How A Family's Frantic Search For Remdesivir Changed One State's Covid Strategy

As with so much of the US response to Covid-19, distribution of remdesivir, possibly the most promising Covid-19 drug, was driven by cronyism and politics.

Determined individuals aided by ethical healthcare personnel have had some impact in imposing a rational and fair structure in some areas. But if this is the best the US can do, fear of the next wave, let alone the next pandemic, is prudent. JL

Eric Boodman reports in Stat:

With its initial, no-rhyme-or-reason distribution of remdesivir, the U.S. government created yet another division between haves and have-nots, inexplicably leaving swaths of the country without the most promising pharmaceutical against coronavirus. What would become statewide policy began with a single desperately ill patient — and a few pharmacists, taking impromptu road trips, improvising secure handoffs, frantically trying to fill in the gaps. The result was individuals trying to turn federally sown confusion into a coherent, ethical plan.

The pharmacists were looking for a gray-haired man in a brown shirt. That’s how he’d described himself a few minutes before, as he was pulling off the interstate. He’d just driven 165 miles west, through much of Tennessee — crisscrossing the crooks in the Caney Fork River, passing through the Cumberland Plateau’s mountain laurels and sandstone bluffs, whizzing past cows in lush springtime pastures — straight into the heart of Nashville. His plan was to pick up the drug, turn around, and drive right back to Oak Ridge, so he could get treatment to a patient that same night, before things got any worse.

But now the pharmacists couldn’t find him, so one stayed back with the cooler while the other walked out to the road as a scout. Even once they found him, they would need to document that he was who he said he was. “People may be trying to obtain this illicitly,” explained Bob Lobo, who helps oversee prescription protocols for the Vanderbilt University Medical Center. He’d accompanied Mark Sullivan, the executive director of adult pharmacy operations, as both backup and witness. “To make sure we did everything possible to prevent any kind of fraud,” he said, “having two people … just seemed like a good idea.”

Usually, their realm was in the basement, sending medications up from the windowless depths to the patient floors above. They’d both largely swapped out their lab coats for dress shirts, overseeing a staff of 300 as they prepared and distributed some 450,000 doses a month. This request, though, the director wanted to handle himself.

Inside the cooler were six doses of remdesivir, the only drug so far proven to work against Covid-19. Less than a week after the Food and Drug Administration had given doctors the emergency go-ahead to use it, seven cardboard boxes had arrived at the hospital’s warehouse, care of the U.S. government, each one containing 40 precious vials. “We were surprised,” said Sullivan. “It pretty much just showed up.”

The hospital’s leaders hadn’t realized, right then, that they’d just won a strange pharmaceutical lottery, determined not by chance, but by some murky federal calculus. When the cases of the drug appeared, on May 6, they imagined other medical centers were also getting these surprise shipments. With what limited clinical trial data had been released, they figured out which of their inpatients were likely to benefit most from the drug, and then doctors began injecting it.

It was only days later, when a request for remdesivir came in from a pharmacist a few hours east of there, in Oak Ridge, that the situation became clear: Vanderbilt was the only hospital in the state to have received any. There was enough for between 25 and 50 patients, depending on how many days of doses each person got. By then, there had been some 1,400 Tennesseans sick enough to require hospitalization. “I should have seen this coming,” said Patty Wright, an infectious disease doctor and one of the leaders of the center’s pandemic response. “There was this moment of: Gosh, what are we going to do? How are we going to make this fair?”

Already, the pandemic had highlighted deep-seated inequalities, disproportionately sickening disadvantaged communities, be they vast rural expanses with few services or dense urban neighborhoods inhabited by essential workers who couldn’t stay home. With its initial, no-rhyme-or-reason distribution of remdesivir, the U.S. government managed to create yet another division between haves and have-nots, inexplicably leaving whole swaths of the country without the single most promising pharmaceutical tool against coronavirus. That included safety net hospitals, where bed after bed held the vulnerable patients who needed it most.

The result was a vision of individuals trying to turn federally sown confusion into a coherent, ethical plan. Tennessee was a case in point. What would become statewide policy began with a single desperately ill patient — and a few pharmacists, taking impromptu road trips, improvising secure handoffs, frantically trying to fill in the gaps.

