Clarence Troutman survived a two-month hospital stay with COVID-19, then went home in early June. But he's far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.
"Before COVID, I was a 59-year-old, relatively healthy man," said the broadband technician from Denver. "If I had to say where I'm at now, I'd say about 50% of where I was, but when I first went home, I was at 20%."
He credits much of his progress to the "motivation and education" gleaned from a new program for post-COVID patients at the University of Colorado, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.
As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurological concerns, anxiety and depression.
"We need to think about how we're going to provide care for patients who may be recovering for years after the virus," said Dr. Sarah Jolley, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth's Post-Covid Clinic, where Troutman is seen.
That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.
One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California-San Francisco, Stanford University Medical Center and the University of Pennsylvania. The Cleveland Clinic plans to open one early next year. And it's not just academic medical centers: St. John's Well Child and Family Center, part of a network of community clinics in South Central Los Angeles, said this month it aimsto test thousands of its patients who were diagnosed with COVID since March for long-term effects.
The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.
"Some of our patients, even those on a ventilator on death's door, will come out remarkably unscathed," said Dr. Lekshmi Santhosh, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UC-San Francisco, called the OPTIMAL clinic. "Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain and shortness of breath, and there's a whole spectrum in between."
'Staggering' Medical Need
It's too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.
Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage six weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.
Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Dr. Zijian Chen, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.
If that estimate is correct — and Chen emphasized that more research is needed to make sure — it translates to patients entering the medical system in droves, often with multiple issues.
How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% — say 500,000 — already have long-lasting symptoms, "that number is staggering," Chen said. "How much medical care will be needed for that?"
Though startup costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.
Chen at Mount Sinai said the specialized centers can help lower health spending by providing more cost-effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.
"We've seen patients that when they come in, they've already had four MRI or CT scans and a stack of bloodwork," he said.
The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what's causing patients' long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.
"I believe in the patients," said Chen.
About half the clinic's patients have received test results showing damage, said Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.
"That makes it more difficult to treat," said Chen.
Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.
The ICU Recovery Center at Vanderbilt University Medical Center, for instance, which opened in 2012, is accepting post-COVID patients.
There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he's heard of at least another dozen post-COVID centers in development.
The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.
"In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab," he said. "Even if the primary thing these clinics did was to say to patients, 'This is real, it is not all in your head,'" he added, "that impact would be important."
A Question of Feasibility
Financing is the largest obstacle, program proponents say. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.
"So, it's not a great time to be pitching a new activity that requires a startup subsidy," said Glenn Melnick, a professor of health economics at the University of Southern California.
At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Santhosh. Mount Sinai's Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.
Jackson, at Vanderbilt, said unfortunately there's not been enough research into the cost-and-clinical effectiveness of post-ICU centers.
"In the early days, there may have been questions about how much value does this add," he noted. "Now, the question is not so much is it a good idea, but is it feasible?"
Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute.
"If these guys get good at treating long-term symptoms, that's good for all of us," said Nichols. "There's not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions."
The federal government did a quick pivot on the threat of the coronavirus spreading through the air, changing a key piece of guidance over the weekend.
On Sept. 18, the Centers for Disease Control and Prevention warned that tiny airborne particles, not just the bigger water droplets from a sneeze or cough, could infect others. It cited growing "evidence."
The move put the CDC in the middle of a debate over how the coronavirus infects people. Its guidelines could make the difference between restaurants, bars and other places where people gather fully reopening sooner or much later.
And it raised more questions about politics at the public health agency and whether White House officials are dictating policy to health authorities.
So what does the science on airborne transmission actually say?
The emerging picture is a work-in-progress, but many of the pieces do point toward the potential for airborne transmission.
The Challenge of Proving Airborne Transmission
The CDC's retracted language said, "There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes)."
Why is this a big deal? It means the guidelines for proper physical distancing might need to be increased.
Six feet is the benchmark for safety that has helped shape the reopening of schools and businesses nationwide. The number is based on the long-held finding that larger water drops from a cough are so heavy that most of them fall to the ground before the 6-foot mark.
But much smaller droplets can hang in the air longer. The debate is whether they carry enough of the virus to infect another person. If the answer is yes, the implications for everyday life could be substantial.
University of Maryland Medical School professor Donald Milton sees plenty of evidence that airborne transmission is a major factor, but he emphasized that a definitive answer is hard to come by.
No one disagrees that being near someone with the disease is the main threat. But Milton said what happens during that time is tough to untangle.
"It could be they cough and you get infected by getting a direct hit on your eye or mouth," Milton said. "Or could it be through an airborne particle that you inhale. Or you might have touched something and then touched your nose or your mouth. It's fiendishly difficult to sort that out."
That said, many incidents and studies point toward the idea that airborne particles play a bigger role than has been thought.
A study published in the Proceedings of the National Academy of Sciences reported that one minute of loud talking could produce "1,000 virus-containing droplet nuclei that could remain airborne for more than eight minutes."
The authors' conclusion? "These are likely to be inhaled by others and hence trigger new infections."
Public transit is a key testing ground.
In China, scientists looked at 126 passengers on two buses making a trip that lasted about an hour and a half. One bus was virus-free, the other had one infected rider. The people on the bus with the virus were 41.5 times more likely to be infected.
Many other researchers have noted the super-spreading event at the 2½-hour-long choir practice of the Skagit Valley Chorale in Mount Vernon, Washington. Of the 61 people who attended, there were 53 confirmed and potential cases and two deaths.
A University of Florida study sampled the air in the hospital rooms of two COVID patients. They found aerosol particles carrying enough viral load to infect someone more than 15 feet away from the patients.
In July, 239 researchers co-signed an open letter that called on national and international health agencies to "recognize the potential for airborne spread" of COVID-19.
Credible studies, they wrote, "have demonstrated beyond any reasonable doubt that viruses are released during exhalation, talking, and coughing in microdroplets small enough to remain aloft in air and pose a risk of exposure."
Still, a July World Health Organization report found while airborne transmission was possible, more robust research was needed to confirm that it presents an appreciable risk.
If public health leaders take airborne transmission more seriously, Milton said, there are a few implications. Most business activity could continue, but restaurants and bars — because masks don't fit with eating and drinking — would face a higher hurdle.
Beyond that, more attention to ventilation in more closed spaces becomes important, as does the supply of N95 masks. Those masks continue to be in short supply.
Daniel Prude's family knew he needed psychiatric care and tried to get it for him. Instead, his encounter with police hours after he was released from Strong Memorial Hospital in Rochester, New York, proved fatal.
This article was published on Tuesday, September 29, 2020 in Kaiser Health News.
When Joe Prude called Rochester, New York, police to report his brother missing, he was struggling to understand why Daniel Prude had been released from the hospital hours earlier. Joe Prude described his brother's suicidal behavior.
"He jumped 21 stairs down to my basement, headfirst," Joe said in a video recorded by the responding officer's body camera in the early hours of March 23. Joe's wife, Valerie, described Daniel nearly jumping in front of a train on the tracks that run behind their house the previous day.
"The train missed him by this much," Joe said, holding his thumb and pointer finger a few inches apart.
"When the doctor called me and told me that they released him, I'm saying, 'How you going to sit here and tell me you're going to release him when he was hurting himself? Come on. You weren't sworn to do that,'" he said on the body camera footage.
At the point of this recorded conversation just after 3 a.m., Joe and Valerie Prude knew only that Daniel was missing, delusional and vulnerable. They didn't know his next encounter with the police would be fatal.
Police would find Daniel minutes later ― naked, acting irrationally. Because he spat in the direction of officers and allegedly said he had the novel coronavirus, officers placed a white hood, called a "spit hood," over his head. When he started trying to stand up, despite being restrained by handcuffs, an officer placed much of his body weight over Daniel's head and pushed it into the pavement.
Daniel died a week later when his family took him off life support. The county medical examiner's autopsy described his death as a homicide and listed the immediate cause of death as "complications of asphyxia in the setting of physical restraint." The incident garnered widespread attention as another example of a Black man killed after an encounter with police.
Less attention has been paid to what happened to Daniel Prude in the preceding hours, when he was treated and released after a psychiatric assessment at Strong Memorial Hospital, run by the University of Rochester Medical Center.
Joe Prude called police at about 7 p.m. on March 22 because he needed help getting Daniel to the hospital. Daniel had been having problems with a PCP addiction, Joe told officers. Now he had begun telling Joe and Valerie that people were out to get him, and he wanted to die.
By about 11 p.m., Daniel was released from the hospital, according to Joe and police records. "He was calm as hell when he got back here," Joe told police.
That didn't last.
