Weeks after the
The request came four days after Henry Ford published a controversial study in the
The FDA denied Henry Ford's request this week.
More: After Fauci criticism,
More: Hydroxychloroquine saved coronavirus patients' lives,
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
The next day, President
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,
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
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
In the weeks that followed, more research suggested that the drug might not help coronavirus patients and could cause some harm.
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
Still, Trump continued to publicly praise the drug's effectiveness, and spoke at
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
But the federal agency didn't revoke emergency use authorization of hydroxychloroquine until
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
Among the critics was Dr.
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
The highly respected
The next day, Dr.
"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
"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
"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
"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.
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