The medical director of a nursing home in Texas has come under fire for giving the anti-malaria drug hydroxychloroquine to coronavirus-positive elderly patients and tracking the outcomes in an "observational study."
The medication has been touted by President Trump and by numerous internet sites, but medical scientists are very sceptical. Although there are several clinical trials being conducted in a desperate effort to identify drugs which will treat the disease, the Food and Drug Administration has not approved hydroxychloroquine for Covid-19.
However, Dr Robin Armstrong, of The Resort, a nursing home in Texas City, near Galveston, gave the drug to dozens of patients after more than half of the 135 residents and more than 30 staff tested positive.
Critics say that there are many ethical problems with Dr Armstrong’s approach. DePaul University bioethicist Craig Klugman writes scathingly:
His “observational study” echoes language used to justify the Tuskegee Study and the Guatemala Syphilis Studies. And Armstrong’s work shares many of the same faults but is more poorly designed. He reports, “It’s actually going well. People are getting better.” Of course, he hasn’t stated what “getting better” means. Nor has he provided any information on what data is being collected, what doses of medication are being used, or what records are being kept. If this is indeed a real trial, then why is it not listed at clinicaltrials.gov?
He even calls for Dr Armstrong to be investigated by police and suspended by the Texas Medical Board. “This case will probably join the annals of human subjects research abuse trials that are a mainstay of responsible conduct of research courses.”
There’s a political angle to the controversy. Dr Armstrong is a staunch and well-connected Republican who used his links with prominent politicians to obtain a stock of hydroxychloroquine.
The merits of the drug have been bandied about in the media, especially after the President expressed his enthusiasm about its possibilities. But scientists are far more circumspect.
"We know the right dosages for malaria and lupus and rheumatoid arthritis but don't know yet what the right dosages are [for Covid-19], that's why we are doing clinical trials to make sure we get it right," Katherine Seley-Radtke, a coronavirus expert at the University of Maryland, told NPR. "I just find it amazing that everybody, including the President, thinks that this is just no big deal to go ahead and take this."
Michael Cook is editor of BioEdge
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