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.
Prolonged fatigue could indicate poor sleep habits — but it could also be a lingering effect of mini-strokes.
That’s according to a new study from Aalborg University Hospital in Denmark, which was published this week in Neurology, the medical journal of the American Academy of Neurology (AAN).
A mini-stroke — medically known as a transient ischemic attack (TIA) — is a temporary blockage of blood flow to the brain that causes a “short period of symptoms,” according to Mayo Clinic.
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The study found that people who experience a TIA are more likely to report prolonged fatigue lasting up to one year.
“Patients with a presumed transient event reported fatigue at levels comparable to a stroke,” lead study author Birgitte Hede Ebbesen, PT, PhD, a physiotherapist at Aalborg University Hospital, told Fox News Digital.
A new study found that people who experience a mini-stroke are more likely to report prolonged fatigue lasting up to one year. (iStock)
The researchers followed 354 people averaging 70 years of age who had experienced a mini-stroke.
Over a 12-month period, the participants reported their level of fatigue in five areas: overall tiredness, physical tiredness, reduced activity, reduced motivation and mental fatigue, according to a university press release.
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On a scale ranging from 4 to 20 — with 20 being the most fatigued — the participants reported an average score of 12.3 in the two weeks after the mini-stroke, 11.9 at three months, 11.4 at six months and 11.1 at the one-year mark.
Two weeks after the mini-stroke, 61% reported high levels of fatigue. At three, six and 12 months, 54% said they experienced fatigue.
Two weeks after the mini-stroke, 61% reported high levels of fatigue. At three, six and 12 months, 54% said they experienced fatigue. (iStock)
Those who reported prolonged fatigue were twice as likely to have experienced anxiety and/or depression, the study found. Some also reported
“We had encountered fatigue among patients with TIA in clinical settings, so we knew it was there — but the frequency still surprised us,” Modrau told Fox News Digital.
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“Long-term fatigue was common in our group of study participants, and we found that if people experience fatigue within two weeks of leaving the hospital, it is likely they will continue to have fatigue for up to a year.”
Based on these findings, Modrau suggests that people diagnosed with a transient ischemic attack should be monitored for lingering fatigue in the ensuing weeks and months.
A mini-stroke — medically known as a transient ischemic attack (TIA) — is a temporary blockage of blood flow to the brain that causes a “short period of symptoms,” according to Mayo Clinic. (iStock)
“This could help us better understand who might struggle with fatigue long-term and require further care.”
The more commonly known symptoms of stroke include face drooping, arm weakness or slurred speech, which usually resolve within a day, according to Modrau. Some patients also reported long-term cognitive issues.
Causes of post-stroke fatigue
Bradley Serwer, an interventional cardiologist and chief medical officer at VitalSolution, an Ingenovis Health company that offers cardiovascular and anesthesiology services to hospitals nationwide, confirmed that fatigue is very common — and sometimes “debilitating” — following a stroke.
“Fatigue is multifactorial and can rarely be attributed to a single cause,” Serwer, who was not involved in the study, told Fox News Digital.
“Fatigue is multifactorial and can rarely be attributed to a single cause.”
The Maryland-based cardiologist shared the following potential reasons for fatigue following a mini-stroke.
Brain healing: “After a stroke, the brain tries to heal itself,” Serwer said. “This process causes the brain to work harder to ‘rewire’ itself, which results in a higher demand for energy. This often leaves patients feeling drained or fatigued.”
Increased inflammation: This can occur due to the immune response following a TIA.
Reduced levels of chemicals like serotonin, dopamine and norepinephrine can result in depression, fatigue or lack of motivation. (iStock)
Lower levels of neurotransmitters in the brain: Reduced levels of chemicals like serotonin, dopamine and norepinephrine can result in depression, fatigue or lack of motivation, according to Serwer.
Sleep disturbances: “These are very common after a stroke and can lead to significant sleep deprivation,” the cardiologist said.
Medications: Drugs used to treat strokes may have adverse side effects, including fatigue. “Betablockers are excellent blood pressure medications and are often prescribed after a stroke or heart attack, but they may cause notable fatigue,” Serwer noted.
Other factors: “Simple tasks may require more mental effort than before the injury,” the cardiologist said. “Depression or anxiety after a stroke can also be a confounding predictor of fatigue.”
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Potential limitations
The study did have some limitations, the researchers noted.
“It is an observational study and therefore we cannot determine causality,” Modrau said.
“Results are based on self-reported questionnaires, and we cannot be certain that relatives didn’t help fill them out or influence results.”
Drugs used to treat strokes may have adverse side effects, including fatigue. (iStock)
The researchers also did not have information on pre-TIA fatigue levels, although previous studies suggested that it was “much more frequent” after mini-strokes.
Looking ahead, Modrau said she hopes healthcare providers begin to acknowledge lasting fatigue after TIA and provide care pathways for these patients.
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“Up until now, patients with lasting challenges after TIA have been left alone in many cases,” she told Fox News Digital.
“We as a society should start to acknowledge their difficulties instead of viewing them as ‘the lucky ones,’” she continued. “My aim with this study has been to give these patients a voice – and to start to listen to their struggles.”
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Weight-loss medications known as glucagon-like peptide-1 (GLP-1) agonists, which have gained popularity for treating type 2 diabetes and obesity, have been shown to have the surprising secondary benefit of reducing alcohol intake.
