Henry Ford defends hydroxychloroquine study, 'saddened' by drug's politicization
Henry Ford Health System defended Monday a study that determined hydroxychloroquine was effective in lowering COVID-19 death rates but acknowledged the need for additional clinical trials.
The Detroit-based health system agreed that the best study of the drug, as argued by Dr. Anthony Fauci on Friday, was a "double-blind, randomized clinical trial."
But "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," Drs. Adnan Munkarah and Steven Kalkanis wrote in a Monday open letter.
Munkarah is the health system's chief clinical officer, while Kalkanis is the chief academic officer.
"Our promising Henry Ford treatment study should be considered as another important contribution to the other studies of hydroxychloroquine that describes what the authors found in our patient population," Munkarah and Kalkanis wrote. "We — along with all doctors and scientists — eagerly support the need for randomized clinical trials."
The doctors emphasized the importance of "scientific debate" in advancing the knowledge of drugs, but noted the politicization of hydroxychloroquine is an large obstacle to the process.
"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," they wrote, noting researchers' goal is to "allow the science to speak for itself."
"To that end, we have made the heartfelt decision to have no further comment about this outside the medical community," the doctors said.
Fauci told lawmakers Friday that the Henry Ford Health System study was "flawed" because it didn't rely on a randomized, placebo controlled study to determine the drug's effectiveness.
Additionally, the study looked at patients who also were receiving corticosteroids, "which we know from another study gives a clear benefit in reducing deaths with advanced disease," Fauci told the U.S. House Select Subcommittee on the Coronavirus Crisis.
If the hospital system were to find hydroxychloroquine effective using a randomized, placebo-controlled trial, "I would be the first one to admit it and promote it," Fauci said.
The health system found hydroxychloroquine helped lower the rate of death "significantly" in a study that analyzed 2,541 patients between March 10 and May 2. About 13% of those treated with hydroxychloroquine died while 26% of those who did not receive the drug died.
The hospital system warned that its results needed further study, particularly "prospective, randomized controlled trials."
It attributed its findings to earlier treatment, cardiac monitoring, new dosing, a different patient population and the use of steroids early in the infection.
In its Monday letter, the health system said its doctors and researchers in particular recognize a "sense of urgency" to find "a simple, single remedy for COVID-19."
"As an early hot spot for the COVID-19 pandemic, we have seen and lived its devastating effects alongside our patients and families," Munkarah and Kalkanis wrote.
The study conducted between March and May took already available data for a more rapid analysis of the drug's efficacy. But the results, like most study conclusions, "are very difficult to analyze" and never completely free of treatment biases, the Henry Ford Health doctors said.
"Furthermore, it is not unusual that results from such studies vary in different populations and at different times, and no one study can ever be considered all by itself," they wrote.