May 10, 2020 - Health

Gottlieb on government's remdesivir rollout: "We need a better system"

Former FDA commissioner Scott Gottlieb said on CBS News' "Face the Nation" Sunday that the Trump administration needs a "better system" for distributing coronavirus therapeutics, following the chaotic rollout of the drug remdesivir.

Why it matters: As Axios' Jonathan Swan first reported, a breakdown in communication and coordination by the administration resulted in a failure last week to distribute remdesivir to some of the high-priority hospitals where it's most needed.

  • Preliminary data indicates that the drug can help patients recover from the coronavirus more quickly than patients who receive no treatment, but it does not significantly reduce the risk of death from the virus.

The backdrop: Gilead Sciences, which produces remdesivir, donated hundreds of thousands of doses to the federal government after the FDA authorized it as an emergency treatment for coronavirus patients.

  • Gilead CEO Daniel O'Day said last week that the federal government would determine which U.S. cities will receive the drug based on "urgent" need and deliver the medicine.
  • More than 32,000 doses were shipped and delivered last week to Indiana, Massachusetts, New Jersey, New York, Rhode Island, Tennessee and Virginia.
  • Some doses went to less-impacted counties around the U.S., and many other doses remain unshipped.

What he's saying: "If the government is going to take control of the supply of these kinds of therapeutics — and they don't necessarily have to do that, they chose to do that — they need to have a good system in place," Gottlieb said.

  • "I think they should have been trying to push out as many doses as fast as possible because more supply is coming into the market. There's no reason to hoard it or hold on to it."
  • "So hopefully when they start to contemplate the next therapeutic, and there will be more therapeutics in the fall or a vaccine, on how they allocate that, they're going to have a better system in place based on clinical need."

Go deeper: Why Gilead's coronavirus drug is not a "silver bullet"

Go deeper

May 22, 2020 - Health

Update: Study linking hydroxychloroquine to increased death risk is retracted

Hydroxychloroquine. Photo: George Frey/AFP via Getty Images

Editor’s note: The study referenced in this story has been retracted by the medical journal The Lancet due to questions on the veracity of its primary data sources. Read more here.

Coronavirus patients who took hydroxychloroquine or its related drug chloroquine were more likely to die or develop an irregular heart rhythm that can lead to sudden cardiac death, compared to those who did nothing, a retrospective review published in The Lancet shows.

Why it matters: Despite warnings from the Food and Drug Administration, President Trump has insisted the anti-malarial drug as a "game-changer" and admitted he has taken it as a preventative even though the drug is unproven.

19 hours ago - Health

Medical journal retracts study that fueled hydroxychloroquine concerns

Photo: George Frey/AFP via Getty Images

The Lancet medical journal retracted a study on Thursday that found that coronavirus patients who took hydroxychloroquine had a higher mortality rate and increased heart problem than those who did nothing, stating that the authors were "unable to complete an independent audit of the data underpinning their analysis."

Why it matters: The results of the study, which claimed to have analyzed data from nearly 96,000 patients on six continents, led several governments to ban the use of the anti-malarial drug for coronavirus patients due to safety concerns.

Updated 15 hours ago - Health

U.S. coronavirus updates

Data: The Center for Systems Science and Engineering at Johns Hopkins; Map: Andrew Witherspoon/Axios. This graphic includes "probable deaths" that New York City began reporting on April 14.

The Department of Health and Human Services moved on Thursday to require that an individual's race, ethnicity, age and sex be submitted to the agency with novel coronavirus test results.

Why it matters: Some cities and states have reported the virus is killing black people at disproportionately high rates. There are gaps in the national picture of how many people of color are affected, since the data has not been a requirement for states to collect or disclose.