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Oakland clinic gets medical device maker to disclose risk of false blood-oxygen reading

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Oakland clinic gets medical device maker to disclose risk of false blood-oxygen reading

-One of healthcare’s most fundamental tools works less reliably for people with darker skin tones.
– An Oakland clinic’s lawsuit is helping to change that in California.

The pulse oximeter, a device that measures the degree to which red blood cells are saturated with oxygen, is one of healthcare’s most fundamental tools.

So when Dr. Noha Aboelata learned that research stretching back decades showed that the devices routinely failed patients with darker skin tones, she took action.

Aboelata, the founder and chief executive of East Oakland’s Roots Community Health Center, urged the Food and Drug Administration to require makers of pulse oximeters to test their devices on people of color, and to warn consumers about the risk of false readings.

Attorneys for Roots wrote to companies that made or sold pulse oximeters in California, asking them to improve their products and disclose their limitations. When none responded, the clinic filed a lawsuit to force a change in practices.

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A year later, Roots and Aboelata are celebrating their first wins.

Minneapolis-based Medtronic, a leading provider of the devices to hospitals, reached a settlement with Roots last month.

Medtronic agreed to provide brochures and advisory labels on pulse oximeters sold to California hospitals, informing users that the devices can artificially inflate blood oxygen estimates on patients with darker skin. In exchange, Roots dropped its claims against the company.

In a statement, Medtronic said it “looks forward to working with Roots, the FDA and other key stakeholders to ensure health equity can be achieved through technology, educational efforts, and partnerships.”

Three other companies that sell directly to consumers also agreed to place informational labels on their products.

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The suit is proceeding against CVS, Walgreens, GE HealthCare and five other defendants that have not settled, Roots attorney Jonathan Weissglass said.

CVS and GE said they wouldn’t comment on pending legislation. Walgreens didn’t immediately respond for comment, but said earlier this year that it also would not comment on pending litigation.

The settlements are a step toward resolution for a pervasive yet frequently overlooked problem that has haunted medicine for decades.

“This pulse ox issue should never have been allowed to happen, and once it was known, it should not have been allowed to continue,” Aboelata said. “I’m still talking to people every week who don’t know about it.”

A pulse oximeter shines a light that passes through the patient’s skin, blood and tissues, and then measures how much light comes out the other side. They’re typically clipped on a fingertip.

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Before pulse oximeters were widely adopted in the 1980s, the only way to gauge a patient’s blood oxygen saturation was to draw blood from their arterial vein, a painful procedure that had to be followed by immediate laboratory analysis.

Oxygen-rich blood absorbs more infrared light. So does melanin, the pigment that helps determine skin, hair and eye color. As a result, patients with darker skin tones are more likely to get pulse oximeter readings that show their blood oxygen saturation to be higher than it actually is.

As early as 1990, researchers noted that Black patients were more likely to get deceptively high “pulse ox” readings when hypoxic, or suffering from low oxygen.

In 2005, UC San Francisco’s Hypoxia Research Laboratory found the devices were more likely to overestimate oxygen saturation in patients with dark skin than in those with light skin, results the lab confirmed in a follow-up study two years later.

Yet many providers — including those like Aboelata, who focused on addressing racial inequities in healthcare — were unaware of this data. This became a matter of life and death during the COVID-19 pandemic, when pulse oximeter readings became the primary metric hospitals used to determine who should get care.

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CDC guidelines instructed providers to start anyone with pulse ox readings below 90% on oxygen therapy.

A 2020 study of thousands of patients at the University of Michigan found that Black patients, compared with white patients, had nearly three times the rate of “occult hypoxia” — low blood oxygen that goes undetected because pulse oximeter readings are in the normal range.

After reading the study, a pharmacist and cardiologist from the University of Michigan looked at 204 patient records from their hospital.