"He was fine for a little bit, then all of a sudden started acting crazy," Joe said. He told police that Daniel asked him for a cigarette, and when he went to get one, Daniel took off running. He was barefoot, wearing only a tank top and long johns in 30-degree weather.
"He was gone. Track star status. Hauled ass like Carl Lewis," Joe told the officer.
Around 3 a.m. the next day, four hours after his release from the hospital, emergency dispatchers started fielding calls about Daniel Prude. His brother reported him missing, and a tow truck driver spotted him, naked and bloodied, on West Main Street, police records show.
Police body camera footage shows that by 3:20 a.m., officer Mark Vaughn was pressing Daniel Prude's head into the pavement.
While restrained, Prude stopped breathing. An ambulance crew resuscitated him, but he was in critical condition. His brain was damaged after being deprived of oxygen. He died a week later at Strong Memorial after being taken off life support.
The University of Rochester Medical Center said patient privacy laws bar it from discussing the specifics of Prude's treatment and release, but, in general terms, spokesperson Chip Partner said, the hospital is bound by a New York state law that requires patients to be released within 24 hours unless they have a mental illness that is likely to result in serious harm to themselves or others and that requires immediate observation, care and hospital treatment.
The details of Prude's encounters with law enforcement and the healthcare system offer a look into the practice of emergency psychiatry, and how, as inmanybranches ofmedicine in the U.S., mistakes in that field are disproportionately borne by Black people.
Medical decisions in a case like Daniel Prude's are high-stakes, with little margin for error, said Dr. Ken Duckworth, chief medical officer of the National Alliance on Mental Illness.
"Emergency psychiatric assessment is very challenging, and the potential for catastrophic outcomes following your decision is very real," he said.
The hospital where Prude died has faced scrutiny over its treatment of psychiatric patients and discharge procedures before.
In April 2018, federal inspectors found security officers at the hospital had used law enforcement restraint techniques against a pediatric psychiatry patient, breaking her arm and sending her to the emergency room.
Months later, inspectors found the hospital discharged a patient who was in the emergency room with a history of dementia and multiple medical problems despite a discrepancy in her address between her medical record and the information she gave hospital staff.
Two years earlier, inspectors found that hospital staff had placed patients in ankle and wrist restraints without an order to do so, and placed another patient in restraints without documenting when the restraints were released. Restraints are meant to be used only with a physician's order, and federal rules require precise documentation of their use.
None of these incidents at Strong Memorial Hospital garnered media attention at the time they happened or at the time the reports were made public.
Strong spokesperson Partner said that immediately after the April 2018 inspection the hospital changed its public safety protocol to eliminate the use of law enforcement techniques to manage a violent patient unless that patient is being arrested.
He said updated staff training and discharge protocol after these incidents now mitigates the risk of discharging someone who was not ready to be released. "These protocols were well established in 2020 and had absolutely no bearing on the evaluation or treatment of Daniel Prude on March 22," Partner said.
Prude's case is unusual because the consequences of the decision by doctors to release him have played out so publicly, said Duckworth. Usually, emergency room psychiatrists never find out what happened to their patients.
"You make a very big decision, which usually has no known outcome. You put this person in the hospital, you go on to the next patient. You send this person home, you go on to the next patient," he said.
Duckworth said he would not second-guess the actions of Prude's hospital team in the moment, but with the benefit of hindsight, "there's overwhelming evidence that he had a psychotic illness and was quite vulnerable," he said. "He didn't need to die."
In a statement, URMC said its treatment of Prude was "medically appropriate and compassionate."
Several oversight organizations are investigating.
The Joint Commission, which certifies hospitals to receive federal funding, saidit's reviewing Prude's treatment at Strong. New York state's Justice Center is investigating on behalf of the state Office of Mental Health.
The university medical center itself is still conducting an internal clinical review.
In response to questions from NPR and KHN about whether the hospital's treatment of Prude could have been affected by his race, Partner said the medical center asked Dr. Altha Stewart, past president of the American Psychiatric Association, "to conduct a third-party independent review through her lens as a national expert on racism and bias in psychiatric care."
In a separate interview before the request from URMC, she described how unconscious bias can cloud clinicians' judgment and make it difficult for them to make the best possible decisions for their patients.
"It is very clear that in today's healthcare system, bias is built in structurally," Stewart said. "Seeing a tall, imposing Black man who is behaving aggressively puts in place a series of ideas and thoughts and assumptions that direct decision-making."
Psychiatric disorders in Black patients are less likely to be taken seriously than in white patients, Stewart said. Unequal treatment starts early.
"So a Black child with a meltdown is described as aggressive, obstinate, oppositional," she said, "as opposed to traumatized, depressed, anxious."
Those expectations follow Black boys through adulthood and in the healthcare system, increasing the odds that doctors will view Black men as a lost cause and provide subpar care, Stewart said.
She stressed that she does not have any direct knowledge of deficiencies in the care of Daniel Prude, but she said that Black men, like Prude, are disproportionately likely to be misdiagnosed, mistreated and written off as a result of structural bias and unconscious racism.
A group of medical students at the University of Rochester wrote in an open letter that Daniel Prude was "sentenced to death by our failed healthcare system."
"Not only do our current models of healthcare leave gaping holes for individuals such as Daniel to fall through, but they do so in manners which are fraught with racism," the students wrote.
Partner, the medical center spokesperson, said the psychiatry department's Office of Diversity, Inclusion, Culture and Equity will evaluate Daniel's treatment for potential bias. He said the medical center "recognizes that we have a long way to go before we can confidently say that our policies and practices are universally culturally appropriate to the populations we serve."
Both Stewart and Duckworth said reducing the role that police play in addressing mental health crises would increase the odds of survival for a person released too early from psychiatric care.
Federal inspection reports show that hospitals across the country have released patients who, like Prude, ended up in grave danger only shortly thereafter.
In March 2018, a patient with a history of schizophrenia, post-traumatic stress disorder and suicide attempts arrived at Russell County Hospital in Kentucky complaining of alcohol withdrawal, depression, anxiety and pain. An hour and a half later, the patient was discharged with instructions to "follow up with his/her primary care provider and take medications as prescribed." Two hours later, the patient was back in the same hospital. A physician's notes said the patient had drunk a bottle of Benadryl "in effort to kill self."
In August 2018, federal inspectors found that UT Health East Texas Pittsburg Hospital discharged a patient who had verbalized a plan for suicide. The patient got a ride to his truck from the county sheriff. Later that day, the patient was found dead in the truck from a self-inflicted gunshot wound.
Last summer at Stafford County Hospital in Kansas, a patient arrived in the emergency room saying she had drunk half a liter of vodka because she was upset and wanted to die. She told hospital staff that she started drinking that day after two years of sobriety and that she "did not feel safe to go home due to the presence of alcohol." The hospital discharged her 11 minutes later.
Earlier this year, inspectors found that a patient with a history of psychosis went to the emergency room at Mercy Hospital in St. Louis and told staff she needed to get back on her medication. She was delusional, disoriented, homeless and unable to give her name. She was discharged with a voucher for cab fare but no follow-up appointments or services and no plan to ensure she got her medication.
A spokesperson for UT Health East Texas said the health system has since implemented a process for staff to more thoroughly document mental health concerns in patient records. Mercy Hospital in St. Louis said it takes the health and safety of each patient very seriously "regardless of race, ethnicity or ability to pay."
Neither of the other hospitals responded to emails or calls seeking comment.
For a term that's at least 100 years old, "herd immunity" has gained new life in 2020.
It starred in many headlines last month, when reports surfaced that a member of the White House Coronavirus Task Force and adviser to the president, Dr. Scott Atlas, recommended it as a strategy to combat COVID-19. The Washington Post reported that Atlas, a healthcare policy expert from the Hoover Institution of Stanford University, suggested the virus should be allowed to spread through the population so people build up immunity, rather than trying to contain it through shutdown measures.
At a town hall event a few weeks later, President Donald Trump raised the idea himself, saying the coronavirus would simply "go away," as people developed "herd mentality" — a slip-up that nonetheless was understood to reference the same concept.
And as recently as last week, Sen. Rand Paul (R-Ky.) sparked a heated debate at a committee hearing when he suggested that the decline in COVID cases in New York City was due to herd or community immunity in the population rather than public health measures, such as wearing masks and social distancing. Dr. Anthony Fauci, the top U.S. infectious disease official, rebuked Paul, pointing out that only 22% of the city's residents have COVID antibodies.
"If you believe 22% is herd immunity, I believe you're alone in that," Fauci told the senator.
All this talk got us thinking: People seem pretty confused about herd immunity. What exactly does it mean and can it be used to combat COVID-19?
