Marissa Guale is like all too many Americans right now. Her husband and father of her two children, Raul, is on a ventilator in a hospital on Long Island, fighting for his life while sick with COVID-19. Raul, a 34-year-old nurse, likely caught the disease while working in a nursing home. When the National Institutes of Health announced an emergency use authorization for the experimental antiviral drug remdesivir, Marissa scrambled friends and family on Facebook to figure out how to get access for Raul, emailing hospital administrators, senators, and doctors. They pressed the Guale family’s case for a potentially lifesaving treatment on social media to anyone who would listen.
Her confusion about where and how to get access to the drug isn’t unique. All over the country, families, doctors, and hospitals are wondering how to get the drug and on what basis it’s being distributed. The Trump administration, which is in charge of allocation, hasn’t published any guidance on how it’s making decisions about the scarce supplies of the drug.
So who decides which hospitals get remdesivir? And what’s the most ethical way to prioritize access?
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When Raul was hospitalized and put on a ventilator, his wife Marissa enlisted friends to blitz Facebook with posts advocating for Mather Hospital, where he’s being treated, receive an emergency use supply of the drug. In late April, Dr. Anthony Fauci had announced that the results from a worldwide clinical trial showed that the antiviral, which disrupts the virus’s ability to replicate, might be able to shorten hospitalization times for severely ill patients and slightly improve chances for survival. “It’s a very important proof of concept,” Fauci said at a White House press conference. “What it has proven is that a drug can block this virus.”
The data prompted the FDA to issue an emergency use authorization approving its use in severely ill COVID-19 patients.
“Raul’s family is being told that although remdesivir has been approved for clinical trials it is not yet approved to be used at Mather hospital,” one of the Facebook posts pleaded. “We are begging you to change this and allow these treatments to be used at Mather as Raul is running out of time.”
“We were fighting for plasma because they didn't have plasma at the hospital he was at but he did get the plasma last night. We're just waiting,” Guale told The Daily Beast.
Data gaps: Remdesivir isn’t necessarily a silver bullet for dealing with COVID-19. Data from one of the largest randomized clinical trials published in late April showed that patients who received the drug had a mortality rate of 8 percent compared to 11.6 percent for those in a control group. Remdesivir recipients also got out of the hospital an average of four days earlier than those who received a placebo. Those numbers might change, too, since data from the National Institutes of Health’s global study is still awaiting peer review and publication.
Remdesivir, first considered as a potential treatment for Ebola, has been studied in clinical trials for years. The latest study of its effectiveness against COVID-19, backed by the NIH, is the largest yet with a randomized control trial design—the gold standard for testing new drugs.
Because of that, there are still important data gaps for making decisions.
“There are still loads of questions that we don't know about the drug. We don't know whether it has any impact on mortality. We don't know exactly which kind of which patients are most likely to benefit or not likely to benefit,” says Holly Fernandez Lynch, an assistant professor of medical ethics at the University of Pennsylvania. “It's hard to know how to maximize benefit if you don't have enough clinical information to assess which patients are most likely to benefit in which ways and which patients aren't.”
That’s why some argue that allocation decisions should be guided in part by a hospital’s ability to collect data about patient outcomes—mortality and adverse effects—from a remdesivir treatment so that future patients can benefit from a better understanding of the drug’s effects.
Production ramps up: Months before the NIH study sparked hopes, Gilead was already facing high enough demand that it had to restrict compassionate use of remdesivir to severely ill pregnant women and children. In anticipation of the potential success of the drug in clinical trials, the company announced it was ramping up production in early April to an expected 140,000 courses of 10-day treatments. To facilitate global demand, Gilead announced this week that it was “in discussions with some of the world’s leading chemical and pharmaceutical manufacturing companies” in Europe, Asia, and developing countries.
This week, Mather Hospital, part of the Northwell hospital system in Port Jefferson, NY, received a supply of remdesivir under the emergency use authorization granted by the FDA. Patients can now access the drug under that authorization or if they qualify for one of “two clinical trials being done in collaboration with [remdesivir manufacturer] Gilead to study remdesivir as a potential COVID-19 treatment,” according to a statement from Northwell.
