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Reformulating the flu vaccine, Bertagnolli on a tightrope, and doctors on vacation

January 16, 2024
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Reporter and Podcast Producer

Welcome back to the work week! I hope you had a restful long weekend and a happy Martin Luther King, Jr. Day.

public health

Do we need a reformulated flu vaccine? 

Last fall, the World Health Organization and some national drug regulators urged influenza vaccine manufacturers to drop the component known as B/Yamagata from flu vaccines as quickly as possible, citing the fact that this lineage of flu B viruses appears to have been snuffed out during the Covid-19 pandemic. You might think that request would be as simple as deciding to leave blueberries out of a mixed-fruit smoothie, STAT's Helen Branswell writes. But it's not as easy as it sounds.

Dozens of manufacturers around the world make hundreds of millions of doses of flu vaccine each year. To eliminate the B/Yamagata component, hundreds of vaccine licenses without it would need to be reactivated, updated, or applied for from scratch. "From a regulatory and procedural standpoint, this is an extremely complex picture," said Paul Barbosa, associate director for vaccine policy at the International Federation of Pharmaceutical Manufacturers and Associations. Read more from Helen on this complicated vaccine smoothie.


health tech

Even doctors don't know how the FDA approves medical devices

Pop quiz: Did you know that the Food and Drug Administration doesn't require randomized controlled trials before it approves medical devices? If that comes as a surprise, you're not alone: Only 17% of physicians feel they understand the FDA's device approval process, according to a recent national survey published in Health Affairs. Around 41% feel they understand the drug side.

Researchers collected 509 responses from internists, cardiologists, and oncologists. Sixty percent of doctors thought the FDA should require two or more randomized controlled trials for most new devices. Yet, on a separate question, 66% said they felt the FDA's current bar for approval for devices was about right. Read more from STAT's Lizzy Lawrence on the push to help doctors get more informed about regulation.


d.c.

New NIH Director Monica Bertagnolli walks a tightrope

GettyImages-1743255661

Kevin Dietsch/Getty Images

President Biden has promised to require fair prices from drugmakers that use federally funded research — and, in a major recent move, said he'll use government march-in rights on patents for drugs that run afoul of that goal. But the new National Institutes of Health director, locked in the center of this debate, isn't taking any big steps yet. "Our relationship with the pharmaceutical industry, with the industry overall, is really, really critical," Director Monica Bertagnolli told STAT's Sarah Owermohle in an interview. 

Walking this tightrope is just one of the myriad challenges facing Bertagnolli in the first few months of her tenure. The longtime oncologist and former National Cancer Institute director, just the second woman to ever lead NIH, is also facing a storm of questions from Congress around coronavirus research, foreign lab oversight, and how it spends money — particularly as Republicans look to cut costs across the government. Read more about Bertagnolli's looming battles in this far-ranging interview.



health

Opinion: BMI should not be used to gatekeep orthopedic surgery

Here's a scenario that's all too familiar to endocrinologist Jody Dushay: a patient with high body weight and BMI needs a new knee. The surgeon says the patient has to lose 50 pounds first. But! Because the patient has a bad knee, and therefore suffers from chronic pain and immobility, it's impossibly hard to lose weight — even when taking the new weight-loss drugs everyone is raving about (if the patient can get them). 

"Why is there a knee-jerk response by many orthopedists to deny joint replacement surgery to people above a certain BMI (usually 35)?" Dushay asks in a new First Opinion. When she looks at the research, it's unwarranted. "I wish the orthopedic and medical communities could be on a joint mission to see people as entire individuals, not a number on a scale, when deciding who gets what treatment and when," she writes. Read more from Jody on why refusing surgery based on BMI is not the right strategy.


health care

Vacations are necessary medicine for burned-out doctors

Few professions allow for as much vacation time as, say, an international pop star. But for doctors, a lack of vacation time — and then having to work anyway when they do take time off — is associated with higher rates of burnout, according to a new study published Friday in JAMA Network Open.

Researchers performed a cross-sectional survey of doctors in the U.S. between 2020 and 2021.  Among over 3,000 respondents, about 60% had taken fewer than 15 vacation days in the year prior.  While on vacation, 70% found themselves working at least 30 minutes per day. Taking more vacation was, perhaps predictably, associated with less burnout among doctors. More specifically, so was getting a complete break from the electronic health record inbox — part of the job that many doctors have lamented.  

More institutional effort is needed to provide clinical coverage for doctors while on vacation, the researchers wrote. Burnout is a major problem in health care — in a First Opinion from 2020, Sudhakar Nuti wrote that she felt fundamentally changed by burnout: "I feel like I've gone from doctor to debris."


health

Chronic inflammation plus poverty makes for "double whammy" of mortality risk

A 40-year-old who suffers from chronic inflammation has a higher mortality risk than one who doesn't. A 40-year old who lives in poverty has a similarly higher mortality risk than those who don't. But a person who experiences both? They have more than double the risk of dying within 15 years from heart disease and almost triple the risk of dying from cancer within that period compared to people who experience neither, according to a new study published in Frontiers in Medicine. The two factors operate "synergistically," creating a "double whammy," lead author Arch Mainous III said in a press release.

Mainous and his team analyzed nationally representative survey data of adults ages 40 and over, representing about 95 million people. Further research is needed to better understand the clinical relationship between the two factors, they wrote, especially in order to consider potential future screening practices and research.


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What we're reading

  • Workplace wellness programs have little benefit, study finds, New York Times
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  • How much of the world is it possible to model? New Yorker
  • For-profit biomedical institute, backed by billionaires, launches in Cambridge to speed drug discovery, STAT
  •  Can we keep time? Atlantic

Thanks for reading! More tomorrow — Theresa


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