Health
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.
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.”
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.
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.
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.
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.
“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.
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.
“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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Health
Alzheimer’s prevention breakthrough found in decades-old seizure drug
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A drug that has long been used to treat seizures has shown promise as a potential means of Alzheimer’s prevention, a new study suggests.
The anti-seizure medication, levetiracetam, was first approved by the FDA in November 1999 under the brand name Keppra as a therapy for partial-onset seizures in adults. The approval has since expanded to include children and other types of seizures.
Northwestern University researchers recently found that levetiracetam prevented the formation of toxic amyloid beta peptides, which are small protein fragments in the brain that are commonly seen in Alzheimer’s patients.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons, according to the study findings, which were published in Science Translational Medicine.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons. (iStock)
“While many of the Alzheimer’s drugs currently on the market, such as lecanemab and donanemab, are approved to clear existing amyloid plaques, we’ve identified this mechanism that prevents the production of the amyloid‑beta 42 peptides and amyloid plaques,” said corresponding author Jeffrey Savas, associate professor of behavioral neurology at Northwestern University Feinberg School of Medicine, in a press release.
“Our new results uncovered new biology while also opening doors for new drug targets.”
HIDDEN BRAIN CONDITION MAY QUADRUPLE DEMENTIA RISK IN OLDER ADULTS, STUDY SUGGESTS
The brain is better able to avoid the pathway that produces toxic amyloid‑beta 42 proteins in younger years, but the aging process gradually weakens that ability, Savas noted.
“This is not a statement of disease; this is just a part of aging. But in brains developing Alzheimer’s, too many neurons go astray, and that’s when you get amyloid-beta 42 production,” he said.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease. (iStock)
That then leads to tau (“tangles”) — abnormal clumps of protein inside brain neurons — which can kill brain cells, trigger neuroinflammation and lead to dementia.
In order for levetiracetam to function as an Alzheimer’s blocker, high-risk patients would have to start taking it “very, very early,” Savas said — up to 20 years before elevated amyloid-beta 42 levels would be detected.
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“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death,” the researcher noted.
The researchers also did a deep dive into previous human clinical data to determine whether Alzheimer’s patients who were taking the anti-seizure drug had slower cognitive decline. They reported that the patients in that category had a “significant delay” in the span from cognitive decline to death compared to those not taking the drug.
“This analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” the researcher said. (iStock)
“Although the magnitude of change was small (on the scale of a few years), this analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” Savas said.
Looking ahead, the research team aims to find people who have genetic forms of Alzheimer’s to participate in testing, Savas said.
Limitations and caveats
The study had several limitations, including that it relied on animal models and cultured cells, with no human trials conducted.
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Because the study was observational in nature, it can’t prove that the medication caused the prevention of the toxic brain proteins, the researchers acknowledged.
Savas noted that levetiracetam “is not perfect,” cautioning that it breaks down in the body very quickly.
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The team is currently working to create a “better version” that would last longer in the body and “better target the mechanism that prevents the production of the plaques.”
“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death.”
The medication’s common documented side effects include drowsiness, weakness, dizziness, irritability, headache, loss of appetite and nasal congestion.
It has also been linked to potential mood and behavior changes, including anxiety, depression, agitation and aggression, according to the prescribing information. In rare cases, it could lead to severe allergic reactions, skin reactions, blood disorders and suicidal ideation.
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Funding for the study was provided by the National Institutes of Health and the Cure Alzheimer’s Fund.
Fox News Digital reached out to the drug manufacturer and the researchers for comment.
Health
Seniors over 80 who eat specific diet may be less likely to reach 100 years old
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Older adults who avoid meat in their golden years may be less likely to reach age 100 than their meat-eating counterparts, new research suggests.
Researchers tracked more than 5,000 adults aged 80 or older who were enrolled in the Chinese Longitudinal Healthy Longevity Survey.
Between 1998 and 2018, data showed that those who did not eat meat were less likely to reach their 100th birthday than those who consumed animal products regularly.
The findings seem to contradict previous studies that have linked vegetarianism and plant-based diets to lower risks of heart disease, stroke, diabetes and obesity.
Most evidence supporting the benefits of plant-based diets comes from studies tracking younger populations, the researchers noted.
The findings contrast with previous research praising plant-based diets for their positive influence on heart health. (iStock)
The study, published in The American Journal of Clinical Nutrition, points to losses in muscle mass and bone density with age, shifts that can increase the risk of malnutrition and frailty in the “oldest old.”
As people enter their 80s and 90s, the nutritional priority often shifts from preventing long-term chronic diseases to maintaining day-to-day physical function, experts say.
HOW MUCH RED MEAT IS TOO MUCH? EXPERTS WEIGH IN ON FOOD PYRAMID UPDATES
“The headline ‘vegetarians over 80 less likely to reach 100’ sounds surprising, because it contrasts with decades of data linking plant‑forward diets to lower chronic disease risk earlier in life,” Erin Palinski-Wade, a New Jersey-based registered dietitian, told Fox News Digital.
“However, once you see that this research is limited to adults over the age of 80 who are also underweight — and that this link disappears with the consumption of eggs, dairy and fish — the results are less surprising.”
While diets earlier in life tend to emphasize avoiding long-term disease, older age necessitates nutrients and weight maintenance, experts say. (iStock)
In those over 80, restricting animal proteins may be less likely to promote longevity, according to Palinski-Wade, who was not involved in the study.
Eliminating all animal protein — particularly in a population that may already experience diminished hunger cues — can make it more difficult to meet adequate protein needs, potentially increasing the risk of nutrient deficiencies, the nutritionist said.
ALZHEIMER’S SYMPTOMS COULD BE PREDICTED YEARS IN ADVANCE THROUGH ONE SIMPLE TEST
In addition to a higher tendency to be underweight, older populations also face a greater risk of bone fractures due to lower calcium and protein intake.
Potential limitations
The lower rate of vegetarians reaching 100 was only observed in participants identified as underweight, the researchers noted. No such association was found in people who maintained a healthy weight.
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Because being underweight is already linked to greater frailty and mortality risk, the researchers noted that body weight may partly explain the findings, making it difficult to determine whether diet itself played a direct role.
Those incorporating animal-sourced products other than meat were just as likely to live to 100. (iStock)
Additionally, the shortened lifespans were not found in people who continued to eat non-meat animal products, such as fish, dairy and eggs.
Older adults with these more flexible diets were just as likely to live to 100 as those eating meat, as these foods may provide the nutrients necessary for maintaining muscle and bone health, the researchers noted.
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“This is an observational study, so it can only show associations, and does not prove that avoiding meat directly reduces the odds of reaching 100,” Palinski-Wade added.
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The researchers suggested that including small amounts of animal-sourced foods could help older seniors maintain essential nutrients and avoid the muscle loss often seen in those who stick strictly to plants.
Eliminating all animal protein — particularly in a population that may already experience diminished hunger cues — can make it more difficult to meet adequate protein needs, potentially increasing the risk of nutrient deficiencies. (iStock)
Palinski-Wade offered some guidance for those looking to optimize nutrition later in life.
“For adults in their 80s and beyond, especially anyone losing weight or muscle, the priority should be maintaining a healthy weight and meeting protein and micronutrient needs — even if that means adding or increasing fish, eggs, dairy or well‑planned, fortified plant proteins and supplements.”
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Strict vegan or very low‑protein patterns at that age should be carefully monitored by a dietitian or clinician, with attention to B12, vitamin D, calcium and total protein, according to Palinski-Wade.
“Younger and healthier adults can still confidently use plant‑forward or vegetarian patterns to lower long‑term chronic disease risk,” she added.
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