He might’ve been in the wrong place, but his symptoms appeared at just the right time. The signature dry coughs and fevers arose in the first week of May, right as authorities were announcing that remdesivir could quicken Covid-19 recovery, and got worse over the next few days, right as the federal government was parceling out the hundreds of thousands of vials that drug maker Gilead Sciences had donated.

The trouble was one of geography. He lived in South Clinton, what his stepson called “the smaller part of a small town” on the outskirts of Knoxville, tucked between the ridges where the Appalachians petered out in East Tennessee. His wife was sick, too, but her infection was lagging a few days behind. By May 12, his breathing sounded ragged enough that she called an ambulance and watched — feverish, nauseous, and coughing herself — as the medics loaded him up and drove him away, to Methodist Medical Center, in Oak Ridge, one of the many places the federal remdesivir deliveries hadn’t reached.

That worried Clay Goodpasture. He was scared for his stepfather, who would soon be on a ventilator, and scared for his mom, who was getting updates from the doctors while vomiting and contagious and alone. He was 38, working for a tech company in Chicago, feeling powerless, following the death tolls and the remdesivir news — and as he read, the drug became more than a drug. It became something he could do.

He already had a long love-hate relationship with Gilead. On the one hand, the company kept him alive every day; on the other, he felt that it used patents and egregious prices to profit off patients like him who are living with HIV. When he was first diagnosed about a decade ago, he was working as a freelance lighting designer and stage manager. He had no health insurance, and he was terrified — and he soon found that the easiest way for him to afford doctor’s appointments and medications was to volunteer as a test subject, taking on a bit of risk in exchange for free treatment. Goodpasture knew, better than most, both how effective and tricky-to-get Gilead’s drugs could be.

Now, he set about trying to get this one for his family. He figured it might be too late for his stepdad: The medicine plugs up the virus’ ability to copy itself, and so once the body’s immune response to the pathogen starts causing its own damage, there’s less the molecule can do. Still, it seemed worth a shot. The least Goodpasture could do was scope out which hospitals had received the state’s seven cases of remdesivir, so he could tell his mother where to direct the ambulance if she ended up calling one for herself, too.

So he started calling Tennessee hospitals: the one where his stepdad was, in Oak Ridge, two in Knoxville, two more in Nashville, including Vanderbilt. If they let him, he’d talk to someone in the ICU; if not, he’d talk with whoever picked up in the emergency room. When he asked about remdesivir, some had no clue what he was talking about. Others were cagey: “As soon as they heard what I said, they would transfer me back to the Covid hotline.”

He couldn’t blame them. “If you had a stranger calling into a very busy ER asking about drugs … you might not have time, either,” he said. He tried calling two county health agencies, without any luck. He tried tweeting at the state department of public health. “Please help,” he wrote. No response. He wished then that his mom and stepdad lived in a big city. Then they might’ve had a better chance of getting this drug.

Related: 

With remdesivir, Gilead finds itself at strategic crossroads, with its reputation (and far more) at stake

“I wish there was some national directive,” he said. “I wish there was someone spearheading this. It would be great to know exactly where these drugs are going and why.”

Turned out that a pharmacist at Methodist Medical Center named Cary Chrisman had similar questions. On the same day that Goodpasture’s calls were being redirected in an endless, informationless loop, Chrisman’s queries were being answered.

Even for an insider, it wasn’t a straight shot. The department of health referred Chrisman to the board of pharmacy, and the board of pharmacy referred him to Mark Sullivan, at Vanderbilt, who beamed the request up to Patty Wright, a leader of the hospital’s emergency response. She specialized in orthopedic infections — those that festered where amputated limb met prosthetic, or that insinuated themselves into car-crash wounds — but the message reached her where she usually was these days, near the radiology suite, in the bunker-like conference room serving as command center. “The one we would use for a tornado,” she said.

Reading the note gave her an extra little jolt of stress. Already, when those seven cases arrived, the federal government’s instructions seemed awfully broad. Following them would’ve meant nearly every Covid-19 inpatient could get the drug, even those who’d been sick so long that their trouble now seemed to be coming not from the virus but from their own supercharged immune response, in whom remdesivir seemed less likely to provide as much help. So Wright and her colleagues created their own internal rulebook, to squeeze the greatest good out of a small supply. “We didn’t want our own docs to just be like, ‘Let’s give it to everybody!’” she said. “It was just how we were going to hold ourselves accountable.”

