How hydroxychloroquine toes the line between promise and ‘happy talk’ in the coronavirus fight
By: Anjalee Khemlani
After weeks of polarizing debate over the use of two generic anti-malarial drugs, hydroxychloroquine and chloroquine, the Food and Drug Administration this week warned they were not “safe and effective” when used on COVID-19 patients.
However, the hydroxychloroquine debate is far from over, as the drug gets qualified support from others deeply involved in the war against the coronavirus, and is used to treat COVID-19 patients in controlled settings.
President Donald Trump sparked a furor recently, when he floated hydroxychloroquine as a potential game-changer in the battle against the pathogen, which has sickened over 2.7 million globally — nearly 900,000 in the U.S. alone.
Yet according to Henry Miller, founding director of the FDA’s Office of Biotechnology and a Senior Fellow at the Pacific Research Institute, Trump’s public advocacy of the treatment — and the FDA’s initial decision to authorize an emergency use order — gave the debate a needlessly political veneer.
“It’s an example of an FDA action that in a sense was unnecessary…probably politically motivated,” Miller told Yahoo Finance in a recent interview. He also blasted the FDA’s emergency use authorization as unnecessary, because the drug is already approved for off-label uses like lupus and rheumatoid arthritis.
Miller charged that much of the discussion surrounding coronavirus treatments has been tainted by “politically motivated happy talk” that is affecting how officials should interpret the data.
“I’m a Republican, but I resent happy talk, I resent misrepresentation and I resent lies,” Miller added.
The agency’s guidance issued on Thursday stopped short of banning its use altogether. Instead, the FDA recommended consumers do not use it independently, and said health professionals should their judgement when prescribing it for a coronavirus patient.
Trump’s effusiveness was stoked by a couple of inconclusive early studies, one of which was conducted in France. Yet the FDA’s decision amplified the findings of other studies, including a preliminary report from the Department of Veterans Affairs, that suggest the drug may pose more of a risk when used to treat COVID-19 patients.
“It’s upsetting because there is only anecdotal data, except for the extremely questionable French studies and there are real holes in that,” Miller said, adding France’s study has “puzzling flaws.” . . .