An Uncertain Strategy With Great Cost
Herd immunity, also called community or population immunity, refers to the point at which enough people are sufficiently resistant to a disease that an infectious agent is unlikely to spread from person to person. As a result, the whole community — including those who don't have immunity — becomes protected.
People generally gain immunity in one of two ways: vaccination or infection. For most diseases in recent history — from smallpox and polio to diphtheria and rubella —vaccines have been the route to herd immunity. For the most highly contagious diseases, like measles, about 94% of the population needs to be immunized to achieve that level of protection. For COVID-19, scientists estimate the percentage falls between 50% to 70%.
Before the COVID pandemic, experts can't recall examples in which governments intentionally turned to natural infection to achieve herd immunity. Generally, such a strategy could lead to widespread illness and death, said Dr. Carlos del Rio, an expert in infectious disease and vaccines at the Emory University School of Medicine.
"It's a terrible idea," del Rio said. "It's basically giving up on public health."
A new, large study found fewer than 1 in 10 Americans have antibodies to SARS-CoV-2, the virus that causes COVID-19. Even in the hardest-hit areas, like New York City, estimates of immunity among residents are about 25%.
To reach 50% to 70% immunity would mean about four times as many people getting infected and an "incredible number of deaths," said Josh Michaud, associate director of global health policy at KFF. Even those who survive could suffer severe consequences to their heart, brain and other organs, potentially leaving them with lifelong disabilities. (KHN is an editorially independent program of KFF.)
"It's not a strategy to pursue unless your goal is to pursue suffering and death," Michaud said.
What's more, some scientists say natural immunity may not even be feasible for COVID-19. While most people presumably achieve some degree of protection after being infected once, cases of people who recovered from the disease and were reinfectedhave raised questions about how long natural immunity lasts and whether someone with immunity could still spread the virus.
Even the method scientists are using to measure immunity — blood tests that detect antibodies to the coronavirus — may not be an accurate indicator of who is protected against COVID-19, said Dr. Stuart Ray, an infectious disease expert at the Johns Hopkins University School of Medicine.
With so many unanswered questions, he concluded: "We can't count on natural herd immunity as a way to control this epidemic."
Vaccines, on the other hand, can be made to trigger stronger immunity than natural infection, Ray said. That's why people who acquire a natural tetanus infection, for example, are still advised to get the tetanus vaccine. The hope is that vaccines being developed for COVID-19 will provide the same higher level of immunity.
But What About Sweden?
In the political debate around COVID-19, proponents of a natural herd immunity strategy often point to Sweden as a model. Although the Scandinavian country imposed fewer economic shutdown measures, its death rate is less than a fraction of that in the U.S., Paul said at Wednesday's Senate hearing.
But health experts — including Fauci during the same hearing — argue that's a flawed comparison. The U.S. has a much more diverse population, with vulnerable groups like Black and Hispanic Americans being disproportionately affected by the coronavirus, said Dr. Jon Andrus, an epidemiology expert at the George Washington University Milken Institute School of Public Health. The U.S. also has greater population density, especially on the coasts, he said.
When compared with other Scandinavian countries, Sweden's death toll is much higher. It has had 5,880 deaths linked to COVID-19 so far, according to data from Johns Hopkins University. That's nearly 58 deaths per 100,000 residents — several times higher than the death rates of 5 or 6 per 100,000 in Norway and Finland. In fact, as a result of COVID-19, Sweden has recorded its highest death toll since a famine swept the country 150 years ago. And cases are on the rise.
Despite that level of loss, it's still unclear if Sweden has reached the threshold for herd immunity. A study by the country's public health agency found that by late April only 7% of residents in Stockholm had antibodies for COVID-19. In other Swedish cities, the percentage was even lower.
Those findings mirror other studies around the globe. Researchers reported that in several cities across Spain, Switzerland and the U.S. — with the exception of New York City — less than 10% of the population had COVID-19 antibodies by June, despite months of exposure and high infection rates. The results led commentators in the medical research journal The Lancet to write, "In light of these findings, any proposed approach to achieve herd immunity through natural infection is not only highly unethical, but also unachievable."
Herd Immunity Is Still Far Off
The bottom line, medical experts say, is that natural herd immunity is an uncertain strategy, and attempts to pursue it could result in a slew of unnecessary deaths. A vaccine, whenever one becomes available, would offer a safer route to community-wide protection.
Until then, they emphasize there is still plenty to do to counter the pandemic. Wearing masks, practicing social distancing, hand-washing and ramping up testing and contact tracing have all proven to help curb the virus's spread.
"As we wait for new tools to be added to the toolbox," Andrus said, "we have to keep reminding ourselves that there are measures in this very moment that we could be using to save lives."
KHN reporter Victoria Knight contributed to this article.
"No Mercy" is Season One of "Where It Hurts," a podcast about overlooked parts of the country where cracks in the health system leave people without the care they need. Our first destination is Fort Scott, Kansas.
Each season, "Where It Hurts" takes you somewhere new — to an overlooked part of the country to explore cracks in the American health system that leave people frustrated — and without the care they need. The story begins in Fort Scott, Kansas. Rural. Deeply Christian. And sicker than other parts of the state. When Mercy Hospital shut its doors, the town's sense of identity wavered.
Season One "No Mercy" is about the people who remain, surviving the best way they know how. Host and investigative journalist Sarah Jane Tribble spent more than a year revisiting southeastern Kansas, where she grew up, to document the sparking tensions, anger and fear many people felt as they struggled to come to terms with the hospital's closure.
Chapter 1: 'It Is What It Is'
Midwesterners aren't known for complaining. But after Mercy Hospital Fort Scott closed, hardship trickled down to people whose lives were already hard. Pat Wheeler has emphysema. Her husband, Ralph, has end-stage kidney failure, and the couple are barely making ends meet as they raise their teenage grandson. Pat is angry with hospital executives who she said yanked a lifeline from residents. "They took more than a hospital from us," she said.
"Where It Hurts" is a podcast collaboration between KHN and St. Louis Public Radio. Season One extends the storytelling from Sarah Jane Tribble's award-winning series, "No Mercy."
STERLING, Colo. — Tonja Jimenez is far from the only person driving an RV down Colorado’s rural highways. But unlike the other rigs, her 34-foot-long motor home is equipped as an addiction treatment clinic on wheels, bringing lifesaving treatment to the northeastern corner of the state, where patients with substance use disorders are often left to fend for themselves.
As in many states, access to addiction treatment remains a challenge in Colorado, so a new state program has transformed six RVs into mobile clinics to reach isolated farming communities and remote mountain hamlets. And, in recent months, they’ve become more crucial: During the coronavirus pandemic, even as brick-and-mortar addiction clinics have closed or stopped taking new patients, these six-wheeled clinics have kept going, except for a pit stop this summer for air conditioning repair.
Their health teams perform in-person testing and counseling. And as broadband access isn’t always a given in these rural spots, the RVs also provide a telehealth bridge to the medical providers back in the big cities. Working from afar, these providers can prescribe medicine to fight addiction and the ever-present risk of overdose, an especially looming concern amid the isolation and stress of the pandemic.
Mobile health clinics have been around for years, bringing vision tests, asthma treatment and dentistry to places without adequate care. But using health care on wheels to treat addiction isn’t as common. Nor is equipping such motor homes with telehealth capability that expands the reach of prescribing providers to treat hard-to-reach patients in these hard-to-reach rural areas.
“We really believe we bring treatment to our patients and we meet them where they’re at,” said Donna Goldstrom, clinical director for Front Range Clinic, a Fort Collins, Colorado, practice that operates four of the RVs. “So meeting them where they’re at physically is not a long leap from meeting them where they’re at motivationally and psychologically.”
Each RV has a nurse, a counselor and a peer specialist who has personal experience with addiction — and all had to be trained to drive a vehicle that size.
“I never thought when I went to nursing school that I’d be doing this,” Christi Couron, a licensed practical nurse, said as she pumped 52 gallons of diesel fuel into the motor home she works on with Jimenez.
The crew has driven their RV more than 30,000 miles since January, much of it viewed through a cracked windshield courtesy of a summer afternoon hailstorm. Four days a week, they ply the roads from Greeley to the smaller towns near the Nebraska border, as the view goes from mile-high to miles-wide.
Don a Mask, Pee in a Cup
On a dusty lot outside a halfway house in Sterling, Jimenez, the peer specialist, activates the leveling jacks to balance the RV, and the team readies the unit for the day’s slate of patients. The passenger-side captain’s chair flips around to face a table where Jimenez will check in patients. The tabletop is crowded with a printer, a scanner, a laptop and a label-maker. Underneath lie a box of specimen cups and a gallon of windshield washer fluid. The vehicle now has plenty of masks and cleaning supplies on hand, too.
