FDA Denies Henry Ford Health Request To Use Hydroxychloroquine For COVID-19 Patients

"The U.S. Food and Drug Administration informed us that it would not grant our request for an emergency use authorization for hydroxychloroquine for a segment of COVID-19 patients meeting very specific criteria," said Dr. Adnan Munkarah, Henry Ford's executive vice president and chief clinical officer, in a statement.

The patients who would have received the drug would have had to meet the same criteria as those who were enrolled in Henry Ford's initial study:

Age 18 or older Have a positive COVID-19 test Be admitted to any of its six hospitals Be low risk for heart complications based on an electrocardiogram algorithm. A QT interval higher than 500 milliseconds was considered an elevated cardiac risk.

Henry Ford's study was widely criticized because it was observational, retrospective and not randomized or controlled. Additionally, the health system used hydroxychloroquine in combination with dexamethasone, a steroid, which has been known to improve outcomes for people with COVID-19.

Hope, and conflicting research

Early in the pandemic, hydroxychloroquine looked like it could be a promising treatment for COVID-19, but use of the drug quickly became political.

A French study published March 20 suggested the drug helped people with coronavirus, reporting it "is significantly associated with viral load reduction/disappearance in patients with COVID-19." Positive outcomes, it noted, were improved when used in combination with the antibiotic azithromycin.

The next day, President Donald Trump tweeted that hydroxychloroquine and azithromycin "have a real chance to be one of the biggest game changers in the history of medicine."

HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents).....

-- Donald J. Trump (@realDonaldTrump) March 21, 2020

Encouraged by those preliminary findings, researchers around the world began to launch their own investigations of the drug, and the FDA issued an emergency use authorization March 28 to allow doctors to begin treating patients with it in hospitalized settings outside clinical trials.

Henry Ford Health System was among many nationally and across the state to begin using hydroxychloroquine in that way. Michigan Medicine, the Detroit Medical Center and McLaren Health Care also used it.

In early April, both Michigan Medicine and Henry Ford announced they would enroll patients in studies testing the effectiveness of hydroxychloroquine for the treatment of coronavirus. Henry Ford’s study was a retrospective analysis of 2,541 patients hospitalized between March 10 and May 2, 2020 across its six hospitals.

In the weeks that followed, more research suggested that the drug might not help coronavirus patients and could cause some harm.

An April 23 preliminary review of 368 novel coronavirus patients at U.S. Veterans Health Administration hospitals suggested that the use of hydroxychloroquine -- with or without azithromycin -- did not reduce the likelihood of needing a mechanical ventilator and it may actually have made patients more likely to die.

And a review of the initial French study found it was flawed and overstated the benefits of hydroxychloroquine treatment. The review also showed that patients who had bad outcomes after using the drug were dropped from the study, skewing the results.

Still, Trump continued to publicly praise the drug's effectiveness, and spoke at White House Coronavirus Task Force news conferences about how he was taking it himself with hopes it would prevent him from contracting the virus.

With evidence mounting, the FDA issued a warning in late April, urging caution about using hydroxychloroquine in COVID-19 patients.

"Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19," it said. "They are being studied in clinical trials."

The drugs, it warned, "can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia. ... Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines."

But the federal agency didn't revoke emergency use authorization of hydroxychloroquine until June 15, writing: "In light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use."

The World Health Organization announced June 17 that it would stop testing hydroxychloroquine in coronavirus patients through its Solidarity Trial. The National Institutes of Health halted its hydroxychloroquine study a few days later.

The FDA's Adverse Events Reporting System logged 9,363 reports of bad reactions to hydroxychloroquine and related medications just in the first eight months of this year. Of them, 8,936 were classified as serious reactions in which 402 people died.

Comparatively, in all of 2019, there were 8,059 reports of adverse reactions to the drug, and 6,982 were considered serious; 146 people died.

The politics of hydroxychloroquine

When Henry Ford Health System published its hydroxychloroquine study in early July showing success in the treatment of COVID-19 -- cutting the mortality rate from 26% among those who did not receive the medicine to 13% among those who did -- it was met with skepticism by many in the medical community.

Among the critics was Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, who called the study "flawed" in his testimony in late July at a Congressional hearing on the federal government's efforts to control the pandemic.

Patients in the Henry Ford study, Fauci said, were given corticosteroids, which are known to be of a benefit to people with COVID-19. And it wasn't randomized or placebo-controlled, the gold standard for medical studies.

Yet, Henry Ford's hydroxychloroquine research was hailed by the president as proof that the drug he touted from the beginning of the COVID-19 crisis works.

Trump took to Twitter July 6 -- the same day Henry Ford asked the FDA for authorization to resume using hydroxychloroquine in COVID-19 patients -- alleging Democrats disparaged the drug for political reasons.

The highly respected Henry Ford Health System just reported, based on a large sampling, that HYDROXYCHLOROQUINE cut the death rate in certain sick patients very significantly. The Dems disparaged it for political reasons (me!). Disgraceful. Act now @US_FDA @TuckerCarlson @FoxNews

-- Donald J. Trump (@realDonaldTrump) July 7, 2020

The next day, Dr. Steven Kalkanis, Henry Ford Health System's chief academic officer and senior vice president, told the Free Press that medicine shouldn't be political.

"We're scientists, not politicians," Kalkanis said. "We've never had a preconceived agenda with this study or any study regarding hydroxychloroquine. We simply wanted to use the resources and the opportunity of COVID, given that Detroit was such a hard-hit region, to find out which treatments worked and which treatment didn't.

"So early on, we embarked on several different studies, and we wanted to let the data lead us to what is appropriate for patients. We stand behind the results of our study. We found that, you know, among 2,500 patients, the use of hydroxychloroquine cut the death rate in half."

Last week, Henry Ford issued an open letter about its study, saying, "the political climate that has persisted has made any objective discussion about this drug impossible."

The health system said in the letter that it will no longer comment outside the medical community on the use of hydroxychloroquine to treat novel coronavirus.

"We are deeply saddened by this turn of events," said the letter, signed by both Munkarah and Kalkanis.

"Like all observational research, these studies are very difficult to analyze and can never completely account for the biases inherent in how doctors make different decisions to treat different patients. 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."

Trump has continued to support the use of hydroxychloroquine, saying in a July 28 White House news briefing that he believes in its benefit and that "many doctors think it is extremely successful."

"I took it for a 14-day period, and I’m here. Right?" he said. "I’m here. I happen to think it’s -- it works in the early stages. I think front-line medical people believe that, too -- some, many. And so we’ll take a look at it. ... It’s safe. It doesn’t cause problems. I had no problem. I had absolutely no problem, felt no different. Didn’t feel good, bad, or indifferent."

Henry Ford is continuing with another research study of hydroxychloroquine that was announced in April in conjunction with Detroit Mayor Mike Duggan. Called the WHIP COVID-19 study, it's the first large-scale U.S. study to investigate whether using the drug can prevent coronavirus among 3,000 health care workers and first responders.

"The decision does not impact the ongoing WHIP COVID-19 study, a randomized, double-blind investigation of hydroxychloroquine as a preventive treatment," Munkarah said.

The outcome of that research has yet to be published.

Contact Kristen Jordan Shamus: 313-222-5997 or [email protected]. Follow her on Twitter @kristenshamus.

This article originally appeared on Detroit Free Press: FDA denies Henry Ford Health request to use hydroxychloroquine for COVID-19 patients

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