(The Center Square) – Michigan and the federal government disagree on whether two drugs should be used in an attempt to treat the novel coronavirus.
The Food and Drug Administration (FDA) on Saturday issued emergency use authorization for hydroxychloroquine sulfate and chloroquine phosphate, anti-malaria drugs that President Donald Trump and others have touted as a possible treatment for the novel coronavirus.
The U.S. Department of Health and Human Services (HHS) on Sunday accepted 31 million doses of the drugs donated by pharmaceutical companies to treat COVID-19 patients and for use in clinical trials.
“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19,” FDA Chief Scientist Denise M. Hinton wrote in the approval letter.
“When used under the conditions described in this authorization, the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate when used to treat COVID-19 outweigh the known and potential risks of such products.”
The Michigan Department of Licensing and Regulatory Affairs (LARA) on Tuesday threatened “administrative action” against doctors who prescribed either drug “without a legitimate medical purpose.”
LARA said prescribing either drug for COVID-19 may result in a shortage for other proven drug uses, such as treating lupus or rheumatoid arthritis.
Two small studies showed improvement to COVID-19 patients but didn’t prove efficacy.
One study concluded: “[H]ydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin.”
When asked Monday about the FDA approval, Whitmer pointed reporters to a Friday LARA letter reaffirming its stance, but without a direct threat to doctors who prescribe it.
“We want to ensure that doctors have the ability to prescribe these medicines,” Whitmer said.
“We also want to make sure that people who have prescriptions that predated COVID-19 have access to the medications that they need.”
That LARA letter cited a joint statement from the American Medical Association, the American Pharmacists Association, and the American Society of Health-System Pharmacists.
“Stockpiling these medications – or depleting supplies with excessive, anticipatory orders – can have grave consequences for patients with conditions such as lupus or rheumatoid arthritis if the drugs are not available in the community,” they said.
“The health care community must collectively balance the needs of patients taking medications on a regular basis for an existing condition with new prescriptions that may be needed for patients diagnosed with COVID-19. Being just stewards of limited resources is essential.”
HHS Secretary Alex Azar said in a statement that Trump is taking steps to protect Americans and give them hope to find an effective cure.
“Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine,” Azar said.
“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.”