Brazil Pharma Giant Starts Study on Drug Touted by Trump

Brazil pharma giant EMS kicked off a large-scale study on the use of antimalarial drug hydroxychloroquine to treat coronavirus as the pandemic spreads across Latin America.

EMS is studying the use of the drug combined with antibiotic azithromycin on about 1,000 patients with severe and moderate cases of the respiratory disease, Roberto Amazonas, the head of Medical Affairs at EMS, said in an interview. The drug will also be given on its own to 1,300 people with mild cases of the disease, he said.

“What we’re trying to find is scientific data that backs the use of the drug, to know if it really is beneficial,” he said. “The team was working 24-7 to get the protocols approved.”

When reports first started appearing that hydroxychloroquine and chloroquine could be used against COVID-19 -- with U.S. President Donald Trump and his Brazilian counterpart Jair Bolsonaro frequently touting it --, local media reported a run on pharmacies to buy the drug. EMS, known for its vast portfolio of generics, sells the medication in pharmacies across the country for treatment of reumatological diseases and lupus, among others.

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The study, in partnership with some of Brazil’s top hospitals including Albert Einstein and Sirio Libanes as well as 60 laboratories, comes at a time the pace of confirmed cases and deaths are picking up in the region. Brazil had 28,320 cases and 1,736 deaths as of April 15, according to data from the health ministry. With a widespread lack of tests available, some studies suggest the actual number of cases is 12 times the reported.

A lack of available COVID-19 tests also means that patients in severe condition can enter the study without confirmation they have the disease, just using diagnostic criteria, Amazonas said. Those patients, which get the drugs for 10 days, are not being compared to a control group taking a placebo, unlike the moderate and mild cases.

“We don’t know yet what’s the best timing to start the treatment, and that’s something the study should shed light on,” he said. Amazonas added that an optimistic time-line for the first results could be between 30 to 45 days.

Last week, part of a smaller study in Brazil was suspended after patients given higher doses of chloroquine, a closely related drug to hydroxychloroquine, showed “a trend toward higher lethality,” according to a website for preprints of studies that have not yet been vetted or published in a scientific journal. Researchers said the higher chloroquine dosage “should not be recommended for COVID-19 treatment because of its potential safety hazards.”

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On Tuesday, the U.S. Food and Drug Administration added azithromycin to its list of drugs in short supply, which also includes hydroxychloroquine. Many trials across the world are assessing hydroxychloroquine as a preventive drug, not only as a treatment for the disease.

“We’re trying to give an answer to the people on whether the studies that have shown the benefits of hydroxychloroquine in smaller populations holds in a more adequate scientific methodology and a bigger number of patients,” Amazonas said.

--With assistance from Riley Griffin.

To contact the reporter on this story:
Julia Leite in Sao Paulo at jleite3@bloomberg.net

To contact the editors responsible for this story:
Daniel Cancel at dcancel@bloomberg.net

Robert Langreth

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