After patients check in, they go to the RV’s snug bathroom to provide a urine sample. With test strips built into the sides of the cup, results show instantly whether any of 13 categories of drugs — from opiates to antidepressants — are in the urine. The sample is later dropped off at a lab to confirm the results and determine which specific drug is involved. The results help the team understand how best to treat the patients and make sure they use the prescriptions they’re given.
Patients then head to a small exam room in the back, where they connect via video to a nurse practitioner or physician assistant in a brick-and-mortar clinic.
If all goes well, the provider will send over a prescription for Suboxone (a combination medicine containing buprenorphine, which reduces cravings for opioids) or for Vivitrol (a monthly injectable version of naltrexone, which blocks opioid receptors). Once the staffers have the prescription in hand, the RV nurse can give those Vivitrol shots directly and distribute Narcan, a medication that will reverse an opioid overdose. Suboxone prescriptions must be called into a local pharmacy.
Patients also can drop used needles into a sharps container for disposal, but the staffers are not allowed to distribute clean needles. Some patients will talk with counselor Nicky McLean in a room just large enough to fit a table and two chairs.
Within minutes, a couple, who asked not to be identified by name because of the stigma surrounding addiction, arrive early for their appointments. They’ve brought the staff homemade chicken enchiladas. They had been spending $8,000 a month buying OxyContin on the street, and their lives and finances were a wreck. He lost his house. She needs clean urine tests to see her son. The couple started their addiction treatment only three weeks earlier, after he learned about the RV clinic from a friend.
They no longer have a car, so they walked a half-hour to get to their appointment.
“We would’ve done anything to get our drugs,” she said. “Walking 30 minutes to get better, it’s worth it.”
Even before they’ve finished, another patient is at the door. Spencer Nash, 29, has been using opioids since he was 18. Nine years ago, when his wife got pregnant, the couple decided to get clean, driving two hours each way, six days a week, to a methadone clinic in Fort Collins. Now, he walks to the RV, outside the halfway house where he lives, to get his Suboxone prescription.
Filling the Gaps
A few years ago, Robert Werthwein, director of Colorado’s Office of Behavioral Health, heard about a project using RVs for addiction treatment in rural upstate New York. He thought it would work in his state, too. The agency crunched the numbers to see which regions recorded the highest levels of opioid prescriptions and overdoses but lacked addiction treatment.
“We hear too often that in rural Colorado and the mountain regions of Colorado they don’t have the same access to services as the Denver metro and the Front Range regions,” Werthwein said. The state secured a $10 million federal grant for the program. His team brought in health care providers, such as Front Range Clinic, to staff and operate the RVs.
Once the RVs were ready, the staff had to be trained to drive them, which necessitated “a couple of repairs,” Werthwein said. The vehicles first started rolling out in December, eventually serving six regions — and in a seventh area, a place where narrow mountain roads precluded a large RV, one of Werthwein’s teams travels by SUV.
In some communities, the local doctors and others have been less than thrilled, feeling the RVs would attract drug users to their town.
“We’re hoping to address stigma, not just from a public standpoint, but we’re hoping to show providers ‘there is a demand in your community for medication-assisted treatment,’” Werthwein said.
Once the federal grant runs out in September 2022, Front Range Clinic and the other mobile unit operators will inherit and continue to operate the RVs, billing Medicaid and private insurance as they do now for the appointments.
As the RV crew’s 1 p.m. departure time in Sterling approached, one patient remained. The woman, who asked that her name not be published because she didn’t want to be publicly identified as a drug user, arrived at the mobile clinic without an appointment. But they couldn’t take her as a new patient without a urine sample. For two hours, she was in and out of the bathroom, drinking bottles of water, but unable to fill the little plastic cup. Through the bathroom door, the staffers could hear her crying and cursing at herself.
With the battery power on the RV winding down, they coaxed her out of the bathroom. Perhaps tomorrow would work better, they told her. She could continue to rehydrate through the night and then meet the mobile unit at its next stop, Fort Morgan, some 45 minutes away.
The next day, she was still unable to produce a urine sample, whether because of dehydration from her substance use or simply nerves. They asked her to come back again when the RV returned to Sterling the next week, but she never showed up.
In an effort to raise his approval rating on an issue on which he trails Democrat Joe Biden in most polls, Trump on Thursday unveiled his "America First Healthcare Plan."
This article was published on Monday, September 28, 2020 in Kaiser Health News.
When it comes to healthcare, President Donald Trump has promised far more than he has delivered. But that doesn't mean his administration has had no impact on health issues — including the operation of the Affordable Care Act, prescription drug prices and women's access to reproductive health services.
In a last-ditch effort to raise his approval rating on an issue on which he trails Democrat Joe Biden in most polls, Trump on Thursday unveiled his "America First Healthcare Plan," which includes a number of promises with no details and pumps some minor achievements into what the administration calls "monumental steps to improve the efficiency and quality of healthcare in the United States."
As the election nears, here is a brief breakdown of what Trump has done — and has not done — on some key health issues.
Affordable Care Act
Trump has not managed to repeal and replace the Affordable Care Act, despite his claims that the law is dead.
But his administration, and Republicans in Congress, have made changes to weaken the law while not dramatically affecting enrollment in marketplace plans.
Congress failed to rewrite the law in summer 2017, but Republicans who controlled both the House and Senate at the time included in their year-end tax cut bill a provision that reduced the penalty for failing to have health insurance to zero. That change eliminated what was by far the most unpopular provision of the law.
It also sparked a lawsuit by Republican state attorneys general and governors arguing that the tax change undercuts the law and thus should invalidate it. The case is set to be heard by the Supreme Court the week after the Nov. 3 election. The Trump administration is formally supporting the GOP plaintiffs in that suit.
The administration also used executive and regulatory action to chip away at the law's efficacy. Trump ended disputed cost-sharing subsidies to help insurers lower out-of-pocket costs for policyholders with low incomes. And the administration shortened the open enrollment period by half and slashed the budget for promoting the plans and paying people to help others navigate the often-confusing process of signing up.
Administration officials have complained that plans sold on the ACA marketplaces are not affordable, so they set new rules that allowed companies to sell competing "short-term" policies that were less expensive than ACA-sanctioned plans. But those plans are not required to provide comprehensive benefits or cover preexisting conditions.
Now, weeks before the election, federal officials are taking credit for premiums coming down, slightly, on ACA plans. "Premiums have gone down across all of our programs, including in healthcare.gov, which had been previously seeing double-digit rate increases," Seema Verma, who runs Medicare, Medicaid and the ACA exchanges, told reporters in a Sept. 24 conference call.
Premiums have come down this past year, confirmed Sabrina Corlette, who tracks the ACA as co-director of the Center on Health Insurance Reforms at Georgetown University, but only after many of the Trump administration's changes had driven them even higher. Insurers were spooked by the uncertainty — particularly in 2017, about whether the law would be repealed — and Trump's cutoff of federal funding for subsidies.
"The bottom line is, rates have gone up under Trump," Corlette said.
Women's Reproductive Health
Before he was elected, Trump pledged his allegiance to anti-abortion activists, who in turn urged their supporters to vote for him. But unlike many previous GOP presidents who called themselves "pro-life" but pushed the issue to the back burner, Trump has delivered on many of his promises to abortion foes.
Foremost, Trump has nominated two justices to the Supreme Court who were supported by anti-abortion advocates. With the help of the GOP Senate, Trump has also placed 200 conservative judges on federal district and appeals courts.
While many of the policy proposals advanced by the Trump administration are tied up in court, the sheer volume of activity has been notable, outstripping in less than four years efforts by Presidents Ronald Reagan and George W. Bush over each of their two-term presidencies.
Among those actions is a re-implementation and broadening of the "Mexico City Policy" that restricts foreign aid funding to organizations that "perform or promote" abortion. The administration has also moved to push Planned Parenthood out of the federal family planning program and Medicaid program. In addition, it has moved to make private insurance that covers abortion harder to purchase under the Affordable Care Act.
Trump's efforts on women's reproductive health reach beyond abortion to birth control. New rules would make it easier for employers with a "moral or religious objection" to decline to offer birth control as a health insurance benefit. Other rules would make it easier for health workers to decline to participate in any procedure to which they personally object.
COVID-19
Trump often claims that his decision in February to stop most travel from China was a critical factor in keeping the coronavirus pandemic in the U.S. from being worse than it has been. But the "travel ban" not only failed to stop many people from entering the U.S. from China anyway, scientists would later determine that the virus that spread widely in New York and other cities on the East Coast most likely came from Europe.
