Former FDA commissioner weighs in on hydroxychloroquine, Georgia reopening during coronavirus

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Former Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb weighed in Sunday on the use of antimalarial drug hydroxychloroquine as a possible treatment for the novel coronavirus and reacted to several businesses in Georgia reopening during the pandemic.

Speaking on CBS News’ “Face the Nation” on Sunday, Gottlieb said that he doesn’t think doctors should be using hydroxychloroquine “outside of protocols at this point, given the fact that we’ve had now accruing evidence demonstrating really no benefit and some indication that it could be causing harm.”

Gottlieb made the comments two days after the U.S. Food and Drug Administration (FDA) warned against the use of two antimalarial drugs that have been touted as possible treatments for the new coronavirus following reports of “serious heart rhythm problems” in COVID-19 patients treated with the medications.

The drugs hydroxychloroquine and chloroquine should not be used outside of a hospital or clinical setting, the agency said, especially when used alongside the antibiotic azithromycin, also known as a Z-Pak.

“The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin,” the FDA wrote on its website.

The medications, which have been long prescribed to treat rheumatoid arthritis and lupus, have made headlines in recent weeks after President Trump called the drugs a potential “game-changer” for the treatment of COVID-19 after a French study suggested that hydroxychloroquine, in combination with azithromycin, could shorten the duration of illness for coronavirus patients.

In late March, the FDA put in place an emergency-use authorization to try these drugs in severe cases of the virus.

“I think it’s still reasonable to conduct clinical studies with it to see if it could be effective as a treatment, but we’ve done a lot of clinical studies to date and we haven’t turned over a card that’s really shown that the drug is affective,” Gottlieb said on Sunday.

He went on to note that “this [hydroxychloroquine] was being used very widely in New York City and other cities as well, it’s being used very widely in Italy also, off-label as a treatment initially in the setting of this outbreak here in the United States.”

“I think a lot of doctors that I talked to in New York City are starting to pull back from using it right now, given the fact that they really haven’t seen an indication that it’s having a robust treatment effect,” he continued.

Gottlieb also reacted to the fact that on Friday businesses in Georgia started to reopen,  saying he thinks it was the wrong move.

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While he extended Georgia’s state of emergency until May 13, which enforces “shelter in place” orders, Gov. Brian Kemp also allowed for businesses such as bowling alleys, gyms, tattoo parlors, spas, nail salons and movie theaters to start operating.

The order allowed restaurants to reopen April 27, with a restriction on gatherings to 10 people per 500 square feet.

“It does up the risk of infection,” Gottlieb said. “Georgia is certainly not out of the woods.”

He noted that only about one percent of the state’s population has been tested and that the state has reported more than 23,000 coronavirus cases.

“They may have plateaued in their epidemic, maybe, but they’re still accruing a lot of new cases,” Gottlieb said. “And they certainly aren’t coming down in the terms of the number of new cases each day.”

He added that “it’s going to take some time until we see sustained declines in new cases and get to the point where there’s a low enough level of spread in the country that we can feel comfortable about opening up parts of the country.”

“It’s going to be probably mid-May, maybe late May in parts of this nation,” he explained. “Georgia is certainly jumping the gun I think here, getting started too early relative to where they are in the epidemic.”

Kemp has also faced criticism for his decision from President Trump who said he thinks “it’s too soon.”

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According to models and projections used by the White House from the Institute for Health Metrics and Evaluation at the University of Washington, Georgia should not consider reopening until mid-June at the earliest.

Fox News’ Peter Aitken and Madeline Farber contributed to this report.

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