Patients were eligible at first only if their symptoms had appeared within the last 10 days — a window during which the virus was probably still active — and if they were in bad enough shape. The team asked about certain liver and kidney issues that the drug might exacerbate. The decisions had to be made by a small jury of doctors, not the bedside clinician. “It’s hard to be objective when you have the patient in front of you,” Wright said. “It’s easy to say, ‘Well, it’s been 12 days, and the cutoff is 10, but I’ll let this one slide.’” (The cutoff would later be changed to 14 days, based on new data.)

Now, though, their unique, awkward position became all too apparent. Vanderbilt’s jurors had to make a decision about another hospital’s patient — a local court being asked to render judgment well beyond its jurisdiction. Goodpasture’s stepfather seemed to fit their criteria, sick enough to need help getting oxygen, not so sick that he’d been on a ventilator for weeks. But his story contained within it the prospect of other patients like him, more requests for a supply already spread thin. Finally, someone raised the inevitable, uncomfortable question: “Are we willing to give our last vial to somebody else?”

Everyone was silent for a moment.

It was almost strange, after weeks of constant queries and overlapping meetings, to pause for a few seconds, to be able to think. Wright realized then what the answer had to be. They could transfer the drug, or they could transfer the patient, but they couldn’t simply hoard what the federal government had sent to them and to no one else in the state.

“With infectious disease doctors, one of the things we deal with all of our careers is, what we do to one patient can affect the next patient,” she explained. “If a patient gets treated with the wrong antibiotic and develops a resistant infection, then they can pass it to the next.”

“There was this moment of: Gosh, what are we going to do? How are we going to make this fair?”

PATTY WRIGHT, A LEADER OF VANDERBILT UNIVERSITY MEDICAL CENTER’S PANDEMIC RESPONSE

Having the drug accessible at a single hospital wasn’t just unethical; it made for bad public health strategy. One of the greatest worries of the pandemic was that ICUs would run out of space, and this drug, imperfect as it was, might help with that, speeding some patients’ recovery, freeing up beds. But it could only aid in averting deadly bottlenecks if more evenly distributed. Otherwise, it might help create them.

“The hospitals that have the medicine will be overwhelmed,” explained Judith Feinberg, an infectious disease specialist at West Virginia University, who’d signed a letter from two physicians’ groups to the vice president calling for transparency on the federal distribution algorithm. “If it’s your mom, you want to transfer your mom to that hospital, and the doctor wants to transfer your mom to that hospital.”

That thought wasn’t just occurring to the physicians at Vanderbilt. The week before, in Boston, Massachusetts General Hospital proposed donating its allocation of vials to the state department of public health for a more equitable redistribution, if the federal rules would allow it — an idea that the U.S. government then adopted, announcing that each state would be responsible for parceling out future shipments.

But by May 13, when the Oak Ridge request had come in, Tennessee hadn’t yet gotten any more remdesivir, and it wasn’t clear how exactly a hospital might go about giving away its federal allotment. Once again, Vanderbilt’s leaders carefully made up their own rules. They decided that vials were more suited for travel than tube-tangled patients. They decided their remdesivir application form should be barebones, based mostly on lab results, so that unconscious bias couldn’t creep into their determinations. They wouldn’t even ask for a name, Wright said. “Give me their initials, and give me some data, and let’s try not to cloud it.”

The next afternoon, while Chrisman was hurtling westward, Sullivan walked to the double-doored fridge in the IV room, where pharmacists in masks and gowns and booties mix drugs that need injecting, and snapped a picture of the remdesivir he was about to give away. He made sure the lot number and expiration date were legible. He wanted to document everything.

The advice to become a pharmacist had come from his father, a line-worker in a Ford windshield factory, who’d weathered a number of layoffs: “My dad told me that people will always be sick and it’s a reliable job, and, boy, he was right.” He’d spent years helping with solid organ transplants, diagramming complex regimens of immune-suppressants, and now, as he packed vials into a cooler he felt the old thrill of getting to prepare a patient’s scripts himself. But there was also an unusual prickle of anxiety — enough that he wondered for a second whether he’d slipped in the TempTrak, a doohickey that changes color if the temperature goes out of range.

