Henry Ford study on hydroxychloroquine for COVID quietly shut down

Hopes were high early in the pandemic that the antimalarial drug hydroxychloroquine might not only prevent but treat COVID infections. But a growing consensus of outside research didn’t back up Henry Ford’s results. (Shutterstock)

Promoted in April as the first large-scale drug study on the effectiveness of hydroxychloroquine to protect against COVID-19, the Detroit-based clinical trial has quietly been iced.

 

Henry Ford Health System officials told Bridge Michigan they could not find enough participants to continue studying whether the drug could help beat back the deadly pandemic. 

Hydroxychloroquine — an antimalarial drug that has also proven useful in treating rheumatoid arthritis, lupus and other inflammatory diseases — briefly produced some excitement last spring when it was promoted as a potential game-changer by President Trump. But early optimism gave way to broader medical studies, with the nation’s top health agencies eventually determining it was not effective in treating or preventing the spread of the novel coronavirus.     

The Henry Ford study (WHIP COVID-19 clinical trial), was to involve 3,000 health care workers, first responders, public transit drivers, or family members of health workers to determine whether hydroxychloroquine would prevent COVID-19 on the frontlines.

“We know that it’s going to be very popular, and we will try to enroll as many people as we can,” Henry Ford cardiologist William W. O’Neill said at the time of the study’s announcement, held with Detroit Mayor Mike Duggan.

But that optimism proved misplaced, with just 624 people signing up. Henry Ford quietly ended the study just before Christmas.

 

By then, the first U.S.-approved vaccines, by BioNTech/Pfizer, were being shipped across Michigan, using a new technology designed to activate the body’s own immune system to recognize the virus and fight it. A second vaccine, by Moderna, was approved and shipped mid-December.

In ending the hydroxychloroquine study, Henry Ford said it was shifting its focus to vaccines as the “primary strategy of protecting our frontline workers,” according to an emailed statement to Bridge Michigan attributed to Dr. John McKinnon, Henry Ford Health System infectious disease specialist and WHIP COVID-19 co-principal investigator.

High hopes fade 

When the study was first announced in April, Detroiters were desperate. COVID deaths in the city made up nearly a quarter of the state’s total, even though the city has just 7 percent of Michigan’s population. First responders were paying a particularly high price. Days earlier, Mayor Duggan revealed that nearly 500 officers and 100-plus civilians on the police force, and more than 100 city firefighters, remained in quarantine after being exposed to COVID-19.

The mayor and Henry Ford pleaded with officials in the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration to fast-track approval for the trial.

“If this works out, we'll save the lives of first responders around the world,” Duggan said at the announcement.

Initially, the antimalarial drug appeared promising, with small studies indicating it had some antiviral effects to treat people with COVID-19.

In July, Henry Ford researchers said they found that hydroxychloroquine, on its own or combined with the antibiotic azithromycin, improved survival rates among 2,541 Henry Ford patients hospitalized early with COVID-19. President Trump tweeted approvingly about the study as part of his broader push to find a solution to the deadly virus.

Stories from the front  

Bridge Magazine, Detroit Free Press and Michigan Radio are teaming up to report on Michigan hospitals during the coronavirus pandemic. We will be sharing accounts of the challenges doctors, nurses and other hospital personnel face as they work to treat patients and save lives. If you work in a Michigan hospital, we would love to hear from you. You can contact reporters Robin Erb rerb@bridgemi.com at Bridge, Kristen Jordan Shamus kshamus@freepress.com at the Free Press and Kate Wells katwells@umich.edu at Michigan Radio.

But doubts about the effectiveness of hydroxychloroquine had already begun to emerge among frontline clinicians, and were confirmed over time by larger studies that failed to show significant evidence of improvement among coronavirus patients. 

And Henry Ford’s research was heavily criticized by scientists and experts, including Dr. Anthony Fauci speaking in a Congressional hearing, for falling short of the scientific rigor necessary to draw such conclusions.

Related:

In August, Henry Ford posted a letter defending its work, and insisting its study remained “promising.” Due to a “political climate that...has made any objective discussion about this drug impossible,” the letter said, Henry Ford would no longer comment on hydroxychloroquine “outside the medical community.” 

More news arrived in the fall. The World Health Organization published findings in October that indicated the drug had “little or no effect” on death rates among hospitalized COVID patients. 

An editorial in November in the peer-reviewed Journal of the American Medical Association said Trump’s remarks about the drug contributed to the “misguided use of hydroxychloroquine” in coronavirus cases.  

