Novavax's quest to scale up operations underscores how difficult it can be to launch a vaccine ― even with the formula and technology in hand.

This article was published on Monday, July 19, 2021 in Kaiser Health News.

By Sarah Jane Tribble and Rachana Pradhan

On a sweltering June morning, Novavax CEO and COVID vaccine maker Stanley Erck stood on a stage unmasked and did something that would have been unthinkable six months ago: He shook hands with Maryland's governor.

Erck was with Gov. Larry Hogan to announce Novavax's global vaccine headquarters ― a campus expected to house laboratories and more than 800 employees. Hogan called Novavax's future "bright" and marveled that more than 71% of the state's adults had received at least one shot.

None of those was a Novavax vaccine, which is still unavailable for the American public due to delayed clinical trial results and other difficulties. Hogan, for his part, received his first vaccine dose ― made by fellow biotech upstart Moderna ― in January.

"As you can imagine, we're eager to receive our own," said John Trizzino, Novavax's chief commercial officer and interim chief financial officer. Its two-dose COVID vaccine, which showed overall 90.4% efficacy in key U.S. and Mexico trials, has yet to be authorized. "In the meantime," Trizzino said, "we've had to use one of the existing licensed vaccines and we look forward to the booster" made by Novavax.

Looking forward has kept Novavax afloat for decades ― along with its deep ties to grant makers and federal agencies. With its focus on developing vaccines, including for the SARS and MERS pandemics, Erck argues Novavax is "built for this moment." Still, the 34-year-old startup has never brought one to market.

Novavax's quest to scale up operations underscores how difficult it can be to launch a vaccine ― even with the formula and technology in hand. So what happened? It has had the financial backing of the U.S. government and full faith of international agencies. Everything took longer than expected: hiring necessary researchers and scientists, getting supplies and transferring its vaccine technology. It didn't move at warp speed.

America is awash with vaccine options, and Novavax does not plan to file for regulatory authorizations until late July at the earliest. The delay could have dire consequences for people across the globe awaiting a vaccine.

"We're not making aspirin," Trizzino said. "We're making a very complicated biological."

A Moonshot Goal

A year before the COVID pandemic hit, Novavax had a failed late-stage trial on a potential respiratory virus vaccine, after which it cut its workforce and sold off all its manufacturing capabilities. So, when more than $2 billion in federal and international funding landed at its doorstep, Novavax found itself developing both "a vaccine and a company" in 12 months, said Dr. Gregory Glenn, president of research and development.

Novavax's proprietary secret ingredient is Matrix-M, an immune booster. Executives say the additive ― derived from Chilean soapbark trees ― works so well that less of an antibody-producing antigen would be needed with it in a vaccine. One financial filing said Matrix-M "has the potential to be of immense value."

Equipped with its recombinant nanoparticle vaccine mixed with Matrix-M, Novavax deployed a core team of employees, dubbed "SuperNOVAs," to crisscross the globe. They assembled a manufacturing network and shared vaccine technology in India, South Korea, Spain, Japan and the Czech Republic as well as in the United States ― about 20 contract manufacturing and test sites in all.

"This takes time and expertise," Trizzino said. "You just simply can't hand over the recipe and then walk away from it and expect you're going to have a high-quality product."

Novavax is contracted to form the backbone of the COVAX initiative, having promised 1.1 billion doses starting this year for developing countries. And while President Joe Biden announced the U.S. would donate 500 million doses of the Pfizer-BioNTech vaccine abroad, Novavax is still seen as vital to urgent efforts worldwide to battle the virus and its variants.

Novavax's moonshot goal of producing 2 billion shots a year increasingly looks like a pipe dream for 2021. "It is very hard to accept that they will make 2 billion doses as they had originally committed. I'm very skeptical," said Prashant Yadav, a healthcare supply chain expert and senior fellow at Harvard's Center for Global Development.

One of Novavax's biggest challenges, Yadav said, is relying on "so many sites" that aren't fully under its control, while other manufacturers own their plants. The more places Novavax produces the vaccine, the more challenging it is to make sure the vaccine and its elements are comparable in every place.

When Novavax executives announced another delay in May, the company's stock plummeted to $121 a share ― down 62% from a high of about $319 in February. As the company's fortunes rose last year, Novavax executives cashed out tens of millions of dollars in common stock, according to securities filings. Last year, after the company benefited from grants and government contracts, CEO Erck sold $9.3 million in company shares, Glenn sold $14 million, and Trizzino sold $11.3 million.

Those top executives continued selling in 2021. Erck sold more than $22.5 million worth of common stock in early July.

Novavax executives use trading plans, and the sales often appear at the same time each month. In June, after Novavax announced its long-awaited U.S. and Mexico clinical trial results, Glenn sold more than 8,000 shares for $1.5 million. As a measure of the company's spectacular rise in the pandemic, Glenn purchased 1,000 shares of stock in December 2016 for the price tag of just $1,446.

