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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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GLP-1 Drugs Linked to Osteoporosis and Gout: Here’s How To Stay Safe

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GLP-1 Drugs Linked to Osteoporosis and Gout: Here’s How To Stay Safe


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Ozempic-style drugs could slash complication risks after heart attacks, research suggests

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Ozempic-style drugs could slash complication risks after heart attacks, research suggests

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A popular class of weight-loss drugs may prevent life-threatening cardiac complications by opening microscopic blood vessels that often remain blocked after a heart attack, according to a study published this week in Nature Communications.

The research, led by the University of Bristol and University College London, identified a biological brain-gut-heart signaling pathway. 

This discovery appears to explain how GLP-1 drugs — which mimic glucagon-like peptide-1, a hormone that helps regulate blood sugar and appetite — protect heart tissue from a condition known as “no-reflow.”

“In nearly half of all heart attack patients, tiny blood vessels within the heart muscle remain narrowed, even after the main artery is cleared during emergency medical treatment,” Dr. Svetlana Mastitskaya, the study’s lead author and a senior lecturer at Bristol Medical School, said in a press release.

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“This results in a complication known as ‘no-reflow,’ where blood is unable to reach certain parts of the heart tissue.”

In nearly half of all heart attack patients, tiny capillaries (blood vessels) remain narrowed even after the main blocked artery is cleared. (iStock)

This lack of blood flow increases the risk of heart failure and death within a year. GLP-1 medications could prevent this, according to the researchers.

How it works

When the GLP-1 hormone is released in the gut or administered as a drug, it sends a signal to the brain, which then sends a signal to the heart that switches on special potassium channels in tiny cells called pericytes.

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When these channels open, the pericytes relax, which allows the small blood vessels (capillaries) to widen and improve blood flow to the heart muscle, the researchers noted.

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The new study used animal models and cellular imaging to track how GLP-1 interacts with heart tissue. When the researchers removed the potassium channels, the drugs no longer protected the heart — confirming they play a key role.

The findings suggest that existing GLP-1 medications, already used for type 2 diabetes and obesity, could be repurposed as emergency treatments. (iStock)

The findings suggest that existing GLP-1 medications, already used for type 2 diabetes and obesity, could be repurposed as emergency treatments during or immediately after a heart attack to reduce tissue damage.

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The researchers noted several limitations, including that the study relied on animal models.

Clinical trials are necessary to determine whether the brain-gut-heart pathway operates with the same timing and efficacy in humans.

While the study highlights the drug’s immediate benefits during a heart attack, it des not establish whether long-term use of these drugs provides a pre-existing level of protection. (iStock)

Additionally, while the study highlights the drug’s immediate benefits during a heart attack, it does not establish whether long-term use of the medication provides a pre-existing level of protection.

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The research was primarily funded by the British Heart Foundation.

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Do collagen supplements really improve skin? Major review reveals the truth

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Do collagen supplements really improve skin? Major review reveals the truth

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Collagen supplements have exploded in popularity, touted as everything from an anti-aging miracle to a muscle recovery booster.

But a sweeping new review conducted by U.K. researchers suggests that while collagen may help improve skin elasticity and ease arthritis pain, it does little for athletic performance or wrinkle reduction.

Researchers from Anglia Ruskin University analyzed 16 systematic reviews and 113 randomized controlled trials involving nearly 8,000 participants worldwide, which they say is the most extensive evaluation of collagen’s health effects to date. 

The review found consistent evidence that collagen supplementation improves skin elasticity and hydration over time and provides significant relief from osteoarthritis-related joint pain and stiffness, according to findings published in Aesthetic Surgery Journal Open Forum. 

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A large U.K. review found that collagen supplements may improve skin elasticity and hydration over time. (iStock)

The researchers, however, did not find meaningful improvements in post-exercise muscle recovery, soreness or tendon mechanical properties (strength, springiness and stretch resistance).

“Collagen is not a cure-all, but it does have credible benefits when used consistently over time, particularly for skin and osteoarthritis,” co-author Lee Smith, professor of public health at Anglia Ruskin University, said in a statement.

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“Our findings show clear benefits in key areas of healthy aging, while also dispelling some of the myths surrounding its use,” Smith added.

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Collagen, the most abundant protein in the body, supports skin, bones, tendons, cartilage and connective tissue, according to experts. Natural collagen production begins to drop in early adulthood and declines more sharply with age.

The study found that collagen supplements may help reduce joint pain and stiffness in people with osteoarthritis. (iStock)

The review found that long-term collagen supplementation was linked to improved skin firmness and hydration, but did not help skin roughness — a proxy for visible wrinkles. 

Benefits appear to accumulate gradually, suggesting that collagen should not be viewed as an “anti-wrinkle ‘quick fix,’ but as a foundational dermal support for individuals seeking holistic skin maintenance,” the researchers said.

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“If we define anti-aging as a product or technique designed to prevent the appearance of getting older, then I believe our findings do support this claim for some parameters,” Smith told the BBC. “For example, an improvement in skin tone and moisture is associated with a more youthful-looking appearance.”

Collagen supplementation was linked to reduced pain and stiffness in people with osteoarthritis, with stronger benefits seen over longer periods of use, and showed modest improvements in muscle mass and tendon structure that may support healthy aging. 

Collagen did not significantly improve skin roughness, a marker of visible wrinkles. (iStock)

However, it did not show meaningful results when used as a fast-acting sports performance supplement, and evidence for benefits related to cholesterol, blood sugar, blood pressure and oral health was mixed or inconclusive.

Dr. Daniel Ghiyam, a California-based physician and longevity specialist, said the findings align with what he sees in clinical practice.

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“Collagen is a targeted support tool, not a foundation of health or performance,” Ghiyam, who was not involved in the study, told Fox News Digital. “When marketed that way, it makes sense. When marketed as a cure-all, it doesn’t hold up to the data.”

The authors noted that while many previous collagen studies have received financial support from the supplement industry, the current review did not receive industry funding.

Experts say collagen supplements may offer modest benefits for skin hydration and joint comfort, but they are not a cure-all. (iStock)

The team called for more high-quality clinical trials examining long-term outcomes, optimal dosages and differences between collagen sources, such as marine, bovine and plant-based alternatives. 

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Among its limitations, the review could not determine whether certain forms of collagen work better than others or what the optimal regimen should be. 

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While the review included randomized controlled trials, the quality of the studies varied, with newer research generally showing stronger results.

Experts say more data and studies are needed to build on the findings. They also noted that diet plays a crucial role in skin health.

Collagen supplements, often sold as powders or pills, may improve skin elasticity and ease joint pain, experts say. (iStock)

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Dr. Erum Ilyas, a Pennsylvania-based dermatologist and chair of dermatology at Drexel University College of Medicine, noted that the review analyzed previously published meta-analyses rather than generating new primary data.

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“At this time, I have not seen sufficiently strong independent evidence to routinely recommend collagen supplements to my patients,” Ilyas, who was not involved in the review, told Fox News Digital.

“Although some studies show modest improvements in markers such as hydration and elasticity, there remains limited independent, biopsy-confirmed evidence demonstrating sustained increases in dermal collagen content,” she added.

Fox News Digital has reached out to the researchers for comment.

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