In a study published in February, they found that Black patients’ blood oxygen readings on pulse oximeters were on average 6% higher than the actual blood oxygen levels measured in their arterial blood samples. In contrast, pulse oximeters overestimated white patients’ blood oxygen by just 1% on average.

Artificially high blood oxygen readings could lead physicians to underestimate how much blood is pumping from a patient’s heart or overestimate the degree of resistance in the patient’s vascular system, the researchers said.

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“Those sorts of measurements can impact how we care for patients with heart failure, and can impact their candidacy for more intense treatment options like heart transplants and heart pumps,” cardiologist Dr. Scott Ketcham said.

Currently, the FDA recommends — but doesn’t require — that pulse oximeter makers ensure that in their clinical trials, either two participants or 15% of total participants are “darkly pigmented” people, a definition open to interpretation.

In February 2021, the FDA issued a safety notice cautioning users that pulse oximeters can be thrown off by a number of variables, including skin pigment.

In February, an agency advisory panel recommended that the FDA require that new devices be tested on at least 24 people whose skin tones collectively span the Monk Skin Tone scale, a 10-color palette often used to train artificial intelligences to recognize people of different colors.

The proposal would divide the scale into three parts, with each part represented by at least 25% of study participants.

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Though the FDA indicated that it would issue new guidelines for pulse oximeter manufacturers by Sept. 30, it has not done so yet. The agency is working to release the updated guidance “as expeditiously as possible,” a spokesperson said.

The FDA also funded a study at UCSF’s Hypoxia Research Laboratory to better understand the relationship between skin pigment and pulse ox accuracy. The research team is preparing its results for publication now, said Dr. Phil Bickler, director of the UCSF lab and an investigator on the study.

Until then, making sure their devices work equally well for users of all skin tones is optional for manufacturers.

When Manhattan Beach-based BodiMetrics, a maker of wearable health monitors, sought FDA clearance for its most recent smart ring fitness tracker, the company opted to broaden the range of skin tones represented in its study population. One-third of its study population had darker skin pigment, compared with the FDA-recommended minimum of 15%.

“It’s a lot more money to do the clinical studies [to] prove that we didn’t have a pigmentation problem,” BodiMetrics founder and chief operating officer Neil Friedman said. “But that was our goal … to make sure that people had a device that properly measured their blood oximetry and prevented them from being misdiagnosed or potentially dying.”

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Political stress: Can you stay engaged without sacrificing your mental health?

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Political stress: Can you stay engaged without sacrificing your mental health?

It’s been two weeks since Donald Trump won the presidential election, but Stacey Lamirand’s brain hasn’t stopped churning.

“I still think about the election all the time,” said the 60-year-old Bay Area resident, who wanted a Kamala Harris victory so badly that she flew to Pennsylvania and knocked on voters’ doors in the final days of the campaign. “I honestly don’t know what to do about that.”

Neither do the psychologists and political scientists who have been tracking the country’s slide toward toxic levels of partisanship.

Fully 69% of U.S. adults found the presidential election a significant source of stress in their lives, the American Psychological Assn. said in its latest Stress in America report.

The distress was present across the political spectrum, with 80% of Republicans, 79% of Democrats and 73% of independents surveyed saying they were stressed about the country’s future.

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That’s unhealthy for the body politic — and for voters themselves. Stress can cause muscle tension, headaches, sleep problems and loss of appetite. Chronic stress can inflict more serious damage to the immune system and make people more vulnerable to heart attacks, strokes, diabetes, infertility, clinical anxiety, depression and other ailments.

In most circumstances, the sound medical advice is to disengage from the source of stress, therapists said. But when stress is coming from politics, that prescription pits the health of the individual against the health of the nation.

“I’m worried about people totally withdrawing from politics because it’s unpleasant,” said Aaron Weinschenk, a political scientist at the University of Wisconsin–Green Bay who studies political behavior and elections. “We don’t want them to do that. But we also don’t want them to feel sick.”