Related: 

With little data, doctors struggle to decide which Covid-19 patients should get remdesivir

The handoff took place in the airport-like pull-through in front of the hospital, where patients were being picked up and dropped off. Once Lobo had spotted Chrisman — he had to be the guy with the whitish gray hair and brown shirt, trying to look conspicuous — he called over Sullivan, who arrived with the cooler and asked to see Chrisman’s driver’s license. Turned out he’d left it in his car. But then Sullivan spotted his hospital ID on a lanyard, and decided that would do the trick. He snapped a picture. “Just so I could prove it was him,” he said. “In case the FDA wanted any information.”

They chatted. They bumped elbows. Then Chrisman took the cooler and drove off.

Yet as Sullivan’s father predicted, there were always more sick people, and he still had plenty of work. Even before he’d fulfilled Chrisman’s remdesivir request, others began trickling in — from Cookeville, a few from Memphis — slow at first, then gaining momentum. The same afternoon that he was orchestrating that first handoff, the Tennessee Hospital Association’s board was deciding on a remdesivir distribution strategy to recommend for the entire state, and the members unanimously voted to adopt the plan that Wright and her colleagues had rushed into being for Goodpasture’s stepfather.

The next day — Friday, March 15 — when the federal distributor dropped off 2,280 vials of remdesivir at the department of health, a truck soon swept it away to a walk-in fridge in a Vanderbilt warehouse.

Until they could set up a more robust online order form, Sullivan became the state’s remdesivir guardian. He used a spreadsheet to track how many minutes elapsed between receiving a request from an outside hospital and responding with the physician jurors’ approval or denial. He fielded pleas while he was tending to his holly bushes, and while he was over in his daughter’s backyard, watching from a sad, safe distance as his 2-year-old grandson splashed in a kiddy pool. If the doctors in charge didn’t answer his email quickly enough, he’d ping them by text, to keep waiting times down, though he didn’t have to do it very much.

“Let’s see right here, 40 minutes, 139 minutes, 54 minutes, 25 minutes,” said his colleague Bob Lobo, reading from the spreadsheet. “And this is over the weekend, mind you, when he’s out there laying mulch.”

A few pharmacists subsequently pulled a Chrisman, driving to pick up vials for their patients themselves, but most used courier or delivery services. The setup wasn’t perfect. There was still some awkwardness in one hospital being granted the state’s authority to accept or deny another hospital’s request. Yet it settled some of the head-spinning questions Goodpasture had come up against, making clear exactly how much remdesivir there was, where it was kept, and what the criteria were for getting it. Most importantly, to Sullivan, what allowed the most judicious use of a scarce resource was to have a single, centralized method for all of Tennessee, with the same rules applied to everyone.

Over the course of the next few weeks, the federal government’s distribution strategy improved, to correct what officials themselves acknowledged was a discrepancy between a region’s initial remdesivir allocation and its need. Still, even as Vanderbilt tweaked its own method — setting up an online intake system to relieve Sullivan from his state of constant vigilance, updating the eligibility criteria to match the latest study results — it contained reminders of a lapse, idiosyncrasies that might have been different if the initial country-wide procedure had been more coherent. Within it was both a story of a good deed and a cautionary tale.

As Lloyd Doggett, a Democratic congressman from Texas, told STAT, “We know that remdesivir brings only modest improvement. But when we get a really strong treatment, or if we get a vaccine, the failure of the administration in distributing this medication is concerning for what lies ahead.”

He was right about remdesivir: For some, the medication was so effective that they were discharged from the hospital before they could finish their course, but not for everyone. Goodpasture’s stepdad was in the second camp. He’d gotten the first dose that same night. About a week after his clinicians had drawn it out of the vial, squirted it into a saline solution bag, and piggybacked it onto his IV, he was doing so poorly that Goodpasture worried he might soon need to write an obituary.

By early June, after the U.S. had moved past 100,000 coronavirus deaths and was erupting with protests over unceasing police violence against Black citizens, he wrote in an email, “My stepfather is still alive … hanging in there on a ventilator in critical condition. I am super down about the state of the world and I don’t really want to talk.