Novavax spokesperson Amy Speak said the company has programs in place to ensure best practices on stock sales. "Most people, including our executives, sell stock for a wide variety of reasons," she said, adding that Novavax's executives have "generally sold a fraction of their overall holdings in the company."

Charles Duncan, a biotechnology research analyst at Cantor Fitzgerald, called Novavax a "show me" investment in May. "It's one thing to have a place to make it," he said. "It's another thing to be able to make it there and get it certified."

'Hadn't Heard of COVID-19'

John Kutney, Novavax's senior director of manufacturing, joined a BioBuzz video in December, in an effort to recruit urgently needed talent. Kutney described the technology transfer as taking a recipe and teaching it to others. With that mission, he has traveled to the Czech Republic, Spain and the United Kingdom as well as Texas, North Carolina and New England.

When Novavax began work on its vaccine in January 2020, "most of us hadn't heard of COVID-19 and we were only beginning to become aware of what was happening in China," Kutney said. Novavax adapted its established vaccine platform to the new virus and then had to scale and transfer it to larger manufacturing sites, build a global supply chain and develop a regulatory strategy for emergency use.

"These steps would normally take years," he said.

The key step of transferring Novavax's vaccine technology can take three to six months, depending on the quality of the partner's team. Once equipment and raw materials are secured, the teams start with small batches ― first with a 50-liter bioreactor, then a 200-liter and eventually a 2,000-liter bioreactor, checking to make sure the partner operators know the process every step of the way.

"What we're trying to do here is not easy," said Fred Shemer, Novavax's vice president of quality systems and compliance, in the video: "It's a challenging situation."

In March 2020, Novavax received the first $4 million of nearly $400 million pledged by the Coalition for Epidemic Preparedness Innovations. CEPI is a global alliance backed by the Bill and Melinda Gates Foundation, which previously supported Novavax with $89 million for a vaccine for a common respiratory virus.

CEPI's investment jump-started Novavax's technology transfer to plants across Europe and Asia. It helped Novavax partner with SK bioscience in South Korea and paid for ramping up production at Praha Vaccines, which Novavax eventually bought, in the Czech Republic. It also supported scaling up production of Matrix-M at facilities in Sweden and Denmark.

Operation Warp Speed awarded $1.6 billion in July 2020 to Novavax so it would produce 100 million doses ― one of the largest awards from the Trump administration's vaccine incubator. It was "kind of a stunning number for us," Trizzino said. In December, officials bumped the total to $1.74 billion with no changes to the previous contract. Novavax also has a $60 million contract with the Department of Defense for 10 million doses.

Paul Mango, a former senior official at the Department of Health and Human Services, said it wasn't a "big concern" for the Trump administration that Novavax had no successful vaccine. After all, that was also true for Moderna, which went on to launch its wildly successful mRNA vaccine.

Operation Warp Speed's personnel resources and financial support would help carry the day. "We thought we could do it," Mango said.

At the time, Trump officials invested in several vaccine platforms to hedge bets because it wasn't known what would work, if any. "We didn't want to put all our eggs in mRNA," he said. "We didn't want to put all our eggs in viral vector," the platform used by Johnson & Johnson and AstraZeneca. Novavax's technology uses a more established process with a baculovirus grown inside insect cells in a bioreactor.

"It was very important to have that array of technologies," Mango said. "We had to pick the ones that had the best early results and the ones we thought could go through clinical trials before the spring of 2021."

Novavax scientists have spent years collaborating with officials at federal agencies such as the National Institutes of Health, National Institute of Standards and Technology, and Walter Reed National Military Center ― sometimes hiring from their ranks. In 2011, Novavax signed a $179 million contract to develop a seasonal and pandemic influenza vaccine with BARDA, the Biomedical Advanced Research and Development Authority.

As concerns about COVID-19 rose, Novavax and BARDA began another negotiation, but Operation Warp Speed officials "stepped over the top," Trizzino said. They asked Novavax what it would take to ramp up large-scale manufacturing, run a 30,000-subject clinical trial and the follow-on trials, and produce millions of doses.

"They said, 'Do all these things in parallel paths. You don't worry about the funding risk. You do the work and we'll pay for those activities,'" Trizzino recalled.

Troubles in Texas

It was a tall order. Novavax had worked with Emergent BioSolutions and signed a contract for manufacturing in early 2020, but BARDA pushed Novavax to partner instead with Fujifilm Diosynth Biotechnologies and its plants in North Carolina, Texas and the U.K.

In retrospect, Trizzino said, Novavax "dodged a bullet." Production problems at Emergent's Baltimore plant led to contamination or suspected contamination of millions of Johnson & Johnson and AstraZeneca doses, and in June federal regulators declared 60 million J&J doses unusable, The New York Times first reported.

