Health

FDA OK's Addition To Stockpile Of Malaria Drugs For COVID-19 – KCCU

Published

4 years ago

March 30, 2020

Over the weekend, the Food and Drug Administration granted two malaria drugs “emergency use authorization” for the treatment of COVID-19. The move makes it easier to add the medicines to the strategic stockpile, which can be drawn upon in the current public health emergency.

The drugs — chloroquine and hydroxychloroquine — have been identified as potential COVID-19 treatments based on lab tests and small, limited studies in humans.

But gold standard clinical trials in the United States only just got underway. Preliminary results from those studies aren’t expected for weeks or months.

One thing is for sure, the FDA decision doesn’t reflect an official determination that the drugs work against the coronavirus.

“This is not FDA approval of hydroxychloroquine or chloroquine for the treatment of COVID-19,” says epidemiologist Rajesh Gandhi, who is leading Massachusetts General Hospital’s COVID-19 treatment task force. “There’s an epidemic of misinformation out there, and we need to combat that.”

The emergency use authorization only applies to the supply of these two drugs in the Strategic National Stockpile, the government’s storehouses of emergency medical supplies located in warehouses throughout the country.

Hospitals would need to request access to the drugs through their states, and the medicines would only be distributed to patients who have been hospitalized and tested positive for COVID-19, but for whom a “clinical trial is not available, or participation is not feasible,” according to the FDA.

“It’s nice to know that they have it in the event we’re running low or going to run out,” says Onisis Stefas, chief pharmacy officer at Northwell Health in New York, where doctors are already using the drug for patients who can’t be enrolled in clinical trials. “It’s good to have this as backup.”

The emergency use authorization won’t affect patients seeking this drug from their local pharmacies, where shortages have been reported.

Sandoz, the generic and biosimilar arm of drugmaker Novartis, donated 30 million doses of hydroxychloroquine to the stockpile. Bayer Pharmaceuticals donated 1 million doses of chloroquine. The Department of Health and Human Services announced on Sunday that it accepted these doses “for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials.”

President Trump began promoting both drugs at his daily coronavirus press briefings earlier this month, prompting a spike in hydroxychloroquine prescriptions and concern about shortages and accidental poisonings.

If the drugs were helpful, doctors would be pleased to have a treatment option.

“We were told patients with COVID-19 who received this drug cleared the virus better than patients that did not receive the drug,” says Francois Nosten, who directs the Shoklo Malaria Research Unit in Thailand, and has been working with chloroquine and hydroxychloroquine for decades. “But it’s not sufficient information to be sure that this drug can be used or should be used in treating patients more widely.”

Preliminary findings often don’t pan out.

“The whole history of infectious disease is littered with drugs we all thought were going to be promising but turned out … not to be,” Mass General’s Gandhi says, adding that some of these medicines even turned out to be harmful.

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Health

The US is mailing Americans COVID tests again. Here’s how to get them

Published

4 hours ago

September 26, 2024

Anne Joseph

WASHINGTON (AP) — Americans can once again order COVID-19 tests, without being charged, sent straight to their homes.

The U.S. government reopened the program on Thursday, allowing any household to order up to four at-home COVID nasal swab kits through the website, covidtests.gov. The tests will begin shipping, via the United States Postal Service, as soon as next week.

The website has been reopened on the heels of a summer COVID-19 virus wave and heading into the fall and winter respiratory virus season, with health officials urging Americans to get an updated COVID-19 booster and their yearly flu shot.

“Before you visit with your family and friends this holiday season, take a quick test and help keep them safe from COVID-19,” U.S. Health and Human Services Assistant Secretary for Preparedness and Response Dawn O’Connell said in a statement.

U.S. regulators approved an updated COVID-19 vaccine that is designed to combat the recent virus strains and, they hope, forthcoming winter ones, too. Vaccine uptake is waning, however. Most Americans have some immunity from prior infections or vaccinations, but under a quarter of U.S. adults took last fall’s COVID-19 shot.

Using the swab, people can detect current virus strains ahead of the fall and winter respiratory virus season and the holidays. Over-the-counter COVID-19 at-home tests typically cost around $11, as of last year. Insurers are no longer required to cover the cost of the tests.

Before using any existing at-home COVID-19 tests, you should check the expiration date. Many of the tests have been given an extended expiration from the date listed on the box. You can check on the Food and Drug Administration’s website to see if that’s the case for any of your remaining tests at home.

Since COVID-19 first began its spread in 2020, U.S. taxpayers have poured billions of dollars into developing and purchasing COVID-19 tests as well as vaccines. The Biden administration has given out 1.8 billion COVID-19 tests, including half distributed to households by mail. It’s unclear how many tests the government still has on hand.

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Health

Free COVID tests are back. Here’s how to order a test to your home

Published

4 hours ago

September 26, 2024

Anne Joseph

WASHINGTON (AP) — Americans can once again order free COVID-19 tests sent straight to their homes.

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Health

Disability rights groups launching Charter challenge against MAID law

Published

4 hours ago

September 26, 2024

Anne Joseph

TORONTO – A coalition of disability rights groups says it is launching a Charter challenge against a part of Canada’s law on medical assistance in dying.

The group, which also includes two individual plaintiffs, argues that what’s known as track two of the MAID law has resulted in premature deaths.

Under the law, patients whose natural deaths are not reasonably foreseeable but whose condition leads to intolerable suffering can apply for a track-two assisted death.

The coalition says track two of the MAID law has had a direct effect on the lives of people with disabilities and argues medically assisted death should only be available to those whose natural death is reasonably foreseeable.

The executive vice-president of Inclusion Canada – which is part of the coalition – says there has been an alarming trend where people with disabilities are seeking assisted death due to social deprivation, poverty and a lack of essential supports.

Krista Carr says those individuals should instead be supported in order to live better lives.

This report by The Canadian Press was first published Sept. 26, 2024.

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