Although the White House has a coronavirus task force, the administration primarily has allowed states and localities to determine their own restrictions and timetables for closing and opening. The administration also had difficulty distributing medical supplies from a stockpile established for exactly this purpose. The president's son-in-law and White House adviser, Jared Kushner, said at one point that the purpose of the stockpile was to supplement state supplies, not provide them.
Testing was also a problem. An early test developed by the Centers for Disease Control and Prevention turned out to be faulty, and despite continued promises by administration officials, testing remains less available six months into the pandemic than most experts recommend. Meanwhile, Trump has claimed repeatedly — and falsely — that if the U.S. did less testing there would be fewer cases of the virus.
But many public health observers say the administration's biggest failing during the pandemic has been the lack of a single national message about the coronavirus and the best ways to prevent its spread.
More than 200,000 people in this country have died. Although the United States has only 4% of the world's population, it has recorded 21% of the fatalities around the globe.
Prescription Drug Costs
Trump pledged to attack high drug costs as one of his main campaign themes in 2016 and again this year. But he has not had the success he hoped for.
In one of the administration's biggest moves, the Department of Health and Human Services approved a rule last week that allows states to set up programs to import drugs from Canada, where they are cheaper because the Canadian government limits prices. Yet, it's unclear if the program will get off the ground, given drug industry opposition and resistance from the Canadian government.
In his healthcare policy speech Thursday, Trump promised to send each Medicare beneficiary a $200 discount card over the next several months to help them buy prescription drugs. The initiative is being done under a specific innovation program and must not add to the deficit. Administration officials Friday could not answer where they will get the nearly $7 billion to pay for what is perceived by many observers as a last-ditch stunt to win votes from older Americans.
The president previously signed an executive order that seeks to tie the price Medicare pays for drugs to a lower international reference price. The administration, however, hasn't released formal regulations to implement the policy, which could take years, and the policy is expected to be challenged in court by the drug industry.
In addition, Medicare will cap the price of insulin at $35 per prescription starting in 2021 for people getting coverage through some drug plans. More than 3 million Medicare beneficiaries use insulin to control their diabetes.
Trump also signed a law banning gag clauses used by health plans and pharmacy benefit managers to bar pharmacists from telling consumers about lower-priced drug options.
The administration's plan to require drug companies to provide prices in pharmaceutical advertising has been beaten back in court.
The administration points to the increased number of generic drugs that have been approved since Trump was elected, but many of those drugs are not on the market. That's because generic companies sometimes make deals with brand-name manufacturers to delay introducing lower-cost versions of their medicines.
At the same time, several bills the president supported to lower prices have stalled in Congress because of partisan differences and industry opposition.
"I don't think there has been any meaningful action that has had meaningful effect on drug prices," said Katie Gudiksen, a senior health policy researcher at The Source on Healthcare Price and Competition, a project of UC Hastings College of the Law in San Francisco.
Yet, she said, it's possible Trump's harsh criticism of the industry has had a chilling effect that led to lower prices.
Still, out-of-pocket costs for many individuals continue to climb as private and government insurance shifts more responsibility to the patient via higher cost sharing. Good Rx, an online site that tracks drug prices, noted this month that prescription drug prices have increased by 33% since 2014, faster than any other medical service or product.
Medicaid
The Trump administration has tried — but largely failed — to make many major changes to the state-federal health insurance program that covers more than 70 million low-income Americans.
Efforts by Republicans to repeal the Affordable Care Act would have ended the federal funding for the District of Columbia and the38 states that expanded their programs for everyone with incomes under 138% of the federal poverty level, or about $17,609 for an individual. About 15 million people have gained coverage through the expansion.
Trump administration officials have argued that Medicaid should be reserved for the most vulnerable Americans, including traditional enrollees such as children, pregnant women and the disabled, and not used for non-disabled adults who gained coverage under the ACA's expansion. Since Trump took office, seven states have expanded Medicaid — Idaho, Maine, Missouri, Oklahoma, Nebraska, Utah and Virginia.
In 2018, federal officials allowed states for the first time to require some enrollees to work as a condition for Medicaid coverage. The effort resulted in more than 18,000 Medicaid enrollees losing coverage in Arkansas before a federal judge halted implementation in that state and several others. The case has been appealed to the Supreme Court.
The administration also backed a move in Congress to change the way the federal government funds Medicaid. Since Medicaid's inception in 1966, federal funding has increased with enrollment and health costs. Republicans would like to instead offer states annual block grants that critics say would dramatically reduce state funding but that proponents say would give states more flexibility to meet their needs.
When the congressional attempt to establish block grants failed, the administration tried through executive action to implement a process allowing states to opt into a block grant. Yet only one state — Oklahoma — applied for a waiver to move to block-grant funding, and it withdrew its request in August, two weeks after voters there narrowly passed a ballot initiative to expand Medicaid to 200,000 residents.
Medicaid enrollment fell from 75 million in January 2017 to about 71 million in March 2018. Then the pandemic took hold and caused millions of people to lose jobs and their health coverage. As of May, Medicaid enrollment nationally was 73.5 million.
The administration's decision to expand the "public charge" rule, which would allow federal immigration officials to more easily deny permanent residency status to those who depend on certain public benefits, such as Medicaid, has discouraged many people from applying for Medicaid, said Judith Solomon, senior fellow with the Center on Budget and Policy Priorities, a research group based in Washington, D.C.
Medicare
Seniors were among Trump's most loyal voters in 2016, and he has promised repeatedly to protect the popular Medicare program. But not all his proposals would help the seniors who depend on it.
For example, invalidating the Affordable Care Act would eliminate new preventive benefits for Medicare enrollees and reopen the notorious "doughnut hole" that subjects many seniors to large out-of-pocket costs for prescription drugs, even if they have insurance.
Trump also signed several pieces of legislation that accelerate the depletion of the Medicare trust fund by cutting taxes that support the program. And his budget for fiscal 2021 proposed Medicare cuts totaling $450 billion.
At the same time, however, the administration implemented policies dramatically expanding payment fortelehealth services as well as a kidney care initiative for the millions of patients who qualify for Medicare as a result of advanced kidney disease.
Surprise Billing
Trump in May 2019 promised to end surprise billing, which leaves patients on the hook for often-exorbitant bills from hospitals, doctors and other professionals who provide service not covered by insurance.
The problem typically occurs when patients receive care at health facilities that are part of their insurance network but are treated by practitioners who are not. Other sources of surprise billing include ambulance companies and emergency room physicians and anesthesiologists, among other specialties.
An effort to end the practice stalled in Congress as some industry groups pushed back against legislative proposals.
"The administration was supportive of the pretty consumer-friendly approaches, but obviously it doesn't have any results to speak of," said Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy in Los Angeles.
"At the end of the day, plenty of people in Congress did not really want to get something done," he said.
Taking a different route, the administration finalized a rule last November that requires hospitals to provide price information to consumers. The rule will take effect Jan. 1. A federal judge shot down an attempt by hospitals to block the rule, although appeals are expected.
Brian Blase, a former Trump adviser, said this effort could soon help consumers. "Arguably, the No. 1 problem with surprise bills is that people have no idea what prices are before they receive care," he said.
But Adler said the rule would have a "very minor effect" because most consumers don't look at prices before deciding where to seek care — especially during emergencies.
Public Health/Opioids
Obesity and the opioid addiction epidemic were two of the nation's biggest public health threats until the coronavirus pandemic hit this year.
The number of opioid deaths has shown a modest decline after a dramatic increase over the past decade. Overall, overdose death rates fell by 4% from 2017 to 2018 in the United States. New CDC data shows that, over the same period, death rates involving heroin also decreased by 4% and overdose death rates involving prescription drugs decreased by 13.5%.
The administration increased funding to expand treatment programs for people using heroin and expanded access to naloxone, a medication that can reverse an overdose, said Dr. Georges Benjamin, executive director of the American Public Health Association.
Meanwhile, the nation's obesity epidemic is worsening. Obesity, a risk factor for severe effects of COVID-19, continues to become more common, according to the CDC.
Twelve states — Alabama, Arkansas, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Oklahoma, South Carolina, Tennessee and West Virginia — have a self-reported adult obesity prevalence of 35% or more, up from nine states in 2018 and six in 2017.
Benjamin said some of the administration's other policies, such as reducing access to food stamps and undermining clean air and water regulations, have made improving public health more difficult.
But the pandemic has been the major public health issue this administration has faced.
"We were doing a reasonable job addressing the opioid epidemic until COVID hit," Benjamin said. "This shows the fragility of our health system, that we cannot manage these three epidemics at the same time."
