FDA authorizes use of anti-malaria drugs #hydroxychloroquine and #chloroquine for #coronavirus care #COVID19

“Give it to me, doc!”

Right on the heels of my last post, which wasn’t optimistic for hydroxychloroquine….

From Politico:

The Food and Drug Administration on Sunday issued an emergency use authorization for hydroxychloroquine and chloroquine, decades-old malaria drugs championed by President Donald Trump for coronavirus treatment despite scant evidence.

The agency allowed for the drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” HHS said in a statement, announcing that Sandoz donated 30 million doses of hydroxychloroquine to the stockpile and Bayer donated 1 million doses of chloroquine.

Source: FDA issues emergency authorization of anti-malaria drug for coronavirus care – POLITICO

French researcher Didier Raoult​ M.D./Ph.D. and associates recently published their results of an 80-patient study using hydroxychloroquine and azithromycin in COVID-19 patients. From the abstract:

This [treatment] allowed patients to rapidly [be] [discharged] from highly contagious wards with a mean length of stay of five days. We believe other teams should urgently evaluate this cost-effective therapeutic strategy, to both avoid the spread of the disease and treat patients as soon as possible before severe respiratory irreversible complications take hold.

So their focus seems to be on reducing viral shedding from infected patients, rather than on overall clinical outcomes, e.g., reduction of death, reduced admissions to hospital and ICU. Click for an explanatory article at TechStartUps.

Dr David Gorski has already done a thorough fisking of the study, so I won’t bother. For example:

I was scratching my head as I read this. By this description, these patients mostly had mild disease. Only 15% had fever? Fever is a prominent feature of symptomatic adults with COVID-19. Only 53% had lower respiratory tract infection symptoms? Four of the patients (5%) were asymptomatic? 92% had low COVID-19 severity scores as measured by the National Early Warning Score (NEWS)? Why were they even admitted in the first place, rather than instructed to isolate themselves in their homes? That’s what’s generally done; asymptomatic SARS-CoV-2-positive patients and patients with mild COVID-19 symptoms are generally just told to stay home for at least two weeks and call if their symptoms worsen. Later in the paper, we learn that only 15% of these patients required oxygen, while only three required ICU admission, with one death.


Basically, this is a nothingburger of a paper. It studied patients with low severity or even asymptomatic COVID-19 disease, the vast majority of whom would likely have cleared the virus just as fast without the medications. Again, this is such a useless paper, even as an observational paper, that it tells us, in essence, nothing new.

Helpfully, Dr Gorski also commented on New York’s 15-minutes-of-fame Dr   Vladimir Zelenko. Dr G is not a fan, calling some of his actions and words irresponsible and unethical. Not having a large legal defense fund, I’m not often as outspoken as Dr Gorski. Yes, the truth is defense against libel, but how much truth can I afford? Not much.

A final thought from Dr Gorski:

I fear that, when all is said and done, the COVID-19 pandemic will be the single greatest opportunity for grifters and snake oil salesmen. Until a vaccine and/or effective treatment is developed, the grift will continue.

Steve Parker, M.D.

Steve Parker MD, Advanced Mediterranean Diet

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