Hydroxychloroquine is not effective or safe, the FDA found, and should not be used as an emergency coronavirus treatment.
DETROIT, MI — A study by the Henry Ford Health System of the controversial drug hydroxychloroquine as a coronavirus treatment has gained a number of harsh critics in the scientific community. Among them, the Food and Drug Administration.
Following their findings, Henry Ford requested permission from the FDA to treat patients with the controversial drug, but the FDA rejected that request, saying the drug is not proven effective and not safe enough to warrant its use on an emergency basis.
“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for COVID-19,” said FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah in a statement. “The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.”
And the FDA, as well as leading coronavirus expert Dr. Anthony Fauci, found Henry Ford’s proposed evidence unconvincing.
Henry Ford’s Shaky Science
Medical studies normally consist of randomized, placebo-controlled experimentation, and often are “double-blind,” meaning the doctors administering the study don’t know at the time what patients are on placebo and what ones are on the medication being studied. Further, patients in a study must not be on any other medication that can produce similar results to those being tested for. Fauci said Ford’s study failed on both those fronts.
“The Henry Ford Hospital study that was published was a non-controlled, retrospective cohort study that was confounded by a number of issues including the fact that many people who received hydroxychloroquine were also receiving corticosteroids, which we know from another study gives a clear benefit in reducing deaths with advanced disease,” Fauci testified to Congress. “So that study is a flawed study.”
Ford is presently conducting a more refined study, the health system said in a statement attributed to Dr. Adnan Munkarah, executive vice president and chief clinical officer of the Henry Ford Health System. That study is testing 3,000 volunteer health workers ot see if hydroxychloroquine affects outcomes as related to contracting the virus.
“The [FDA’s] decision does not impact the ongoing WHIP COVID-19 study, a randomized, double-blind investigation of hydroxychloroquine as a preventive treatment,” the statement read. “We continue to use remdesivir and convalescent plasma to treat COVID-19 patients where clinically indicated.”
Trump Pushes Hydroxychloroquine’s Use
Results in other studies have not been positive for hydroxychloroquine. In fact, a study reported by COURIER showed the drug actually contributed to more deaths.
One instance of hydroxychloroquine’s use in Michigan, The ‘Gander reports, left a patient on a ventilator, unconscious, for a month.
As President Donald Trump aggressively pushed the use of hydroxychloroquine, even claiming to take it himself, the FDA issued warnings against the drug’s use in late April.
“Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19,” it said. “[The drug] 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.”
Despite this, President Trump continues to advocate for the drug’s use.
Henry Ford is also taking part in a vaccine trial by the company Moderna.
Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, told Reuters Friday that if the Trump administration pressures the agency to approve such a vaccine the way it did with hydroxychloroquine before that vaccine is found to be safe and effective, he would resign.
“You have to decide where your red line is, and that’s my red line,” he said. “I would feel obligated [to resign] because in doing so, I would indicate to the American public that there’s something wrong.”