Protecting people with preexisting medical conditions is an issue that has followed President Donald Trump his entire first term. Now, Trump has signed an executive order that he says locks in coverage regardless of anyone's health history. "Any healthcare reform legislation that comes to my desk from Congress must protect the preexisting conditions or I won't sign it," Trump said at a Sept. 24 signing event.
With the executive order, Trump said, "This is affirmed, signed and done, so we can put that to rest."
Health law and health policy experts say Trump has put nothing to rest.
"It has been and will continue to be the policy of the United States to give Americans seeking healthcare more choice, lower costs, and better care and to ensure that Americans with pre-existing conditions can obtain the insurance of their choice at affordable rates."
Joe Antos with the American Enterprise Institute, a market-oriented think tank, said the order "has no technical content."
"All it really is, is a statement that he wants one or more of his departments to come up with a plan. And he doesn't give any guidance or the vaguest outline of what that plan should be."
It takes more than a bill title to actually deliver guaranteed coverage. A Republican measure in the Senate is a good example. It's called the Protect Act, but it has loopholes that would allow insurance companies to drop coverage of certain expensive diseases from all their policies.
So far, Republican proposals have not matched what the Affordable Care Act already provides. And University of Pennsylvania law professor Allison Hoffman said Trump's executive order doesn't change that.
"The language itself guarantees nothing near the protections in the Affordable Care Act, and such sweeping protections are only possible by congressional action, not regulation," Hoffman said.
Trump and other Republicans on the campaign trail have faced repeated questioning about what will happen if the U.S. Supreme Court invalidates the Affordable Care Act. The White House is strongly behind a legal case to declare it unconstitutional. Oral arguments before the court are scheduled for Nov. 10.
Indiana University health law professor David Gamage said the executive order is no stopgap should the White House win that argument.
"Were the court to hold the Affordable Care Act unconstitutional, the executive order would still do nothing, because it has no enforcement power," Gamage said.
Larry Levitt, head of health policy at KFF, a widely used source of neutral healthcare data, called Trump's order "a pinky promise to protect people with preexisting conditions."
Trump's critics have said the order runs counter to the administration's goal of undoing the Affordable Care Act. But as Levittand others point out, there are other ways to guarantee coverage to everyone.
Lanhee Chen at Stanford University's Hoover Institution said high-risk pools remain a popular idea in conservative circles.
"Most conservative analysts, for example, have supported a system of well-funded high-risk pools at the state level to provide protections for the impacted population," Chen said.
High-risk pools have been around for decades. With them, the government, rather than a private insurance company, pays for a person's care. But as with everything in healthcare, you don't get something for nothing. State high-risk pools in the past lacked enough money to cover the large number of people with needs.
Hoffman said some high-risk pools charged very high premiums, making them unaffordable to many people.
Coverage for preexisting conditions is a persistent issue because so many Americans have them or fear having them in the future.
KFF estimates that 54 million Americans have a preexisting condition that would have led to a denial of coverage in the individual insurance market before the Affordable Care Act took effect.
STERLING, Colo. — Tonja Jimenez is far from the only person driving an RV down Colorado's rural highways. But unlike the other rigs, her 34-foot-long motor home is equipped as an addiction treatment clinic on wheels, bringing lifesaving treatment to the northeastern corner of the state, where patients with substance use disorders are often left to fend for themselves.
As in many states, access to addiction treatment remains a challenge in Colorado, so a new state program has transformed six RVs into mobile clinics to reach isolated farming communities and remote mountain hamlets. And, in recent months, they've become more crucial: During the coronavirus pandemic, even as brick-and-mortar addiction clinics have closed or stopped taking new patients, these six-wheeled clinics have kept going, except for a pit stop this summer for air conditioning repair.
Their health teams perform in-person testing and counseling. And as broadband access isn't always a given in these rural spots, the RVs also provide a telehealth bridge to the medical providers back in the big cities. Working from afar, these providers can prescribe medicine to fight addiction and the ever-present risk of overdose, an especially looming concern amid the isolation and stress of the pandemic.
Mobile health clinics have been around for years, bringing vision tests, asthma treatment and dentistry to places without adequate care. But using healthcare on wheels to treat addiction isn't as common. Nor is equipping such motor homes with telehealth capability that expands the reach of prescribing providers to treat hard-to-reach patients in these hard-to-reach rural areas.
"We really believe we bring treatment to our patients and we meet them where they're at," said Donna Goldstrom, clinical director for Front Range Clinic, a Fort Collins, Colorado, practice that operates four of the RVs. "So meeting them where they're at physically is not a long leap from meeting them where they're at motivationally and psychologically."
Each RV has a nurse, a counselor and a peer specialist who has personal experience with addiction — and all had to be trained to drive a vehicle that size.
"I never thought when I went to nursing school that I'd be doing this," Christi Couron, a licensed practical nurse, said as she pumped 52 gallons of diesel fuel into the motor home she works on with Jimenez.
The crew has driven their RV more than 30,000 miles since January, much of it viewed through a cracked windshield courtesy of a summer afternoon hailstorm. Four days a week, they ply the roads from Greeley to the smaller towns near the Nebraska border, as the view goes from mile-high to miles-wide.
Don a Mask, Pee in a Cup
On a dusty lot outside a halfway house in Sterling, Jimenez, the peer specialist, activates the leveling jacks to balance the RV, and the team readies the unit for the day's slate of patients. The passenger-side captain's chair flips around to face a table where Jimenez will check in patients. The tabletop is crowded with a printer, a scanner, a laptop and a label-maker. Underneath lie a box of specimen cups and a gallon of windshield washer fluid. The vehicle now has plenty of masks and cleaning supplies on hand, too.
After patients check in, they go to the RV's snug bathroom to provide a urine sample. With test strips built into the sides of the cup, results show instantly whether any of 13 categories of drugs — from opiates to antidepressants — are in the urine. The sample is later dropped off at a lab to confirm the results and determine which specific drug is involved. The results help the team understand how best to treat the patients and make sure they use the prescriptions they're given.
Patients then head to a small exam room in the back, where they connect via video to a nurse practitioner or physician assistant in a brick-and-mortar clinic.
If all goes well, the provider will send over a prescription for Suboxone (a combination medicine containing buprenorphine, which reduces cravings for opioids) or for Vivitrol (a monthly injectable version of naltrexone, which blocks opioid receptors). Once the staffers have the prescription in hand, the RV nurse can give those Vivitrol shots directly and distributeNarcan, a medication that will reverse an opioid overdose. Suboxone prescriptions must be called into a local pharmacy.
Patients also can drop used needles into a sharps container for disposal, but the staffers are not allowed to distribute clean needles. Some patients will talk with counselor Nicky McLean in a room just large enough to fit a table and two chairs.
Within minutes, a couple, who asked not to be identified by name because of the stigma surrounding addiction, arrive early for their appointments. They've brought the staff homemade chicken enchiladas. They had been spending $8,000 a month buying OxyContin on the street, and their lives and finances were a wreck. He lost his house. She needs clean urine tests to see her son. The couple started their addiction treatment only three weeks earlier, after he learned about the RV clinic from a friend.
They no longer have a car, so they walked a half-hour to get to their appointment.
"We would've done anything to get our drugs," she said. "Walking 30 minutes to get better, it's worth it."
Even before they've finished, another patient is at the door. Spencer Nash, 29, has been using opioids since he was 18. Nine years ago, when his wife got pregnant, the couple decided to get clean, driving two hours each way, six days a week, to a methadone clinic in Fort Collins. Now, he walks to the RV, outside the halfway house where he lives, to get his Suboxone prescription.
Filling the Gaps
A few years ago, Robert Werthwein, director of Colorado's Office of Behavioral Health, heard about a project using RVs for addiction treatment in rural upstate New York. He thought it would work in his state, too. The agency crunched the numbers to see which regions recorded the highest levels of opioid prescriptions and overdoses but lacked addiction treatment.
"We hear too often that in rural Colorado and the mountain regions of Colorado they don't have the same access to services as the Denver metro and the Front Range regions," Werthwein said. The state secured a $10 million federal grant for the program. His team brought in healthcare providers, such as Front Range Clinic, to staff and operate the RVs.
Once the RVs were ready, the staff had to be trained to drive them, which necessitated "a couple of repairs," Werthwein said. The vehicles first started rolling out in December, eventually serving six regions — and in a seventh area, a place where narrow mountain roads precluded a large RV, one of Werthwein's teams travels by SUV.
In some communities, the local doctors and others have been less than thrilled, feeling the RVs would attract drug users to their town.
