Should the NIH have halted the remdesivir trial early?

Remdesivir is the first clinically validated drug to show an effect against Covid-19. So why did the NIH halt its large placebo-controlled trial of the drug? A top NAIAD official described to STAT’s Matthew Herper why the agency stopped researchers’ ability to collect more mortality data on the drug.

Once the trial demonstrated that hospitalized Covid-19 patients were discharged about four days faster, that was evidence enough that even the patients in the placebo arm should receive the drug, said H. Clifford Lane, NIAID’s clinical director. “How many patients would we want to put at risk of dying,” he said, for just a little bit more proof of remdesivir’s efficacy?

Not all scientists agree that it was the right choice — because now it remains an open question as to whether the drug can save lives.

The federal plan to dole out remdesivir

There’s been mass confusion over how remdesivir is allocated to hospitals around the country. In response, the federal government announced Saturday that it will bring more transparency to the process.

Gilead Sciences, which makes remdesivir, said it will donate 607,000 vials of the antiviral to treat about 78,000 patients over the next six weeks. State health departments will then distribute the doses among hospitals that need them, “because state and local health departments have the greatest insight into community-level needs in the Covid-19 response,” the Department of Health and Human Services said in a statement.

Patients will only qualify for the drug if they need some sort of mechanized breathing support, the FDA said.

New thyroid, lung cancer drug approved

Eli Lilly just achieved FDA approval for Retevmo, a gene-specific therapy that treats certain forms of lung and thyroid cancer. The drug targets tumors with alterations in the RET gene, specifically by blocking an enzyme the gene codes for — and helping prevent the cancer cells from growing.

The drug, which is taken orally, has been approved to treat metastatic non-small cell lung cancer and advanced medullary thyroid cancer, if the the tumors have tested positive for a RET mutation. The drug’s approval process was accelerated by regulators, and was granted orphan drug status — which tacks on extra time for Eli Lilly to market the drug exclusively.

Maryland governor scuttles prescription pricing board

Drug pricing has been a particularly important issue for Maryland legislators — which makes it surprising that the state’s governor has vetoed state funding for the “Prescription Drug Affordability Board.” The entity was set up last year to lay out the maximum price the state would pay for medication, STAT’s Ed Silverman writes.

Maryland Gov. Larry Hogan, a Republican, wrote that permanent funding for the board was “unconscionable" in the midst of pandemic, as it “would raise taxes and fees at a time when many are already out of work and financially struggling.”