Home Health News COVID-19 Update: FDA Pulls HCQ Authorization, New-Onset Diabetes – Medscape

COVID-19 Update: FDA Pulls HCQ Authorization, New-Onset Diabetes – Medscape

11 min read
7
21

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

Here are the coronavirus stories Medscape’s editors around the globe think you need to know about today:

FDA Ends Emergency Use Authorization of Hydroxychloroquine

The US Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) it issued in March to allow use of hydroxychloroquine and chloroquine for hospitalized COVID-19 patients who fit certain criteria and could not participate in a clinical trial.

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The revocation of the EUA follows a warning the agency issued in April that cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

The FDA also warned today that co-administering remdesivir with chloroquine or hydroxychloroquine may reduce the antiviral activity of remdesivir. The FDA has issued a revised fact sheet for healthcare providers. The warning is based on a recently completed nonclinical laboratory study, the agency said in a media release.

“The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said.

Global Registry for COVID-19 and New-Onset Diabetes

Emerging evidence suggests that COVID-19 may trigger the onset of diabetes in healthy people, so researchers have now established a new global registry to collect data on patients with COVID-19–related diabetes.

Not everyone agrees, however, that SARS-CoV-2 somehow triggers diabetes in people who did not have it before getting COVID-19. Says one expert: “This registry is a great first step in trying to answer the question of…whether the diabetes is actually new…because some people may have [had] undiagnosed diabetes.”

Hypertension Tied to Increased Mortality

In a retrospective analysis of the medical records of nearly 3000 COVID-19 patients treated at a hospital in Wuhan, China, investigators found that patients with hypertension had a twofold increase in the relative risk of mortality compared with normotensive patients.

Patients with untreated hypertension had an approximately twofold increase in mortality compared to patients with treated hypertension.

Vaccine Concerns

As manufacturers around the world race to develop COVID-19 vaccines, experts are wrestling with logistical and policy dilemmas, including how to distribute vaccine fairly to all nations, how to prioritize dosing within a country, how to ensure that a successful vaccine will be affordable, and how to overcome vaccine hesitancy and already-exploding misinformation campaigns.

“It’s very likely that we’ll have a vaccine by the middle of next year, said Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. If that happens, it would cut a 10- to 20-year process down to 18 months, he said.

The speed is a double-edged sword: It could end the pandemic sooner if there is equitable global distribution, but it could also trigger vaccine hesitancy if people believe that safety is being overlooked.

Health Workers Resort to Etsy, Shady Deals to Find Safety Gear

The global pandemic has ordinary healthcare workers going to extremes in a desperate hunt for medical supplies, Kaiser Health News reports. Community clinics, nursing homes, and independent doctors, in particular, find themselves on the fringe of the supply chain for masks, gowns, gloves, and ventilators.

A nursing home worker in New Jersey rendezvoused with “the parking lot guy” to cut a deal for gowns. A cardiologist in South Carolina tried his luck with “shady characters” to buy ingredients to blend his own hand sanitizer. A director of safety-net clinics in Florida learned basic Chinese and waited outside past midnight for a truck to arrive with tens of thousands of masks. Sourcing, he says, has “basically come down to a huge dose of ‘God, I hope these guys are legit.'”

Asymptomatic Transmission?

There has been confusion recently about whether people infected with SARS-CoV-2 who do not have symptoms can transmit the virus to others. “In fact, we do have evidence that individuals without symptoms can spread the virus,” biostatistician Natalie E. Dean, PhD, of the University of Florida, Gainesville, writes in Medscape. “This is the likely reason why SARS-CoV-2 has been harder to contain than its relative, SARS-CoV.”

But it’s hard to detect transmission by people without symptoms, and even harder to measure how frequently it occurs. Dean explains the key concepts necessary to understand the science.

How Did Retracted Studies Pass Peer Review?

On June 4, The New England Journal of Medicine and The Lancet retracted two much-criticized papers based on data from a previously little-known healthcare analytics company called Surgisphere. This tiny company claimed to house a system of fully integrated data from the electronic health records of at least 671 hospitals across six continents.

“However, it seems unlikely that the data exist as advertised,” Andrew D. Althouse, PhD, of the University of Pittsburgh in Pennsylvania, writes in Medscape. What happened? How did the reviewers for the journals miss what, in retrospect, seems obvious?

“Reviewers are expected to critique the science put in front of them,” Althouse writes, “but not necessarily to question whether it was real in the first place.”

In Memoriam

As frontline healthcare workers care for patients with COVID-19, they commit themselves to difficult, draining work and also put themselves at risk of infection. More than 1000 throughout the world have died.

Medscape has published a memorial list to commemorate them. We will continue updating this list as, sadly, needed. Please help us ensure this list is complete by submitting names with an age, profession or specialty, and location through this form.

If you would like to share any other experiences, stories, or concerns related to the pandemic, please join the conversation here.

Ellie Kincaid is Medscape’s associate managing editor. She has previously written about healthcare for Forbes, the Wall Street Journal, and Nature Medicine. She can be reached at ekincaid@medscape.net or on Twitter @ellie_kincaid.

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