Health experts clash over use of certain drugs for COVID-19
Health officials around the world are arguing over the use of certain drugs for COVID-19, resulting in different treatment options for patients depending on where they live.
On Friday, a World Health Organization guideline panel advised against the use of the antiviral remdesivir in hospital patients. There is no evidence that it improves survival or avoids the need for breathing apparatus.
However, in the United States and many other countries, the drug was the standard of care as a large government-run study found other benefits - it cut recovery time for hospitalized patients by an average of five days, from 15 days to 10 days.
Within the U.S., a federal guideline panel and some leading medical groups have not endorsed two other therapies approved by the Food and Drug Administration for emergency use - Eli Lilly's experimental antibody drug and convalescent plasma, the blood of COVID-19 survivors. The groups say there isn't enough evidence to recommend for or against them.
Doctors also aren't sure when or when to not take the only medications known to improve survival for the sickest COVID-19 patients: dexamethasone or similar steroids.
And with news on Thursday that the anti-inflammatory drug tocilizumab might help, things got darker. As with the main WHO study on remdesivir, the preliminary results on tocilizumab have not yet been published or fully verified by independent scientists, leaving doctors unsure of what to do.
"It's a real dilemma," said Dr. Derek Angus of the University of Pittsburgh, who is involved in a study testing many of these treatments. "We need to see the details."
Dr. Rochelle Walensky, chief infectious disease chief at Massachusetts General Hospital, agreed.
"It's really difficult to practice medicine by press release," she said on a podcast Thursday with an editor of a medical journal. Until the guidelines of the National Institutes of Health confirm a treatment: "I really hesitate to name ... this standard of care."
Angus said there are valid questions about all drug studies.
"It's not uncommon for professional guidelines to mismatch. It's just that everything is under scrutiny with COVID-19," he said.
The divide over remdesivir, sold by Gilead Sciences Inc. as Veklury, is the most serious. The WHO guidelines emphasize that the drug does not save lives. This is heavily based on a WHO-sponsored study that was larger but much less rigorous than the US-led study that found it to have other benefits.
The drug is given through an IV for about five days, and its high cost and lack of "meaningful effect" on mortality make it a poor choice, the WHO panel concluded.
Gilead charges $ 3,120 for a typical treatment course for patients with private insurance and $ 2,340 for those covered by government health programs in the US and other developed countries. Much cheaper versions are sold by generic drug manufacturers in low- and middle-income countries.
This week, the Institute for Clinical and Economic Review, a nonprofit group that analyzes drug prices, said remdesivir should be priced around $ 2,470 for hospitalized patients with moderate to severe illness because of the cost savings from fewer days of care. However, it's only worth $ 70 for patients with milder disease, the group concluded.
The price can also lead to lower demand. In October, U.S. health officials said hospitals had only bought about a third of the doses of remdesivir they had been offered in previous months when the drug was in short supply. Between July and September, 500,000 treatment courses were made available to state and local health departments, but only about 161,000 were purchased.
In a separate development, the FDA issued emergency approval on Thursday to use another anti-inflammatory drug, baricitinib, to be used in conjunction with remdesivir. In one study, the addition of baricitinib saved a heavy day off for the average recovery time of seriously ill hospital patients.
Lilly now sells baricitinib as Olumiant, used to treat rheumatoid arthritis, the rarer form of arthritis that occurs when a faulty or overreacting immune system attacks the joints and causes inflammation. An overactive immune system can cause serious problems for coronavirus patients too.
Marilynn Marchione can be followed on Twitter at http://twitter.com/MMarchioneAP
The Associated Press Department of Health and Science is supported by the Department of Science Education of the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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