"We're hoping to address stigma, not just from a public standpoint, but we're hoping to show providers 'there is a demand in your community for medication-assisted treatment,'" Werthwein said.
Once the federal grant runs out in September 2022, Front Range Clinic and the other mobile unit operators will inherit and continue to operate the RVs, billing Medicaid and private insurance as they do now for the appointments.
As the RV crew's 1 p.m. departure time in Sterling approached, one patient remained. The woman, who asked that her name not be published because she didn't want to be publicly identified as a drug user, arrived at the mobile clinic without an appointment. But they couldn't take her as a new patient without a urine sample. For two hours, she was in and out of the bathroom, drinking bottles of water, but unable to fill the little plastic cup. Through the bathroom door, the staffers could hear her crying and cursing at herself.
With the battery power on the RV winding down, they coaxed her out of the bathroom. Perhaps tomorrow would work better, they told her. She could continue to rehydrate through the night and then meet the mobile unit at its next stop, Fort Morgan, some 45 minutes away.
The next day, she was still unable to produce a urine sample, whether because of dehydration from her substance use or simply nerves. They asked her to come back again when the RV returned to Sterling the next week, but she never showed up.
There is a small chance that Pfizer's vaccine trial will yield results by Nov. 3. But it could still take weeks for FDA review. Here's everything that has to happen and how to tell a political stunt from a real vaccine.
This article was published on September, September 26, 2020 in ProPublica.
Despite President Donald Trump’s promises of a vaccine next month and pundits’ speculation about how an “October surprise” could upend the presidential campaign, any potential vaccine would have to clear a slew of scientific and bureaucratic hurdles in record time.
In short, it would take a miracle.
We talked to companies, regulators, scientific advisers and analysts and reviewed hundreds of pages of transcripts and study protocols to understand all the steps needed for a coronavirus vaccine to be scientifically validated and cleared for public use. As you’ll see, it’s a long shot in 38 days.
There are three key milestones that must be met:
A clinical trial would need to observe enough infections to demonstrate that the vaccine is better than a placebo. Right now, Pfizer’s trial is the furthest along. Pfizer has said it expects results by the end of October, but analysts who follow the company aren’t so sure it’ll be that soon or whether the results will be conclusive.
Pfizer would have to turn its trial data into an application to the Food and Drug Administration. The company could either apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an emergency use authorization, which is more flexible. Pfizer has said it could submit its application almost immediately.
The FDA has to review the data and decide whether the vaccine is ready to go to market. That could take several weeks to a month, said Dr. Mark McClellan, who led the FDA from 2002 to 2004.
“All of this put together makes it more likely that it’ll be a late 2020 availability,” McClellan said.
None of this is to say that Trump couldn’t suddenly call a White House press conference to try to grab headlines and declare victory. But knowing all the steps that would have to come first can help the public discern between a true, scientifically validated vaccine and a mere political stunt.
Yes, Pfizer could have trial results by the end of October.
Results from ongoing trials are closely guarded so that researchers (and investors) have no opportunity to mess with them. Under strict trial rules that vaccine makers and the FDA set up in advance, there are only a few predetermined times when a data monitoring board is scheduled to look at the data. The purpose of those check-ins (known as “interim analyses”) is to see if there’s already enough evidence to conclude that the vaccine either works or doesn’t.
According to the trial rules that Pfizer released last week, it has four of these check-ins before the final analysis. The first one occurs when 32 people in the trial get sick with COVID-19.
Yes, that is a tiny number in a study designed to enroll 30,000 participants. But it could be enough to show that the vaccine works if far more of the infections occur in people who took the placebo than in those who got the vaccine, so much so that it’s probably not random.
The vaccine “would have to be way, way better to meet an interim stopping boundary,” said Frank Harrell Jr., professor of biostatistics at Vanderbilt University.
If six or fewer of the first 32 cases are people who got the vaccine, that suggests the vaccine reduced COVID-19 cases by 76%. Under Pfizer’s trial rules, the company can then conclude that its vaccine is effective enough to submit its application to the FDA. If, on the other hand, 15 or more of the first 32 infections are people who got the vaccine, it would mean the vaccine doesn’t work and the study ends.
The better the vaccine works, the longer it would take to reach 32 cases, because fewer vaccinated people would get sick and more of the infections would have to occur in the placebo group.
So when exactly will Pfizer get to 32 cases?
Analysts at JPMorgan estimate that this first readout would occur on Oct. 31 if the vaccine is 70% effective, or on Nov. 2 if the vaccine is 80%. Their model also estimates that Pfizer is more than twice as likely to be able to file for approval at 80% effectiveness vs 70% effectiveness.
The JPMorgan analysts’ prediction is roughly in line with official public statements from Pfizer, though the company has projected even more confidence. “We have a good chance that we will know if the product works by the end of October,” CEO Albert Bourla said Sept. 13 on CBS’ “Face the Nation.”
The key thing we don’t know is how fast people in Pfizer’s trial are getting sick. The trial doesn’t intentionally expose people to the virus; it waits to see who catches it on their own. Even though the pandemic is far from under control, the coronavirus is not spreading as fast as it was a few months ago. The study started with a baseline assumption that just 1.3% of participants would be infected over the course of a year.
It’s possible that the thousands of people who signed up for Pfizer’s study could be getting sick faster or slower than that, depending on how bad the outbreak is where they are. If Pfizer’s trial infection rate is 1.5 to 2 times faster than publicly reported case counts, then Pfizer’s first readout could be Oct. 12-19 with a 70% effective vaccine, or Oct. 14-22 with 80% efficacy, according to JPMorgan’s model.
“When the trials started there were a lot more cases in the U.S. at that time,” said Dr. Vamil Divan, an analyst at the bank Mizuho. “That’s a key unknown. How many of these participants are enrolled in hotter areas versus New York or Boston?”
To protect the integrity of trials like this, the drugmakers running them aren’t supposed to know what the data is showing as it comes in. And yet, company executives have led some observers to believe they know how many people have tested positive for COVID-19.
“They’re making projections based on how rapidly they’re accruing data, and they probably know the total number of events,” said Susan Ellenberg, professor of biostatistics at the University of Pennsylvania.
“When they say things like that, first of all, it does some wonders for their stock prices,” she added.
In a statement, Pfizer said that it expects results “as early as the end of October” based on current infection rates. The trial, the company said, “was designed to evaluate the safety and efficacy of the vaccine candidate as fast as possible.”
“Having said that,” the company added, “neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial.”
It’s highly unlikely that the next front-runner, Moderna, could have results before the election. The JPMorgan analysts’ model suggests that infection rates would have to be four times the publicly reported rate for Moderna to be able to report results before Nov. 3.
Dr. Tal Zaks, Moderna’s chief medical officer, told investors on Sept. 17 that “some time in November is sort of a reasonable base case” for the first look at Moderna’s results. (ProPublica’s board chairman, Paul Sagan, is a member of Moderna’s board and a company stockholder.)
Other developers are further behind. AstraZeneca’s trial is paused in the U.S. while the company investigates what happened with a participant who had a bad reaction. Johnson & Johnson is just beginning its large-scale, end-stage trial, months behind the other three.
So Pfizer is the only company with a shot at results before the election. And if the company has results to share, it’s unlikely to let political implications get in the way. The company has an ethical obligation not to delay a product that is ready to save lives, despite the risk that a vaccine announced on the eve of a contentious election could stoke partisan perceptions.
“Once you have signs of a vaccine’s effectiveness, it’s very difficult to argue anything is ethical other than making it available to those most at risk,” Dr. Mani Foroohar, an analyst with the investment bank SVB Leerink, said. “But it’s also very difficult to make the argument that you should do anything that undermines public trust. That’s one of the problems when you introduce powerful political pressures into what is meant to be a boring, dry, unemotional process.”
Once Pfizer gets results, it’s poised to seek the FDA’s go-ahead swiftly.
As soon as Pfizer has conclusive data, it will submit an application to the FDA. The application will include data from all previous trials as well as proof that the company can consistently manufacture millions of vaccine doses.
Pfizer’s CEO has indicated that the company is ready to turn around its application in a flash, if not on the same day it has results. “We will try to be able to be ready to submit with the speed of light, once we have the results ready,” Bourla said at an investor presentation on Sept. 16.
Pfizer has two options when submitting its FDA application. It can apply for an EUA or a full approval, known as a biologics license application, or BLA. An EUA would only allow Pfizer to market its vaccine for the pandemic’s duration — during the declared “emergency” period that we are currently in. If the company receives full licensure, on the other hand, its product can remain on the market forever. In its statement, Pfizer said it plans to continue its study after a possible EUA to collect more long-term data.
