By
Sandi Doughton
Seattle Times staff reporter
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Researchers say enrollment in the trials plummeted after preliminary reports of possible heart arrhythmias associated with the drugs, followed by a U.S. Food and Drug Administration warning that they should be administered only in hospitals or clinical trials.
“
Once that news came out, our enrollment fell almost down to zero,” said UW epidemiologist Dr. Ruanne Barnabas, who’s
leading a study to find out if hydroxychloroquine can prevent infection in people like health-care workers who have been exposed to the virus.
Barnabas and other researchers say the potential risks of the drugs have been exaggerated in the heated political controversy ignited when Trump first began promoting them. Critics of the president blasted him for touting unproven medications, while his supporters have accused scientists of cover-ups and conspiracies.
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A group of researchers at Columbia University say they are pulling the plug on a similar clinical trial, partly as a result of flagging enrollment.
“The problem with all the exposure that hydroxychloroquine has received is that at first, everybody wanted to take it… and now nobody wants to take it,” said Dr. Jon Giles, leader of the Columbia project.
“It’s gone from one extreme that’s bad for science to another extreme, which is also not good for science.”
The
FDA warning in late April came after reports of potentially dangerous disruptions in heart rhythms in
hospitalized patients in Brazil
receiving high doses of hydroxychloroquine.
Another analysis of patients at U.S. Veterans Affairs hospitals suggested death rates were higher among patients treated with the drug, but there was no control group or adjustment for severity of illness.
For people with no underlying heart or kidney problems, there is no evidence the drug — at the doses used in the clinical trials — poses serious risks of cardiac problems, said Dr. William O’Neill, who is overseeing a trial at the Henry Ford Health System in Detroit.
“We have decades of experience with this drug,” he said.
“It’s one of the few drugs approved for use during pregnancy and for lactating women.”
Enrollment has also slowed in
O’Neill’s study, which is focused on testing hydroxychloroquine’s ability to protect people who work in high-risk settings, like hospitals, nursing homes and prisons, from infection. The project was funded by the Bill & Melinda Gates Foundation, which is interested in inexpensive drugs that might be used to fight COVID-19, the disease caused by the novel coronavirus, in developing countries.
O’Neill’s team has given hydroxychloroquine to about 1,700 people so far, with no serious side effects, he said.
