Dr. Fauci calls Michigan hospital’s hydroxychloroquine study ‘flawed’

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, adjusts his face mask during a House Subcommittee on the Coronavirus crisis hearing, Friday, July 31, 2020 on 
Capitol Hill

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, adjusts his face mask during a House Subcommittee on the Coronavirus crisis hearing, Friday, July 31, 2020 on Capitol Hill in Washington. (Kevin Dietsch/Pool via AP)AP

The nation’s leading expert on infectious disease poked holes Friday in a Michigan hospital’s recent study involving the use of hydroxychloroquine as a coronavirus treatment.

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said during a July 31 congressional hearing a Henry Ford Health System study that found hydroxychloroquine cut the COVID-19 death rate significantly was a “flawed” trial.

He noted that the study wasn’t a randomized, placebo-controlled trial, which he called the gold standard for such studies.

“The Henry Ford Hospital study that was published was a non-controlled, retrospective cohort study that was confounded by a number of issues including the fact that many people who received hydroxychloroquine were also receiving corticosteroids, which we know from another study gives a clear benefit in reducing deaths with advanced disease.

“So that study is a flawed study.”

Fauci was asked about the study while testifying before the U.S. House of Representatives Subcommittee on the Coronavirus.

On July 2, Detroit’s Henry Ford Health System published a report that found hydroxychloroquine cut the death rate in sick patients hospitalized with COVID-19, without heart-related side-effects.

In a large-scale retrospective analysis of 2,541 patients hospitalized between March 10 and May 2 across the system’s six hospitals, 13% of those treated with hydroxychloroquine alone died, compared to 26.4% not treated with the malaria drug.

Dr. Marcus Zervos, division head of Infectious Disease for the health system, who co-authored the study, said the findings were highly analyzed and peer-reviewed.

“We attribute our findings that differ from other studies to early treatment, and part of a combination of interventions that were done in supportive care of patients, including careful cardiac monitoring,” Zervos said in a prepared statement.

“Our dosing also differed from other studies not showing a benefit of the drug. And other studies are either not peer-reviewed, have limited numbers of patients, different patient populations or other differences from our patients.”

The study was published in the International Journal of Infectious Diseases, the peer-reviewed, open-access online publication of the International Society of Infectious Diseases.

Asked about the trial, Fauci said, “You can peer-review something that’s a bad study.”

He went on to say that none of the randomized, placebo-controlled trials have shown any efficacy of hydroxychloroquine for use in treating coronavirus patients.

“Having said that, I will state, when I do see a randomized, placebo-controlled trial that looks at any aspect of hydroxychloroquine, either early study, middle study or late, if that randomized, placebo-controlled trial shows efficacy, I would be the first one to admit it and promote it.”

“I don’t have any horse in the game one way or the other. I just look at the data.”

Zervos also noted that study results should be interpreted with some caution, should not be applied to patients treated outside of hospital settings and require further confirmation in prospective, randomized controlled trials that rigorously evaluate the safety and efficacy of the drug for COVID-19 treatment.

According to the U.S. Centers for Disease Control & Prevention, hydroxychloroquine is a U.S. Food & Drug Administration (FDA)-approved arthritis medicine that also can be used to prevent or treat malaria. It is available in the United States by prescription only.

On June 15, the FDA determined that based on emerging scientific data, chloroquine and hydroxychloroquine are “unlikely to be effective in treating COVID-19.” The FDA revoked the emergency use authorization that allowed for the drugs to be used to treat certain hospitalized patients with COVID-19.

Safety issues related to the use of the drug include serious heart rhythm problems, blood and lymph system disorders, kidney injuries and liver problems and failure, according to the FDA.

“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” said FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah in a prepared statement.

“The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.”

COVID-19 PREVENTION TIPS

In addition to washing hands regularly and not touching your face, officials recommend practicing social distancing, assuming anyone may be carrying the virus.

Health officials say you should be staying at least 6 feet away from others and working from home, if possible.

Use disinfecting wipes or disinfecting spray cleaners on frequently-touched surfaces in your home (door handles, faucets, countertops) and carry hand sanitizer with you when you go into places like stores.

Michigan Gov. Gretchen Whitmer has also issued executive orders requiring people to wear face coverings over their mouth and nose while in public indoor and crowded outdoor spaces. See an explanation of what that means here.

Additional information is available at Michigan.gov/Coronavirus and CDC.gov/Coronavirus.

For more data on COVID-19 in Michigan, visit https://www.mlive.com/coronavirus/data/.

Read more on MLive:

4 reasons why Michigan’s low coronavirus death rate isn’t cause for complacency

‘Are masks bad for your health?,’ plus 8 other coronavirus myths and truths

Michigan reports 715 coronavirus cases for Thursday, July 30; highest daily average since May 2

Friday, July 31: Latest developments on coronavirus in Michigan

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