For others, though, it’s still unclear about when, where, and who will get the antiviral medication since the Trump administration hasn’t provided any specific guidance about how it’s distributing the drug.
The emergency use authorization announced by the FDA specified a broad range of eligible patients—adults and children with severe cases of the disease as defined by the need for ventilators or external oxygen—but didn’t offer much as to which regions would get the drug.
The authorization said that “distribution of the authorized remdesivir will be controlled by the United States (U.S.) Government” which “will distribute to hospitals and other healthcare facilities...in collaboration with state and local government authorities, as needed.”
Earlier this week, the Trump administration told CNN that the White House Coronavirus Task Force would oversee the distribution of the drug for now — on what basis exactly, they wouldn’t say. The is to transfer longer term distribution decisions to FEMA and HHS.
Neither the White House task force nor the Department of Health and Human Services responded to questions from The Daily Beast about allocation.
But questions from doctors and public health organizations are piling up. Earlier this week, the HIV Medicine Association and the Infectious Diseases Society of America released an open letter to Vice President Mike Pence and the White House Coronavirus Task Force asking them to publish a remdesivir allocation plan which “should be transparent and should be based on state and regional COVID-19 case data and hospitalization rates.”
Similarly, the American Society of Health-System Pharmacists, which represents 55,000 pharmacists across the country, wrote its own letter to the task force warning that "the process for hospitals to access [remdesivir] remains unclear" and urging the White House to “make public its process for determining which hospitals will receive the drug.”
The ethics of life and death decisions: So how should remdesivir be distributed? “There are lots of papers that have been published with allocation principles. The thing that they generally agree on is that the way you allocate is to maximize benefit,” says Fernandez Lynch.
There’s plenty of arguments about how to define the kind of benefit that should guide allocation. Some point to age and lifespan as important metrics while others argue for basing decisions on the size of a region’s outbreak. Regardless of how you define it, ethicists say it’s important for governments to do so publicly.
“You need to make it clear who’s going to get access and why so that the public can interrogate your reasons and hold your feet to the fire for behaving in an appropriate manner,” says Fernandez Lynch.
Stockpile fight 2.0: Even before remdesivir received an emergency use authorization, many questioned the Trump administration’s decision-making over the distribution of scarce pandemic resources. Hospitals in hard-hit areas like Miami and New York blasted HHS for its decision to distribute $100 billion in emergency grants for hospitals from the CARES Act based on past medicare billing rather than current COVID-19 caseloads. Governors also criticized the White House for its decision about how to distribute supplies from the Strategic National Stockpile, the federal government’s supply of potentially lifesaving N95 masks, personal protective equipment, and ventilators intended to prepare the country to handle a pandemic. While some worried that states like Florida were receiving supplies based on electoral politics more than need, federal officials argued that distribution was based on a formula that included a state’s population size, as well as its COVID-19 caseload.
In any case, the lack of transparency—something that has haunted the Trump administration even before the pandemic—has bred distrust. And that’s why the decisions about how to distribute remdesivir may be important beyond its moderate clinical impact on the disease.
Remdesivir is far from a cure for COVID-19 but it’s the first of what may be a series of therapeutics that could be approved to treat the disease in the near future. Monoclonal antibodies—synthetically produced antibodies that bind to and destroy coronavirus spike proteins—are undergoing clinical trials this summer and researchers are looking into whether a handful of anti-inflammatory drugs could help prevent the overactive immune response that plagues many COVID-19 patients.
In a pandemic scenario, the demand for anything that works is instantly global while supplies are limited, at least initially. Establishing a transparent and fair process for distributing remdesivir now could help the federal government head off other, more contentious fights over future drugs.
Still fighting: Raul’s family ultimately managed to get him on remdesivir, despite some early confusion and a worrying complication. He went into renal failure and, given that some patients experienced renal impairment as a side effect of remdesivir, there were concerns that the drug could further harm his kidneys. In an email to The Daily Beast, Marissa wrote that her husband was given access to the drug on Friday. ”Could be harmful for him right now but we had to take the chance,” she wrote.
