De FDA racete om artsen de veelbelovende remdesivirbehandeling te laten gebruiken. Nu wachten ziekenhuizen op het wachten op voorraden. (GILDE)mei 12, 2020
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- A promising coronavirus treatment called remdesivir was approved last week for emergency use in the US.
- Now, some hospitals are having a hard time getting the drug for their patients.
- The US government is deciding which hospitals will get the drug and how much they will get.
- “There are people who are getting diagnosed right now who qualify for treatment and don’t have access to it,” Dr. Taison Bell, an infectious disease and critical care physician at the University of Virginia said.
- Visit Business Insider’s homepage for more stories.
Dr. Tony Reed, the chief medical officer at Temple University Hospital in Philadelphia, has seen remdesivir in action. The hospital system gave the drug to patients in trials to help figure out how well the coronavirus treatment works.
When US regulators approved the emergency use of remdesivir on Friday, saying the treatment could help some severely ill patients recover more quickly, Reed and the team at Temple expected that they’d get more access to the medication.
The approval decision made distribution of remdesivir the responsibility of the US government.
In the days since, Reed has been told that Temple is not on the government’s list, meaning it won’t be able to get additional doses of the medication, outside of the trial still underway.
The decision to leave Temple off the list has left Reed feeling frustrated, in part because of how many COVID-19 patients the hospital is seeing. Temple’s hospitals have had just under 1,000 COVID-19 admissions, Reed said.
“We’re frustrated we’re not in the haves and we’re frustrated that we don’t know how that decision was made,” Reed said. “Frankly, I’ve got sick and dying patients that last week, I was able to get on the study drug, and this week I’m not able to get on the drug I know can help them.”
As the government figures out which hospitals will get the drug, severely ill patients who should qualify for treatment aren’t getting it, doctors across the country told Business Insider.
In some cases, hospitals don’t have the drug on hand yet, or aren’t able to give it to patients outside the narrow confines of clinical trials. Clinicians said they aren’t sure when it will come or how much supply they’ll get.
“There are people who are getting diagnosed right now who qualify for treatment and don’t have access to it,” said Dr. Taison Bell, an infectious disease and critical care physician at the University of Virginia.
Bell said he didn’t know when, or if, Virginia’s medical center would get a supply of the drug provided via the emergency use order.
Any delay may be harmful to patients. Antivirals like remdesivir generally work better when given earlier on in the course of an infection. Gilead Sciences, the biotech company that makes remdesivir, has put out some preliminary data suggesting that may be the case with this drug as well.
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‘I was hoping to get something this week’
“We have sick patients in our hospitals that we’d love to treat with remdesivir prior to them decompensating and going to the ICU,” said Dr. Steven R. Smith, the chief scientific officer at AdventHealth in Orlando. “I was hoping to get something this week. It certainly hasn’t happened yet.”
AdventHealth wasn’t involved in clinical trials of the drug, and Smith said it hasn’t been able to figure out how to get remdesivir under the FDA’s emergency pathway. He said doctors can get it under an expanded access program for very sick patients, but the health system wants to use it earlier in the course of treatment.
The Federal Emergency Management Agency deferred a request for comment to the US Department of Health and Human Services. HHS didn’t respond to questions from Business Insider.
In a Wednesday statement to Politico, HHS said it is working with the Federal Emergency Management Agency to “finalize the process for equitable distribution.”
The agencies are using AmerisourceBergen to ship the drug to selected hospitals. AmerisourceBergen declined to comment.
Temple’s Reed said he was told by AmerisourceBergen’s specialty pharmacy ASD Healthcare that distribution of the drug began on Wednesday.
Gilead has said it’s providing its entire existing supply of the drug, about 140,000 treatment courses, to patients at no cost, and the company is working to ramp up production. CEO Dan O’Day said today that the company began shipping the drug over the weekend and the government is overseeing deliveries.
