FDA clarifies that no drugs are approved to treat COVID-19 after Trump names 2 contenders

The Week via Yahoo News ^ | 03/20/2020 | Peter Weber

[SeekAndFind]

President Trump held up two drugs as possible treatments for COVID-19, the disease caused by the new coronavirus, in a conference call with governors on Thursday. He said chloroquine, an older drug used to treat malaria, lupus, and rheumatoid arthritis, was "very powerful" and has shown "very, very encouraging early results," adding that the Food and Drug Administration has approved the drug for use against the coronavirus.

The FDA said in a subsequent statement that "there are no FDA-approved therapeutics or drugs to treat, cure, or prevent COVID-19." Doctors can prescribe chloroquine "off-label," for unapproved uses, to treat COVID-19 patients.

Chloroquine, which can be lethal if taken by children or in large doses, will be tested in a "large, pragmatic clinical trial" with coronavirus patients, FDA Commissioner Stephen Hahn told reporters after Trump's briefing. German pharmaceutical giant Beyer said Thursday it is donating 3 million tablets of its chloroquine phosphate drug, Resochin, to the U.S. government for COVID-19 treatment research. Resochin is not currently approved for use in the U.S. Rising Pharmaceuticals, the only U.S. manufacturer of chloroquine, nearly doubled the drug's price on Jan. 23 — then restored the original price after an outcry, calling the price hike "coincidental," the Financial Times reports.

Dr. Ross McKinney Jr., chief scientific officer for the Association of American Medical Colleges, told reporters Thursday that while chloroquine may look promising in test tubes, he's "skeptical it will be effective" in COVID-19 patients. Infectious disease experts are more optimistic about the other treatment Trump mentioned, the experimental antiviral drug remdesivir from Gilead Sciences. Remdesivir is being tested in at least five experiments.

Researchers are also experimenting with HIV medications, several treatments for rheumatoid arthritis, and the Japanese flu medicine favipiravir, The Associated Press reports.

[ClearCase_guy]

Doctors can prescribe chloroquine "off-label," for unapproved uses, to treat COVID-19 patients.

Good enough for me.

[Diogenesis]

like quinine these are relatively benign materials
and there is already CLINICAL SIGNIFICANCE.

the PRESIDENT should fire the FDA director.

[cuban leaf]

Thanks to the FDA, a friend had to go to Mexico to get the Gerson treatment for her stage four cancer. She’s now over ten years cancer free.

[cuban leaf]

The fda is a joke and worse than useless. Read this and search on 100%:
https://drive.google.com/file/d/186Bel9RqfsmEx55FDum4xY_IlWSHnGbj/view

[George from New England]

Deep state will never die. Where is that silver arrow? was that the last millenium? Did that disappear as part of y2k?

[dowcaet]

This crisis has proven how inept both the CDC and FDA truly are. Is it any wonder Trump had to call in the private sector for help!

[mad_as_he$$]

The lawyers are licking their chops waiting to sue Dr’s for using these drugs in an off label manner.

[ConservativeInPA]

Gotcha yellow journalism. Anything, just anything to put the president’s word in doubt. Did present Trump say they were FDA approved? No. Was he trying to give hope. Yes. Does the media want to see the downfall of America. Yes. And as a result, they will call for the nationalization of everything. Just a kinder, gentler word for socialism and a centralized, command and controlled economy.

[seawolf101]

Imagine what a national health care program would be like. It would take forever to approve new drugs and see a doctor.

[eartick]

and if we have to wait on the FDA to approve it, we could be waiting for years.

The FDA got its HUGE bureaucratic fiefdom stepped on by PDJT and they did not like it.

Keep slugging Mr. President

[Bayard]

Yahoo spinning this as best they can to make Trump look bad.

But its Yahoo news, were you expecting decency?

[jeffc]

Following its precedence, the FDA will not approve a drug to fight COVID-19 until well after it has died off...

[muskah]

Damn the FDA they are so concerned about CYA that they are unwilling to move forward even as people die. This is nothing new. It is business as usual.

[ExSES]

“Off Label” use of many drugs in use worldwide is common amongst physicians who care more about their patients than bureaucrats at the FDA. However, they do so at great risk as there is no end of lawyers who will sue at the drop of a hat and point out that the FDA did not list a particular drug as approved for the condition treated.

[mmichaels1970]

Dr. Ross McKinney Jr., chief scientific officer for the Association of American Medical Colleges, told reporters Thursday that while chloroquine may look promising in test tubes, he's "skeptical it will be effective" in COVID-19 patients.

Except that it apparently HAS been effective on COVID-19 patients. Granted not enough data to extrapolate it out over an entire population, but to infer that the only positive evidence has been via testing in test tubes is disingenous.

Had he rephrased to say that even though researchers have seen positive results in limited numbers of human patients, he remains skeptical that it will be effective on the wider population.

I'd have been fine with that.

[colorado tanker]

The FDA would like the American people to know they will stand in the way to prevent any drug from being approved to treat this disease until it’s too late to do any good. Business as usual.

[lgjhn23]

“....the PRESIDENT should fire the FDA director.....”
Amen to that!!! The FDA is as useless as teats on a boar hog. They’re nothing but another big govt bureaucracy and need to just get out of the way.

[grey_whiskers]

Dr. Ross McKinney Jr., chief scientific officer for the Association of American Medical Colleges

should be sent to Qom, immediately.

[VanDeKoik]

“”there are no FDA-approved therapeutics or drugs to treat, cure, or prevent COVID-19.” Doctors can prescribe chloroquine “off-label,” for unapproved uses, to treat COVID-19 patients. “

Translation:

We didnt FDA approve this because the process we have involves many steps and months, but it can be used for this unofficially with no interference from us.

Idiot reporter:

“FDA clarifies that no drugs are approved to treat COVID-19 after Trump names 2 contenders”