After U.S. Food and Drug Administration said hydroxychloroquine doesn't help coronavirus patients, Henry Ford Health System asked permission to use it.
Weeks after the U.S. Food and Drug Administration revoked emergency use authorization of hydroxychloroquine to treat COVID-19, saying the drug doesn't help coronavirus patients and has potentially dangerous side effects, Henry Ford Health System filed for permission to continue using it.
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. 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 .....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.
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.
"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 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.
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. "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.
"We are deeply saddened by this turn of events," said the letter, signed by both Munkarah and Kalkanis.
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