A team of international researchers from Ireland and Saudi Arabia followed 262 adult patients with obesity who started taking two GLP-1 medications: liraglutide or semaglutide.
Among the regular drinkers, weekly alcohol intake decreased by 68%, from approximately 23 units of alcohol to around 8 units.
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The findings were recently published in the journal Diabetes, Obesity and Metabolism and were also presented last week at the European Congress on Obesity in Spain.
GLP-1 agonists mimic a hormone called GLP-1, which is released from the gastrointestinal system after eating, according to study co-author Carel Le Roux, a professor at University College Dublin.
Weight-loss medications known as glucagon-like peptide-1 (GLP-1) agonists have been shown to have the surprising secondary benefit of reducing alcohol intake. (iStock)
These medications activate GLP-1 receptors in the brain, decreasing the sense of “reward” people feel after eating or drinking, eventually leading to reduced cravings for both food and alcohol, he told Fox News Digital.
“It is this commonality of function that suggests the GLP-1 receptors in the brain may be a therapeutic target for not just the disease of obesity, but also for alcohol use disorder,” the professor said.
Study findings
Before the participants started the weight-loss drugs, they self-reported their weekly alcohol intake, then were categorized as non-drinkers, rare drinkers or regular drinkers.
Approximately 72% had at least two follow-up visits and 68% reported regular alcohol consumption.
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After starting the weight-loss medications, the participants’ weekly average alcohol intake decreased by almost two-thirds overall — from approximately 11 units of alcohol to four units after four months of treatment with the GLP-1 agonists.
The reduction in alcohol use was comparable to the decrease that can be achieved by nalmefene, a drug that decreases the “buzz” feeling in people with alcohol use disorder in Europe, according to the researchers.
Among the regular drinkers, weekly alcohol intake decreased by 68%, from approximately 23 units of alcohol to around 8 units. (iStock)
For the 188 patients who were followed over an average of four months, none had increased their alcohol intake after starting the weight-loss medications.
Patients reported that after an evening meal, they were too full to have their usual drink — and when they did drink, they reported becoming full extremely quickly and drinking at a slower pace, Le Roux noted.
“The findings in this study suggest that we may have just found a therapeutic target for alcohol use disorder.”
This suggests that the experience was less enjoyable, partly due to the reduced rate of alcohol absorption.
Some patients also reported that they didn’t enjoy the flavor of the alcoholic beverages as much, and also that hangovers were much worse.
All of these experiences showed that the weight-loss medications create “guard rails” that prevent most patients from drinking excessively, giving them a degree of control over their alcohol intake, according to Le Roux.
After starting the weight-loss medications, the participants’ weekly average alcohol intake decreased by almost two-thirds overall. (iStock)
“The findings in this study suggest that we may have just found a therapeutic target for alcohol use disorder — the GLP-1 receptor,” the professor told Fox News Digital.
“This finding potentially opens the possibility of an entirely new pharmacological treatment paradigm, which could be used in conjunction with conventional methods, such as behavior therapy and group support.”
Potential limitations
The study was limited by its relatively small number of patients, the researchers acknowledged.
Also, the researchers were not able to verify the participants’ self-reported alcohol intake, and roughly one-third of them were not available for follow-up.
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There was also no control group, which means the researchers couldn’t prove that taking weight-loss medication reduces alcohol intake.
The main advantage of GLP-1 agonists is that they only need to be taken once a week and continue to work for the entire week. (iStock)
“Randomized, controlled trials with diverse patient populations — including patients diagnosed with alcohol use disorder — are needed to provide the quality and quantity of data that could be used to support an application for licensing the medication for the treatment of alcohol use disorder,” Le Roux said.
(One such trial is currently underway in Denmark.)
Study implications
With the current medications available to treat alcohol use disorder, the “major problem” is compliance, Le Roux said — “because the cravings for alcohol tend to come in waves.”
“This means a patient might be fully committed to treatment at one point in the week, but then stop taking the medication later in the week when a craving comes,” the professor added.
“This research suggests a promising ancillary benefit of GLP-1 analogs, potentially influencing cravings for alcohol and offering a new avenue for managing alcohol use disorder,” a physician said. (iStock)
There are currently three FDA-approved medications to treat alcohol use disorder: naltrexone (which helps decrease cravings by reducing the “buzz” feeling that comes with drinking alcohol); disulfiram (which helps some people avoid alcohol by making them feel sick when they drink), and acamprosate (which restores the balance of hormones in the brain to reduce cravings), according to the National Institute on Alcohol Abuse and Alcoholism.
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But less than 10% of people with alcohol use disorder get the proper treatment, with many resuming use within the first year of treatment, past research shows.
The main advantage of the GLP-1 agonists is that they only need to be taken once a week and continue to work for the entire week.
For the 188 patients who were followed over an average of four months, none had increased their alcohol intake after starting the weight-loss medications. (iStock)
Outside experts say the study’s findings highlight the potential of weight-loss medications to help treat alcohol use disorder.
“This research suggests a promising ancillary benefit of GLP-1 analogs, potentially influencing cravings for alcohol and offering a new avenue for managing alcohol use disorder,” Dr. Fatima Cody Stanford, obesity medicine physician at Massachusetts General Hospital and Harvard Medical School, who was not part of the study, told Fox News Digital.
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“While the exact mechanisms are still being explored, the findings contribute to our understanding of the broader benefits of GLP-1 analogs beyond obesity treatment,” Stanford added.
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