Modern life is full of stressors of all kinds: paying bills, pleasing difficult bosses, getting along with frenemies, caring for children or aging parents (or both).

The stress that stems from politics isn’t fundamentally different from other kinds of stress. What’s unique about it is the way it encompasses and enhances other sources of stress, said Brett Ford, a social psychologist at the University of Toronto who studies the link between emotions and political engagement.

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For instance, she said, elections have the potential to make everyday stressors like money and health concerns more difficult to manage as candidates debate policies that could raise the price of gas or cut off access to certain kinds of medical care.

Layered on top of that is the fact that political disagreements have morphed into moral conflicts that are perceived as pitting good against evil.

“When someone comes into power who is not on the same page as you morally, that can hit very deeply,” Ford said.

Partisanship and polarization have raised the stakes as well. Voters who feel a strong connection to a political party become more invested in its success. That can make a loss at the ballot box feel like a personal defeat, she said.

There’s also the fact that we have limited control over the outcome of an election. A patient with heart disease can improve their prognosis by taking medicine, changing their diet, getting more exercise or quitting smoking. But a person with political stress is largely at the mercy of others.

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“Politics is many forms of stress all rolled into one,” Ford said.

Weinschenk observed this firsthand the day after the election.

“I could feel it when I went into my classroom,” said the professor, whose research has found that people with political anxiety aren’t necessarily anxious in general. “I have a student who’s transgender and a couple of students who are gay. Their emotional state was so closed down.”

That’s almost to be expected in a place like Wisconsin, whose swing-state status caused residents to be bombarded with political messages. The more campaign ads a person is exposed to, the greater the risk of being diagnosed with anxiety, depression or another psychological ailment, according to a 2022 study in the journal PLOS One.

Political messages seem designed to keep voters “emotionally on edge,” said Vaile Wright, a licensed psychologist in Villa Park, Ill., and a member of the APA’s Stress in America team.

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“It encourages emotion to drive our decision-making behavior, as opposed to logic,” Wright said. “When we’re really emotionally stimulated, it makes it so much more challenging to have civil conversation. For politicians, I think that’s powerful, because emotions can be very easily manipulated.”

Making voters feel anxious is a tried-and-true way to grab their attention, said Christopher Ojeda, a political scientist at UC Merced who studies mental health and politics.

“Feelings of anxiety can be mobilizing, definitely,” he said. “That’s why politicians make fear appeals — they want people to get engaged.”

On the other hand, “feelings of depression are demobilizing and take you out of the political system,” said Ojeda, author of “The Sad Citizen: How Politics is Depressing and Why it Matters.”

“What [these feelings] can tell you is, ‘Things aren’t going the way I want them to. Maybe I need to step back,’” he said.

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Genessa Krasnow has been seeing a lot of that since the election.

The Seattle entrepreneur, who also campaigned for Harris, said it grates on her to see people laughing in restaurants “as if nothing had happened.” At a recent book club meeting, her fellow group members were willing to let her vent about politics for five minutes, but they weren’t interested in discussing ways they could counteract the incoming president.

“They’re in a state of disengagement,” said Krasnow, who is 56. She, meanwhile, is looking for new ways to reach young voters.

“I am exhausted. I am so sad,” she said. “But I don’t believe that disengaging is the answer.”

That’s the fundamental trade-off, Ojeda said, and there’s no one-size-fits-all solution.

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“Everyone has to make a decision about how much engagement they can tolerate without undermining their psychological well-being,” he said.

Lamirand took steps to protect her mental health by cutting social media ties with people whose values aren’t aligned with hers. But she will remain politically active and expects to volunteer for phone-banking duty soon.

“Doing something is the only thing that allows me to feel better,” Lamirand said. “It allows me to feel some level of control.”

Ideally, Ford said, people would not have to choose between being politically active and preserving their mental health. She is investigating ways to help people feel hopeful, inspired and compassionate about political challenges, since these emotions can motivate action without triggering stress and anxiety.

