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Firings at FDA Decimated Teams Reviewing AI and Food Safety

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Firings at FDA Decimated Teams Reviewing AI and Food Safety

In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. It scooped up food chemists, lab-safety monitors and diabetes specialists who helped make needle pricks and test strips relics of the past.

Trying to keep up with breakneck advances in medical technology and the demands of a public troubled by additives like food dyes, the agency enticed scores of midcareer specialists with remote roles and the chance to make a difference in their fields.

In one weekend of mass firings across the F.D.A., much of that effort was gone. Most baffling to many were the firings of hundreds whose jobs were not funded by taxpayers. Their positions were financed through congressionally approved agreements that routed fees from the drug, medical device and tobacco industries to the agency.

Known as user fees, the money provides adequate staffing for reviews of myriad products. While criticized by some, including the nation’s new health secretary, Robert F. Kennedy Jr., as a corrupting force on the agency, the industry funds are also widely viewed as indispensable: They now account for nearly half of the agency’s $7.2 billion budget.

Though the F.D.A. is believed to have lost about 700 of its 18,000 employees, some cuts hit small teams so deeply that staff members believe the safety of some medical devices could be compromised.

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Among the layoffs were scientists supported by the fees who monitor whether tests pick up ever-evolving pathogens, including those that cause bird flu and Covid. They hobbled teams that evaluate the safety of medical devices like surgical staplers, new systems for diabetes control and A.I. software programs that scan millions of M.R.I.s and other images to detect cancer beyond the human eye. The cuts also eliminated positions for employees who have played a role in assessing the brain-implant technology in Elon Musk’s Neuralink devices.

The layoffs affected so many key experts that a major medical device trade group has requested that the Trump administration reconsider the job cuts.

The dismissals also included lawyers who warned retailers about underage tobacco sales and scientists who studied the safety of e-cigarettes and new heat-not-burn devices. The tobacco division — which is fully funded by an excise tax on cigarettes — lost about 85 staff members.

Dr. Robert Califf, the F.D.A. commissioner under President Biden, said the personnel cutbacks seemed scattershot. Taking a not-so-subtle aim at Mr. Musk’s Department of Government Efficiency, which is reducing the federal work force, Dr. Califf said the layoffs were, in effect, “anti-efficiency.”

“These are not hires that are done arbitrarily,” he said. “They’re done to meet a need.”

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A lawsuit challenging the firings filed by unions, including one that represents some F.D.A. employees, failed to stop the layoffs in a ruling issued Thursday. Other cutbacks reduced the 2,000-member staff of the F.D.A.’s food division, which is supported by tax dollars.

Jim Jones, the former director of the division who resigned on Monday over the cuts, said that he had briefed the Trump transition team on his efforts to create a new office that would review a premier target of Mr. Kennedy and his agenda to Make America Healthy Again: food additives that are already on the market.

Nine people from that food-chemical-safety staff of 30 are gone, including specialized toxicologists and chemists, Mr. Jones said in an interview.

“They’ve created a real pickle for themselves,” by cutting staff members working on a key priority, Mr. Jones said. “You just can’t do an assessment for free and you can’t ban chemicals by fiat.”

In interviews with 15 current and former agency staff members, they said those who were laid off had been probationary employees, a group that included agency veterans who took on new roles, were recently promoted or were hired in the last two years.

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Those who remained said that they had been scrambling to pick up pressing medical device reviews and move forward with studies to bulletproof methods for detecting deadly bacteria during inspections at food production sites.

Divisions that review novel medications, vaccines and gene therapies were largely spared. Officials with the F.D.A.’s parent agency, the Department of Health and Human Services, did not respond to requests for comment.

The F.D.A. employees fired last weekend were notified in uniformly worded emails that their skills were not needed and that their performance was “not adequate to justify further employment by the agency.” Yet many of them said that their performance reviews had said they exceeded expectations.

Tony Maiorana, 37, a chemist, worked on product approval and safety in the fast-changing field of diabetes devices. In the last decade, the field has moved from painful needle pricks and test strips to systems that measure glucose levels just below the skin and automatically infuse the needed insulin.

The work of reviewing new products is painstaking: Novel algorithms measure and dispense insulin; materials implanted in the body must evade rejection by the immune system; and millions of patients from toddlers to the elderly are at risk if devices malfunction.

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Still, about half of Dr. Maiorana’s product-review team was eliminated, he said.

“If you’re a patient and you complain, we are the ones that field your complaints,” he said. “We are the ones that monitor the death reports. We’re the ones that are telling companies: ‘Hey, there’s a big pattern of error happening here. People are dying or ending up in the hospital because of your device’ and ‘What has changed? What happened?’”

