Weeks after the US Food and Drug Administration revoked the emergency use authorization of hydroxychloroquine to treat COVID-19, claiming the drug did not help coronavirus patients and had potentially harmful side effects, Henry Ford Health System requested permission to continue it.
The Detroit-based health care formula told Free Press this week that it had requested emergency use authorization on July 6 to resume treatment of some COVID-19 patients with the drug, which is commonly used as an antimalarial drug and for others with autoimmune diseases.diseases like lupus..
The application came four days after Henry Ford published a debatable analysis in the International Journal of Infectious Diseases reporting that hydroxychloroquine had halved the COVID-19-related mortality rate.The peer-reviewed observational study contradicted other published reports showing that the drug does not affect patients with coronavirus and would possibly cause central rhythm disorders in some people.
The FDA rejected Henry Ford’s request this week.
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“The U.S. Food and Drug Administration.He has informed us that he will grant our application for emergency authorization for hydroxychloroquine for a segment of COVID-19 patients who meet very express criteria,” said Dr. Adnan Munkarah, executive vice president and leading clinical director Henry Ford., in a prayer.
Patients who won the drug met the same criteria as those enrolled in Henry Ford’s initial study:
Ford’s study was widely criticized for being observational, retrospective and non-randomized or controlled.In addition, the fitness formula used hydroxychloroquine in mixture with dexamethasone, a steroid known to cause COVID-19 in other people.
At the beginning of the pandemic, hydroxychloroquine gave the impression of being a promising remedy for COVID-19, but the use of the drug has temporarily become political.
A French study published on 20 March reported that the drug helped others with coronavirus, noting that it is “particularly related to reducing/disappearing viral load in patients with COVID-19”.Positive results, he noted, were advanced when used in mixture with the antibiotic azithromycin.
The next day, President Donald Trump tweeted that hydroxychloroquine and azithromycin “have a genuine character of being one of the greatest revolutionaries in the history of medicine.”
Encouraged by these initial results, researchers around the world began launching their own research on the drug, and the FDA issued an emergency use authorization on March 28 to allow doctors to begin treating patients with the drug in hospital settings outside the doors of clinical trials.
Henry Ford Health System was one of many countries and states that started hydroxychloroquine in this way, Michigan Medicine, Detroit Medical Center and McLaren Health Care also used it.
In early April, Michigan Medicine and Henry Ford announced that they would recruit patients into studies testing the efficacy of hydroxychloroquine for the treatment of coronavirus. Ford’s examination was a retrospective investigation of 2,541 patients hospitalized between March 10 and May 2, 2020 at its six hospitals..
In the following weeks, additional studies warned that the drug may not be affected by coronavirus and could cause damage.
An initial April 23 review of 368 patients with new coronaviruses at U.S. Veterans Health Administration hospitals.But it’s not the first time He cautioned that the use of hydroxychloroquine, with or without azithromycin, did not increase the likelihood of needing a mechanical fan and, in fact, would make patients more likely to die.
And a review of the original French test found that the benefits of hydroxychloroquine treatment were too expensive.The review also showed that patients who misbehaved after using the drug were excluded from the test, taking the results.
Still, Trump continued to publicly praise the effectiveness of the drug and spoke at white house Coronavirus Press Meetings about how he took it himself in the hope that it would save him from contracting the virus.
With increased evidence, the FDA issued a warning last April, asking for caution regarding the use of hydroxychloroquine in patients with COVID-19.
“Hydroxychloroquine and chloroquine have not been shown to be effective in treating or preventing COVID-19,” he said.”They are being studied in clinical trials.”
The drugs, he warned, “can cause central rhythms such as longer QT periods and a dangerously immediate central frequency called ventricular tachycardia …Patients who also have other fitness disorders such as central and kidney disease are more likely to have an increased risk.of those disorders at the center when taking those medications.”
