Not long after researchers in England said the low-cost steroid dexamethasone reduced deaths among hospitalized COVID-19 patients, health experts around the world started raising alarm bells about the study—and the extreme enthusiasm it generated.
Tuesday, researchers funded by the U.K. government said dexamethasone lowered the risk of death in COVID-19 patients on ventilators or oxygen by 35% and 20%, respectively. But they only released a summary of the data, rather than the full study. That irked some high-profile doctors, particularly in the wake of hydroxychloroquine's dramatic rise and fall.
“It will be great news if dexamethasone, a cheap steroid, really does cut deaths by one-third in ventilated patients with COVID-19, but after all the retractions and walkbacks, it is unacceptable to tout study results by press release without releasing the paper,” said Atul Gawande, M.D., author and former CEO of healthcare venture Haven, on Twitter.
RELATED: U.K. endorses dexamethasone in COVID-19 hours after groundbreaking data release
In England, the top-line results were enough to convince the National Health Service (NHS) to approve dexamethasone for use in all COVID-19 patients requiring ventilation. And the World Health Organization vowed to update its clinical guidance on treating the coronavirus to incorporate the new data on the steroid.
But those endorsements of dexamethasone came on the heels of perhaps the most extraordinary of the COVID-19 walk-backs: the FDA’s retraction of its emergency use authorization for hydroxychloroquine in COVID-19. The agency pulled its approval of the malaria drug, which had been loudly endorsed by President Donald Trump, after controlled studies revealed it provided no benefit to patients.
The hydroxychloroquine debacle was clearly on the mind of Hilary Jones, a well-known physician and TV commentator in Britain. He urged viewers in an on-air interview Wednesday not to “go rushing to the shop asking for dexamethasone,” which, like hydroxychloroquine, is a decades-old drug that’s inexpensive. However, “it’s not a preventative,” he said.
What’s more, Jones pointed out, “the death rate even with dexamethasone is still 28%. So, it’s still massively high; this is still a very nasty virus.” The clinical trial, he added, will need to “show real benefit over risk.”
RELATED: FDA yanks chloroquine's emergency OK after data show it doesn't work against COVID-19
One well-known problem with steroids is that they can suppress the immune system, which could complicate the recovery process for any virus. That concern was voiced to Reuters by Thomas McGinn, M.D., deputy physician-in-chief at Northwell Health. He said he wouldn’t recommend the use of dexamethasone to treat COVID-19 without seeing the full results of the U.K. study published in a peer-reviewed journal—a sentiment echoed by physicians at the University of Washington and Massachusetts General Hospital.
The U.K. trial of dexamethasone, called Recovery, enrolled more than 11,500 patients at 175 NHS hospitals. The researchers are “working to publish the full details” of the study as soon as possible, according to a statement.
"really" - Google News
June 17, 2020 at 09:15PM
https://ift.tt/2AAxGRm
Is dexamethasone really a COVID-19 breakthrough? Not so fast, doctors say - FiercePharma
"really" - Google News
https://ift.tt/3b3YJ3H
https://ift.tt/35qAk7d
Bagikan Berita Ini
0 Response to "Is dexamethasone really a COVID-19 breakthrough? Not so fast, doctors say - FiercePharma"
Post a Comment