Saturday, November 21, 2020

Remdesivir discouraged by WHO

On Thursday, a WHO review panel issued new guidelines recommending against the use of remdesivir for COVID-19 — even though the medicine is one of the few to win regulatory approval as a treatment for the disease.

After a clinical trial in April showed that remdesivir sped up the recovery of people with severe cases of the disease, the U.S. snapped up millions of vials of the drug from its manufacturer Gilead Sciences. Over the summer, European regulators rapidly signed off on the product, leading to nations around the world signing purchase agreements for the drug. And last month, the U.S. Food and Drug administration also signed off.

Now the WHO says remdesivir doesn't do much of anything to improve the health of people hospitalized with COVID-19.

[...]

Remdesivir gained even more prominence in October when it was given to President Donald Trump as part of his treatment after he contracted the virus.

The WHO panel says it's possible there may be some benefit from the drug. But its relatively high cost along with the risks posed by giving it intravenously led them to recommend against using it.

  NPR
But, hey...we've got the world's supply.
The retail price of remdesivir in the U.S. was set by Gilead at $520 a dose. A typical treatment course requiring six or more doses costs thousands of dollars per patient.

[...]

On Thursday, Gilead issued a statement saying it was disappointed in the WHO's decision. The pharmaceutical company and other advocates of remdesivir point to a National Institutes of Health study from April that showed the drug cut the recovery time for patients with severe cases of the disease by five days.

[...]

"When WHO guidelines are made, it involves different values that are much broader than the things considered by the FDA, which weighs very heavily the clinical outcome data."

Those broader considerations that the WHO is considering include the cost of remdesivir, the complexity of administering it in a medical setting, the potential risks giving it as an infusion — and weighing that against the potential benefits. Smith says the FDA, on the other hand, is looking primarily at clinical improvement from using the drug: whether patients' symptoms improve, whether fewer people die, for example.

"This is really consistent with how we think about health care in the U.S.," she says, "which is that we're willing to spend a lot of money on health care for a very small improvement. And that is not the model everywhere in the world."
Here, we're more than willing to enrich insurance companies.

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