- US regulators authorized the emergency use of a promising coronavirus drug, remdesivir, last week.
- The government is now responsible for getting the drug to hospitals so that they can treat patients.
- Doctors and hospitals told Business Insider they were struggling to figure out whether they would get the drug, when shipments would show up, and how allocation decisions were made.
- Doctors across the country have expressed frustration over the confusion and lack of transparency.
- We still don’t know how the US government is making these decisions and which hospitals will eventually get the drug.
- Visit Business Insider’s homepage for more stories.
A week ago, US regulators scrambled to allow the emergency use of a promising coronavirus treatment.
The quick action reflected the urgency of a pandemic that’s still infecting 30,000 people a day in the US and has killed more than 75,000. It came just two days after the National Institutes of Health said the drug, remdesivir, helped hospitalized COVID-19 patients recover more quickly.
It was a moment that sparked hope that scientific ingenuity could chart a path out of the health crisis.
But since that emergency OK, the government’s response has fallen far short.
A week later, the Trump administration has provided little information on its plan to get the drug to hospitals and patients. Frontline doctors have been left in the dark, and patients don’t have access to a drug that may help them recover from serious illness, Business Insider first reported on Wednesday.
Gilead Sciences, the maker of remdesivir, gave supplies to the US government, which is in charge of doling out the drug.
“There is currently significant confusion and lack of information regarding the criteria the federal government is using to allocate this limited supply of donated remdesivir,” said Dr. Julie Ann Justo, an infectious-disease physician at Prisma Health-Midlands, a health system headquartered in Columbia, South Carolina.
Justo added that she was unaware of any South Carolina health systems that are slated to receive remdesivir.
A scramble to figure out who’s getting remdesivir
“Unfortunately, the lack of a transparent process to request and obtain this donated remdesivir has led to the local expenditure of significant time and personnel resources within health systems,” she said. “A more transparent allocation process would significantly ease this burden.”
Federal agencies have declined to answer questions about the distribution plan. The initial strategy was for the Department of Health and Human Services and the Federal Emergency Management Agency to work together, according to Axios.
In response to questions about the plan from Business Insider, FEMA said Wednesday that HHS was handling distribution. HHS hasn’t responded to requests for comment from Business Insider.
On Friday, Bloomberg News reporter Jordan Fabian said that Dr. Deborah Birx, the White House’s coronavirus-response coordinator, would take charge. The White House didn’t respond to a request for comment.
The response was hamstrung by “a complete breakdown in communication and coordination within the Trump administration,” Axios reported on Thursday.
Some healthcare workers, frustrated with the lack of clarity, looked to Twitter to figure out who is getting the drug. Conan MacDougall, a clinical-pharmacy professor at the University of California, San Francisco, has been aggregating responses from hospitals across the nation.
Through an anonymous survey, MacDougall has mapped out 13 health systems that have received the drug and dozens more that have been rejected.
MacDougall told Business Insider he didn’t believe his map should be necessary and that he hopes for a clearer federal response.
“I think everyone knows that there isn’t going to be nearly enough drug and that rules for distribution are required,” he wrote in an email. “But it seems reasonable to share what those rules are.”
The lack of transparency has left doctors with much confusion about when, or if, they will get the drug. Here’s what we know and don’t know so far about the government’s response.
Which hospitals are going to get remdesivir?
HHS hasn’t answered this question. But Axios’ Jonathan Swan reported Friday that the drug had been “shipped and delivered on Tuesday to Indiana, Massachusetts, New Jersey, Rhode Island, Tennessee and Virginia.”
It’s unclear which hospitals in these seven states will get the drug. Axios also reported that HHS would decide on Friday and Saturday on the next 16 states to receive remdesivir.
Providence St. Joseph Health, a 51-hospital health system based on the West Coast, has 16 hospitals that are involved in remdesivir clinical trials and still receiving doses through those trials. No hospitals beyond those 16 will be receiving remdesivir via the government, the health system told Business Insider.
Some hospitals and states are working to take the problem into their own hands. Four Massachusetts hospitals received remdesivir, and they’re working with state health officials to figure out how to share the drug statewide, Ann Scales, a spokeswoman for the Massachusetts Department of Public Health, said.
Massachusetts General Hospital said it got enough remdesivir to treat about 170 patients on Wednesday. The hospital decided to turn the drug over to the state after learning it was the only facility in Boston to get any, Dr. Alyssa Letourneau, the director of the hospital’s antimicrobial-stewardship program, said.
Who decides who gets the drug? How are they making those calls?
HHS hasn’t answered this question. Gilead has made it clear it isn’t its decision.
No federal agency has publicly taken leadership of the distribution process. The government is using AmerisourceBergen to ship the drug, but the drug wholesaler is simply executing orders.
According to a document from the healthcare-services company Vizient obtained by Business Insider, the US government is deciding which health systems get the drug “based on case level data.” HHS did not respond to questions about which criteria are being used to guide these decisions.
But in Philadelphia, Temple University Hospital has been told it won’t get the drug, despite its nearly 1,000 COVID-19 admissions. Temple has treated the most coronavirus cases in the city, The Philadelphia Inquirer reported.
Meanwhile, Penn Medicine expects to get the drug, but Dr. William Short, an infectious-disease physician there, said it could take a couple weeks.
Short said he was surprised by the lack of information, given the urgency of the pandemic.
How much remdesivir does the US government have?
Axios reported that Gilead offered to donate more than 600,000 doses of remdesivir to the US government. Gilead has previously said it has a supply of about 1.5 million doses.
A Gilead spokesperson confirmed Wednesday to Business Insider that it donated “a portion” of its supply but declined to provide specifics. HHS didn’t respond to a question about how much of the drug the US government has available.
Axios also reported that more than 32,000 doses were shipped to those first seven states. It’s not clear if the government plans to distribute the entire supply of remdesivir in the near term or stagger the distribution over time.
When can selected hospitals expect to receive the drug?
HHS did not respond to this question. Doctors across the nation gave varying answers based on what they are hearing. Some hospitals are expecting to receive remdesivir this week, while others think it could take several weeks.
Other hospitals that have yet to be notified if they’ve been selected to receive the drug are not sure if they will get any remdesivir.