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FDA Issues Emergency Authorization of Anti-Malaria Drugs to Treat Coronavirus

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FDA Issues Emergency Authorization of Anti-Malaria Drugs to Treat Coronavirus

2020-03-30 13:14:40

By Laura Tucker, Staff writer; Image: Prescription medicine (Image source: Public domain)

 

 

The medical world disagrees with the possible effects of anti-malaria drugs, hydroxychloroquine and chloroquine, that Donald Trump has been pushing as a treatment for coronavirus COVID-19. Nevertheless, the Food and Drug Administration issued an emergency use authorization for the drugs to treat those affected by the pandemic, despite there being little evidence that they will be effective. 

The Department of Health and Human Services said in a statement that the FDA is allowing the malaria 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." The statement added that Sandoz has donated 30 million doses of hydroxychloroquine to the stockpile, while Bayer donated 1 million doses of chloroquine.

 

The White House supported this push by the FDA, with COVID-19 having no proven treatment or cure. It's already been approved by the agency to be tested on New York patients who are seriously ill with the virus. Some hospitals have already added it to their treatment plans. 

"Let's see how it works," said Trump at a press briefing on Sunday, referencing its current use in New York. "It may. It may not."

 

HHS Secretary Alex Azar tweeted praise for Trump and the emergency use authorization, stating, "Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine." 

However, scientists remain skeptical of the use of the drugs on COVID-19 patients because of the lack of data of its success as well as the notion it will limit the use of the drugs for patients with other conditions that are normally treated with the therapy. Instead, they'd like to see the FDA conduct clinical trials as it would normally do.

 

Yet, the FDA's push is expected to lead to more access to the drugs, which would allow for more donations. A second emergency use authorization is being considered that would allow more manufacturers to produce the drugs," according to three officials. 

Commercially-available hydroxychloroquine is normally used to treat lupus and rheumatoid arthritis, along with malaria. After it was mentioned by Trump, investors, TV hosts, and White House advisers have talked it up.

 

Yet, lupus and arthritis patients are complaining they haven't been able to fulfill their prescriptions for hydroxychloroquine, and there are some reports that some doctors are hoarding it for themselves, not even their patients. Federal officials have privately lamented Trump's focus on the drugs, as it distracts from efforts to find more promising therapies. 

"I would like to see who at FDA's [Medical Countermeasures Initiative] signed off on this EUA despite the total lack of scientific evidence that chloroquine/hydroxychloroquine are beneficial in the treatment of COVID-19," tweeted the FDA's former acting chief scientist Luciana Borio. "EUA is supposed to be issued when the evidence indicates that benefits outweigh the risks."

 

Trump is behind the push to experiment with these drugs and not hold things up with the normal protocols because of the unprecedented situation. When asked on Friday whether his agencies should wait for more evidence on these drugs, he pointed to the need for timeliness and suggested there may be disagreements with Dr. Anthony Fauci, the White House's infectious-disease specialist, who has been known to disagree with Trump on many issues regarding the coronavirus. 

"I think Tony would disagree with me ... [but] we have a pandemic, we have people dying now," he said, adding that he'd spoken to the FDA and was frustrated with their timeline. "They indicated that we'll start working on it right away. It could take a year," he added. "I said, 'What do you mean a year? We have to have it tonight.' "

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