“We want to counteract this pattern where the more involved you are, the worse you are,” Ford said.

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The benefits would be felt across the political spectrum. In the APA survey, similar shares of Democrats, Republicans and independents agreed with statements like, “It causes me stress that politicians aren’t talking about the things that are most important to me,” and, “The political climate has caused strain between my family members and me.”

“Both sides are very invested in this country, and that is a good thing,” Wright said. “Antipathy and hopelessness really doesn’t serve us in the long run.”

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Video: SpaceX Unable to Recover Booster Stage During Sixth Test Flight

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Video: SpaceX Unable to Recover Booster Stage During Sixth Test Flight

President-elect Donald Trump joined Elon Musk in Texas and watched the launch from a nearby location on Tuesday. While the Starship’s giant booster stage was unable to repeat a “chopsticks” landing, the vehicle’s upper stage successfully splashed down in the Indian Ocean.

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Alameda County child believed to be latest case of bird flu; source unknown

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Alameda County child believed to be latest case of bird flu; source unknown

California health officials reported Tuesday that a child in Alameda County tested positive for H5 bird flu last week.

The source of infection is not known — although health officials are looking into possible contact with wild birds — and the child is recovering at home with mild upper respiratory symptoms.

Health officials have confirmed the “H5” part of the virus, not the “N1.” There is no human “H5” flu; it is only associated with birds.

The child was treated with antiviral medication, and the sample was sent to the U.S. Centers for Disease Control and Prevention for confirmatory testing.

The initial test showed low levels of the virus and, according to the state health agency, testing four days later showed no virus.

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“The more cases we find that have no known exposure make it difficult to prevent additional” infections, said Jennifer Nuzzo, professor of epidemiology and director of the Brown University School of Public Health’s Pandemic Center. “It worries me greatly that this virus is popping up in more and more places and that we keep being surprised by infections in people whom we wouldn’t think would be at high risk of being exposed to the virus.”

A statement from the California Department of Public Health said that none of the child’s family members have the virus, although they, too, had mild respiratory symptoms. They are also being treated with antiviral medication.

The child attended a day care while displaying symptoms. People the child may have had contact with have been notified and are being offered preventative antiviral medication and testing.

“It’s natural for people to be concerned, and we want to reinforce for parents, caregivers and families that based on the information and data we have, we don’t think the child was infectious — and no human-to-human spread of bird flu has been documented in any country for more than 15 years,” said CDPH Director and State Public Health Officer Dr. Tomás Aragón.

The case comes days after the state health agency announced the discovery of six new bird flu cases, all in dairy workers. The total number of confirmed human cases in California is 27. This new case will bring it to 28, if confirmed. This is the first human case in California that is not associated with the dairy industry.

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The total number of confirmed human cases in the U.S., including the Alameda County child, now stands at 54. Thirty-one are associated with dairy industry, 21 with the poultry industry, and now two with unknown sources.

In Canada, a teenager is in critical condition with the disease. The source of that child’s infection is also unknown.

Genetic sequencing of the Canadian teenager’s virus shows mutations that may make it more efficient at moving between people. The Canadian virus is also a variant of H5N1 that has been associated with migrating wild birds, not cattle.

Genetic sequencing of the California child’s virus has not been released, so it is unclear if it is of wild bird origin, or the one moving through the state’s dairy herds.

In addition, WastewaterScan — an infectious disease monitoring network led by researchers from Stanford University and Emory University, with laboratory support from Verily, Alphabet Inc.’s life sciences organization — follows 28 wastewater sites in California. All but six have shown detectable amounts of H5 in the last couple of weeks.

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There are no monitoring sites in Alameda Co., but positive hits have been found in several Bay Area wastewater districts, including San Francisco, Redwood City, Sunnyvale, San Jose and Napa.

“This just makes the work of protecting people from this virus and preventing it from mutating to cause a pandemic that much harder,” said Nuzzo.

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