Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Coronavirus Pandemic Delays FDA Review of Vaping Products
A review of vaping products has been delayed by the coronavirus outbreak, the U.S. Food and Drug Administration announced Thursday.
The agency said that a federal court granted its request to delay the May 12 deadline for companies to submit applications for vaping products to Sept. 9, the Associated Press reported.
The FDA said the pandemic made it difficult for its staff and companies to meet the original deadline for the review that’s part of the agency’s plans to regulate vaping products such as e-cigarettes and flavored solutions.
Last year, health advocacy groups sued the FDA to speed up its review of vaping products and the court ruled that the agency must set the May 12 deadline for product applications, the AP reported.
Premature Posting of Remdesivir Findings Were ‘Inconclusive,’ Drug Maker Says
Inconclusive findings from a study investigating the antiviral drug remdesivir as a treatment for COVID-19 were posted to the World Health Organization’s website “prematurely,” drug maker Gilead Sciences said Thursday.
The study that included 237 patients and was halted early for its small size were posted Thursday and have since been removed, CNN reported.
A screenshot of the posting published by STAT on Thursday said “remdesivir use was not associated with a difference in time to clinical improvement” and “in this study of hospitalized adult patients with severe Covid-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits.”
“Today, information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe Covid-19 disease in China was prematurely posted on the World Health Organization website. This information has since been removed, as the study investigators did not provide permission for the publication of the results. Furthermore, we believe the post included inappropriate characterizations of the study,” Dr. Merdad Parsey, Gilead’s chief medical officer, said in a statement on Twitter, CNN reported.
“The study was terminated early due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusions,” the tweet said. “As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease. We understand the available data have been submitted for peer-reviewed publication, which will provide more detailed information from this study in the near future.”
The company said there are a number of ongoing Phase 3 studies examining remdesivir’s potential as a COVID-19 treatment, CNN reported.
“These studies will help inform whom to treat, when to treat and how long to treat with remdesivir,” according to Gilead.
Some animal studies have shown that remdesivir treats coronaviruses that are similar to the new coronavirus that causes COVID-19, CNN reported.
NY State May Have 10 Times More Coronavirus Infections Than Thought
A new study suggests that up to 2.7 million people in New York may have been infected with the new coronavirus — a number 10 times higher than the confirmed cases in the state.
The preliminary findings from the state’s first coronavirus antibody study were announced Thursday by Gov. Andrew Cuomo. Nearly 14% of people tested positive, meaning they had the coronavirus at some point and recovered, NBC News reported.
The results are based on 3,000 random samples from 40 locations in 19 counties. While they suggest a much higher rate of infection, they also mean that the state’s death rate may be much lower than previously thought.
As of Thursday, there had been nearly 16,000 COVID-19 deaths. With 250,000-plus confirmed cases, the death rate would be as high as 16%, but that falls to about 0.5% with 2.7 million cases, NBC News reported.
However, it’s difficult to determine the state’s actual COVID-19 death rate because the state’s official report counts death in hospitals and nursing homes, but not at-home deaths or other “probable” cases, noted Cuomo, who said that researchers continue to analyze the antibody study data.
A recent study in Los Angeles County, California found the rate of coronavirus infection there could have been 55 times higher than reported, which would also mean a far lower death rate than believed, NBC News reported.
Copyright © 2023 HealthDay. All rights reserved.