That same month, a study in the peer-reviewed Lancet medical journal noted no significant difference in COVID rates among those who were taking hydroxychloroquine for other reasons, such as for lupus.

On Dec. 21, Henry Ford alerted the federal database of clinical trials that it was terminating the trial. Henry Ford officials, who declined to be interviewed despite repeated requests, are now notifying trial participants, according to its statement to Bridge. 

As COVID bore down in Detroit last spring, Mayor Mike Duggan and local health leaders pleaded with the federal government to fast-track approval of a study on the effects of hydroxychloroquine. (Screenshot)

In addition to low participation, Henry Ford researchers said they realized the “extremely low rate of infection” among its trial’s participants would make it “extremely unlikely” to discern whether the drug had an effect.

Hospital officials said they are analyzing the data they collected and will submit it to the U.S. Food and Drug Administration when complete.

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Comments

Rob Pollard
Mon, 01/11/2021 - 4:11pm

What a complete and utter embarrassment for Henry Ford Health.

They went out too early, got defensive when it was pointed out, and when they tried to prove they were right, they couldn't do that either.

Michelle Carlson
Tue, 01/12/2021 - 4:34pm

I respectfully disagree Rob. In the beginning of the pandemic we were desperate to find answers. It was a study that’s all. Henry Ford never claimed that it would prevent you from getting the virus. They were studying
the effects of hydroxychloroquin on those who had the virus to see if it caused milder symptoms. What is wrong with that? It’s a scientific study. Good for them.

realscience
Tue, 01/12/2021 - 11:36am

Pretty sad that whitmir shut down a treatment that can help simply because President Trump said it might help. The left in all it's glory, rides again!

Tucker
Tue, 01/12/2021 - 1:06pm

My doctor revealed he prescribed himself some hydroxychloroquine when initial data presented possibility of this being a possible treatment. Guess who's lost a patient for unethical behavior? And now with Henry Ford's quiet withdrawal - glad my workplace sponsored health care lets me do whatever I want. Free market is a B.

Jimbo
Tue, 01/12/2021 - 1:54pm

Not true! I and 4 other people I know volunteered for this study and were never called. This is another politicization effort.

Corrupt
Tue, 01/12/2021 - 4:08pm

It's sad that the powers that be chose hatred over a drug that was proven to work.

William Ripskull
Tue, 01/12/2021 - 4:36pm

What you state isn't true. Front line workers were exactly who were singing the praises of HCQ. They were using it and seeing great success and thousands of doctors all over the world still are. It was Democrats who wanted to prevent Trump from getting a win, and more importantly who wanted the pandemic to last as long as possible and do as much damage to the economy and Trump as possible, particularly into the election so to allow mail-in balloting, that invented horror stories of HCQ use. They paraded the typical Washington agency bureaucrats, whatever doctors they could find that would refute its use (even ones that hadn't treated a single Covid patient), the MSM with their own doctors and "experts", and representatives of big pharma who were trying to sell $1000/dose solutions instead of $1.50 HCQ, all for the purpose of preventing HCQ use. They were successful. There is no telling how many patients died because the Democratic Party favors political power over human life.

Bill Carson
Tue, 01/12/2021 - 6:07pm

This report is inconsistent with my wife's experience with the study. As an ICU nurse, she was given an opportunity to participate, and did so in the spring. But sometime in the late summer or early fall she was informed that the study had been canceled due to poor results as I recall. The was also told that she had been in the placebo group. But this article claims that the study was ended later due to lack of volunteers. Something's fishy here, much like every dirt cheap treatmemt for CV-19.

Anonymous
Tue, 01/12/2021 - 7:37pm

they realized the “extremely low rate of infection” among its trial’s participants would make it “extremely unlikely” to discern whether the drug had an effect.
I found the quote above extremely interesting as all Americans are supposedly at risk for this infectious virus, yet the trial participants couldn't catch the virus. Perhaps the meds were functioning as a preventitive.

Tom Wu
Tue, 01/12/2021 - 9:57pm

If an HCQ study does not use Zinc, the study is designed to fail.

HCQ works because it is a Zinc ionophore, which means it transports Zinc into cells. It is the Zinc that has the anti-vital activity.

Enrico
Thu, 01/14/2021 - 5:36pm

My hospital treatment was HCQ, Zinc, Vitamin D, and antibiotics. I was able to walk to my bathroom without much trouble after 2 days. I always take Zinc and VD, so the only thing new was the HCQ. It absolutely worked for me. As far as the trial, I never really heard anything about signing up. I was actually expecting to get a call about donating blood.