The bar for an EUA is lower than for full approval. By law, an EUA can be issued so long as “the product may be effective in diagnosing, treating, or preventing” the disease and “the known and potential benefits of the product … outweigh the known and potential risks.” In contrast, the standard for a full approval requires a drugmaker to prove not only that the product is safe and effective, but also that the product is pure and can be consistently made, because vaccines are biological products made from living materials.
For the COVID-19 vaccine, the FDA has said that it is going to raise the bar for an EUA, going beyond the usual requirements. Previously, the FDA has said a vaccine should be at least 50% effective. The FDA is reportedly close to announcing new standards to include at least two months of monitoring the health of trial participants after they receive their second shot. That could end up being the biggest hurdle to authorizing a vaccine before the election. Trump said on Wednesday that he might reject the new guidelines, but companies and FDA officials might still choose to observe them.
In a statement, the FDA said that “for a vaccine for which there is adequate manufacturing information,” an EUA “may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or the FDA has completed its formal review of the biologics license application.”
Pfizer said in a statement that it anticipates providing the agency safety data, including the median of two months safety information after the second dose, on a rolling basis. The trial has enrolled more than 31,000 participants, and 19,000 have received the second dose so far, the company said.
“The standards FDA is reportedly considering for a covid vaccine EUA represent appropriate balance between speed and safety in a crisis,” Dr. Scott Gottlieb, who led the FDA earlier in the Trump administration and serves on Pfizer’s board, tweeted on Thursday. “Even under EUA; you want higher assurance of safety and benefit for vaccine given to healthy people vs. drug given to those already sick.”
“Any political effort to shortcut [the] process or degrade reasonable standards will be [a] Pyrrhic victory if people lack confidence in a vaccine,” Gottlieb added.
The FDA will thoroughly review the application, and that’ll take a while.
Once the FDA receives a company’s submission, the agency’s review process consists of several steps which, put together, could take weeks to complete.
The FDA is the only health regulator in the world that asks drugmakers for raw data files and does its own analysis, said Dr. Joshua Sharfstein, the FDA’s former principal deputy commissioner from 2009 to 2011. “Now would not be the moment to stop” that practice, he said, despite the urgent need for a vaccine.
Besides reviewing clinical trial data, the FDA also inspects vaccine developers’ manufacturing capabilities to ensure that every vaccine batch can be made consistently and that the process is squeaky clean, so that no impurities can make their way into a vial of product. This process involves a lot of paperwork sent from the companies to the agency and also, usually, on-site inspections at manufacturing plants. The agency declined to comment on whether it had already completed on-site inspections for Pfizer and Moderna.
After the FDA finishes its assessment of the company’s application, it typically presents the data to an external advisory committee in a public meeting. Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, has said that the agency is committed to holding advisory committee meetings to review individual vaccine candidates.
Those meetings will take time to schedule, but it’s an essential step, according to experts both inside and outside the agency.
“How will [the public] know that we’re not, like, holding something in and sweeping something under the rug? Well, the way they’re going to know that is because any vaccine that we issue an emergency use authorization for will go to a public advisory committee meeting,” Marks said in a Sept. 10 webinar hosted by the Duke Margolis Center for Health Policy. “It’ll be critical for people to see what’s in the briefing packages, they’ll be able to see the discussion among an impartial group of advisers, they’ll see the committee recommendation and they’ll see the public dialogue that will take place at that committee.”
Advisory committee members vote on whether they recommend product approval. While the FDA does not have to follow the committee’s recommendations, the votes are public.
“It protects against political interference — it’s important,” Sharfstein said.
We contacted every advisory committee member and interviewed six of them about how they would evaluate an EUA application for a COVID-19 vaccine. These members (speaking for themselves, not for the FDA) indicated they would expect to see a level of evidence that could be tough to meet in the next 38 days.
One factor in their caution is that a premature EUA could make it harder to definitively evaluate an effective vaccine, because subjects in ongoing trials may drop out and new enrollments in trials with placebos would no longer be feasible.
“If an EUA came too soon where we don’t have sufficient clinical efficacy data, it would make it very hard to actually complete the study as written,” Dr. Paul Spearman, director of infectious diseases at Cincinnati Children’s Hospital, said. “You would want to have enough clinical efficacy data by the time of an EUA to be pretty darn certain.”
Another committee member is Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine. She also expressed caution about basing a hugely consequential decision on such a small number of cases, like the 32 in Pfizer’s first look.
“It’s hard for me to say with these small numbers will we have meaningful data to make a decision on,” Chatterjee said. “I have not made up my mind on any of this because I need to see and discuss with colleagues what the data are and what the implications might be.”
One option would be for the FDA to grant an EUA for a specific group of people, such as health care workers or the elderly, who are more vulnerable to COVID-19.
The data would have to support a specific vaccine use that aligns with a recognized unmet medical need, said Dr. Michael Kurilla, an advisory committee member and the director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, part of the National Institutes of Health. For example, it’s possible a vaccine could work well in young people but not so well in older people. In that case, it might not be that beneficial, because older people are much more vulnerable to serious disease.
“It’s not simply a matter of saying we will EUA this product,” Kurilla said. “We have to be very careful to define what it is we’re trying to address.”
Dr. Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia, said he would like to see robust safety data, to make sure there are no neurological side effects, from Pfizer and Moderna. Both companies are developing so-called mRNA vaccines, a type of vaccine technology that has never been approved before. He noted that most people who get vaccines are healthy, so the bar for letting a vaccine go to market is necessarily much higher than for treatments intended for severely ill COVID-19 patients.
Finally, the FDA considers the committee’s advice and makes its final decision on whether it will greenlight the product. Normally, the FDA aims to review applications for full approval within 10 months for standard reviews and six months for priority reviews.
It’s unclear exactly how quickly an EUA review can be completed for the COVID-19 vaccine. The only other vaccine that has ever received an EUA was an anthrax vaccine, but it’s not a useful comparison because the vaccine was already in use and the 2005 authorization was granted to allow the US. Department of Defense to resume giving the shots to military personnel after the mandatory vaccination program had been suspended.
Some steps could potentially be skipped when doing a review for an EUA as compared with a full approval, according to McClellan, the former FDA commissioner. For example, any vaccines needed for this pandemic won’t need long-term storage, because they’ll all be used quickly, so companies won’t need to run tests and demonstrate to the agency that their vaccines can be stored for months on end. But to receive full approval, the agency might require that.
Still, McClellan estimated, the agency’s review process from the time it receives an application to issuing an EUA could take up to a month.
All of this is just to get to yes on a vaccine. Getting shots in millions of people’s arms is another story. The two vaccine front-runners from Pfizer and Moderna pose additional logistical challenges because they have to be kept frozen.
What could go wrong?
Having read through all these steps, you can start to see the points where the process could break down and how the public might find out about it.
If a company lowers the bar for efficacy. The first four vaccine contenders have all released their clinical trial rules (Pfizer, Moderna, AstraZeneca and Johnson & Johnson), so the public should be able to assess whether the shots have met the companies’ own standards to prove it works. If they unexpectedly change their schedules or the standards, that’s concerning.
If the FDA backtracks on its commitment to consult the independent advisory board, or if the agency’s leaders reject the committee’s advice, it would be a sign that they’re acting under political pressure without scientific support.
If FDA career scientists get overruled by political appointees, that would also be a major sign of political pressure. The decision on whether or not to authorize a vaccine will fall on Marks, head of the biologics division. FDA Commissioner Stephen Hahn, however, has authority to overrule Marks’ decision, and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn’s call.
If FDA officials quit. Marks has said he’d resign if the agency authorizes an unproven or unsafe vaccine.
Ultimately, the FDA and everyone involved in vaccine development are seeking the perfect balance between speed and caution: Faced with a deadly virus that’s taken the lives of more than 200,000 Americans and upended life, devastating the economy and tearing away the livelihoods of so many, of course there is an imperative not to waste any time and an urgent desire for a vaccine.
Yet a bad vaccine could do more harm than good, and even the perception of a vaccine that is not thoroughly vetted could be just as bad, if the public doesn’t feel confident in taking it.
“A vaccine only works if it’s safe, effective and administered,” meaning people have to be willing to take it, said Bruce Mehlman, a political adviser to companies at the lobbying firm Mehlman Castagnetti Rosen & Thomas. (He doesn’t represent any pharmaceutical clients.) “If it becomes another culture war football like masks, it will not help us get past the virus and return to normal.”
It’s unlikely we’ll see a vaccine authorized in October, but to ensure the shot is safe, effective, pure and trustworthy, waiting a little longer with the knowledge that no steps have been skipped may be well worth it.