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Pulse oximeters — and their long-ignored inaccuracies — get FDA scrutiny today

(SYLVIA JARRUS FOR STAT)

Today’s the day an FDA committee takes up the performance of pulse oximeters — the ubiquitous devices marshaled in Covid-19 to detect oxygen levels in infected patients — and their inaccuracy in people with darker skin. One question, STAT’s Usha Lee McFarling writes: What took so long? Studies going back to 2005 show that melanin in darker skin skews readings, overestimating how much oxygen is in the blood. In the 1960s, engineers working on a device for NASA discussed making a device that would work on all skin colors.

“I’m a trained pulmonary and critical care physician and was not aware of these old studies … they never made it into the textbooks I used,” said Michael Sjoding, an assistant professor at the University of Michigan who led a 2020 study on pulse oximeters that drew the first widespread attention to the problem. Read more on the history and the issues facing today’s meeting. And watch a short explainer of how pulse oximeters do and don't work.

Vaccine to prevent RSV in newborns is effective, Pfizer says

Just as respiratory infections seem to be returning with a vengeance after Covid-induced lulls, there’s some good news about respiratory syncytial virus, also called RSV. Pfizer said this morning its maternal RSV vaccine reduced the rate of severe illness in newborns by 81.8%, meeting the pivotal study’s goal. The company plans to file the data on the vaccine with regulators by the end of the year. RSV is a common cause of illness and infection in young infants. By giving the vaccine during pregnancy — as now happens with pertussis and flu — researchers hope antibodies generated by mothers would be transferred to infants.

After years without progress, preventatives for RSV are now emerging. Sanofi and AstraZeneca are developing a monoclonal antibody against the infection. GlaxoSmithKline had also been developing a vaccine against RSV, but the company stopped three clinical trials in February for undisclosed safety reasons. STAT’s Matthew Herper has more.

Advanced practice clinicians take in a bit more industry funding than physicians

Physicians taking money from drug and medical device makers is a familiar story, as are questions about conflicts of interest. It turns out that in the U.S., a slightly larger share of advanced practice clinicians — nurse practitioners, physician assistants, and other providers — than physicians accept such payments. Here’s how it breaks down: 36% of advanced practice clinicians accepted payments from industry, compared with 35% of physicians, according to new findings in JAMA.

Of the $1.9 billion in industry payments to medical providers in 2021, about 94% still went to 1.1 million doctors last year while the 640,000 advanced practice clinicians took in $119 million. “The fact that one-third of [advanced practice clinicians] are receiving payments of some sort is very significant in terms of what that could mean for how it affects patient care,” co-author and resident physician Audrey Zhang told STAT’s Tara Bannow. Read more.

Closer look: With Republicans near congressional control, science is on the line

(AL DRAGO/AFP via Getty Images)

We know that Anthony Fauci has become a lightning rod for Republican frustration over what many conservative lawmakers argue is unbridled Covid-19 spending and unfettered federal power during the pandemic. But the discontent is broader than one person's record. Republican staffers and lobbyists tell STAT that Republican leaders plan to throw the spotlight on spending and transparency at health agencies from the CDC to CMS.

Some of the most vocal critics of scientists and agencies like the NIH and the CDC, including Sen. Rand Paul of Kentucky (above), are poised to ascend to powerful committee chairmanships that will enable them to conduct sweeping investigations and put health officials on public trial. The new chairmanships could also give them the ability to tighten the purse strings for health agencies’ budgets — and to deny funding outright for new Covid-19 measures or other Biden health priorities. STAT’s Sarah Owermohle and Rachel Cohrs explore the potential impact.

Monoclonal antibody for malaria shows promise

The need is clear for a better way to control malaria. The disease, caused by a mosquito-borne parasite, kills half a million people a year, most of them children living in Africa. Antimalarial medicines, insecticide-treated nets, and vaccines with 36% effectiveness are the current tools, but progress has stalled. New research from a Phase 2 trial in 742 adults shows some success with a monoclonal antibody to block infection over a six-month malaria season in Mali. A single intravenous infusion gave up to 88.2% protection while 78.2% of people in a placebo group were infected.

Writing in NEJM, the authors call it a proof of concept. A companion editorial cautions, “It is difficult to conceive the large-scale implementation of an intervention administered as a single intravenous infusion of 100 ml over a period of 30 minutes.”

Covid disturbs our gut microbiomes, too, and not in a good way

Covid infections can disrupt our gut microbiomes, new research concludes, changing the population of microbes for the worse. A study in Nature Communications shows that the Covid-19 virus can cut down the diversity of “good” microorganisms, allowing species resistant to antibiotics to thrive and in some cases potentially lead to dangerous bloodstream infections. The researchers studied the problem in mice and then in stool samples from 96 patients infected in 2020, teasing out whether the use of antibiotics, more common early in the pandemic, or their infections were to blame for the rise in antibiotic-resistant bugs.

They determined that the infection came first and the dominance of antibiotic resistance second. “We suggest that investigating the underlying mechanism behind our observations will inform the judicious application of antibiotics and immunosuppressives in patients with respiratory viral infections and increase our resilience to pandemics,” they write.

What to read around the web today

In Africa's monkeypox outbreak, sickness and death go undetected, Reuters
Smiling faces might help the drug ketamine keep depression at bay, NPR
A psychiatry wait list had 880 patients; a hospital couldn’t keep up, Washington Post
Cholera outbreaks surge worldwide as vaccine supply drains, New York Times
Opinion: Inconsistent clinical practices thwart wider use of personalized medicine, STAT