- The extreme shortage of the COVID-19 drug remdesivir means that hospitals are being forced to make tough decisions about whom to treat.
- There are still far more COVID-19 patients than available doses of remdesivir.
- Last week, the government began distributing remdesivir directly to hospitals.
After the initial distribution of the COVID-19 drug remdesivir to hospitals was heavily criticized, the U.S. federal government has started shipping the medication to state health agencies, who will decide which hospitals receive it.
While this has taken some of the pressure off the federal government, there are still far more COVID-19 patients than available doses of remdesivir.
This leaves states, hospitals, and physicians to make the tough decisions about which patients receive this antiviral medication.
So far, it’s the only medication that has shown any effectiveness against SARS-CoV-2, the coronavirus that causes COVID-19.
Initial distribution of drug lacked transparency
At the end of last month, preliminary data from a remdesivir clinical trial showed that the drug sped up patients’ recovery.
Within days of the announcement, the Food and Drug Administration (FDA) approved remdesivir for
Last week, the government began distributing remdesivir directly to hospitals. But it was unclear why some hospitals with low numbers of COVID-19 patients received the drug, while others that had been hard-hit by the pandemic received none.
Shortly after the distribution of remdesivir began, Dr. Benjamin P. Linas, an infectious disease physician at Boston Medical Center, tweeted:
“Apparently the Remdesivir has been distributed. [Boston Medical Center] got none. We have the second highest absolute case count and highest per bed in Boston. 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?”
After physicians and hospitals expressed outrage, the Department of Health and Human Services (HHS) decided to give remdesivir to state health agencies and let them manage its distribution.
HHS said in its press release that it’s distributing the drug to “areas of the country hardest hit by the pandemic,” but it didn’t specify how that decision was made.
It also expects to deliver remdesivir to all 50 states, as well as U.S. territories, the Veterans Health Administration, and the Indian Health Service. But it offered no timeline.
Lack of clinical trials on drug make decisions harder
As of last month, there’s only enough remdesivir in the world for around 140,000 patients, according to its drugmaker, Gilead Sciences. About 55 percent of this has been reserved for the United States, according to HHS.
Gilead is working to manufacture more remdesivir, with a goal of being able to treat 1 million patients by December of this year.
The company has also signed a license agreement with pharmaceutical company Mylan, which would manufacture and distribute the drug to low- and middle-income countries.
As of May 13, the United States has had more than 1.3 million confirmed cases of COVID-19, with numbers still rising.
Until the availability of remdesivir increases dramatically, hospitals are left to decide which patients get the drug and which ones don’t.
And in states that haven’t received any remdesivir yet, physicians need to have difficult conversations with patients and their families about why they don’t have access to the drug.
These decisions are made more difficult by the lack of clinical information about remdesivir.
“So far [this drug] is one of the only things that shows any type of efficacy with respect to COVID-19, but we don’t know exactly how much,” said Daniel G. Orenstein, JD, MPH, a visiting assistant professor at the Indiana University Robert H. McKinney School of Law.
The clinical trial on which the FDA based its emergency use authorization found that remdesivir shortened patients’ hospital stays by about 4 days.
But the full study data hasn’t been released, so we don’t know whether the drug reduced the risk of death.
That leaves doctors to decide whether to give remdesivir to a sicker patient or someone who is early on in their infection. Research with other drugs may hold clues.
Some antivirals work better when given to a patient earlier — before the virus has had a chance to multiply, and before it causes damage to the organs through what’s known as a “cytokine storm.”
That might suggest that patients should receive the drug before they need to be put on a ventilator. But there’s no guarantee that this is the best choice.
Some patients who aren’t on a ventilator will recover on their own. So, if you give the drug to them, a sicker patient who may have been helped by it could miss out.
“These are very complicated ethical problems,” Orenstein said. “But the absence of really good clinical information makes it almost impossible to have a clear answer.”
Deciding which COVID-19 patients to treat first
Orenstein says certain overarching ethical principles can help guide these decisions.
One is transparency, something that was lacking in the government’s initial allocation of remdesivir to hospitals.
“What are the criteria being used to make the decision? Who is making the decision? That needs to be clearly communicated to everyone involved,” Orenstein said.
These are conversations that hospitals have already had around ventilators as patients with severe COVID-19 flooded intensive care units in certain cities.
The authors of a March opinion piece in the New England Journal of Medicine recommended that decisions about which patients would get a ventilator be made by a triage officer or triage committee.
This would shield physicians on the front lines — who have a duty to care for their own patients — from having to make these decisions.
The next principle is fairness. People should have an equal opportunity to benefit from a treatment.
“We don’t want to be disadvantaging people who are in underserved communities or who are suffering disproportionately due to preexisting inequalities,” Orenstein said.
This isn’t an easy decision to make, especially when allocating a drug that’s so scarce.
“Given that we don’t know yet if remdesivir is more effective in a 25-year-old healthy patient or a 60-year-old patient with certain comorbidities, it may be that a coin flip is the fairest process,” Orenstein said.
Discussions about transparency and fairness extend beyond conversations about which patients in U.S. hospitals should receive the drug.
The authors of an
“If nations pursue a competitive race to develop effective vaccines and therapeutics, there will be only be losers, no winners,” they wrote.
“The threat posed by the novel coronavirus knows no borders. Only a well-coordinated global plan that harnesses the best science and delivers it to everyone in need can effectively counteract the COVID-19 scourge and future pandemics.”
Source: Read Full Article