Fujifilm's Texas site, like Emergent's plant in Baltimore, was set up in the aftermath of the 2009 H1N1 pandemic to better prepare federal officials for the next one. It received $265 million last July to quickly boost manufacturing capacity, according to a federal contract.

The site began production in January but had to slow the cadence of its manufacturing lines for "troubleshooting" during Novavax's technology transfer process, Fujifilm spokesperson Christine Jackman said. The plant is producing the Novavax vaccine and another undisclosed COVID vaccine.

Trizzino said Fujifilm's site in North Carolina was up and running quickly, but Texas didn't have as much experience so "it's taken us a bit longer to ramp that up." A March inspection by the Food and Drug Administration found overcrowded and unorganized storage areas, a failure to consistently follow cleaning procedures and questions about why there was a backlog of batches, according to documents obtained by KHN in response to a public records request. The backup formed because bulk drug substance was being made faster than the facility could review produced batches, Fujifilm's Jackman said.

FDA inspectors called Fujifilm's operations "sub optimal quality," according to an April response memo written by Gerry Farrell, Fujifilm's chief operating officer for the facility. He said the criticism resonated and promised a thorough review with fixes completed in April and May.

Novavax and Fujifilm work closely to ensure all batches are reviewed and inspected by both companies' quality control teams, said Speak, the Novavax spokesperson. The number of doses produced in Texas to date have not met projections. However, responding to federal inspections in Texas has not delayed Novavax's vaccine development because Fujifilm's North Carolina plant is the primary supplier of vaccine doses for the initial federal approval, Speak said.

Novavax's manufacturing process is complicated because the vaccine is made in steps in different places. One plant makes the protein antigen, and another makes the adjuvant. Then the two components go to a final fill-and-finish facility where they are combined into 10-dose vials.

Its Matrix-M relies on quillaja extract from soapbark trees. The extract is also an additive in root beer and Slurpees. Novavax warned investors in its December 2020 financial filings that an inability to secure enough of the extract could delay production and prevent it from meeting "obligations under our various collaborations and supply agreements." Still, Trizzino said that supply is "not an obstacle to total number of doses."

Supply shortages have plagued the industry. For Novavax, those supplies included 2,000-liter bioreactor bags, used to culture cells; depth filters for the purification process; and the growth media, which is used to feed the cells.

Not having raw materials forced Novavax to trim the number of test batches that manufacturing lines could run. It has also taken longer to create quality control tests, known as assays, to ensure that vaccines are consistent and establish a standard quality for all subsequent batches. Those delays slowed the company's ability to properly train operators, Trizzino said.

Novavax is working to reach "a level of comfort that we're able to produce these batches and then go to full capacity," Trizzino said. Novavax is working to complete the final phases of validating those tests.

Too Late?

At the headquarters event, Glenn acknowledged that Novavax is late to the game. But the global demand is still enormous, he stressed.

"We know that 2 billion people worldwide have received at least one shot," he said, "but there are 6 billion people that need to be inoculated."

The company is working to prove its vaccine will be useful even after the pandemic is contained. With its Matrix-M adjuvant, Novavax is testing a combined flu and COVID vaccine, which is showing strong results in ferrets and hamsters. Novavax is also focused on booster shots.

Novavax joined mix-and-match trials this spring in the U.K. to test whether its vaccine works when paired with Moderna, Pfizer or AstraZeneca's vaccines. Glenn said the results, so far, have been promising that "we're going to be able to use our vaccine after other licensed vaccines."

First, though, "the world has to collectively, as one, really stymie this global pandemic," said Dr. Dawd Siraj, a University of Wisconsin professor specializing in infectious diseases.

Siraj said Novavax's delays shouldn't cast doubt on the quality of the vaccine itself, given the positive trial results it has reported globally.

The shot is a "very good vaccine," he said, that could help turn the tide in developing countries unable to support their own vaccine development.

"Let us never miss the most important point here," Siraj added. "Anyone who is getting a vaccine that is approved, the chances of dying, the chances of requiring ICU care, the chances of requiring a ventilator and high-flow oxygen, they almost disappear."

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

Rachana Pradhan: rpradhan@kff.org, @rachanadixit

Colorado, and most of the nation, has now moved into a new phase involving targeted efforts and individual interactions and using trusted community influencers to persuade the hesitant to get jabbed.

This article was published on Friday, July 16, 2021 in Kaiser Health News.

By John Daley, Colorado Public Radio

Horns blared and drums pounded a constant beat as fans of the Mexican national soccer team gathered recently at Empower Field at Mile High in Denver for a high-profile international tournament.

But the sounds were muted inside a mobile medical RV parked near the stadium, and the tone was professional. During halftime of Mexico's game against the U.S., soccer fan Oscar Felipe Sanchez rolled up his sleeve to receive the one-dose COVID-19 vaccine.

