In a letter dated Saturday, but only released late on Sunday, the FDA announced that it had issued an emergency use authorization to use chloroquine phosphate and hydroxychloroquine sulfate from the Strategic National Stockpile to treat hospitalized Covid-19 patients. In its statement, the FDA acknowledged the thin basis for this approval:
“Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. "The safety profile of these drugs has only been studied for FDA approved indications, not COVID-19."
Here is a link to the thoroughly massaged press release issued by HHS on Sunday explaining this decision: www.hhs.gov/…
The political nature of this press release is amply demonstrated by the following language:
“President Trump is taking every possible step to protect Americans from the coronavirus and provide them with hope,” said HHS Secretary Alex Azar. “Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine. The President’s bold leadership and the hard work of FDA and HHS’s Assistant Secretary for Preparedness and Response have succeeded in securing this large donation of medicine. We’ll continue working around the clock to get American patients access to therapeutics that may help them battle COVID-19, while building the evidence to evaluate which options are effective.”
The justification for an Emergency Use Authorization is supposed to be as follows:
An EUA may be issued if the FDA determines that, among other criteria, the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, and there are no adequate, approved, available alternatives.
There are zero KNOWN benefits of these drugs in treating Covid-19, since there have been zero clinical trials of them for that purpose. And the supposed POTENTIAL benefits are based upon less than a handful of anecdotal reports, which have actually been contradicted by other reports that they seem to have no beneficial effect for Covid-19 patients.
It should be noted that it’s already legal for physicians to prescribe off-label uses for FDA approved drugs for other than their approved purpose(s), and this has been going on for a long time. In some cases, this has been well accepted by the medical profession — especially where there is little interest by pharmaceutical companies in sponsoring studies since the drug is a generic one and there is a sound scientific basis for thinking it will work in treating the additional disease.
However, I’ve never heard of an emergency use authorization being granted for use of a drug where the scientific evidence is as extremely limited as it is in the case of chloroquine and hydroxychloroquine in treating Covid-19. If the donated drugs in the federal stockpile are to be used for something, perhaps they should be used to supply pharmacies so that these drugs can be available to treat lupus and rheumatoid arthritis patients who can’t get them because of all the off-label prescriptions that are being written for them by doctors like the cardiologist in New York who trust Trump more than they do actual scientific evidence.
This emergency use authorization stinks to high heaven. It smells to me like Trump intimidated the FDA into issuing it. So much for the disgusting Trump-fluffing by various media outlets about how yesterday’s presser demonstrates that he is finally listening to the actual experts.