FDA rejects Henry Ford system's bid for hydroxychloroquine approval

Karen Bouffard
The Detroit News

The federal Food and Drug Administration has rejected a July 6 request by Detroit-based Henry Ford Health System for approval to use hydroxychloroquine in treating some COVID-19 patients. 

The health system's request followed a Henry Ford study showing that the controversial drug was effective in lowering the death rate among COVID-19 patients.

The study was questioned by the scientific community, including by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who described it as "flawed" in testimony before federal lawmakers in late July. 

In a Thursday statement attributed to Dr. Adnan Munkarah, executive vice president and chief clinical officer of the Henry Ford Health System, said the authorization was requested specifically for the same type of patients described in the study.

"The (FDA's) decision does not impact the ongoing WHIP COVID-19 study, a randomized, double-blind investigation of hydroxychloroquine as a preventive treatment. We continue to use remdesivir and convalescent plasma to treat COVID-19 patients where clinically indicated," the statement said.

"At the same time, we remain focused on advancing efforts to develop a safe and effective vaccine against COVID-19. 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." 

The FDA did not immediately respond to a request for information on its denial. 

Henry Ford Health System has agreed that the best study of the drug, as argued by Fauci, is a "double-blind, randomized clinical trial." But it defended the study by saying "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. Munkarah and Steven Kalkanis, chief academic officer, wrote in an open letter.  

The study is among several coronavirus-related studies being conducted at the five-hospital health system based in Detroit. 

Henry Ford Health System has recruited volunteers to receive trial COVID-19 vaccines developed by Moderna. It's one of 90 nationwide and the only site in Michigan to offer the drug during Phase 3 testing. Researchers hope to enroll 30,000 volunteers across the country to receive the vaccine, which is administered through two injections.

Moderna is developing the vaccine in partnership with the National Institutes for Health. Nationwide, more than 150 coronavirus vaccines are being developed, and 20 of those are closer to or in clinical trials. 

Henry Ford also is heading up the first large-scale study in the country to find out if hydroxychloroquine can prevent COVID-19. 

About 3,000 volunteer health workers and first responders are being studied to see if those who take regular doses of the drug are less likely to come down with the disease compared with those who are given a placebo pill.