptick, said Dr. Colby Tyson, associate director of inpatient psychiatry. She's seen children's mental health deteriorate due to a likely increase in family conflict — often a consequence of the chaos caused by the pandemic. Without school, connections with peers or employment, families don't have the opportunity to spend time away from one another and regroup, which can add stress to an already tense situation.
"That break is gone," she said.
The higher demand for child mental health services caused by the pandemic has made finding a bed at an inpatient unit more difficult.
Now, some hospitals report running at full capacity and having more children "boarding," or sleeping in emergency departments before being admitted to the psychiatric unit. Among them is the Pediatric Mental Health Institute at Children's Hospital Colorado. Williams said the inpatient unit has been full since March. Some children now wait nearly two days for a bed, up from the eight to 10 hours common before the pandemic.
Cincinnati Children's Hospital Medical Center in Ohio is also running at full capacity, said clinicians, and had several days in which the unit was above capacity and placed kids instead in the emergency department waiting to be admitted. In Florida, Andrews said, up to 25 children have been held on surgical floors at Wolfson Children's while waiting for a spot to open in the inpatient psychiatric unit. Their wait could last as long as five days, she said.
Multiple hospitals said the usual summer slump in child psychiatric admissions was missing last year. "We never saw that during the pandemic," said Andrews. "We stayed completely busy the entire time."
Some facilities have decided to reduce the number of beds available to maintain physical distancing, further constricting supply. Children's National in D.C. cut five beds from its unit to maintain single occupancy in every room, said Dr. Adelaide Robb, division chief of psychiatry and behavioral sciences.
The measures taken to curb the spread of covid have also affected the way hospitalized children receive mental health services. In addition to providers wearing protective equipment, some hospitals like Cincinnati Children's rearranged furniture and placed cues on the floor as reminders to stay 6 feet apart. UPMC Western Psychiatric Hospital in Pittsburgh and other facilities encourage children to keep their masks on by offering rewards like extra computer time. Patients at Children's National now eat in their rooms, a change from when they ate together.
Despite the need for distance, social interaction still represents an important part of mental healthcare for children, clinicians said. Facilities have come up with various ways to do so safely, including creating smaller pods for group therapy. Kids at Cincinnati Children's can play with toys, but only with ones that can be wiped clean afterward. No cards or board games, said Dr. Suzanne Sampang, clinical medical director for child and adolescent psychiatry at the hospital.
"I think what's different about psychiatric treatment is that, really, interaction is the treatment," she said, "just as much as a medication."
The added infection-control precautions pose challenges to forging therapeutic connections. Masks can complicate the ability to read a person's face. Online meetings make it difficult to build trust between a patient and a therapist.
"There's something about the real relationship in person that the best technology can't give to you," said Robb.
For now, Krissy is relying on virtual platforms to receive some of her mental health services. Despite being hospitalized and suffering brain damage due to the overdose, she is now at home and in good spirits. She enjoys geometry, dancing on TikTok and trying to beat her mother at Super Mario Bros. on the Wii. But being away from her friends, she said, has been a hard adjustment.
"When you're used to something," she said, "it's not easy to change everything."
If you have contemplated suicide or someone you know has talked about it, call the National Suicide Prevention Lifeline at 1-800-273-8255, or use the online Lifeline Crisis Chat, both available 24 hours a day, seven days a week.
As I prepared to get my shot in mid-December as part of a covid vaccine trial run by Janssen Pharmaceuticals, I considered the escape routes. Bailing out of the trial was a very real consideration since two other vaccines, made by Moderna and Pfizer-BioNTech, had been deemed safe and effective for emergency approval.
Leaving the trial would be a perfectly sane decision for me or anyone who had volunteered for an ongoing covid experiment. Why risk getting covid-19 if I was given a placebo, a shot with no vaccine in it? The way tests are designed, I might not be told whether I received the vaccine until the clinical trial is over, months from now.
Dropping the placebo arm could also be ethically sound from the company's point of view. Researchers frequently halt trials when they have a product that works — or manifestly doesn't. And the two approved vaccines are 95% effective.
That very real choice for thousands of people offering to join or remain in the ongoing vaccine tests creates a conundrum for science and for society. If trials can't go forward, that could very well have an impact on the world's supply of covid vaccines and eventually on vaccine prices, especially if booster shots are needed in years to come. In markets where there are only two competing drugs, prices can shoot sky-high. If there are four or five on the market, competition usually kicks in to control costs.
In short, the welcome arrival of two covid vaccines deemed safe has uncovered a series of ethical and logistical challenges. And it has governments, companies and scientists scrambling for solutions.
