Weeks after the U.S. Food and Drug Administration revoked the authorization to use hydroxychloroquine emergency to treat COVID-19, claiming that the drug did not help coronavirus patients and had potentially harmful side effects, Henry Ford Health System requested permission to continue it.
Detroit-based health care formula told Free Press this week that it had requested an emergency use authorization on July 6 to resume treatment for some COVID-19 patients with the drug, which is commonly used as a malaria drug and for others with autoimmune diseases. diseases such as lupus.
The application came four days after Henry Ford published a debatable study in the International Journal of Infectious Diseases reporting that hydroxychloroquine had halved the COVID-19-related mortality rate. The peer-reviewed observational examination contradicted other published reports that showed that the drug does not affect coronavirus patients 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 request for emergency authorization for hydroxychloroquine for a segment of COVID-19 patients with very express criteria,” said Dr. Adnan Munkarah, Executive Vice President and Executive Leader of Henry Ford. Doctor, in a statement.
Patients who won the drug met the same criteria as those enrolled in Henry Ford’s initial study:
Ford’s examination was widely criticized for being observational, retrospective and not 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 March 20 reported that the drug helped others with coronavirus, noting that it “is particularly related to the reduction/disappearance of viral load in patients with COVID-19”. Positive results, he noted, were taken a step forward 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 the 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 in studies to test the effectiveness of hydroxychloroquine for the treatment of coronavirus. Ford’s examination was a retrospective investigation of 2,541 hospitalized patients between March 10 and May 2, 2020 at its six hospitals.
In the following weeks, additional studies have warned that the drug may not be affected by coronavirus and may cause damage.
An initial April 23 review of 368 patients with new coronaviruses at U.S. Veterans Health Administration hospitals warned that the use of hydroxychloroquine, with or without azithromycin, did not increase the likelihood of needing a mechanical ventilator and, in fact, would make patients more likely to die.
And a review of the initial French review revealed that the benefits of hydroxychloroquine treatment were imperfect and overrated. The review also showed that patients who had poor effects after the drug were excluded from the test, distorting the effects.
Still, Trump continued to publicly praise the effectiveness of the drug and spoke at the White House’s Working Group’s press meetings on coronavirus about how he took it himself in the hope that it would save him from contracting the virus.
With the accumulation of 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. Arrangement… Patients who also have other physical fitness disorders, such as central and kidney disease, are more likely to be at increased risk. of those disorders of the center when taking those medications.”
But the federal firm did revoke emergency use authorization for hydroxychloroquine until June 15, writing, “In ongoing serious adverse heart situations and other potential serious side effects, the known and prospective benefits of chloroquine and hydroxychloroquine no longer outweigh the potential dangers to 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 its use of hydroxychloroquine a few days later.
The FDA’s Adverse Cause Reporting formula recorded 9,363 reports of adverse reactions to hydroxychloroquine and related medications in the first 8 months of this year. Of these, 8,936 were classified as severe reactions in which another 402 people died.
By comparison, in 2019, there were 8059 reports of adverse drug reactions and 6982 were severe; 146 more people died.
When Henry Ford Health System published its study on hydroxychloroquine in early July, the good fortune of the COVID-19 remedy appeared, reducing the mortality rate of 26% among those who did not obtain the drug to 13% among those who did so, it was found with skepticism. many members of the medical community.
Critics included Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who called the test “defective” in his testimony last July at a Congressional hearing on the federal government’s pandemic efforts.
The patients in Henry Ford’s study, Fauci said, gained corticosteroids, which are known to be for other people with COVID-19. And it 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 touted since the beginning of the COVID-19 crisis is working.
Trump turned to Twitter on July 6, the day Henry Ford asked the FDA for permission to resume the use of hydroxychloroquine in COVID-19 patients, alleging that Democrats denigrated the drug for political reasons.
The next day, Dr. Steven Kalkanis, education director 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 hydroxychloroquine test. We’re just looking to use COVID’s resources and opportunity, because Detroit was a hard-hit region, to find out what remedies were running and what remedy they weren’t.
“At first, we embarked on several other studies and sought knowledge to lead us to what is right for patients. We discovered the effects of our study. We found that, among 2500 patients, the use of hydroxychloroquine has halved the mortality rate.”
Last week, Henry Ford published an open letter about his study, saying that “the political climate that has persisted has caused there to be an objective discussion about this drug.”
The fitness formula stated on the letter that it would no longer comment outdoors to the medical network about the use of hydroxychloroquine to treat the new coronavirus.
“We are deeply saddened by the events,” the letter, signed by Munkarah and Kalkanis, said.
“Like all observational research, these studies are very difficult to analyze and can never complete the biases inherent in the way 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 times, and no examination can ever be thought of as if you were alone.”
Trump continued 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. Isn’t that right?” He said. “I’m here. I think it works in the early stages. I think the front-line doctors too, some, many. So let’s take a look at it. Array… That’s why I didn’t have any problems. I probably didn’t have any problems, I didn’t feel different. I didn’t feel good, bad or indifferent.”
Henry Ford is conducting other hydroxychloroquine studies that was announced in April in collaboration with Detroit Mayor Mike Duggan. Called COVID-19 whip, this is the first large-scale U.S. exam. To determine whether the use of the drug can save you from coronavirus in 3,000 physical care staff and lifeguards.
“The resolution has no effect on the ongoing WHIP COVID-19 study, a random double-blind research on 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]. Follow her on Twitter @kristenshamus.