Last Wednesday, the US National Institutes of Health said a remdesivir study succeeded, showing the drug helped patients recover 31% faster than those who got a placebo. Two days later, US regulators authorized its broader use in hospitalized patients with severe COVID-19.
To date, some patients have had a difficult time getting remdesivir. Michael Goldsmith, a 34-year-old husband and father in New Jersey, was on a ventilator for 22 days with the coronavirus, while his family fought for him to get access to the drug, as Business Insider’s Anna Medaris Miller previously reported. He was never able to get it, and eventually recovered enough to go home.
Doctors are waiting for an answer on remdesivir supplies
With a scarce supply of the drug, the government now faces a difficult task of allocating Gilead’s donation. As crucial days tick by since the emergency authorization, hospitals across the US told Business Insider they’ve received little or no information on when they’ll get remdesivir.
Dr. William Short, an infectious disease physician at the University of Pennsylvania, said it could take a couple weeks for remdesivir to reach his hospital. Some patients who are in clinical trials will still be able to get the drug, but others will be left out, he said.
“We are totally stuck. That’s the part we are all waiting for, an answer,” he said. “They say within the next few weeks.”
He said he was anticipating a call about an emergency supply decision soon after the authorization, given the urgency of the pandemic.
“I honestly thought we were going to have it over the weekend,” Short told Business Insider.
US government takes the lead on distribution, providing little clarity
US officials have said they would choose hospitals based on levels of need, but haven’t provided more details on how they are making that determination.
“Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir,” an FAQ posted by the US Food and Drug Administration states.
It has only been a few days since the drug was OK’d for emergency use. The drug distribution process typically takes weeks, if not months, to move from approval to widespread use. But the urgency of the pandemic is testing yet another system not designed to move so quickly.
“I think we’re just seeing the normal roadblocks that are in place from getting a drug manufactured and distributed are still there,” Bell said. “Even though we are trying to shorten it as much as possible, that still takes time and we don’t have time right now.”
The large New York hospital system Northwell Health is “cautiously optimistic about receiving supplies of remdesivir in the next few days,” said Dr. David Battinelli, Northwell’s chief medical officer.
Dr. Elizabeth Hohmann, the principal investigator of the NIH trial at its Massachusetts General Hospital site told Business Insider she expects to get the drug as early as this week. As to how exactly the shipment of drug is arriving at the hospital, “It’s a bit of a mystery to us,” Hohmann said.
Some hospitals have access to remdesivir through trials
Hospitals involved in clinical trials of remdesivir can get the drug for their patients by enrolling them in those trials.
Dr. Jason Goldman, the principal investigator of Gilead-run trials at Swedish Medical Center in Seattle, said the trial still has room for additional participants.
“The emergency use authorization is going to be great for all the hospitals in the country that haven’t signed up for the trial,” Goldman said. “We still have access via the trials.”
A key study, led by the US National Institutes of Health, will start up again soon. Patients who qualify will get remdesivir, and some will get an additional drug called baricitinib, a rheumatoid arthritis treatment that’s thought to help some patients with the coronavirus.
Bell said he is particularly worried for hospitals that aren’t participating in remdesivir studies. They will be solely dependent on the US government to distribute remdesivir to them.
This could disproportionately affect hospitals with less resources serving poorer communities and exacerbate some of the racial inequities that COVID-19 has already laid bare.
“Medical centers that tend to serve these communities also tend to be chronically underfunded and under-resourced and not have as much influence with decision-makers at the government level,” Bell said. “I worry about the inner-city publicly funded hospital versus the well-funded private hospital that might have access to billionaires on their board and be able to send planes to China to get N-95 masks, for example.”
A demand crunch seems inevitable
Gilead has already spent weeks ramping up its production capabilities for remdesivir. But the complex drug is much harder to make than a typical pill. It is given as an intravenous infusion.
The biotech aims to produce 1 million treatment courses by the end of 2020. But in the face of a pandemic, this likely won’t satisfy the need for the drug.
“The demand is going to be phenomenal,” Bell said.