Sanchez is a house painter in Colorado Springs. After getting sick with COVID a few months ago, he thought he should get the vaccine. But because of the illness, he was advised to wait a few weeks before getting the shot. Asked if he's glad he got it, Sanchez answered through a translator: "Yes! He's more trusting to go out."

Bringing the mobile vaccine program to an international soccer match was the latest effort by the state of Colorado and its local partners to meet unvaccinated residents wherever they are, rather than ask them to find the vaccine themselves.

Long gone are the days in early spring when vaccine appointments were snatched up the instant they became available, and healthcare workers worried about making sure patients were eligible under state and federal criteria for age and health status.

Colorado, and most of the nation, has now moved into a new phase involving targeted efforts and individual interactions and using trusted community influencers to persuade the hesitant to get jabbed.

With about half of Colorado's 5.78 million people now fully immunized, the challenge cuts across all demographic groups. According to the state's vaccination dashboard, men are slightly more hesitant than women and rural residents are more hesitant than urban dwellers. Younger Coloradans have been less likely than their elders to prioritize the shots.

But perhaps no group has been harder to get vaccinated than Coloradans who identify as Hispanic. Despite Hispanics making up more than 20% of the state population, only about 10% of the state's doses have gone to Hispanic residents, according to the state's vaccination dashboard.

The gap is not as wide nationally: Hispanics, or Latinos, make up 17.2% of the U.S. population, and 15.8% of people who have gotten at least one dose — and whose race/ethnicity is known — are Hispanic.

At first, the gap in Colorado seemed to be an issue of inadequate access to healthcare. Nearly 16% of Hispanic Coloradans are uninsured, according to a KFF report. That's more than double the rate for white Coloradans. That disparity may play a role, even though the vaccine itself is free, with no insurance requirement.

Denver has hit the 70% threshold for resident vaccination, but some Latino neighborhoods are getting vaccinated at much lower rates, according to Dr. Lilia Cervantes, an associate professor in the department of medicine at Denver Health.

"There are some very high-risk neighborhoods where most of the community are first-generation or foreign-born individuals," said Cervantes. "And that is where we're seeing the highest disparities."

According to data from Denver's health agencies, about 40% of Latinos older than 12 are vaccinated in Denver County — that's far below the roughly 75% rate for whites.

Latinos make up 29% of the Denver population but represent nearly half of cases and hospitalizations.

If the state hopes to reach broad levels of protection from the virus, Cervantes said, "I think that it is critical that we improve vaccine uptake in our most marginalized groups, including those who are undocumented and those who are Spanish-language dominant." Cervantes added she's concerned the state will keep seeing a higher COVID positivity rate in those marginalized groups, who make up much of the essential workforce. "This past year, I think we have seen stark health inequities in the Latino community."

All this portends a more uneven pandemic, said Dr. Fernando Holguin, a pulmonologist and critical care doctor at the Latino Research & Policy Center at the Colorado School of Public Health.

He worries cases, hospitalizations and deaths will keep flaring up in less vaccinated communities, especially predominantly Hispanic populations in parts of Colorado or other states where overall vaccination rates are poor. "They're at risk, especially moving into the fall of seeing increasing waves of infections. I think it is really critical that people really become vaccinated," Holguin said. Even as parts of Colorado and parts of the U.S. — like the Northeast — are getting vaccinated at high rates, for the mostly unvaccinated "COVID infections in certain communities still will be devastating for them," he said.

He's especially concerned about migrant farmworkers, who often have poor access to the internet and may struggle to find good information about the vaccine and avoiding the virus. "So overcoming those access, cultural, language barriers is important," he said.

When asked what the state has done to reach out to Latino Coloradans, a health department spokesperson pointed to over 1,500 "vaccine equity clinics" in 56 counties; the Workplace Vaccination Program, which partners with businesses and organizations to provide vaccine clinics at worksites; and a Spanish-language Facebook page and COVID website. She said the state's "Power the Comeback" campaign is available in English and Spanish and aims to reach disproportionately affected populations with awareness ads, testimonial videos and animated videos.

About a third of all adults in the U.S. are unvaccinated, a "shrinking pool" that skews younger and includes people more likely to identify as Republican or Republican-leaning, according to a KFF COVID-19 Vaccine Monitor report.

They also tend to be poorer, less educated and more likely to be uninsured. The KFF report found 19% of unvaccinated adults are Hispanic; of that group, 20% said they will "wait and see" about getting vaccinated, and 11% said they'd "definitely not" get it.

Both Cervantes and Holguin credit local, state and community groups with aggressively looking to boost vaccination rates among Latino Coloradans, while also encouraging them to keep recruiting trusted community voices from within, to help deliver the message.

