Henry Ford Health System is standing by its hydroxychloroquine study after it came up during a congressional hearing in which Dr. Anthony Fauci testified last week.
The hospital’s study found treatment with the anti-malaria drug “significantly” cut the death rate in COVID-19 patients. But Fauci, the nation’s leading expert in infectious disease, said the study was confounded by a number of issues, including that it wasn’t a randomized, placebo-controlled trial.
In
an open letter on the discussion surrounding Fauci’s comments, health system leaders agreed that double-blind, randomized clinical trials are the most well-accepted method to determine the efficacy of a treatment. However, they noted that such studies take a long time to design, execute and analyze.
“Therefore, a whole scientific field exists in which scientists examine how a drug is working in the real world to get as best an answer as they can as soon as possible,” the letter reads. “These types of studies can be done much more rapidly with data that is already available, usually from medical records.”
The letter also points out the impact of political dynamics on the debate around hyrdoxychloroquine as a coronavirus treatment. President Donald Trump has repeatedly pushed the drug as an effective treatment, while many health officials have cast doubt on its safe and effective usage.
“Unfortunately, the political climate that has persisted has made any objective discussion about this drug impossible, and we are deeply saddened by this turn of events,”
the letter reads. “Our goal as scientists has solely been to report validated findings and allow the science to speak for itself, regardless of political considerations.”
In early July, Henry Ford Health System reported having success cutting the death rate in sick patients hospitalized with COVID-19, using hydroxychloroquine, without heart-related side effects.
The retrospective analysis looked at 2,541 patients hospitalized between March 10 and May 2 across the system’s six hospitals. The study found 13% of those treated with the drug alone died compared to 26.4% not treated with it.
Henry Ford’s study was published in the International Journal of Infectious Disease, the peer-reviewed, open-access online publication of the International Society of Infectious Diseases.
Last week, Fauci poked holes in the study while asked about it during a House of Representatives Subcommittee on the Coronavirus hearing in Washington D.C.
“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.”
The director of the National Institute for Allergy and Infectious Diseases went on to say none of the randomized, placebo-controlled trials have shown any efficacy of hydroxychloroquine for use in treating coronavirus patients.
“I don’t have any horse in the game one way or the other,” Fauci said. “I just look at the data.”
Henry Ford’s open letter was written by Executive Vice President Adnan Munkarah and Senior Vice President Steven Kalkanis and published on the health system’s website Saturday, Aug. 1.
In it, Munkarah and Kalkanis said the “promising” treatment study should be considered another important contribution to the other studies of hydroxychloroquine
“We – along with all doctors and scientists – eagerly support the need for randomized clinical trials,” they wrote. “We also want to point out that scientific debate is a common occurrence with almost every published study. In part, this is what fuels the advancement of knowledge – challenging one another on our assumptions, conclusions and applications to get to a better place for the patients we collectively serve.”
The health system’s study can be read in full
in the International Journal of Infectious Diseases, here.
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.
Safety issues related to the use of hydroxychloroquine include serious heart rhythm problems, blood and lymph system disorders, kidney injuries and liver problems and failure, according to the FDA.
In a recent interview on NBC’s Meet The Press, Brett Giroir, the Trump administration’s coronavirus testing coordinator, said he could not recommend hydroxychloroquine because trials “do not show any benefits.”
“At first, hydroxychloroquine looked very promising,” Giroir said. “There were not the definitive studies. At this point in time, there’s been five randomized, controlled, placebo-controlled trials that do not show any benefit to hydroxychloroquine. So at this point in time we don’t recommend that as a treatment, there’s no evidence to show that it is.”
You sweet, sweet summer children. I never want to hear you talk again.
