May 11, 2020

Inside the Trump admin's revised plan to distribute remdesivir

Daily Briefing

    Health care providers nationwide have expressed frustration over a lack of transparency in the Trump administration's distribution of remdesivir, which is the only drug that's received an emergency use authorization (EUA) from FDA to treat patients with Covid-19. On Saturday, HHS announced a new plan for doling out the drug that will rely on state health departments.

    Covid-19 weekly webinar: What health care leaders need to know

    Confusion, frustration as Trump admin works to distribute remdesivir

    Late last month, FDA issued an EUA allowing providers to use Gilead Sciences' remdesivir to treat certain hospitalized patients with Covid-19, the disease caused by the new coronavirus. The move came after NIH released preliminary data from a closely watched clinical trial suggesting the drug may help patients recover from the disease faster. The trial showed that patients with remdesivir had 31% faster recovery time on average than those who received a placebo. The trial also showed patients with severe cases of Covid-19 treated with remdesivir had lower mortality rates than those who received a placebo—though Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, said the difference was not statistically significant.

    Under the EUA, Gilead provided supplies of remdesivir directly to the federal government and authorized distributors. The federal government was working with authorized distributors to allocate the drug to hospitals and health care facilities in collaboration with local and state governments.

    On May 3, Gilead Chair and CEO Daniel O'Day said the company had donated its entire stockpile of remdesivir to the federal government. On May 5, more than 32,000 doses of remdesivir were distributed to hospitals in Indiana, Massachusetts, New Jersey, New York, Rhode Island, Tennessee, and Virginia, Axios reports.

    However, Trump administration officials told Axios that remdesivir wasn't distributed to some high-priority hospitals in areas most affected by the country's Covid-19 epidemic, and one official told Axios that some of those doses went to hospitals in areas that have been comparatively less affected by the epidemic than others.

    "Some went to the wrong places, some went to the right places," a senior official told Axios. The official added, "We don't know who gave the order" regarding where the doses went, "[a]nd no one is claiming responsibility."

    According to Axios, a source familiar with a May 6 meeting of the White House's coronavirus task force said members of the task force expressed frustration over the matter, and Vice President Pence, who is leading the task force, instructed HHS Secretary Alex Azar to be more involved in ensuring remdesivir is distributed to hospitals most in need.

    Doctors express frustration, call for more transparency

    Health care providers nationwide expressed frustration over the lack of transparency regarding how the federal government was distributing remdesivir.

    "Will we get it? Yes, no? What's the speed at which we're going to get it?" Peter Chin-Hong, a professor of medicine at the University of California-San Francisco School of Medicine, said. "Every day that you delay getting the drug to a particular hospital or a community means lives lost."

    "I think people are frustrated," Michael Ison, a professor of infectious diseases at the Northwestern University Feinberg School of Medicine, said. "We've got patients [who] are sick and dying from Covid-19. We want to give them the best possible therapy and we don't have access to it. We don't know how to get access to it. No one knows how to advocate for your hospital to have this drug made available to your patients."

    Ison added that the lack of transparency could affect how providers treat patients with Covid-19. "If we know we're going to get [remdesivir] for patients, we may hold off on giving other therapies because we know we're going to be getting this therapy that we can offer them instead," he said.

    Benjamin Linas, an epidemiologist at Boston Medical Center, questioned why his hospital didn't receive the drug despite having a large number of Covid-19 patients. "We have the second highest absolute case count and highest per bed in Boston," Linas wrote in a tweet posted May 6. "We also had no access to early trials. Today, the family of a dying patient asked me why we do not have [remdesivir]. What am I supposed to say?"

    Hospitals that had received doses of remdesivir also were unsure of how they were chosen to receive the drug.

    "I legitimately do not have any insight into how hospitals were selected," said Paul Biddinger, director of Massachusetts General Hospital's Center for Disaster Medicine. The hospital received enough doses of remdesivir to treat about 170 patients.

    Doctors also said they don't have access to the full results from NIH's remdesivir clinical trial, which means they're unsure of how the drug will affect people in different demographic groups.

    "What the situation requires us to do is make decisions without the information we need, so we are flying blind," Mark Siedner, an infectious disease doctor at Mass General, said.

    Further, Aadia Rana, an infectious disease doctor at the University of Alabama at Birmingham, said her hospital wasn't sure if it would be able to get additional doses of remdesivir once the doses the hospital has run out. "This of course puts us in a Catch-22 with regards to distributing our available limited supply," she said.

    In light of the confusion, the Infectious Disease Society of America called on the Trump administration to release details on how it is distributing remdesivir. The group in a letter sent last week to Pence wrote, "The plan for distributing remdesivir should be transparent and should be based on state and regional Covid-19 case data and hospitalization rates. Supplies of remdesivir should be distributed on a regional basis with equitable distribution within the region to states and within states to hospitals."

    White House announces changes for remdesivir rollout

    On Friday, the White House announced that it will help coordinate the federal government's distribution of remdesivir, with Deborah Birx, who is serving as the coordinator of the White House's coronavirus task force, serving as one of the chief consultants on how the drug will be distributed.

    White House press secretary Kayleigh McEnany said Birx is "the person who's constantly reviewing the numbers, constantly reviewing the data. And she really has the best grasp as to how that should be distributed."

    In addition, HHS on Saturday said it now plans to deliver doses of remdesivir to state health departments, which then will determine which hospitals will receive the drug and distribute it.

    "State health departments will distribute the doses to appropriate hospitals in their states because state and local health departments have the greatest insight into community-level needs in the Covid-19 response," HHS said. The department added, "Health care providers interested in administering the donated experimental drug should contact their state health department."

    HHS also clarified that the donated doses of remdesivir must be used for Covid-19 "patients on ventilators or on extracorporeal membrane oxygenation or who require supplemental oxygen due to room-air blood oxygen levels at or below 94%."

    HHS said early last week it sent does of remdesivir to Indiana, Massachusetts, New York, New Jersey, Rhode Island, Tennessee, and Virginia. On Thursday, HHS also began sending doses of the drug to Connecticut, Illinois, Iowa, Maryland, and Michigan, as well as additional doses to New Jersey, the department said. HHS said it expects to deliver doses of the drug to all 50 states, U.S. territories, the Indian Health Service, and the Veterans Health Administration for distribution.

    According to STAT News, HHS did not provide details on how the federal government is determining where to distribute the drug or how it is deciding the amount of doses it's distributing to each location (Swan, Axios, 5/8; Azad, CNN, 5/8; Brennan, Politico, 5/7; Boodman/Ross, STAT News, 5/6; Armour/Walker, Wall Street Journal, 5/8; Rowland/McGinley, Washington Post, 5/7; Alonso-Zaldivar, Associated Press, 5/8; Mason, Reuters, 5/8; Facher, STAT News, 5/9; HHS release, 5/9).

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