Alex Azar explains that the HCQ EUA revoke, means it is available to anyone with a script
Source: FDA letter revolking EUA status
On the 15th June, the FDA declared in an almost melodramatic reveal that they were revoking the emergency use authorisation on chloroquine sulfate and hydroxychloroquine sulfate.
“This means it could be available for off-label early treatment, instead of limited to only hospitalized patients.”
AAPS Tweet
The FDA stated that they had seen studies that suggest HCQ did not have efficacy in the hospital setting. They cited a number of studies that affirmed this position. They excluded any studies that suggested positive efficacy, such as the dozens that are on this link. HCQ Research, studies, clinical trials and global announcements
So how is this a win?
The AAPS is at the early stages of a legal stoush with the FDA for stopping the broader use of hydroxychloroquine as a life saving tool. Ironically, this EUA revoke by FDA is a win for the American Association of Physicians and Surgeons (AAPS), and a win for many doctors in the U.S. that want to prescribe hydroxychloroquine, but have had their hands completely tied. It is also a big win for Dr Vladimir Zelenko, who had treated over 1400 COVID patients with success.
Main stream media has been telling an anti Trump/anti HCQ narrative for a few months now. FDA has selected as their studies of reference, only those that matched a narrative of ” look at that, HCQ is no darn good”.
Oh contraire! There are an abundance of studies showing HCQ does indeed significantly reduce the intensity of COVID especially when combined with azithromycin and zinc, and treated early. Many doctors around the globe, and indeed entire countries, such as Qatar and Turkey have shown repeated success but emphasise that treating early will drastically reduces the need for hospitalisation, and ICU.
How is the FDA revolking an emergency use authorisation of value?
The explanation from AAPS on what this all means is below:
There’s a lot of confusion around what the FDA’s “Emergency Use Authorization” for HCQ actually did and what rescinding it means.
The EUA was never meant to expand the use of HCQ and it only applied to the supply donated to the National Strategic Stockpile (NSS).
In fact, the EUA was put in place to improperly restrict use of the donated drugs to only hospitalized patients. The now infamous “whistle-blower” Rick Bright, PhD, admits that he pushed for the EUA to impede use (not expand it).
The Trump administration wanted to make the donated HCQ available for early treatment outside of hospital settings, but Rick Bright pushed for an EUA to restrict use to hospitals where it is often too late for the treatment to be beneficial.
Today’s revocation of the EUA by the FDA is, in a sense, an admission that the agency erred by limiting the supply in the NSS to use in hospitalized patients.
A good outcome of today’s FDA order is that it states that the NSS supply of HCQ “can be distributed in interstate commerce.” This means it could be available for off-label early treatment, instead of limited to only hospitalized patients.”
So rescinding the EUA does NOT mean that HCQ cannot be used for early treatment of COVID-19 patients.
It means that the supply of the drug stuck in the stockpile is now free from the EUA’s retractions, once it is released into the consumer supply chain. “Retractions” should be “restrictions” in the Tweet they sent out.
Related
Wuhan, China: Hydroxychloroquine Clinical Benefits Become Clearer(Opens in a new browser tab)
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