"You know, it's not going to be Dr. [Anthony] Fauci saying something, that someone translates in Spanish, that you need to get vaccinated," Holguin said. "There's going to be people in the community convincing others to get vaccinated."

At Empower Field, soccer fan Diego Montemayor of Denver echoed that sentiment, saying some fans who got shots themselves urged friends who came to the stadium to visit the RV and get one, too. "When they hear people that they trust sharing their experiences, that goes a long way," Montemayor said.

Community health advocate Karimme Quintana agreed. She had come to the game as well to spread the word about the safety and efficacy of the vaccine. She works as a promotora de salud pública, a public health outreach worker, focusing her efforts on Denver's majority-Latino Westwood neighborhood. Quintana said that population may trust someone close to them more than even a doctor.

"They need to be more educated about the COVID because they have a lot of questions," said Quintana, whose button read "¿Tiene preguntas sobre COVID? Pregúnteme." ("Do you have questions about COVID? Ask me.")

"Latino people, they listen [to] the neighbor, they listen [to] my friend," Quintana said.

University of Colorado Health nurse Danica Farrington said the vaccine effort at the soccer tournament was heavily promoted beforehand on billboards and big screens inside the stadium during the game.

"They just plastered it everywhere and said, go get your shot," she said. "That's pretty influential."

The carnival atmosphere at the stadium helped him make the pitch, said Jesus Romero Serrano, a community ambassador with Denver's mayor's office: "It's a Mexico game versus Honduras! So lots of Latinos are here. This is the perfect place to be, to reach the Latin community. Absolutely!"

To capitalize on the playful spirit of the day, Romero Serrano wore a Mexico soccer jersey and a red-and-green luchador wrestling mask. In his work with the city government, he's what you could call a community influencer. He filtered through the tailgate crowd in the parking lot, handing out cards about where to get a vaccine.

As he circulated, he admitted it's sometimes hard for some Latino Coloradans to overcome what they see as years of historical mistreatment or neglect from medical providers. "They don't trust the healthcare system," he said.

Still, Romero Serrano kept wading into the crowd, shaking hands and shouting over the constant din of the drum bands, asking people whether they had gotten a vaccine.

The most common answer he heard was "everybody has it" — but he was skeptical about that, thinking people were just being nice.

A few miles from the stadium is the Tepeyac Community Health Center, in the predominantly Hispanic Globeville neighborhood. That's home base for Dr. Pamela Valenza, a family physician and the chief health officer at the clinic. She tries to address her patients' fears and concerns about the new vaccines, but many have told her they still want to wait and see that people don't have serious side effects.

Valenza's clinic recently held more vaccine events, at more convenient times that didn't interfere with work, like Friday evenings, and offered free grocery cards for the vaccinated. She said she likes the idea of pairing vaccines with fun.

"The Latino culture — food, culture and community — is such a central part of the Latino community," Valenza said. "Making the events maybe a little bit more than just a vaccine might encourage some community members to come out."

This story comes from NPR's health reporting partnership with Colorado Public Radio and Kaiser Health News (KHN).

John Daley, Colorado Public Radio: @CODaleyNews

The president's infrastructure plan calls for highway removal to right historical injustices and improve the health of people who live nearby.

This article was published on Thursday, July 15, 2021 in Kaiser Health News.

By Sarah DiGiulio

Mandela Parkway, a four-lane boulevard enhanced by a median with trees and a curving footpath, stretches along a 24-block section of West Oakland. It's the fruit of a grassroots neighborhood campaign to block reconstruction of an elevated freeway leveled by the Loma Prieta earthquake in 1989 and reimagine the thoroughfare to replace it.

Since the parkway's 2005 completion, 168 units of affordable housing have sprung up along its route. The air is measurably freer of pollutants than it was when the Cypress Freeway ran through the area.

A federal report heralded the project as the type of socially minded renovation that can make appropriate, if partial, amends for the devastation wrought on low-income neighborhoods by the freeway-building boom of earlier decades.

"Community involvement was a very important part of the rebuilding process," said the report, which concluded, "West Oakland residents got what they wanted."

Unfortunately, that's not entirely the case.

Although the 1.3-mile strip of land that Mandela Parkway passes through has cleaner air and better amenities than when it was a freeway spur, many of the neighborhood's original residents are no longer there to enjoy it, forced out by rising rents and housing costs. And West Oakland more broadly, bordered by the massive Port of Oakland, is still crisscrossed by elevated freeways where cars and heavy trucks spew hundreds of tons of pollutants every year.

The successes and failures of the Mandela Parkway are emblematic of the challenges faced by a new urban renewal movement that seeks to replace dozens of stretches of elevated urban freeways built in the 1950s, '60s and '70s across the United States. These highways bisected cities, displacing residents and businesses in what were frequently lower-income, working-class, non-white neighborhoods. Pollution and noise plague the health of those who continue to live nearby.

