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| © Gilead Sciences via AP Vials of remdesivir are stopped at a Gilead manufacturing site. |
By Zachary Brennan, POLITICO
Doctors across the country are demanding that the Trump administration explain how it is distributing the sole drug proven to help coronavirus patients to hospitals.
Physicians and infectious-disease experts say that the government has so far ignored some medical centers that are treating large numbers of coronavirus patients. The drug’s maker, Gilead, has donated an unspecified number of doses to the government, which has put HHS and FEMA in charge of doling out the drug to hospitals.
So far the rollout has been chaotic. About 25 hospitals have been approved to receive the drug, but doctors say it’s not clear how the government — through its contractor, AmerisourceBergen — is making those decisions. A spokesperson for the company said the administration is choosing which facilities receive the drug and how much they get.
Adding to the confusion, a senior HHS official told POLITICO that the government has not finalized its plan for distributing remdesivir.
That has frustrated doctors on the front lines of the pandemic. “The plan for distributing remdesivir should be transparent and should be based on state and regional Covid-19 case data and hospitalization rates,” the Infectious Diseases Society of America and the HIV Medicine Association said in a letter Wednesday to Vice President Mike Pence.
Yet Boston Medical Center, its city’s largest public safety-net hospital, “got none,” Benjamin Linas, an epidemiologist at the hospital, tweeted on Wednesday. “We have the second highest absolute case count and highest per bed in Boston,” he wrote. “We also had no access to early trials. Today, the family of a dying patient asked me why we do not have RDV. What am I supposed to say?”
And Judith Feinberg, infectious disease doctor and chairwoman of the HIV Medicine Association, said there’s widespread concern among physicians that remdesivir isn’t reaching many coronavirus hot spots. “We would like this not to be random,” she said, noting that there has not been any indication from the government that it isn’t.
To help figure out where the drug was going, Conan Macdougall, a professor of clinical pharmacy at the University of California, San Francisco, surveyed hospitals across the country about their access to remdesivir. He told POLITICO that he was able to identify about half of the 25 hospitals set to receive stocks of the drug.
All but two of the facilities he uncovered are located on the East Coast, even though many areas in the interior U.S. and West Coast have also been hit hard by the virus. But there’s not a clear divide, such as between red states and blue states, that explains which facilities have been given access to the drug.
“From what we can see of the 10 [hospitals] we do have data on and the many that we do not, there isn’t a clear politicization as to distribution by geography,” Macdougall said.
Further complicating the situation, at least one governor has said his state has received the drug directly from Gilead. Maryland Gov. Larry Hogan said Wednesday that the company gave 1,600 doses of remdesivir, which will go to unspecified hospitals in Montgomery and Prince George’s counties, just outside of Washington, D.C. A spokesperson for Hogan did not respond to questions about which hospitals would get the drug.
Meanwhile, some hospitals that received remdesivir from the government aren’t sure how best to distribute it. The FDA gave Gilead an emergency use authorization for the drug based on data from a clinical trial conducted by the National Institute of Allergy and Infectious Diseases, but neither agency has released detailed results from the study.
Francisco Marty, an associate professor at Harvard Medical School, said he’s been working with North Shore Medical Center in Massachusetts — which received a shipment of 1,000 doses of remdesivir on Wednesday — to strategize how to give out the drug based on his experience with remdesivir during a clinical trial.
Other hospitals that have received remdesivir from the FDA through its “expanded access program,” which gives patients access to the drug outside of clinical trials, aren’t sure whether they’ll be able to get more.
Aadia Rana, an infectious disease doctor at the University of Alabama at Birmingham's hospital, said her facility isn’t sure if it will able to restock through the expanded access program after its current inventory runs out. “This of course puts us in a Catch-22 with regards to distributing our available limited supply,” she said.
Rana said that AmerisourceBergen told the hospital that it may receive remdesivir in the future through the new government distribution program, however.
U.S. doctors are also watching to see how demand for the drug globally affects the available supply. Gilead said it would donate 1.5 million doses, or enough for about 140,000 people, for use worldwide. It’s not clear what percentage of those doses will go to U.S. hospitals. Japan on Thursday became the second country to authorize use of remdesivir based on data from the NIAID trial, and European regulators are reviewing the drug.
In the meantime, American doctors like Feinberg are left frustrated and wondering about how many of their patients will have access to a potentially life-saving medicine — and who will make that choice.
“Who the hell is the decisionmaker?” she said. “Is it HHS or some other part run by some political crony? We don’t have any information that there’s any kind of fairness, and when [the drug is] in short supply, fairness is paramount.”