Dr. Maiorana said that he had expected his government job would be “chill,” but it turned out to be intense. His team had to assess whether studies of new devices that had never been used in humans were safe for adults and children. They also had to watch online marketplaces for diabetes technology that had not been approved by the agency.

“This is the reason the F.D.A. was founded — to protect the public,” Dr. Maiorana said.

Albert Yee, 59, an expert in biomechanics and robotics, was fired on Saturday. In his unit, four of 11 staff members, who review the safety of surgical robots, were let go.

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Robotic surgery is increasingly employed in operating rooms across the country, used in cardiothoracic, gynecological and bariatric surgeries. Dr. Yee had worked in the industry and in academia before joining the F.D.A.

He said his team was highly specialized, including an expert with a doctorate in medical robotics and a physician who had conducted robotic operations.

He said that robotic devices had become so complex that the team’s diverse expertise was critical to evaluate not just the safety of such tools but also concerns about cybersecurity.

“All of these devices now — if they’re attached to the hospital network, they become an avenue to get into the hospital network or get into the device itself,” Dr. Yee said.

He said the team also fielded a flood of applications for surgical apparatus developed abroad that were similar to those made by companies based in the United States. He said the applications required close attention to catch problems that could endanger patients.

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“The institutional knowledge we’re losing is just horrific,” he said. “I am concerned about public safety with this type of purge.”

Nathan Weidenhamer was a lead reviewer of cardiovascular devices and other high-risk implants.

He said he was shocked and disappointed to be laid off because he and other reviewers in the device division were partly funded by industry-generated fees.

“I naïvely thought we were important, critical public servants and I’d be spared,” he said.

The layoffs clearly did not skip over employee slots created and funded by the agreements negotiated with the industries, congressional lawmakers and F.D.A. officials. The industries provide billions of dollars in return for staff equipped to meet strict deadlines for decisions on product approvals — though not all go in companies’ favor. The money is also used to make the F.D.A. a competitive employer in specialized fields that require advanced degrees.

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Some of the deadlines are viewed by F.D.A. staff members as demanding, particularly the 30-day clock requiring them to authorize or add comments to studies of devices that are being implanted in humans for the first time. If the agency does not respond within that time-frame, the study is given a green light under the law.

The depth of cuts to medical device staff prompted AdvaMed, a trade association for the industry, to push back in a letter to a top Health and Human Services official.

The letter detailed about 180 medical device staff cuts, which included 25 experts in artificial intelligence, a 20 percent reduction in biostatisticians who evaluated studies of novel devices and the loss of molecular biologists with expertise in diagnostic tests that pinpoint a cancer subtype. The firings also applied to a top official who was recently recruited to oversee about 10,000 product applications and meeting requests per year.

The group said it appreciated the Trump administration’s efforts to improve efficiency. But “they may have missed the mark on how they rolled it out,” Scott Whitaker, the president of AdvaMed, said in an interview.

Medical device companies benefit when the F.D.A. is well staffed with people who have the expertise to guide the safe development of new technology, he added.

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“One that is slow and overregulates is not good,” he said. “One that is under-resourced and doesn’t regulate at all — that’s not good either.”

Alice Callahan contributed reporting.

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Brain Health Challenge: Test Your Knowledge of Healthy Habits

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Brain Health Challenge: Test Your Knowledge of Healthy Habits

Welcome to the Brain Health Challenge! I’m Dana Smith, a reporter at The New York Times, and I’ll be your guide.

To live a healthy life, it’s crucial to have a healthy brain. In the short term, it keeps you sharp and firing on all cylinders. In the long term, it can reduce your risk of cognitive decline, dementia and stroke.

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Practicing basic healthy behaviors, like eating nutritious food and getting regular exercise, is the best way to enhance your brain power and protect the longevity of your neurons. These types of lifestyle habits can benefit the brain at any age. And while they won’t guarantee that you’ll never develop dementia or another brain disease, several clinical trials have shown that they can improve cognition or slow decline.

Every day this week, you’ll do an activity that’s good for your brain, and we’ll dig into the science behind why it works. Some of these activities can provide a small immediate cognitive benefit, but the bigger reward comes from engaging in them consistently over time. So along with the neuroscience lessons, we’ll include a few tips to help you turn these actions into lasting habits.

To keep you accountable, we’re encouraging you to complete this challenge with a friend. If you don’t have a challenge buddy, no problem: We’re also turning the comments section into one big support group.

