Tag: Stat News

Pulse oximeters’ inaccuracies in darker-skinned people require urgent action, AGs tell FDA

Mary Pat Campbell

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Link:https://www.statnews.com/2023/11/07/pulse-oximeters-attorneys-general-urge-fda-action/

Excerpt:

More than two dozen attorneys general are urging Food and Drug Administration officials to take urgent action to address disparities in how well pulse oximeters, the fingertip devices used to monitor a person’s oxygen levels, work on people with darker skin.

In a Nov. 1 letter, the AGs noted that it had been a year since the FDA convened a public meeting of experts, who called for clearer labeling and more rigorous testing of the devices, and that no action had been taken.

“We, the undersigned Attorneys General, write to encourage the FDA to act with urgency to address the inaccuracy of pulse oximetry when used on people with darker toned skin,” said the letter, written by California Attorney General Rob Bonta and signed by 24 other attorneys general.

Pulse oximeters’ overestimation of oxygen levels in patients with darker skin has, in a slew of recent research studies, been linked to poorer outcomes for many patients because of delayed diagnosis, delayed hospital admissions, and delayed access to treatment, including for severe Covid-19 infections. Higher amounts of pigments called melanin in darker skin interfere with the ability of light-based sensors in pulse oximeters to detect oxygen levels in blood.

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The delay has frustrated health care workers who use pulse oximeters and have studied them and followed the progress toward creating new devices that work better. “I just get mad that these things are not on the market,” Theodore J. Iwashyna, an ICU physician at Johns Hopkins, told STAT. “Just last week in my ICU, I had a patient whose pulse oximeter was reading 100% at the same time that his arterial blood gas showed that his oxygen levels were dangerously low. I need these things to work, and work in all my patients.”

Author(s):Usha Lee McFarling

Publication Date: 7 Nov 2023

Publication Site: STAT News

A new way to visualize the surge in Covid-19 cases in the U.S.

Mary Pat Campbell
A new way to visualize the surge in Covid-19 cases in the U.S.

Graphic:

Excerpt:

The number represented by the line could be thought of as the velocity of cases in the U.S. It tells us how fast case counts are increasing or decreasing and does a good job of showing us the magnitude of each wave of cases.

The chart, however, fails to show the rate of acceleration of cases. This is the rate at which the number of new cases is speeding up or slowing down.

As an analogy, a car’s velocity tells you how fast the car is going. Its acceleration tells you how quickly that car is speeding up.

Using Covid-19 case data compiled by the Center for Systems Science and Engineering at Johns Hopkins University and Our World in Data, combined with data from the Centers for Disease Control and Prevention, STAT was able to calculate the rate of weekly case acceleration, pictured below.

Author(s): Emory Parker

Publication Date: 26 July 2021

Publication Site: STAT News

CDC’s slow, cautious messaging on Covid-19 seems out of step with the moment, public health experts say

Mary Pat Campbell
CDC’s slow, cautious messaging on Covid-19 seems out of step with the moment, public health experts say

Excerpt:

When the CDC issued new guidelines recently on when people still need to wear masks, the guidelines were seen as so conservative that they prompted a primetime rant on “The Daily Show.”

“I know science is difficult … but who’s running messaging at the CDC?” asked the show’s host, Trevor Noah.

Some public health experts are asking the same question. Most experts interviewed for this story say the agency has struggled to take advantage of the latest scientific findings to communicate as rapidly as possible with the American public. And when the guidance is issued, it tends to be overly cautious.

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Still, public health officials say the conservative nature of the agency’s approach to Covid is a marked departure from how it deals with other major public health issues, like HIV and opioid use disorder.

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Multiple experts told STAT that they fear the CDC’s recommendations are becoming irrelevant for most Americans. They worry, too, that guidelines, like the CDC’s advice on masking, so seriously underplay the benefits of getting vaccinated that they risk dissuading people from getting a shot in the first place.

Author(s): Nicholas Florko

Publication Date: 11 May 2021

Publication Site: Stat News

Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA

Mary Pat Campbell
Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA

Excerpt:

The same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”

Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”

Author(s): Aaron Siri

Publication Date: 23 February 2021

Publication Site: Stat News

CDC estimated a one-year decline in life expectancy in 2020. Not so — try five days

Mary Pat Campbell
CDC estimated a one-year decline in life expectancy in 2020. Not so — try five days

Excerpt:

The Centers for Disease Control and Prevention made headlines last week when it announced that Covid-19 had reduced the average life expectancy of Americans in 2020 by a full year. The news seemed to starkly illustrate the devastation wrought by our nation’s worst public health crisis in 100 years.

But there was a problem. The pandemic’s appalling toll could not have reduced life span by nearly that much. My own estimate is that when Covid-19’s ravages in 2020 are averaged across the country’s entire population, we each lost about five days of life.

The CDC’s mistake? It calculated life expectancy using an assumption that is assuredly wrong, which yielded a statistic that was certain to be misunderstood. That’s exactly the type of misstep the agency can’t afford to make. Not now, not after former President Trump’s relentless attacks on its credibility. Not after his advisers were caught altering and editing the agency’s monthly reports to downplay the pandemic.

Author(s): Peter B. Bach

Publication Date: 25 February 2021

Publication Site: Stat News

U.S. life expectancy fell by a year in the first half of 2020, CDC report finds

Mary Pat Campbell
U.S. life expectancy fell by a year in the first half of 2020, CDC report finds

Graphic:

Excerpt:

Looking further at racial disparities in the data, the gap in life expectancy between non-Hispanic white and Black people widened from 4.1 years in 2019 to six years in the first half of 2020 — the largest gap since 1998.

“The disparities between those populations have been declining consistently, since we began estimating life expectancy, which goes back to 1900,” she said. 

The gap between Hispanic and white non-Hispanic individuals narrowed, however, from three years in 2019 to 1.9 in 2020.

Author(s): Rebecca Sohn

Publication Date: 18 February 2021

Publication Site: Stat News

A public option for health insurance could be a disaster, especially in times of crisis

Mary Pat Campbell
A public option for health insurance could be a disaster, especially in times of crisis

Excerpt:

Basic assumptions about the long-term costs of a public option are flawed. Research we have done shows that a public option will mean soaring deficits and debts because politicians in Washington will eventually succumb to political pressure both to subsidize enrollee premiums and to pay doctors and hospitals closer to what they are paid by private insurance rather than by existing government programs like Medicare and Medicaid. According to our calculations, the public option would add $800 billion to deficits in the first 10 years and increase the federal debt by more than 30% of the gross domestic product by 2050 — the equivalent of $6 trillion in today’s economy.

The effects on the budget are even worse when the economy suffers or if health costs unexpectedly rise. How much worse? With support from the Partnership for America’s Health Care Future — a coalition of leading health care providers, insurers, biopharmaceutical companies and employers that oppose one-size-fits-all health care — we looked at a few ways policymakers might adjust the public option to respond to future economic shocks and the impact these changes would have on long-term deficits and debt.

Author(s): Lanhee J. Chen, Tom Church, and Daniel L. Heil

Publication Date: 11 February 2021

Publication Site: Stat News