See more at POLITICO
Doctors across the country are demanding that the Trump administration explain how it is distributing the sole drug proven to help coronavirus patients to hospitals.
Physicians and infectious-disease experts say that the government has so far ignored some medical centers that are treating large numbers of coronavirus patients. The drug’s maker, Gilead, has donated an unspecified number of doses to the government, which has put HHS and FEMA in charge of doling out the drug to hospitals.
So far the rollout has been chaotic. About 25 hospitals have been approved to receive the drug, but doctors say it’s not clear how the government — through its contractor, AmerisourceBergen — is making those decisions. A spokesperson for the company said the administration is choosing which facilities receive the drug and how much they get.
Adding to the confusion, a senior HHS official told POLITICO that the government has not finalized its plan for distributing remdesivir.
That has frustrated doctors on the front lines of the pandemic. “The plan for distributing remdesivir should be transparent and should be based on state and regional Covid-19 case data and hospitalization rates,” the Infectious Diseases Society of America and the HIV Medicine Association said in a letter Wednesday to Vice President Mike Pence.
Yet Boston Medical Center, its city’s largest public safety-net hospital, “got none,” Benjamin Linas, an epidemiologist at the hospital, tweeted on Wednesday. “We have the second highest absolute case count and highest per bed in Boston,” he wrote. “We also had no access to early trials. Today, the family of a dying patient asked me why we do not have RDV. What am I supposed to say?”
And Judith Feinberg, infectious disease doctor and chairwoman of the HIV Medicine Association, said there’s widespread concern among physicians that remdesivir isn’t reaching many coronavirus hot spots. “We would like this not to be random,” she said, noting that there has not been any indication from the government that it isn’t.
To help figure out where the drug was going, Conan Macdougall, a professor of clinical pharmacy at the University of California, San Francisco, surveyed hospitals across the country about their access to remdesivir. He told POLITICO that he was able to identify about half of the 25 hospitals set to receive stocks of the drug.
All but two of the facilities he uncovered are located on the East Coast, even though many areas in the interior U.S. and West Coast have also been hit hard by the virus. But there’s not a clear divide, such as between red states and blue states, that explains which facilities have been given access to the drug.
“From what we can see of the 10 [hospitals] we do have data on and the many that we do not, there isn’t a clear politicization as to distribution by geography,” Macdougall said.
Further complicating the situation, at least one governor has said his state has received the drug directly from Gilead. Maryland Gov. Larry Hogan said Wednesday that the company gave 1,600 doses of remdesivir, which will go to unspecified hospitals in Montgomery and Prince George’s counties, just outside of Washington, D.C. A spokesperson for Hogan did not respond to questions about which hospitals would get the drug.
Meanwhile, some hospitals that received remdesivir from the government aren’t sure how best to distribute it. The FDA gave Gilead an emergency use authorization for the drug based on data from a clinical trial conducted by the National Institute of Allergy and Infectious Diseases, but neither agency has released detailed results from the study.
Francisco Marty, an associate professor at Harvard Medical School, said he’s been working with North Shore Medical Center in Massachusetts — which received a shipment of 1,000 doses of remdesivir on Wednesday — to strategize how to give out the drug based on his experience with remdesivir during a clinical trial.
Other hospitals that have received remdesivir from the FDA through its “expanded access program,” which gives patients access to the drug outside of clinical trials, aren’t sure whether they’ll be able to get more.
Aadia Rana, an infectious disease doctor at the University of Alabama at Birmingham's hospital, said her facility isn’t sure if it will able to restock through the expanded access program after its current inventory runs out. “This of course puts us in a Catch-22 with regards to distributing our available limited supply,” she said.
Rana said that AmerisourceBergen told the hospital that it may receive remdesivir in the future through the new government distribution program, however.
U.S. doctors are also watching to see how demand for the drug globally affects the available supply. Gilead said it would donate 1.5 million doses, or enough for about 140,000 people, for use worldwide. It’s not clear what percentage of those doses will go to U.S. hospitals. Japan on Thursday became the second country to authorize use of remdesivir based on data from the NIAID trial, and European regulators are reviewing the drug.
In the meantime, American doctors like Feinberg are left frustrated and wondering about how many of their patients will have access to a potentially life-saving medicine — and who will make that choice.
“Who the hell is the decisionmaker?” she said. “Is it HHS or some other part run by some political crony? We don’t have any information that there’s any kind of fairness, and when [the drug is] in short supply, fairness is paramount.”
See more at POLITICO