"The world's vaccine experts are saying the longer we can carry out a placebo-controlled trial the better," Matthew Hepburn, who runs the vaccine development arm of Operation Warp Speed, the multibillion-dollar federal program to fight covid-19, told me. "But as a volunteer in the Janssen trial, you can always drop out."
As for the best way to resolve broader problems, "it's a debate in real time," he said.
Generally, there are two aspects to the debate. First, what should be done with placebo recipients of the Moderna and Pfizer trials now that it's clear both shots prevent the disease and appear safe? Second, how can the scores of companies in the United States and overseas that are still testing covid vaccines adapt when there are apparently reliable products already on the market?
The FDA's advisory committee debated the first question during two meetings in December. They heard Stanford University statistician Steven Goodman argue in favor of a "double-blind crossover" modification of the Pfizer and Moderna trials. Everyone who got placebo shots in the trials would now get two doses of the real vaccine, and vice versa. That way everyone would be protected but still "blind" as to when they were properly vaccinated.
Such a rejigger of the current trial would provide more data on the vaccine's safety and durability of protection, although the longer-term comparison of vaccine versus placebo would be lost. It's a marvelous idea in principle, the panelists agreed, but pretty hard to carry out. Neither Moderna nor Pfizer has agreed to it.
Pfizer wants to "unblind" placebo recipients of its vaccine — to reveal they got the saline solution and give them the real thing — once their risk group gets its turn in line for the vaccine. It has already started vaccinating healthcare workers who got the placebo.
Moderna, which has thousands of soon-to-expire leftover doses from its trial, said it intends to unblind its trial and vaccinate all the placebo recipients. In doing so, it would be recognizing the altruistic service the test subjects made to science and society by joining the trial.
Another proposal would split the placebo recipients in the trial into two groups. In one group, everyone would get a single dose of the vaccine. In the other, each would get two doses. This would be a way of testing evidence that emerged during the Pfizer and Moderna trials that a single dose might provide sufficient protection. If that were true, vaccination of the country could happen nearly twice as fast, because there would be twice as many doses of vaccine to go around.
No one knows to what extent the Food and Drug Administration could force the hands of the two companies, which still expect to get full licensure for their vaccines this year. Moderna is considered more amenable to the suggestion since, unlike Pfizer, it got nearly $1 billion in federal funding to develop its vaccine.
Other vaccine developers — including Operation Warp Speed participants Janssen (owned by Johnson & Johnson), AstraZeneca, Novavax, Sanofi and Merck & Co. — are closely watching to see which path is taken.
They are in a race against time — a race that may not end well for those running late in getting their vaccine out. And halting those efforts could hurt billions of people elsewhere in the world whose lives and livelihoods will depend on the arrival of plentiful, cheap vaccines.
One problem is finding willing test subjects. As increasing numbers of Americans are vaccinated, and the virus recedes from our shores, "the fewer the number of people eligible to participate in trials," said Susan Ellenberg, professor of biostatistics at the University of Pennsylvania.
For now, AstraZeneca and Janssen appear well situated. Both have closed enrollment in their U.S. trials and are likely to file within a few months for emergency use authorizations, like those that have allowed Moderna and Pfizer to start vaccinating the public.
Novavax officials last week started their late-stage trial in the U.S. and predict they can get full enrollment before the majority of the U.S. population is vaccinated.
Sanofi and Merck, whose timetables are more drawn out, are more likely to conduct most of their trials overseas.
In theory, drug companies could overcome these hurdles by testing multiple vaccines against one another and against approved vaccines. Dr. Steven Joffe, a University of Pennsylvania bioethicist, proposed in a recent JAMA article that Operation Warp Speed pay for such a trial.
Scientists and policymakers batted around the idea of a single U.S. trial, with multiple vaccine candidates competing against one another and a single placebo arm, during initial discussions last spring about the creation of Operation Warp Speed.
The idea went nowhere in the United States. It was taken up by World Health Organization officials and major biomedical research groups, which have tried to create such a vaccine trial in the rest of the world — with little success thus far.
So, for now, future vaccine trials are somewhat up in the air.
"There's this tension created by getting the first vaccines out there so quickly," said David Wendler, a senior researcher in bioethics at the National Institutes of Health's Clinical Center. "For public health it's good, but it has the potential to undermine our ability to keep going on the research side and really knock out the virus."
Companies, governments and outside funders need to quickly develop consensus on appropriate trial designs and regulatory processes for additional covid vaccines, added Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative.
As for me, I decided I would stay in the Janssen trial. However, the day before I was scheduled to get my injection — real or fake — the research organization running the inoculations called to say I failed to make the cut: J&J had stopped its trial enrollment.
So, I'll buy some new masks and get in line for my vaccine with everyone else.