The FDA’s Big Fat Hydroxychloroquine Blunder

The blunder is in this comment from the FDA’s revocation of its EUA for hydroxychloroquine:

Hospitalized patients were likely to have greater prospect of benefit (compared to ambulatory patients with mild illness) and could be more closely monitored for potential toxicity, although it was recognized that enrollment in a clinical trial would be the best option when using these drugs so that data on safety and effectiveness could be obtained.

Hospitalized patients had likely already cleared the virus by the time they were hospitalized. This was known at the time of the EUA revocation. So giving antivirals after the virus had already been cleared was kind of…pointless. So the FDA knew that giving hydroxychloroquine to hospitalized patients wasn’t going to help them, barring some miraculous method of action. However, that wasn’t the biggest blunder.

To find the blunder, we have to look at the history of hospitalized patients. Most of them had no fever when they were hospitalized. They had low oxygen levels and maybe shortness of breath. This was moderate covid. But did all these patients go from a healthy status to suddenly getting moderate covid? No. They all went through the mild covid phase, then their disease progressed.

Preventing the progression of mild covid to moderate covid was the point of giving hydroxychloroquine. So the FDA’s conclusion that hospitalized patients with moderate covid would benefit more from hydroxychloroquine than ambulatory patients with mild covid was a blunder. A colossal blunder. A blunder that killed hundreds of thousands of people. Manslaughter. Careless and reckless.

But how would doctors prevent progression of mild covid? 72 hours. From the onset of symptoms. That’s the window for giving hydroxychloroquine. How do we know this? From a consilience of evidence. Didier Raoult found that the virus reached a maximum load at 72 hours. (Published April 27, 2020, well before the EUA revocation in June.) Johns Hopkins researchers found that false negatives of PCR tests reached a minimum at three days after symptom onset. (Published August 18, 2020.) Accinelli, et. al., found that the time to first treatment within the first 72 hours of symptom onset with hydroxychloroquine was key to preventing fatality. (Published November, 2021). All ignored by the FDA.

But the importance of a time window for treating a respiratory viral illness wasn’t known at the time, was it? Actually, it was. In January 2020. There was an advisory from the CDC to treat high risk influenza patients early. “Early treatment with antiviral medications is recommended for hospitalized patients and high-risk outpatients, including children younger than two years. Clinicians should…promptly start antiviral treatment of severely ill and high-risk patients with suspected influenza without waiting for laboratory confirmation.” So the CDC knew that early treatment of respiratory diseases was key in January of 2020. So why didn’t the CDC issue a similar advisory for covid? Why didn’t the CDC warn the FDA that it was making a colossal blunder?

But how would doctors be able to treat patients within 72 hours of symptom onset? It’s only the high risk patients who urgently need treatment. Doctors could call their high risk patient list ahead of time to inform them that they need to seek treatment as soon as symptoms occur–even before laboratory testing. And if doctors relied on testing, they would miss a minimum of 20% of their patients, because of the problem with rampant false negatives from lab tests. So doctors would have to treat based on clinical suspicion of covid. And, of course, an advisory from the CDC would be needed to inform doctors about proper management of high risk ambulatory covid patients. Which has been lacking all this time. For two years. So hundreds of thousands of people died premature deaths.

So, I am just some random jerk on the interwebz, yet I figured all this out. No medical training even. So why are we funding the FDA and CDC, where people have medical training but can’t figure this out???