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Remdesivir and the good news for treating patients 0:45
(CNN) - The United States Government's current supply of remdesivir, the only drug known to work against covid-19, will run out by the end of the month, Dr. Robert Kadlec, a Health Department official, told CNN and US Human Services. USA (HHS).
The last shipment of the drug by the Government will be released the week of June 29. Gilead Sciences, the company that makes the drug, is preparing to produce more, but it is unclear how much will be available.
"Right now, we are waiting to hear from Gilead about its expected delivery availability of the drug as we move from June to July," Kadlec said. "We are not in negotiations, but in discussions with Gilead as they project what the availability of their product will be."
Last month, the US Food and Drug Administration. USA The FDA has emergency authorized remdesivir, an intravenous antiviral medication studied to treat Ebola, but now used in hospitalized covid patients. While not a highly successful drug, a study shows that it cuts the hospital stay by four days from 15 to 11 days.
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The government has been working to assist Gilead "with some of the challenges in its supply chain in terms of raw materials and to accelerate the process," said Kadlec, HHS assistant secretary for preparedness and response.
He added that it is clear that "whatever the supply, there may not be enough for everyone who needs it."
Kadlec said Gilead has given a "general range" of product deliveries for July and August, which then "expands significantly from September, October and through the fall as they open the valve on their production and processing."
Gilead has offered few public details, but has said it plans to have more than 500,000 treatment cycles available by October, and more than a million by December.
"After the donation, the company will work closely with governments and healthcare systems to provide access to healthcare providers to prescribe remdesivir to appropriate patients," it says on a website for healthcare providers.
"We plan to work with the United States government to determine the distribution of remdesivir after the donation," Gilead spokeswoman Sonia Choi told CNN in a statement Sunday.
Fear of high prices
Beginning in early May, the Government began to distribute a supply of remdesivir donated by Gilead. The company has provided 940,000 vials of the drug, or enough for about 121,000 patients, according to HHS.
Now that the free supply is almost over, there are concerns that Gilead will charge it at a high price.
"The price that Gilead can charge, as with any pharmaceutical product in the United States, seems like the sky's the limit: whatever the sick and dying pay," said Rep. Lloyd Doggett, a Texas Democrat who chairs the subcommittee on Health of the House of Representatives.
Last month, Doggett joined Rep. Rosa DeLauro, the Connecticut Democrat who chairs the House subcommittee on Health, Work and Education Assignments, and wrote a letter to HHS Secretary Alex Azar asking for details on any deal. between Gilead and the Government regarding remdesivir. They noted that taxpayers helped finance drug development.
"HHS has not answered any of our questions about pricing and what it is doing to protect taxpayer investment in remdesivir, a drug that would not even be used if it weren't for the taxpayer investment of approximately US $ 70 million in development, "Doggett told CNN, adding that the taxpayers were" basically the investing angels in remdesivir. "
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Under the terms of the FDA emergency authorization, the distribution of remdesivir is controlled by the Government. But Kadlec said no final decisions have been made on how the drug will be administered after this month, whether the government will continue to purchase it, or whether it will be sold through normal channels like any other drug.
Sufficient remdesivir for about half of hospitalized patients, official says
In early May, the Government distributed a small amount of remdesivir directly to approximately two dozen hospitals across the country without explaining why those hospitals were chosen over others.
In the midst of a protest, HHS began distributing remdesivir to state health departments, but questions remained. For example, the week of May 4, California and Texas received the same amount of remdesivir, even though California had many more coronavirus patients.
The shortage in some places was severe. San Francisco, for example, had 70 patients in the hospital with covid-19, but there was only enough remdesivir for about four of them.
Now, HHS is using a distribution formula based on the number of patients reported by hospitals to the agency. And while HHS did not originally disclose where remdesivir was headed, the agency now publishes on its website the amount of drug going to each state.
"We learned from that first day's shipment that we needed to find a better way to do it," Dr. John Redd, an HHS official, said in an interview with CNN. "So we paused and moved on to a better, more refined model that targets exactly where patients are and where they are currently receiving treatment."
He said the amount of remdesivir distributed last week could potentially treat about half of covid patients in US hospitals. USA, based on the number of patients reported by hospitals to HHS.
The federal government sends the drug to state health departments, and those departments decide which hospitals will receive it and how much they will receive. However, remdesivir is not appropriate for all covid patients, and doctors ultimately decide which patients are treated with the drug.
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