Today, as many of these roadways near or pass the end of their intended lifespans, policymakers, social justice advocates and urban planners have called for them to come down.

President Joe Biden's administration agrees. His infrastructure plan calls for highway removal to right historical injustices and improve the health of people who live nearby. At least four bills in Congress would fund such efforts, though none is assured passage.

But the Cypress Freeway conversion shows how complicated it is to accomplish highway removal in a way that improves the health and well-being of the longtime residents wronged by the roadways' legacy. The effects of neighborhood "greening" can be paradoxical, leading to "green gentrification."

There's abundant evidence that living near highways is bad for human health: Research has linked it to higher rates of hypertension, heart attack, neurological illnesses like Alzheimer's disease and multiple sclerosis, worse birth outcomes, and asthma, especially in kids.

But the evidence is shakier on whether transforming the roadways reverses these problems, said Regan Patterson, a transportation equity research fellow for the Congressional Black Caucus Foundation.

A 2019 study conducted by Patterson and Robert Harley of the University of California-Berkeley's Department of Civil and Environmental Engineering showed that rerouting the Cypress Freeway — Interstate 880 — and building the Mandela Parkway cut nitrogen oxides by an annual average of 38%, and soot by 25%, along the parkway. But West Oakland in general is still heavily polluted by the rerouted I-880, as well as I-580 and I-980.

"You cannot talk about Mandela Parkway if you don't talk about the impact of all three highways," said Margaret Gordon, 74, a founding member of the West Oakland Environmental Indicators Project, an environmental justice organization.

And the very upgrade of the area along Mandela Parkway — coupled with the arrival of Big Tech company offices in the area — has contributed to property values spiking and longtime residents leaving. Black residents, who made up 73% of the population around the expressway in 1990, accounted for only 45% in 2010, according to Patterson's research. Median home values along the parkway jumped by $261,059 in that time frame.

"Green gentrification" is a paradoxical effect of projects intended to support healthier communities, said Jennifer Wolch, a professor of city and regional planning at UC-Berkeley. Her research, focused on the overall public health effects of urban greening, shows that rising housing costs and displacement of longtime residents can also damage their health. Other research has found that residents from marginalized groups reported a lower sense of community after "greening" transformations.

Longtime Latino residents, for example, reported avoiding segments of Chicago's 606 pedestrian trail that run through mostly white neighborhoods because of concerns of discrimination. Well-off white residents were more likely than Black residents to use the Atlanta BeltLine, a 33-mile network of trails and parks.

None of these problems seal an argument against highway removal, say urban activists. The Congress for the New Urbanism, a nonprofit focused on sustainable urban development, has identified 15 highways in major U.S. cities that are ripe for removal in its 2021 "Freeways Without Futures" report.

The lesson, instead, is to pay attention to the wishes of longtime community members in planning these infrastructure projects, said Jonathan Fearn, a member of the Oakland Planning Commission and a founder of ConnectOakland, an advocacy group involved in plans to tear down 2-mile-long I-980 and redesign the area.

Highway removal and neighborhood renewal should focus on making communities less car-dependent, and adding affordable housing and other amenities, said Dr. Richard Jackson, professor emeritus at the Fielding School of Public Health at UCLA and former director of the National Center for Environmental Health at the Centers for Disease Control and Prevention.

For example, creating community land trusts — nonprofits that buy vacant lots in communities and sell them back to residents at reduced rates — can help ensure affordable housing and rent stability.

Some of the congressional bills under consideration have provisions that would require anti-displacement strategies. But the $1.2 trillion Bipartisan Infrastructure Framework put forward by the Biden administration, which includes funding for a $1 billion "reconnecting communities" program, offers few details about ameliorating displacement.

If the projects get done, conversations about whom they benefit should happen early on, said Ben Crowther, program manager for the Congress for the New Urbanism's Highways to Boulevards program. But it's "very encouraging," he said, that federal bills to fund the remakes include strategies for making sure current residents benefit.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Healthcare Foundation.

Addicts often fall victim to two huge gaps in the U.S. healthcare system: a paucity of addiction treatment and high medical costs.

This article was published on Thursday, July 15, 2021 in Kaiser Health News.

By Aneri Pattani

Jameson Rybak tried to quit using opioids nearly a dozen times within five years. Each time, he'd wait out the vomiting, sweating and chills from withdrawal in his bedroom.

It was difficult to watch, said his mother, Suzanne Rybak, but she admired his persistence.

On March 11, 2020, though, Suzanne grew worried. Jameson, 30 at the time, was slipping in and out of consciousness and saying he couldn't move his hands.

By 11 p.m., she decided to take him to the emergency room at McLeod Regional Medical Center in Florence, South Carolina. The staff there gave Jameson fluids through an IV to rehydrate, medication to decrease his nausea and potassium supplements to stop his muscle spasms, according to Suzanne and a letter the hospital's administrator later sent her.