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There are so many fascinating ways your daily behaviors affect your brain. Take sleep, for example.

Lots of studies have shown that getting a good night’s rest (seven to eight hours) is associated with better memory and other cognitive abilities. That’s because sleep, especially REM sleep, is when your brain transfers short-term memories — things you learned or experienced during the day — into long-term storage.

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Sleep is also when your brain does its daily housekeeping. While you rest, the brain’s glymphatic system kicks into high gear, clearing out abnormal proteins and other molecular garbage, including the protein amyloid, which is a major contributor to Alzheimer’s disease. A buildup of amyloid is one reason experts think that people who routinely get less sleep have a higher risk of dementia.

What other behaviors play a big role in brain health? For today’s activity, we’re going to test your knowledge with a quiz. Share your score with your accountability partner and in the comments below — I’ll be in there too, cheering you on.

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What your butt shape could reveal about your health, according to scientists

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What your butt shape could reveal about your health, according to scientists

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An often-overlooked part of the body may reveal important clues about overall health.

Researchers from the University of Westminster in the U.K. discovered that the shape of the gluteus maximus muscle in the buttocks changes with age, gender, lifestyle and frailty, as well as certain conditions like osteoporosis and type 2 diabetes.

Using advanced MRI scans that create 3D images, researchers revealed “distinct” patterns in the gluteus maximus associated with type 2 diabetes.

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This suggested that the shape of the muscle, rather than the size, may “reflect underlying metabolic differences,” a press release stated.

The findings were presented in December at the annual meeting of the Radiological Society of North America (RSNA) in Chicago.

Butt shape may indicate underlying health conditions, according to new research. (iStock)

Unlike previous studies looking at muscle size or fat, the 3D imaging identified exactly where the muscle changes occur, according to the researchers.

As one of the largest muscles in the human body, the gluteus maximus “plays a key role” in metabolic health, according to lead study author E. Louise Thomas, Ph.D., professor of metabolic imaging at the University of Westminster’s School of Life Sciences.

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The researchers analyzed more than 61,000 MRI scans from a large UK health database to better understand the muscle’s structure.

The data also included the participants’ physical measurements, demographics, disease biomarkers, medical history and lifestyle habits. The researchers studied how these variables were linked to muscle shape over time.

An infographic from the Radiological Society of North America presentation displays research findings on the shape of the gluteus maximus. (RSNA)

“People with higher fitness, as measured by vigorous physical activity and hand grip strength, had a greater gluteus maximus shape, while aging, frailty and long sitting times were linked to muscle thinning,” study co-author Marjola Thanaj, Ph.D., a senior research fellow at the University of Westminster’s Research Centre for Optimal Health, said in the release.

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The researchers concluded that butt shape changes may indicate an “early functional decline” and “metabolic compromise” in type 2 diabetes patients.

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Men with type 2 diabetes showed muscle shrinkage, while women displayed enlarged muscle, likely due to “infiltration of fat” within it, according to the researchers.

These results suggest that men and women have “very different biological responses to the same disease,” Thanaj suggested.

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Butt shape changes may indicate an “early functional decline” and “metabolic compromise” in type 2 diabetes patients.  (iStock)

Men who were categorized as “frail” were recognized as having more “general shrinkage” across the gluteus maximus, but women experienced a “limited” frailty effect.

Building strong glutes for better health

Strengthening the glutes is an “investment in long-term health,” according to Tanya Becker, co-founder of Physique 57 in New York City.

“While full-body strength training is essential, focusing on your glutes — the largest muscle group in your body — deserves special attention,” she told Fox News Digital.

“While full-body strength training is essential, focusing on your glutes — the largest muscle group in your body — deserves special attention.” (iStock)

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Becker refers to the glutes as the body’s “shock absorbers,” because they protect the lower back, knees and hips from taking on stress they weren’t designed to handle. 

Larger muscle groups also burn more calories and help regulate blood sugar, the expert added, noting that muscles are often referred to as the “organ of longevity.”

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Strengthening the glutes also helps to protect the lower back, hips and knees, and also improves posture and balance, reducing the risk of falls and improving mobility.

“People with higher fitness, as measured by vigorous physical activity and hand grip strength, had a greater gluteus maximus shape.”

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Becker recommends traditional weighted exercises like squats, lunges and bridges, although they are not suited for everyone, especially older adults with injuries and joint pain.

“Pilates and barre classes offer bodyweight exercises that are ideal for beginners or individuals with physical limitations,” she suggested. “They can be done anytime, anywhere, making them accessible for beginners before progressing to weighted versions.”

