FDA Pulls Emergency Approval of Hydroxychloroquine for COVID-19

[admin]

If this article is correct on the FDA's reasons for revoking EUA for hydroxy, the FDA is guilty of manslaughter. The retracted study published in Lancet was widely reported as an outright fraud, BEFORE the FDA revoked EUA for HCQ.
https://www.covid-19forum.org/index.php?topic=23.msg23#msg23

Why did the FDA cite a fraudulent study, that had been retracted by authors at least the week before, as a reason to revoke EUA status for hydroxychloroquine, that has been demonstrated to be safe over it's 65 year history? Let alone it is up to 99% effective in early treatment of COVID-19.
https://www.covid-19forum.org/index.php?topic=23.msg105#msg105

This while they gave EUA to $3,000 Remdesivir, even though the NIH study showed it did not result in "a statistically significant reduction in mortality", and the side effects of this new drug are relatively unknown.
https://www.covid-19forum.org/index.php?topic=19.0

https://www.usnews.com/news/health-news/articles/2020-06-15/fda-pulls-emergency-approval-of-hydroxychloroquine-for-covid-19

FDA Pulls Emergency Approval of Hydroxychloroquine for COVID-19

June 15, 2020
U.S. News & World Report
More

(HealthDay)

MONDAY, June 15, 2020 (HealthDay News) -- The U.S. Food and Drug Administration has withdrawn its emergency authorization for the use of two malaria drugs championed by President Donald Trump in the fight against COVID-19.

The agency said in a letter Monday that the drugs, hydroxychloroquine and chloroquine, are "unlikely to be effective" as treatments for the coronavirus, The New York Times reported.

The FDA now says the drugs should not be used outside of clinical trials.

Despite its earlier cautious approval, this isn't the first time the agency has voiced concern about the experimental medicines. The FDA had already issued a warning that they might cause dangerous heart rhythm abnormalities.

However, despite a lack of evidence supporting the drugs as coronavirus preventatives, Trump not only touted the drugs, he announced that he took hydroxychloroquine for about two weeks after two White House staffers tested positive for COVID-19.

The FDA in March sanctioned use of the drugs in hospitals to treat COVID-19 patients. But after reviewing data on the drugs, the FDA has now concluded that the risks of taking them outweigh any benefit. This was especially true for hydroxychloroquine, the Times said.

FDA chief scientist Denise Hinton said in the letter that the Biomedical Advanced Research and Development Authority had asked that the drugs' authorization for COVID treatment be revoked. The authority is a division of the U.S. Department of Health and Human Services that oversees treatments in public health emergencies.

Hydroxychloroquine and chloroquine, which have long been used legitimately to treat malaria and lupus, have had their share of bad press when it came to their use against COVID-19.

Two major studies cast doubts on the drugs but were retracted on June 4 because the data used could not be verified. One report was published May 22 in The Lancet, while the other was published May 1 in the New England Journal of Medicine.

Both concluded that hydroxychloroquine and chloroquine were of no use in treating COVID-19 and might even cause heart harms.

Another study -- this time a "gold standard" randomized clinical trial -- found that hydroxychloroquine could not prevent COVID-19 any better than a placebo.

So this study, had nothing to do with treatment of COVID-19. Besides which it was an absolutely ridiculous study since HCQ was only given for 5 consecutive days, when for prophylaxis the label indicates weekly for 2 weeks before entering a malaria zone, and a study in India showed that for COVID it takes 4 weeks to begin to work and 6 weeks for 80% protection.
https://www.covid-19forum.org/index.php?topic=154.0

Also, 40% of those taking hydroxychloroquine developed side effects including nausea, upset stomach or diarrhea. However, no serious side effects or heart problems occurred in that study, the researchers said.

In that trial, published online June 3 in the New England Journal of Medicine, researchers randomly assigned more than 800 people in the United States and Canada to take hydroxychloroquine, or a placebo, for five days. All of the participants had been exposed to people with COVID-19.

Everyone who knows anything about HCQ as prophylaxis would recognize the absurd nature of this study. It can take weeks of taking HCQ before the preventive effects go into place. Let alone that countries with malaria and high usage of HCQ have very little death from COVID and these are generally 3rd world countries.

Overall, 12% of those taking hydroxychloroquine developed COVID-19 as did 14% taking the placebo, the findings showed. The difference was not statistically significant, the study authors noted.

"Our objective was to answer the question of whether hydroxychloroquine worked to prevent disease or did not work," said lead researcher Dr. David Boulware, an infectious disease doctor at the University of Minnesota. "While we are disappointed that this did not prevent COVID-19, we are pleased that we were able to provide a conclusive answer," Boulware said in a university news release.

Health care workers all over the rest of the world are enjoying considerable immunity from COVID by taking HCQ as a prophylaxis.

Since it likely can't be credited to a lack of knowledge, the FDA would seem to have once again demonstrated it is little more than a shill for Big Pharma.
https://www.covid-19forum.org/index.php?topic=100.msg104#msg104

But then the FDA and even individual researchers there, are raking in millions from big pharma.
https://www.covid-19forum.org/index.php?topic=35.0