July 29, 2020 – Experts are warning about messages in a controversial video shared by President Donald Trump touting the anti-malaria drug hydroxychloroquine as a recommended treatment for the coronavirus.
Former FDA Commissioner Scott Gottlieb, MD, said the verdict on hydroxychloroquine is not in doubt.
“We all hoped it was going to work. … All of the studies that were rigorously done have pointed in the same direction, which is that the drug doesn’t work,” Gottlieb told MSNBC. “I think at this point, we can definitively say hydroxychloroquine doesn’t work. I’m not sure what more we need to do.”
The video was posted to the far-right website Breitbart and features a group of doctors who bill themselves as “America’s Frontline Doctors” speaking outside the U.S. Supreme Court.
Among those speaking was Stella Immanuel, MD, a primary care doctor from Houston who claimed to have treated more than 350 COVID patients.
“I put them on hydroxychloroquine, I put them on zinc, I put them on (the antibiotic) Zithromax and they’re all well,” she said.
Immanuel also said people don’t’ need to wear masks, because “there is a cure.”
The reaction to the video – and Trump’s retweet of it on Twitter — has been swift.
“It is unprofessional to say there is a cure for COVID or a proven way to prevent COVID through the use of a pill,” John Whyte, MD, chief medical officer of WebMD, said in an interview with Men’s Health.
The FDA in June withdrew its Emergency Use Authorization for hydroxychloroquine after several studies showed it failed to prevent or treat COVID and in some cases produced serious side effects. Those include serious heart rhythm problems.
In its announcement, the FDA says neither hydroxychloroquine nor chloroquine phosphate has been shown to provide anti-viral protections against COVID-19.
Early signs that the drugs decreased “viral shedding” of the coronavirus “have not been consistently replicated and recent data from a randomized controlled trial” showed them to have no impact.
Another recent study confirmed that the drug did not help COVID-19 patients.
The study, published last week in the New England Journal of Medicine, found that the drug, with or without azithromycin, did not help COVID-19 patients more than regular care. It also had a higher rate of heart and liver side effects.
As for Trump’s continued support for the drug, Gottlieb said those around him need to make sure “he’s informed of that information. … There is a lot of data right now available that I think could inform a very convincing briefing.”
Trump – who took the drug for 2 weeks — said, “all I want to do is save lives. I don’t care if it’s hydroxy or anything else. All I want to do is save lives. If we can save lives, that’s great.”
The FDA’s move to revoke the authorization for use came after a request by the Biomedical Advanced Research and Development Authority (BARDA), an arm of the U.S. Department of Health and Human Services.
“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” Rear Admiral Denise Hinton, the FDA’s chief scientist, said in a letter to Gary L. Disbrow Ph.D., deputy assistant secretary of the U.S. Department of Health and Human Services.