Doctors said that since the drug is the only approved treatment for Covid-19 patients and is extremely rare, any delay or reduction in availability would be potentially catastrophic.
“We think the sooner you get it when you are seriously ill, the more likely it is to be beneficial, so delays could end up making the difference between whether or not the medication works,” said Ashish Jha, Director Harvard. Global Health Institute and a practicing physician. “The fact that we are so incompetent in our distribution of that that we … ineffectively distribute the therapy that we have is astounding. How can we make this mistake? What are you working on that is more important than that? ”
The initial government distribution in the first week of May was so problematic that the White House coronavirus response coordinator Deborah Birx shared the fallout from state health officials and hospitals with senior officials in the task force, according to three senior administration officials. State officials expressed anger and frustration that the government initially decided which hospitals to send the medication to without consulting them.
These missteps have also raised concerns about how the government could manage the distribution of vaccines, which will likely be even more in demand when they become available. “I hope the experience with remdesivir has taught policymakers to be more prepared and strategic” about handling vaccines, said Steven Joffe, medical ethicist at the University of Pennsylvania.
A spokesperson for the Office of the Under-Secretary for Preparedness and Response (ASPR) of the Department of Health and Social Services, who oversaw the distribution, did not say whether the drug had gone to the wrong hospitals. or if he should be fired. Therefore. Instead, she pointed to a web page explaining how ASPR distributed the drug.
Last week, about 80% of the remdesivir given by Gilead had been distributed, according to the 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.
Accounts shared by state and federal officials indicate that the ASPR started sending cases of donated drugs to hospitals in the early days of May. In a May 5 call, the ASPR first informed state health officials that it was distributing the investigational drug to hospitals across the country, said a health official. State that spoke on condition of anonymity because it was not allowed to speak on a private call. The initial batch of drugs was sent to establishments in 13 states, he said.
Many hospitals, however, were not ready to receive the drugs because they were not alerted in advance, said several senior government and hospital and state officials. State health officials did not know at the outset how the government decided where to send such a limited supply of drugs.
“It surprised everyone,” said the public health official. “States should have been part of the decision-making. They should not be informed after the fact of what is set in motion. “
Some of the drug was sent to the Montefiore Medical Center in New York, for example, but the hospital did not have a refrigerator to store the drug, according to two senior administration officials and a New York health official. . Montefiore did not respond to many requests for comment. It is not known what happened to these medicine vials.
In the 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 relied on was problematic, said the state official during the call.
The ASPR initially used data showing the capacity and size of hospital intensive care beds, as well as case data at the county level, said the state official. But state officials told Kadlec that the data overestimates the need in some parts of the country while underestimating it in others, the state official said.
“The states were disappointed. They were upset. “Why are you doing this this way,” said the official.
On May 9, HHS changed the process, announcing that it would send the drug to states, which would then decide which establishments would receive the drug, how much and when – just as they manage the distribution of the national strategic stock, the health official from the state told me.
The hospital and state officials said the process has improved considerably since then.
Amerisource Bergen, who distributed the drug for Gilead while following government directions, denied that there had been any problems with the company’s distribution of remdesivir to states and hospitals.
“AmerisourceBergen representatives contacted each facility, including health systems and state health departments, designated by the government to receive Remdesivir before the product was shipped to ensure that they had the cold chain capacity and were ready to receive the drug, “company spokesperson Gabe Weissman said in a statement. declaration. “At the end of these shipments, AmerisourceBergen confirmed with each recipient that the quantity and temperature of the medication delivered was appropriate. “
Daniel Abazia, director of pharmacy for Capital Health, a two-hospital system in southern New Jersey, said the confusion over the initial deployment of remdesivir cleared when the state resumed the allocation.
He said the health care system has received two drug shipments and is now in “good shape”, especially as 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 scarce drugs and who should receive them. Some hospitals administer the drug to as many patients as they can who meet the FDA criteria, regardless of whether the drug might run out. Critics of the system claim that it could hurt patients who fall ill later. Other hospitals add conditions or use modified lotteries.
The University of Pittsburgh Medical has more than five dozen out of 19 patients who will qualify for the drug in the next two weeks, but the healthcare system only has 16 patients, said Douglas White, a physician and ethicist in intensive care.
To distribute the drug fairly, he said, the UPMC relies on a modified lottery that gives extra weight to people who are essential workers, such as bus drivers and grocers, as well as to disadvantaged people who traditionally have less access to the health system. . People with terminal illness receive slightly less weight in the lottery.
The shortage of remdesivir, on the other hand, “is already happening across the country,” he said. “It appeared very quickly, and a lot of people are on their back feet trying to figure out what to do. “