Doctors in the United States are cautiously optimistic about clinical trial results from the University of Oxford in England that suggest that a commonly used drug may have a real, measurable impact on the COVID-19 pandemic.
But they need to see the data first.
The drug, a steroid called dexamethasone, reduced deaths among the sickest COVID-19 patients by a third, the researchers said Tuesday. It's the first time, they say, any therapy has been shown to affect mortality for the coronavirus.
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The findings — the results of a clinical trial called the Recovery trial — were issued in a press release, as opposed to an article in a peer-reviewed medical journal. As such, outside experts couldn't scrutinize the data behind the headlines.
"I think there's a good-hearted motivation to try to get helpful findings out as fast as possible, but that can certainly backfire," said Dr. George Anesi, director of the Medical Critical Care Bioresponse Team at the Hospital of the University of Pennsylvania. "The scientific process exists for a reason."
We shouldn't be doing science by press release.
"We shouldn't be doing science by press release," Anesi added.
Dr. Atul Gawande, a surgeon at Brigham and Women's Hospital in Boston, called the findings "fantastic," but quickly added that many questions remain.
Typically, researchers extensively detail their work in scientific journal articles. Before publication, other scientists take an in-depth look at how the study was designed, who the patients were and whether any potential side effects were uncovered — a process called peer review. It takes time — weeks or months in some cases — for independent, unbiased experts to pore over the manuscripts, looking for any concerns.
That process is considered too long during a pandemic, and the pressure to find a safe, effective drug or therapy to treat COVID-19 has been intense. In just six months, the virus has sickened more than 8 million people worldwide, claiming the lives of almost half a million.
Other research released quickly over the past several months has later been found to be problematic. In some cases, otherwise reputable institutions had to retract the studies they published in equally reputable journals.
The information released so far by Oxford shows this clinical trial was large, including data on 2,104 hospitalized patients who received the steroid, and 4,321 patients who did not.
According to the researchers, deaths were reduced by about a third in patients who were sick enough to be put on a ventilator, and by about 20 percent among patients who had trouble breathing, but had not needed ventilation. Dexamethasone did not appear to help patients who did not require oxygen.
But there was little additional information.
Access to the full data can also inform physicians about how therapies can affect certain populations.
"Was it all predominantly Caucasians, or was there a wide variety of different ethnicities, different socioeconomic backgrounds?" Dr. Suraj Saggar, chief of infectious disease at Holy Name Hospital in Teaneck, New Jersey, asked. "Was it all patients who were diabetic, or did it give a good representation of other patient demographics?"
"We want to control for other factors," Saggar added.
A run on the drug?
Dexamethasone is a steroid that has been used for decades to treat a variety of conditions, such as nausea from chemotherapy or anesthesia, altitude sickness, eye infections and even croup in children.
It works by suppressing inflammation, and comes in pills, injections and IVs. It can cause side effects: weight gain, pancreatitis and an increased risk of infection in people who have compromised immune systems.
Some physicians expressed concern that the apparent benefits shown in the U.K. research would lead to a run on the drug, which is usually readily available to doctors and hospitals. This occurred when early studies suggested hydroxychloroquine might be helpful to COVID-19 patients, leading to shortages. Subsequent research found that that drug does not appear to benefit coronavirus patients.
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Indeed, on Tuesday, the Food and Drug Administration reported shortages of dexamethasone in its IV form, citing increases in demand for the drug. It's unclear whether that demand is a reflection of the COVID-19 pandemic or other reasons.
However, some critical care physicians in the U.S. have already been using dexamethasone or a similar steroid for their sickest patients with COVID-19 who are on ventilators.
"I've used it on a few dozen COVID-19 patients in my practice over the last two and a half months," said Dr. Hugh Cassiere, director of critical care medicine at Northwell Health's North Shore University Hospital on Long Island, New York. Cassiere first tried dexamethasone on very ill patients in the intensive care unit because a previous study suggested it could help patients with acute respiratory distress syndrome get off ventilators more quickly — and reduce deaths.
Saggar, of Holy Name Hospital, said he's used a similar steroid called methylprednisolone for hospitalized patients with COVID-19, adding the drug should only be used at a certain point in the disease process, never as a preventive measure.
"There is a narrow window when you can use it," Saggar said. Giving the drug too early might interfere with the body's natural reaction to fight the virus. Wait too long, Saggar said, and patients risk becoming so ill they need to be intubated and put on a ventilator.
It's worked in about a third of Cassiere's sickest COVID-19 patients, he estimated. Despite those anecdotal successes, Cassiere, too, wants to see all of the dexamethasone data from the University of Oxford trial.
"I really would like to see the article itself and go through the statistics," he said, "because when you apply therapies like this to a large amount of patients, I want to be certain that there is a therapeutic effect and no adverse effects."
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