Glute bridges (demonstrated above) are a recommended exercise for strengthening those muscles. (iStock)

Becker shared the following three glute exercises that improve hip mobility, stability and overall strength.

No. 1: Quadruped leg lifts (strengthens entire core and glutes) 

Start on the hands and knees, engage your core, and lift one leg off the floor (bent or straight). Pulse up and down a few inches for 30 to 60 seconds, then repeat on the other leg.

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No. 2: Clamshells (strengthens gluteus medius)

Lie on your side with knees bent at 90 degrees in front of you. Lift your top knee away from your bottom knee, then lower slowly. 

For an increased challenge, lift both feet off the ground while keeping the heels together. Repeat for 30 to 60 seconds per side.

Strong muscles are responsible for maintaining metabolic health, according to Becker. (iStock)

No. 3: Glute bridges (strengthens lower back and glutes) 

Lie on your back with knees bent and feet parallel, a few inches from your hips. Engage your abs, and squeeze your glutes to lift your hips toward knee height, then lower. 

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If you feel pressure in your neck, you’ve lifted too high. Perform for 30 to 60 seconds. Complete three sets with 30-second rests between them.

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Those looking to start a new fitness routine should first consult with a doctor.

Fox News Digital reached out to the study authors for comment.

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Viral New Year reset routine is helping people adopt healthier habits

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Viral New Year reset routine is helping people adopt healthier habits

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What if your New Year’s resolution could fit inside a tote bag? Social media users are trying the “analog bag” trend, replacing phones with offline activities.

The trend is widely credited to TikTok creator Sierra Campbell, who posted about her own analog bag — containing a crossword book, portable watercolor set, Polaroid camera, planner and knitting supplies — and encouraged followers to make their own. 

Her video prompted many others to share their own versions, with items like magazines, decks of cards, paints, needlepoint and puzzle books.

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“I made a bag of non-digital activities to occupy my hands instead of the phone,” said Campbell, adding that the practice has significantly cut her screen time and filled her life with “creative and communal pursuits that don’t include doom-scrolling.”

“I created the analog bag after learning the only way to change a habit is to replace it with another,” she told Fox News Digital.

Social media users are trying the “analog bag” trend, replacing phones with offline activities like cameras, notebooks and magazines. (Fox News Digital)

The science of healthier habits

Research on habit formation supports the idea of the analog bag, according to Dr. Daniel Amen, a California-based psychiatrist and founder of Amen Clinics. 

“Your brain is a creature of habit,” Amen said during an interview with Fox News Digital. “Neurons that fire together wire together, meaning that every time you repeat a behavior, whether it’s good or bad, you strengthen the neural pathways that make it easier to do it again.”

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Studies show that habits are automatic responses to specific cues — such as boredom, stress or idle time — that typically deliver some kind of reward, according to the doctor. When no alternative behavior is available, people tend to fall back on the same routine, often without realizing it.

Research suggests that replacing an old habit with a new one tied to the same cue is more effective than trying to suppress the behavior altogether.

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“[When] cutting out coffee — you need to have another drink to grab for, not just quit cold turkey. It’s how the pathways in our brains work,” Campbell said.

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By substituting a different routine that still provides stimulation and engagement, people can gradually weaken the original habit and build a new automatic response.

Substituting another activity instead of scrolling on your phone can help quell the impulse to reach for it. (iStock)

“Simply stopping a behavior is very challenging,” Amen said. “Replacing one habit with something that is better for your brain is much easier. That’s how lasting change happens, one step at a time.”

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If alternatives are within arm’s reach, people will be more likely to use them, the doctor said. “Your brain does much better with small, simple actions than big, vague intentions.”

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Instead of saying, “I’ll stop scrolling today,” the doctor recommends choosing a small habit you can do in a few moments in specific situations, like knitting 10 rows of a scarf on your commute or reading a few pages of a book while waiting at the doctor’s office.

“If alternatives are within arm’s reach, you’re more likely to use them,” a brain doctor said. “Your brain does much better with small, simple actions than big, vague intentions.” (iStock)

Campbell shared her own examples of how to use an analog bag. At a coffee shop with friends, she said, she might pull out a crossword puzzle and ask others to help with answers when the conversation lulls.

Instead of taking dozens of photos on her phone, she uses an instant camera, which limits shots and encourages more intentional moments.

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In casual outdoor settings, such as a park or winery, she brings a small watercolor set for a quick creative outlet.

“It’s brought so much joy,” Campbell said of the analog bag trend, “seeing how it resonates with so many.”

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