Demand for remdesivir soared after the National Institutes of Health announced on April 29 that a clinical trial had shown that hospitalized patients with advanced covid-19 who received the experimental drug recovered faster than similar patients who received a placebo. Two days later, the Food and Drug Administration, citing those results, approved the drug to treat severely ill patients.
Doctors said that because the drug is the only approved treatment for covid-19 patients and in extremely short supply, any delay or reduced availability would be potentially catastrophic.
“We think the earlier you get it when you’re critically ill, the more likely it is to be beneficial, so delays could end up making the difference between whether the drug is effective or not,” said Ashish Jha, director of the Harvard Global Health Institute and a practicing physician. “The fact that we’d be so incompetent in our distribution of this that we’d … inefficiently distribute the one therapy we have is stunning. How can we make that mistake? What are you working on that’s more important than this?”
The government’s initial distribution in the first week of May was so problematic that White House coronavirus response coordinator Deborah Birx shared fallout from state health and hospital officials with senior staffers on the task force, according to three senior administration officials. State officials had expressed anger and frustration that the government initially decided which hospitals to send the drug to without consulting them.
The missteps also raised concerns about how the government might handle the distribution of vaccines, which are likely to be in even greater demand when they become available. “I hope the experience with remdesivir has taught decision-makers to be more prepared and more strategic” about handling vaccines, said Steven Joffe, a medical ethicist at the University of Pennsylvania.
A spokeswoman for the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR), which oversaw the distribution, did not address whether the drug went to the wrong hospitals or whether any of it had to be sent back as a result. She instead pointed to a Web page explaining how ASPR was allocating the drug.
As of last week, about 80 percent of the donated remdesivir from Gilead had been distributed, according to ASPR. Gilead plans to donate an additional 333,160 vials of the drug by mid-June, according to HHS, bringing the total donation to 940,000 vials.
The accounts shared by state and federal officials indicate that ASPR began sending out cases of the donated drug to hospitals in the first days of May. On a May 5 call, ASPR first informed state health officials it was distributing the experimental drug to hospitals across the country, said one state health official who spoke on the condition of anonymity because he was not authorized to speak about a private call. The initial batch of medicine was sent to facilities in 13 states, he said.
Many hospitals were not prepared to receive the medication, however, because they were not alerted ahead of time, said several senior administration officials and hospital and state officials. State health officials initially did not know how the government was deciding where to send such a limited supply of the medication.
“That caught everyone by surprise,” the state health official said. “The states should have been part of the decision-making. They should not be told after the fact about what’s being put in motion.”
Some of the medication was sent to Montefiore Medical Center in New York, for instance, but the hospital did not have the refrigerator space to store the drug, according to two senior administration officials and one New York health official. Montefiore did not respond to numerous requests for comment. It is unclear what happened to those vials of the drug.
On that same May 5 call after the first distribution, state officials told Robert Kadlec, HHS assistant secretary for preparedness and response, that the data the agency was relying upon was problematic, said the state official on the call.
ASPR initially used data that showed hospital ICU bed capacity and size, as well as county-level case data, the state official said. But state officials told Kadlec that the data overstated the need in some parts of the country while underestimating it in others, the state official said.
“States were disappointed. They were upset. ‘Why are you doing it this way?’” the official recalled them saying.
On May 9, ASPR altered the process, announcing that it would send the drug to states, which would then decide which facilities would get the medicine, how much and when — much as they handle distribution from the Strategic National Stockpile, the state health official said.
Hospital and state officials said the process has since drastically improved.
AmerisourceBergen, which distributed the drug for Gilead while following the government’s directives, denied there were any problems in the company’s distribution of remdesivir to states and hospitals.
“AmerisourceBergen representatives contacted every facility, including both health systems and state health departments, designated by the government to receive Remdesivir prior to shipping product to ensure they had cold chain capability and were prepared to receive the drug,” company spokesman Gabe Weissman said in a statement. “Upon completion of these shipments, AmerisourceBergen confirmed with each recipient that the quantity and temperature of the delivered medication was appropriate.”
Daniel Abazia, director of pharmacy for Capital Health, a two-hospital system in southern New Jersey, said the confusion that surrounded the initial rollout of remdesivir dissipated as the state took over the allocation.
He said the health system has gotten two shipments of the drug and now is in a “good position,” especially since its number of covid-19 patients is decreasing.
Now, with a more coordinated federal response, states and hospitals are grappling with decisions about how to allocate the scarce medication and which covid-19 patients should get it. Some hospitals are administering the drug to as many patients as they can who meet the FDA criteria, without worrying about whether the drug might run out. Critics of that system say it could hurt patients who get sick later. Other hospitals are adding conditions or using modified lotteries.
The University of Pittsburgh Medical Center has more than five dozen covid-19 patients who will qualify for the drug over the next two weeks but the health system has enough for only 16 patients, said Douglas White, a critical-care physician and ethicist there.
To distribute the drug fairly, he said, UPMC relies on a modified lottery that gives extra weight to people who are essential workers, such as bus drivers and grocery store workers, as well as to disadvantaged individuals who traditionally have less access to the health system. Those with terminal illnesses are given slightly less weight in the lottery.
“The amazing thing about this is that we spent so much time preparing for ventilator shortages that didn’t happen — there was lots of smoke and no fire,” White said.
The remdesivir shortage, by contrast, “is already happening around the country,” he said. “It has come up very quickly, and a lot of people are on their back foot, trying to figure out what to do.”