Hydroxychloroquine: US stockpile stuck with 63 million doses of the drug after FDA revokes drug distribution for Coronavirus

CNN via MSN ^ | 06/17/2020 | By Elizabeth Cohen and Wesley Bruer, CNN

[SeekAndFind]

The federal government is stuck with 63 million doses of hydroxychloroquine now that the US Food and Drug Administration has revoked permission for the drug to be distributed to treat coronavirus patients.

The government started stockpiling donated hydroxychloroquine in late March, after President Trump touted it as "very encouraging" and "very powerful" and a "game-changer."

But Monday, the FDA revoked its emergency use authorization to use the drug to treat Covid-19, saying there was "no reason to believe" the drug was effective against the virus, and that it increased the risk of side effects, including heart problems.

That leaves the Strategic National Stockpile with 63 million doses of hydroxychloroquine, plus another 2 million doses of chloroquine, a related drug donated by Bayer, according to Carol Danko, a spokesperson for the US Department of Health and Human Services.

Many public health experts point to all of this as an unfortunate chapter in the history of the pandemic thus far.

"Nationally, we put a great emphasis on one drug, hydroxychloroquine," said David Holtgrave, the dean of the School of Public Health at the University at Albany, who co-authored a study of the drug as a treatment for coronavirus. "I worry that history will judge this as having over-invested in one treatment pathway as opposed to looking more broadly at a larger number of treatment candidates."

Before the FDA revoked its authorization, the stockpile had already distributed 31 million doses. Novartis and Mylan donated doses of the drug to the stockpile.

"HHS is working with the companies that donated the product to determine the available options for the product that remains in the Strategic National Stockpile," Danko wrote in a statement to CNN.

[silverleaf]

Quercetin is another zinc ionophore and is available OTC
Take with zinc = poor man’s hydroxy

[Drago]

224 FDA approved Hydroxychloroquine clinical trials still onging:

https://clinicaltrials.gov/ct2/results?term=Hydroxychloroquine&cond=COVID-19

Just the “Emer. Use” (mostly hospital) authorization pulled back.

[zek157]

Problem is many doctors are very adverse to malpractice lawsuits. Frivolous, or not they are expensive.

Doubt many will use HCQ for a “controversial “ application.

[Malsua]

Quercetin, an over the counter drug, is also a zinc ionophore.

Yes, and Zinc Picolinate seems to be the best form to get absorption.

[suthener]

“At a Trump press conference, a HHS guy, wish I could remember his name, said the drug is legal and can be prescribed by a doctor for any reason.

Fake news.”

I saw that, too. The press is reporting exactly the opposite of what the guy said.

[Chaguito]

That is one extremely obtuse reporter. Ugh!

[Wuli]

The FDA did not “revoke the distribution of hydroxychloroquine for Wuhan Virus use. They removed the FDA’s “emergency use” approval which does not block any doctor from continuing to use it for a Wuhan Virus case, if they chose.

I think we need to, by legislation or executive order (if possible), formally remove the idea that what the FDA says and only what the FDA says is what doctors can legally do. Getting an FDA ruling should be no more than something similar to the “Good house keeping seal of approval”. Nice if you get it, but no matter at all legally.

And insurance companies need to be required do to their own due diligence on health risks and not allowed, by law, to merely get away with parroting the FDA as far as what they will and will not cover.

There are plenty of good, medical and scientific opinions out there. The people at the FDA are not Gods.

[fortheDeclaration]

Yes, I believe the drug was taken off a restricted list and now can be used for other ailments again. It didn’t mean that the drug was being forbidden to be used.