GOVERNORS NEED TO BACK OFF.

• Author: Vliet, Elizabeth Lee

While people's lives and jobs were being devastated by the coronavirus pandemic, governors or state pharmacy boards in Nevada, Michigan, New York, Ohio, and Texas issued emergency orders to restrict which medications doctors can use to save lives.

These politicians have no background in infectious disease, medicine, research design, or epidemiology, yet they presume to dictate to frontline physicians who are reading the emerging research and caring for patients.

Many doctors are using older medicines, FDA approved for more than 70 years and widely employed worldwide to treat malaria, lupus, and rheumatoid arthritis--chloroquine and hydroxychloroquine (Plaquenil). They often add azithromycin (Z-pak), a commonly used antibiotic with some activity against this virus.

These politicians are presuming to decide that doctors may not prescribe these drugs "off-label," i.e., for anything other than the disease for which the FDA originally approved the drug. Their pretext is that we do not have large randomized controlled clinical trials (RCT) for this new indication.

While we are facing one of the most-devastating public health crises in our lifetime, there is no time to wait for the years-long process of an RCT to provide "proof." Doctors who use the drugs can observe firsthand how patients respond.

While governors have been handing down orders, doctors in the U.S. and overseas have been reporting remarkable success in treating COVID-19 patients: reductions in hospitalization, less need for scarce ventilators, less need for ICU and intubations, and significantly lower death rates.

Two studies from France, conducted by Didier Raoult, specialist in infectious disease and viral illness, are very promising. Besides helping relieve signs of illness, hydroxychloroquine plus azithromycin also appear to shorten the period of infectivity, which is critically important in controlling disease spread.

Data on safety and effectiveness of hydroxychloroquine and azithromycin are coming in almost daily from more than 10 countries, including Canada, Australia, Israel, South Korea, and China.

Several governors jumped on this restriction bandwagon soon after Pres. Donald Trump announced at a Corona Task Force briefing that chloroquine and hydroxychloroquine showed hope in treating COVID-19, based on several small clinical studies from Johns Hopkins University, France, and (at last count) eight other countries. He did not say he recommended these medicines, as some...