But the federal firm revoked emergency authorization for hydroxychloroquine until June 15, writing: “In light of ongoing serious cardiac adverse events and other possible serious side effects, the known and prospective benefits of chloroquine and hydroxychloroquine no longer outweigh the potential dangers of legal use.”
The World Health Organization announced on 17 June that it would avoid hydroxychloroquine testing in coronavirus patients as a component of its solidarity trial.The National Institutes of Health discontinued treatment with hydroxychloroquine a few days later.
The FDA’s adverse occasion reporting formula recorded 9,363 reports of adverse reactions to hydroxychloroquine and related drugs in the first 8 months of this year, of which 8,936 were classified as serious reactions in which another 402 people died.
Comparatively, in 2019, there were 8059 reports of adverse reactions to the drug and 6982 were serious; 146 more people died.
When Henry Ford Health System published his study on hydroxychloroquine in early July, with the good luck of the COVID-19 remedy appearing, reducing the mortality rate of 26% among those who did not obtain the drug to 13% among those who did, he was greeted with skepticism by many members of the medical community.
Among the critics was Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who called the test “flawed” in his testimony last July at a congressional hearing on the federal government’s efforts against the pandemic.
Patients in the Henry Ford study, Fauci said, gained corticosteroids, which are known to be for others with COVID-19, and was not randomized or placebo-controlled, the popular gold of medical studies.
However, Henry Ford’s hydroxychloroquine research has been hailed by the president as evidence that the drug he has been promoting since the beginning of the COVID-19 crisis is working.
Trump addressed Twitter on July 6, the day Henry Ford asked the FDA for permission to resume the use of hydroxychloroquine in COVID-19 patients, claiming democrats had denigrated the drug for political reasons.
The next day, Dr. Steven Kalkanis, chief education officer and senior vice president of the Henry Ford Health System, told Free Press that medicine should not be political.
“We are scientists, not politicians,” Kalkanis said.” We have never had a preconceived schedule with this test or any test on hydroxychloroquine.We only sought to use COVID’s resources and opportunity, because Detroit was such an affected region, to find out what remedies were being implemented and what remedy it wasn’t.
“At first, we embarked on several other studies, and we sought to get knowledge to lead us to what is right for patients.We know the effects of our study. We found that among 2500 patients, the use of hydroxychloroquine has halved the mortality rate.”
Last week, Henry Ford sent an open letter about his study, saying that “the political climate that has persisted has made any objective discussion about this drug impossible.”
The fitness formula said in the letter that it would no longer comment outdoors on the medical network about the use of hydroxychloroquine to treat the new coronavirus.
“We are deeply saddened by the events,” said the letter, signed by Munkarah and Kalkanis.
“Like any observational research, these studies are very difficult to analyze and can never complete the biases inherent in how doctors make other decisions to treat other patients.Moreover, it is not unusual for the effects of these studies to spread across the population and other eras, and no examination can ever be thought of as being alone.”
Trump continued with the use of hydroxychloroquine and said at a press conference in a blank space on July 28 that he believed in its benefits and that “many doctors believe it is incredibly effective.”
“I took it for 14 days and I’m here, aren’t I?” he said.I am here. I think it works at first. I think frontline doctors too, some, many.So let’s take a look at it… That’s because I didn’t have any problems.Surely I had no problems, I felt no different, I did not feel well, bad or indifferent.”
Henry Ford is conducting other studies on hydroxychloroquine that was announced in April in collaboration with Detroit Mayor Mike Duggan.Called the COVID-19 whip, this is the first large-scale study in the US.But it’s not the first time About whether the use of the drug can save you coronavirus on 3,000 physical care personnel and first aid personnel.
“The resolution has no effect on the ongoing WHIP COVID-19 study, a random double-blind investigation into hydroxychloroquine as a preventive treatment,” Munkarah said.
The effects of these studies have still been published.
Contact Kristen Jordan Shamus: 313-222-5997 or [email protected] her on Twitter @kristenshamus.