FDA Denies Henry Ford's Request For Hydroxychloroquine Approval

DETROIT, MI — The U.S. Food and Drug Administration this week denied a request by Henry Ford Health System for emergency use of the controversial drug hydroxychloroquine for some patients suffering from the new coronavirus, the health system confirmed Thursday.

The health system said emergency use authorization was requested for the same type of patients described in a recently published study by Henry Ford doctors that has garnered widespread attention and prompted some criticism from one of the nation's leading health officials battling the virus.

"We remain focused on advancing efforts to develop a safe and effective vaccine against
COVID-19," Dr. Adnan Munkarah, executive vice president and chief clinical officer at Henry Ford Health System, said in a statement to Patch. "We are the only site in Michigan enrolling volunteers in the phase 3 trial of the Moderna mRNA-1273 Coronavirus vaccine and evaluating its promise as a vaccine candidate. We continue to believe that a safe and effective vaccine is the best way to protect people from this devastating virus."

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The request to the FDA came after the publication of the study, which revealed that treatment with hydroxychloroquine lowered the death rate significantly in patients hospitalized with the coronavirus.

The study examined 2,541 people hospitalized between March 10 and May 2 across the Henry Ford's six hospitals and found 13 percent of people treated with just hydroxychloroquine died compared to 26.4 percent not treated with hydroxychloroquine.

The study was recently described as "flawed" by Dr. Anthony Fauci, a physician and immunologist who has served as a leading member of President Donald Trump's Coronavirus Task Force.

Read More: Henry Ford Health System Defends Study Fauci Called 'Flawed'

Two doctors at Henry Ford Health System then penned an open letter to the scientific community defending a study on the controversial drug hydroxychloroquine that showed it was effective in lowering the death rate among patients suffering from the coronavirus.

"As an early hotspot for the COVID-19 pandemic, we have seen and lived its devastating effects alongside our patients and families," said Munkarah and Dr. Steven Kalkanis, Senior Vice President and Chief Academic Officer, in the letter. "Perhaps that's what makes us even more determined to rally our researchers, frontline care team members and leaders together in boldness, participating in scientific research, including clinical trials, to find the safest care and most effective treatments.

"While feeling the same sense of urgency everyone else does to recognize a simple, single remedy for COVID-19, we need to be realistic in the time it takes to fully understand the optimal therapy or combination of therapies required of a new virus we are all trying to contain."

The doctors defending the study said they would no longer speak on the matter while adding that the political climate surrounding the coronavirus in the U.S. makes it difficult to evaluate and examine the study's finding.

Related: Hydroxychloroquine Lowers Coronavirus Death Rate: Study