But when they recommended admitting him to monitor and manage the withdrawal symptoms, Jameson said no. He'd lost his job the previous month and, with it, his health insurance.

"He kept saying, 'I can't afford this,'" Suzanne recalled, and "not one person [at the hospital] indicated that my son would have had some financial options."

Suzanne doesn't remember any mention of the hospital's financial assistance policy or payment plans, she said. Nor does she remember any discussions of providing Jameson medication to treat opioid use disorder or connecting him to addiction-specialty providers, she said.

"No referrals, no phone numbers, no follow-up information," she later wrote in a complaint letter to the hospital.

Instead, ER staff provided a form saying Jameson was leaving against medical advice. He signed and Suzanne witnessed.

Three months later, Jameson Rybak died of an overdose in his childhood bedroom.

Missed Opportunities

That March night in the emergency room, Jameson Rybak had fallen victim to two huge gaps in the U.S. healthcare system: a paucity of addiction treatment and high medical costs. The two issues — distinct but often intertwined — can come to a head in the ER, where patients and families desperate for addiction treatment often arrive, only to find the facility may not be equipped to deal with substance use. Or, even if they are, the treatment is prohibitively expensive.

Academic and medical experts say patients like Jameson represent a series of missed opportunities — both medical and financial.

"The emergency department is like a door, a really important door patients are walking through for identification of those who might need help," said Marla Oros, a registered nurse and president of the Mosaic Group, a Maryland-based consulting firm that has worked with more than 50 hospitals nationwide to increase addiction treatment services. "We're losing so many patients that could be identified and helped," she said, speaking generally.

A spokesperson for McLeod Regional Medical Center, where Jameson went for care, said they would not comment on an individual's case and declined to answer a detailed list of questions about the hospital's ER and financial assistance policies. But in a statement, the hospital's parent company, McLeod Health, noted that the hospital adhered to federal laws requiring that hospital ERs provide "immediate stabilizing care" for all patients, regardless of their ability to pay.

"Our hospitals attempt to manage the acute symptoms, but we do not treat chronic, underlying addiction," the statement added.

Suzanne said her son needed more than stabilization. He needed immediate help breaking the cycle of addiction.

Jameson had been in and out of treatment for five years, ever since a friend suggested he try opioids to manage his anxiety and insomnia. He had insurance through his jobs in the hotel industry and later as an electrical technician, Suzanne said. But the high-deductible plans often left him paying out-of-pocket: $3,000 for a seven-day rehab stay, $400 for a brief counseling session and a prescription of Suboxone, a medication to treat opioid use disorder.

After he lost his job in February 2020, Jameson tried again to detox at home, Suzanne said. That's what led to the ER trip.

Treating Addiction in the ER

Hospital ERs across the nation have become ground zero for patients struggling with addiction.

A seminal study published in 2015 by researchers at Yale School of Medicine found that giving patients medication to treat opioid use disorder in the ER doubled their chances of being in treatment a month later, compared with those who were given only referrals to addiction treatment.

Yet providing that medication is still not standard practice. A 2017 survey found just 5% of emergency medicine physicians said their department provided medications for opioid use disorder. Instead, many ERs continue to discharge these patients, often with a list of phone numbers for addiction clinics.

ER Resources to Offer Medications for Opioid Use Disorder

Yale School of Medicine, which published pioneering work on the use of these medications in the ER, offers assessment, treatment and discharge resources for providers.

The American College of Emergency Physicians shares resources on treating opioid use disorder in the ER, and teamed up with the American Society of Addiction Medicine to provide a bedside tool for using buprenorphine.

Jameson didn't even get that, Suzanne said. At McLeod Regional, he was not seen by a psychiatrist or addiction specialist and did not get a prescription for Suboxone or even a referral, she said.

After Jameson's death, Suzanne wrote to the hospital: "Can you explain to me, especially with the drug crisis in this country, how the ER was not equipped with personnel and/or any follow-up for treatment?"

Hospital administrator Will McLeod responded to Suzanne, in a letter she shared with KHN, that per Jameson's medical record he'd been evaluated appropriately and that his withdrawal symptoms had been treated. Jameson declined to be admitted to the hospital, the letter said, and could not be involuntarily committed, as he "was not an imminent danger to himself or others."

"Had he been admitted to our hospital that day, he would have been assigned to social workers and case managers who could have assisted with referrals, support, and follow-up treatment," McLeod wrote.

Nationwide, hospitals are working to ramp up the availability of addiction services in the ER. In South Carolina, a state-funded program through the Medical University of South Carolina and the consulting firm Mosaic Group aims to help hospitals create a standardized system to screen patients for addiction, employ individuals who are in recovery to work with those patients and offer medication for opioid use disorder in the ER.

