Home Health News Trump Expected to Detail New Virus Therapies, but Expansion Could Be Controversial – The Wall Street Journal

Trump Expected to Detail New Virus Therapies, but Expansion Could Be Controversial – The Wall Street Journal

11 min read
0
0
60

FDA Commissioner Stephen Hahn said the agency will test chloroquine, an antimalarial drug, as a coronavirus treatment. The drug could serve as an intermediate therapy before a vaccine becomes available. Photo: Evan Vucci/Associated Press

WASHINGTON—President Trump said Thursday he is directing the Food and Drug Administration to expedite testing and possible broader use of some investigational medicines to help treat patients diagnosed amid the pandemic of the new coronavirus disease.

“Nothing will stand in our way as we pursue any avenue to find what best works against this horrible virus,” Mr. Trump told reporters at a White House news conference.

Mr. Trump specifically mentioned two drugs, chloroquine and hydroxychloroquine, that have long been used for malaria but aren’t approved for the coronavirus, as well as an antiviral drug, remdesivir, that is currently being tested in clinical research on Covid-19, the coronavirus disease.

Some physicians are already using hydroxychloroquine and chloroquine to treat patients with the disease. These therapies were approved decades ago and are off-patent.

“If things don’t go as planned, it’s not going to kill anybody,” Mr. Trump said, arguing that the drugs pose less risk because two of them have been approved for other uses.

That approach is a departure from the FDA’s normal procedure, which is to measure whether a drug achieves a balance of safety and effectiveness against a specific disease. This is done through clinical studies, often with some patients getting a study drug while others are randomly assigned to a control group.

President Trump invoked a law aimed at increasing the production of medical supplies, while looking into self-swabs to expand the coronavirus testing capacity. Photo: Shannon Stapleton/Reuters

However, the FDA has allowed compassionate use of unproven investigational drugs, such as when a patient is otherwise on the verge of death.

There is no known drug to combat the coronavirus, and pharmaceutical industry officials say it could take months to find an effective treatment.

The timing of whether drugs are effective and safe has less to do with regulatory decisions and more about how long drug development takes. Studies must be designed properly to assess whether an experimental medicine works, then patients must be enrolled in the study and tested.

Mr. Trump specifically touted drug company

Gilead Sciences Inc.,

which produces remdesivir, as offering promising therapies.

In addition to Gilead,

Emergent Biosolutions Inc.

and

Takeda Pharmaceutical Co.

are also developing experimental therapies. The companies and industry officials have said that it will be several months before there is an indication of whether the drugs are effective and can be applied broadly to patients infected with the disease.

Takeda said if testing is successful, the company aims to make the therapy available to patients between nine months and 18 months from now.

FDA Commissioner Stephen Hahn, in the news briefing, emphasized that his agency is trying to move as quickly and scientifically as possible.

“FDA’s responsibility to the American people is to ensure that products are safe and effective and we are continuing to do that,” Dr. Hahn said during the news conference. “We are looking at everything that’s coming across our desks as possible treatment options for the coronavirus.”

Dr. Hahn said Mr. Trump had directed the FDA to test chloroquine, adding that the agency wants a “large, pragmatic clinical trial” to test possible benefits of the drug for treating coronavirus.

Former FDA commissioners Drs. Scott Gottlieb and Mark McClellan called for the FDA to work with manufacturers in a paper published Thursday. The two said the agency should create two task forces to develop therapeutics and vaccines, exempt from some regulatory requirements.

Some in the Trump administration are arguing for allowing experimental drugs to get broader use in the country.

WSJ Newsletter

Get an early-morning coronavirus briefing each weekday, plus a health-news update Fridays: Sign up here.

In an interview on Fox News Wednesday night, Health and Human Services Secretary Alex Azar said that Mr. Trump is “going to make sure that even drugs on an experimental basis get available to the American people.”

Write to Thomas M. Burton at tom.burton@wsj.com, Andrew Restuccia at Andrew.Restuccia@wsj.com and Jared S. Hopkins at jared.hopkins@wsj.com

Copyright ©2019 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Let’s block ads! (Why?)


Source link

Load More Related Articles
Load More By admin
Load More In Health News

Leave a Reply

Your email address will not be published. Required fields are marked *

Check Also

'COVID fatigue' blamed for second surge in coronavirus cases; Chicago health experts warn people not to let their guard down – WLS-TV

CHICAGO (WLS) — Seven months into the pandemic and Illinois residents say they’…