Where Docs, Nurses Stand on COVID Emergency Use Authorizations

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Physicians and nurses in a Medscape poll indicated how likely they were to order or use treatments or vaccines approved for emergency use by the US Food and Drug Administration (FDA).

One question in the poll, first posted on September 2, asked readers whether they would get a COVID-19 vaccine if the FDA were to issue an emergency use authorization (EUA) for one before phase 3 trials were complete and the vaccine became available to them.

Seventeen percent of physicians said yes; 63% said no; and 20% said they were unsure. Younger physicians were more likely to say they would not get a vaccine under such circumstances (68% of those younger than 55 years said no vs 61% of those aged 55 years and older.)

On Tuesday, the Washington Post reported that the FDA is expected to roll out a tough new standard for emergency authorization of a COVID-19 vaccine as early as this week.

Nurses were less likely than physicians to say yes (11%); 69% said no; and 20% said they were unsure. Answers did not vary substantially by age.

The poll was taken after Medscape Editor-in-Chief Eric Topol, MD, sent an open letter on August 31 to Stephen Hahn, MD, commissioner of the FDA, detailing why he thinks recent FDA EUAs of interventions to treat COVID-19 have not been evidence-based. 

Topol cited three EUAs specifically: one for hydroxychloroquine on March 30 (revoked in June for lack of evidence), one for convalescent plasma on August 23, and an expanded EUA for remdesivir to treat any patient hospitalized for COVID-19, not just those with severe disease.

The letter drew more than 500 comments.

Another poll question concerned the use of plasma collected from survivors of COVID-19 as a treatment for the disease.

The National Institutes of Health’s COVID-19 Treatment Guidelines committee said earlier this month that current data are insufficient to recommend for or against using convalescent plasma to treat patients who have COVID-19.

Question: Based on the available data cited for the FDA’s EUA of convalescent plasma, would you order it or have you ever ordered it for hospitalized COVID-19 patients?

Answer Physicians (%) Nurses (%)
Yes, I have ordered it  9   2
Yes, I would order it 28  40
No, I would not order it 44  29
Unsure 19  29

 

An otolaryngologist who responded to the poll wrote, “As to whether or not I would consider prescribing convalescent plasma for a seriously ill COVID patient, yes I would. And if I ever found myself falling off a cliff, I would try to grab onto any twig projecting from the cliff.”

However, the responder said the biggest problem with the EUA for plasma was the “false claims about efficacy.”

“The data are not convincing of its efficacy for COVID-19, and convalescent plasma had no significant effect in Ebola. The best situation for using plasma would be in a clinical trial.”

Clinicians were also asked about whether they would order or have ordered remdesivir given the available clinical trial evidence that supported the EUA. Physicians were more likely to say they had or would order it (42%) than were nurses at 37%.

But there was a considerable amount of uncertainty in both groups surrounding the drug. Only slightly more physicians (44%) said no than said yes and 14% were unsure. Among nurses, 39% said no and 24% were unsure.

Among physicians, answers on remdesivir differed by work setting. Whereas 37% of hospital physicians said they would or had ordered remdesivir, 52% of those who were office-based answered that way.

Overall, most physicians and nurses (about 60%) reported they had not treated hospitalized patients with COVID-19.

Commenters had different views on the evidence behind EUAs. Some stood by their support for hydroxychloroquine even though the EUA for it was revoked on June 15.

A reader who agreed with Topol’s criticism of the EUAs wrote, “People in significant leadership roles must be held accountable for their actions. If you serve in an office and are receiving intolerable political pressure from superiors to take actions that are inconsistent with your training and personal integrity, then you have but a few options.

“Convince your superiors of their misguided directives or resign. History is not going to be kind to those who have supported these unscientific and completely inappropriate positions.”

A registered nurse wrote that issuing the EUA can be a disincentive for completing clinical trials.

“The saddest thing isn’t so much that EUAs are allowed in emergencies (if truly believed potential benefit outweighs potential risk) but when it is allowed to get in the way of well-planned and designed research that can actually determine its true usefulness,” she wrote.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick

Medscape survey. Published online September 2, 2020.

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