Federal government guidelines for emergency use of hydroxychloroquine, an antimalarial for COVID-19 patients, may have actually caused the drug to fail.
Indeed, the guidelines limit the use of the drug to people sick enough to be hospitalized. However, many doctors suspect that if the drug turns out to be beneficial, it may be more effective at the onset of the disease.
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“This is the case with any therapy,” said Dr. George Diaz, an infectious disease specialist at the Providence Regional Medical Center in Everett, Washington. “Generally, the earlier you use it, the more effective it is. “
Antiviral treatments work by reducing the amount of virus in the body. It is best to administer them early, as symptoms start and the viral load is still low. For example, Tamiflu, an antiviral used to treat the flu, works best as soon as possible.
“When you give it to someone who is already super sick, it probably won’t have an impact because the damage has already been done,” said Dr. Ken Lyn-Kew, pulmonologist at the ICU’s intensive care unit. National Jewish Health, one in Denver.
At least anecdotal, a handful of intensive care doctors across the country told NBC News that they had seen no evidence that the drug helps their sickest patients in intensive care.
“We use it,” said Dr. Hugh Cassiere, pulmonologist and medical director of respiratory care services at North Shore University Hospital in Long Island, New York, a hotspot of the pandemic in the United States. “But we haven’t really seen any effectiveness. “
“I am not convinced it works,” said Lyn-Kew, adding, “I have not seen anyone have anything close to what I would call a miraculous cure because of hydroxychloroquine. “
In Louisiana, Dr. Josh Denson, a physician in pulmonary medicine and intensive care at Tulane University Medical Center in New Orleans, said that “many patients are doing well and tolerate it, but I don’t think it makes a difference.” difference. “
I have not seen anyone have anything close to what I would call a miraculous cure because of hydroxychloroquine.
“We use it; that’s all we have, “added Denson. Louisiana has also been badly affected by the coronavirus, with at least 16,284 cases and 582 deaths.
“I cannot honestly say that I think it is necessarily an effective agent at this point,” said Diaz, of the Providence Regional Medical Center in Washington state. Diaz was involved in the treatment of the first patient in the United States diagnosed with coronavirus.
New use of a drug decades old?
Hydroxychloroquine, and a related compound called chloroquine, has been around for decades. It is used to treat malaria, as well as some autoimmune diseases, including lupus rheumatoid arthritis.
President Donald Trump and other political and business leaders have touted the use of the drug after a few small studies have suggested it may be effective against the coronavirus.
Last month, the Food and Drug Administration issued an emergency use authorization, allowing health care providers to use the drug for the disease, even though the drug has not been approved as a specific treatment for COVID -19.
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It is not known how many hospitals across the country have tried hydroxychloroquine. While many seem to be, some are not.
“UC San Diego Health does not support the use of drugs in a way that there is not yet scientific evidence to support safety and efficacy,” the hospital system wrote in an email. to NBC News, adding that investigators were preparing to participate in clinical trials to do their own studies on the drug.
The ICU doctors at Northwestern Medicine in Chicago don’t use it either. “Our intensive care group believes that there is insufficient data to support its use for routine use for COVID-19 patients, especially when they become seriously ill,” said Dr. Ben Singer , assistant professor of pulmonary medicine and intensive care at Northwestern. Feinberg University medical school said.
This week, the Centers for Disease Control and Prevention returned to their advice on using hydroxychloroquine for COVID-19 on the agency’s website, no longer offering dosing recommendations. The CDC has also deleted information on these early studies of the drug.
Science so far
One of the first studies to consider hydroxychloroquine as a potential treatment for COVID-19 came out of China in early February. This study looked at how the drug behaves at the cellular level, but did not look at how it would work in patients.
Small studies in China and France then suggested that the drug could be effective in the treatment of patients with COVID-19.
But, “These reports were about patients who received a particular drug and then improved. We know that most people with COVID-19 are improving on their own, “said Dr. Wesley Self, an emergency room physician at Vanderbilt University Medical Center in Nashville. , Tennessee, who studies the drug.
We need real science behind this disease.
“If you took these same people and didn’t give them the drugs, many of them would, we think, report similar recovery rates,” said Self.
In other words, it is possible that these patients have improved clinically, whether they have received hydroxychloroquine or nothing at all.
In addition, these studies were published online before undergoing what is known as peer review, which means that other scientists had not been able to analyze the data and report potential flaws. . Peer review is considered essential for quality research.
“People take these tiny studies and cite them as the gospel,” said Lyn-Kew. “We need real science behind this disease,” adding that the doctors “are desperately looking for something to help people.”
The science to come
Doctors across the country are investigating in real time to see if the drug could actually help treat severe cases or even prevent coronavirus infections.
Researchers from NYU Langone in New York and the University of Washington Medical Center in Seattle are recruiting 2,000 people who have been in contact with a COVID patient, but who did not develop symptoms themselves.
Participants will receive hydroxychloroquine or vitamin C every day for two weeks and will be tested regularly for COVID-19.
The study “may provide answers by summer on whether a preventive dose of the drug is safe and effective,” according to a press release published online by NYU Langone. “If so, the strategy could give health officials a much-needed boost to slow person-to-person transmission. “
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New York Governor Andrew Cuomo said Monday that New York doctors are making progress in testing hydroxychloroquine for COVID-19 patients because “there is anecdotal evidence that it is promising.”
But until there is definitive and solid research on the matter, doctors are left with dueling anecdotes about the effectiveness of hydroxychloroquine. Some anecdotes suggest an advantage; others do not.
Self, of Vanderbilt, is conducting a randomized clinical trial of the drug.
Patients will be randomly selected to receive hydroxychloroquine or a placebo. Neither the patients, the doctors, nor the people who will assess the results at the end of the project will know which patients received the actual drug and which patients received a dummy pill.
Ten patients were enrolled in the past four days. But “it’s just too early to know whether the drug works or not,” said Self.
Potential for harm – and hope
All drugs have potential side effects. Hydroxychloroquine is no different.
The medicine can cause an irregular heartbeat, which can be fatal in some patients. Very sick people in intensive care units can be particularly at risk, says Self, as they tend to be more sensitive to the side effects of medication in general.
“We need to understand if the side effects of this drug are worse than all the benefits,” said Self.
Because it is believed that the drug might work better at first, the Vanderbilt study only enrolls patients within 10 days of the development of coronavirus symptoms, such as cough, fever, extreme fatigue, or shortness of breath.
Hydroxychloroquine “is clearly promising,” said Self. “But we really need the clinical trial data to understand what it does to our patients. “
“We have a duty to know this before we start prescribing for thousands and potentially millions of people. “
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