Now that the federal government has begun distributing the experimental Covid-19 drug remdesivir, hospitals are in a bind. So far, it’s the only medication that has shown benefit for coronavirus patients in rigorous studies. But there isn’t enough for everyone who’s eligible. That leaves doctors with a wrenching ethical decision: Who gets the drug, and who doesn’t?
As if the question wasn’t hard enough on moral grounds alone, it’s made even trickier by a dearth of data: Clinicians still don’t have the fine-grained study results showing which patients are most likely to benefit from the medication. Other antiviral medications work best when given earlier on in the course of illness — and anecdotally, that seems true for remdesivir, too — but it’s hard to make such calls with any certainty if you don’t have robust data.
“We hate being in this position. We want to have enough for everyone,” said Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital. “And if we don’t, we want to have enough information, so with this limited resource, we can distribute it in the best way possible. We feel like our hands are tied without those data.”
What doctors do have is the press release put out by the National Institute of Allergy and Infectious Diseases on April 29, saying that hospitalized patients who’d gotten remdesivir had recovered quicker than those who’d received a placebo — an average of 11 days versus 15 days. The improvement was enough for researchers to start giving the placebo group the drug as well, before they could statistically prove whether or not it increased a person’s chances of surviving Covid-19.
Within days of the announcement, the Food and Drug Administration issued an emergency authorization so clinicians could start treating patients with remdesivir. The plan was for the federal government to distribute 607,000 vials — enough for around 78,000 people — which the manufacturer, Gilead Sciences, had committed to donating over the next six weeks as it raced to ramp up production.
But the initial allocation of the drug last week was heavily criticized by clinicians, who were baffled as to why some of the hardest-hit medical centers had been skipped over. In Massachusetts, for instance, the four hospitals initially chosen to receive remdesivir decided the federal allocation wasn’t equitable, and agreed to donate their supply to the state’s Department of Public Health, for redistribution to around 40 medical centers with the highest numbers of Covid-19 inpatients.
Then, over the weekend, the Trump administration announced it had adopted a similar plan for the whole country, with state health agencies coordinating distribution.
Already, families are clamoring for remdesivir. Israel Dahan, an attorney from outside of New York City, knows how terrible this virus can be. On March 31 — the day his 54-year-old brother died of Covid-19 — their mother was taken to the hospital and put on a ventilator for the same disease. She’s been at Westchester Medical Center ever since, sedated, with machines helping her lungs to breathe. Dahan is now trying to get remdesivir for her, but he said the hospital hadn’t initially received any.
“We’ve heard this medication has worked for Covid patients,” Dahan said. “This is our mother. Why wouldn’t we give her every opportunity to get better? I recognize there’s no guarantee, but why wouldn’t I try?”
His family was especially frustrated to hear that hospitals in New York City had received some of the drug. “It’s there, it’s sitting in hospitals 20 miles away,” he said. He knows that other families are in the exact same position, that they want the drug just as much as he does: “I don’t know how they’re rationing it. … I mean, I get it, there are only so many doses, so how do you decide?”
That’s exactly what clinicians are racing to figure out. As Erin Fox, director of drug information and support services at the University of Utah Medical Center, explained, the eligibility criteria from the federal government aren’t much help.
“It’s very broad,” Fox said. “If you have 20 patients but only two vials, how do you decide which two patients get those vials? There’s no severity criteria for who would best be helped by this product. That’s why we need to see the data from the trial.”
As the federal guidance stands, anyone with Covid-19 severe enough to bring their blood oxygen saturation down to 94% is eligible, whether they need a bit of extra oxygen, a machine to push air into their own lungs, or a device that will pump their blood out to an external lung-replacing machine.
“This could be somebody who is mildly short of breath and is uncomfortable and who might be more comfortable on a wee bit of oxygenation — some people don’t even detect that their oxygenation is low at 94%,” said Walensky. But, she went on, it could also be somebody on the brink of death. “It’s almost the entire spectrum of inpatient disease.”
Most specialists agree that the earlier you treat someone, the better, because part of what makes some people so sick is not the infection itself, but the inflammation that comes with the immune response.
“The key thing is that the antiviral blocks the virus,” said Francisco Marty, an infectious disease physician at Brigham and Women’s Hospital, in Boston, who is running a clinical trial of remdesivir. That means that the medication probably can’t undo all the lung damage the illness has already caused.
But that isn’t ironclad. It’s based partially on what researchers have seen in other viral diseases, and partially on anecdotes from clinicians conducting trials. “We know so little about how patients respond to remdesivir that it’s unclear if remdesivir use is more impactful for lower-acuity, earlier disease-state patients vs. higher-acuity, late disease-state patients,” said Ryan Bariola, an infectious disease specialist at the University of Pittsburgh Medical Center.
Even the evidence on how many doses each patient should receive is still up in the air, Bariola added.
For now, hospitals are scrambling to figure out how to make their allocations do the most good for the greatest number of people. “In terms of extrapolating the results to the very elderly and all the other patients that have Covid — I think we have to just take our best guess,” said Dan Culver, a pulmonologist at Cleveland Clinic. “Remdesivir, from what we can tell right now, looks like it may be helpful, but I think it would be a mistake to think of this as a cure.”
At Mass. General, meanwhile, clinicians are considering prioritizing those who are sick enough to be hospitalized — after all, the drug is delivered intravenously — but haven’t been sick for too long. “At some point, there’s going to be a lottery because there are going to be too many patients for the drug,” Walensky said. “If somebody has been in the ICU for two weeks, we think that it’s probably not going to do much good in that patient. They may have a different lottery system than patients who are earlier in the course of disease.”
Most of all, she wishes there were more drug to go around, and more data about it. “We’re in this position of rationing this drug that we’re not confident will make for meaningful differences in outcomes — like differences in survival.”
From what the public reads, this “drug” only shortens ventilator time. It most certainly is not a cure for Covid. It got elevated far too prematurely to immediate use – without real trial study variables and background on drug interactions, pre-existing medical conditions, contra-indications, etc. Indeed, Doctors are forced to play a simplistic yet cruel eenie-meenie-miney-mo “selection criteria” game. This must be highly frustrating, and screams out for drastic guidance acceleration.
Based on the sloppy curtailing of the clinical trial, no one. Unless, the ICU structure is running out of beds and equipment.
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