The initiative had worked with seven ERs as of June. It was in discussions to work with McLeod Regional hospital too, program staffers said. However, the hospital backed out.

The hospital declined to comment on its decision.

ER staffs around the country often lack the personnel to launch initiatives or learn about initiating addiction treatment. Sometimes affordable referral options are limited in the area. Even when the initial prescribing does occur, cost can be a problem, since Suboxone and its generic equivalent range in price from $50 to over $500 per prescription, without insurance.

In South Carolina, which has not expanded Medicaid, nearly 11% of the population is uninsured. Among patients in the state's program who have been started on medications for opioid use disorder in ERs, about 75% are uninsured, said Dr. Lindsey Jennings, an emergency medicine physician at MUSC who works on the statewide initiative.

Other parts of the country face similar concerns, said Dr. Alister Martin, an emergency medicine physician who heads a national campaign to encourage the use of these medications in the ER. In Texas, for example, hundreds of doctors have gotten certified to provide the medications, he said, but many patients are uninsured and can't pay for their prescriptions.

"You can't make it effective if people can't afford it," Martin said.

Too Late for Charity Care

Throughout the night at McLeod Regional hospital's ER, Jameson worried about cost, Suzanne said.

She wanted to help, but Jameson's father and younger brother had recently lost their jobs, and the household was running on her salary as a public school librarian.

Suzanne didn't know that nonprofit hospitals, like McLeod, are required by the federal government to have financial assistance policies, which lower or eliminate bills for people without the resources to pay. Often called charity care, this assistance is a condition for nonprofit hospitals to maintain their tax-exempt status.

But "nonprofits are actually doing less charity care than for-profits," said Ge Bai, an associate professor at Johns Hopkins University who published a study this year on the level of charity care provided by different hospitals.

That's in part because they have wide leeway to determine who qualifies and often don't tell patients they may be eligible, despite federal requirements that nonprofit hospitals "widely publicize" their financial assistance policies, including on billing statements and in "conspicuous public displays" in the hospital. One study found that only 50% of hospitals regularly notified patients about eligibility for charity care before initiating debt collection.

McLeod Regional's most recent publicly available tax return states that "uninsured patients are screened at the time of registration" and if they're unable to pay and ineligible for governmental insurance, they're given an application.

Suzanne said she doesn't remember Jameson or herself receiving an application. The hospital declined to comment on the Rybaks' case and whether it provides "conspicuous public displays" of financial assistance.

"Not once did anybody tell us, 'Let's get a financial person down here,' or 'There are grant programs,'" Suzanne said.

Mark Rukavina, with the nonprofit health advocacy group Community Catalyst, said most hospitals comply with the letter of the law in publicizing their assistance policy. But "how effective some of that messaging is may be a question," he said. Some hospitals may bury the policy in a dense packet of other information or use signs with vague language.

A KHN investigation in 2019 found that, nationwide, 45% of nonprofit hospital organizations were routinely sending medical bills to patients whose incomes were low enough to qualify for charity care. McLeod Regional hospital reported $1.77 million of debt from sending bills to such patients, which ended up going unpaid, for the fiscal year ending in 2019.

Believing they couldn't afford in-patient admission, the Rybaks left the hospital that night.

After the ER

Afterward, Jameson's withdrawal symptoms passed, Suzanne said. He spent time golfing with his younger brother. Although his application for unemployment benefits was denied, he managed to defer payments on his car and school loans, she said.

But, inside, he must have been struggling, Suzanne now realizes.

Throughout the pandemic, many people with substance use disorder reported feeling isolated and relapsing. Overdose deaths rose nationwide.

On the morning of June 9, 2020, Suzanne opened the door to Jameson's room and found him on the floor. The coroner determined he had died of an overdose. The family later scattered his ashes on Myrtle Beach — Jameson's favorite place, Suzanne said.

In the months following Jameson's death, hospital bills for his night in the ER arrived at the house. He owed $4,928, they said. Suzanne wrote to the hospital that her son was dead but received yet another bill addressed to him after that.

She shredded it and mailed the pieces to the hospital, along with a copy of Jameson's death certificate.

Twelve days later, the health system wrote to her that the bill had been resolved under its charity care program.

What Experts Say Patients Should Know about Hospital Charity Care

Ask for the hospitals' financial assistance policy. Nonprofit hospitals are required to have one and to provide you a copy. Many for-profit hospitals have such policies, too.

Always apply. Don't assume you won't qualify because you're working or have insurance.

Ask about alternatives. Even if you don't qualify for charity care, the hospital may be able to offer discounts or flexible payment plans.

Ask to meet with financial counselors or someone from the hospital's finance office to discuss your options.

Ask about assistance programs in the community. Does the hospital know of any local organizations that could help you enroll in insurance coverage or cover part of your bill through a grant program?

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Aneri Pattani: apattani@kff.org, @aneripattani