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F.D.A. Reinstates Fired Medical Device, Food and Legal Staffers

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F.D.A. Reinstates Fired Medical Device, Food and Legal Staffers

The Food and Drug Administration has reinstated dozens of specialized employees involved in food safety, review of medical devices and other areas who were laid off last week, according to more than a dozen workers who got called back.

The total number of employees recalled was not immediately clear. But a person familiar with the conversations said nearly all of the roughly 180 medical division employees who had been let go would get their jobs back. More than a dozen workers across a handful of teams said that they had received a call or email reinstating their employment; some reported that up to a dozen others on their teams had also been brought back.

The F.D.A. and its parent agency, the Department of Health and Human Services, did not respond to requests for comment.

The workers had been fired as part of the Trump administration’s efforts, led by Elon Musk, to significantly downsize the federal government and cut costs. But the salaries of many of the fired F.D.A. staff members had been funded by fees companies pay the F.D.A., not taxpayer money.

Many of the reinstated jobs were financed by those kinds of fees, but some such employees were still out of work. Those whose job were funded by an excise tax on cigarettes, for example, said they were not called back to work over the weekend. Those workers reviewed applications for new tobacco products and studied the safety of emerging tobacco products, including e-cigarettes and devices that heat up tobacco but do not burn it.

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On Friday, The New York Times featured the accounts of laid-off staff members who reviewed the safety of surgical robots, cardiovascular devices and diabetes-care systems that infuse insulin. All had their jobs back as of Monday morning.

AdvaMed, a trade association for medical device makers, had pushed the administration in a letter and in meetings to ensure that workers who review those products got their jobs back. The industry’s funds have helped the device review division hire experts, including doctors with experience using the devices. The industry funds are approved periodically in agreements passed by Congress that also include strict deadlines to make approval decisions.

Reinstated workers, who spoke on the condition of anonymity because they feared retaliation, said about a dozen staffers from the agency’s chief counsel got their jobs back, including lawyers who supported medication policy. About a dozen who oversee cardiovascular devices and another 12 who authorize artificial intelligence software programs were also restored. Others were called back to their jobs assessing food-chemical safety, a priority of the new health secretary, Robert F. Kennedy Jr.

In interviews, employees who returned on Monday reported a feeling of whiplash and frustration, but also of relief to get back to work.

Dr. Robert Califf, F.D.A. commissioner during the Biden administration, called the staff cuts “anti-efficiency” because many recent hires had been recruited to fill knowledge gaps at the agency, including in artificial intelligence and food-chemical safety. He also said the cuts were made with no regard to well-being of workers.

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“It’s despicable to treat fellow human beings this way and a sign of immaturity of the people doing it,” he said in a text message on Monday.

The fired workers had uniformly been told that their performance was “not adequate to justify further employment by the agency.” Yet many of the dismissed workers — reinstated and not — said their performance reviews from the agency had been excellent.

Alice Callahan contributed reporting.

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Guava for Weight Loss Is a Real Thing—Here’s the Juicy Truth

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Guava for Weight Loss Is a Real Thing—Here’s the Juicy Truth


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How Guava for Weight Loss Melts Belly Fat Faster




















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Single workout cuts cravings, offering new hope for smokers trying to quit

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Single workout cuts cravings, offering new hope for smokers trying to quit

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If you’re trying to quit smoking, try a brisk walk or bike ride to curb your craving for a cigarette.

Researchers found that just one workout can reduce the urge to light up. But the type of exercise you do and how you do it makes a big difference.

High-intensity, aerobic exercise is most effective at reducing people’s cigarette cravings, a review of 59 randomized controlled trials involving more than 9,000 adults found.

FITNESS EXPERT REVEALS SIMPLE RULE TO GET IN SHAPE WITHOUT DREADING THE GYM: ‘JUST MOVE’

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“Single-bout exercise reduced acute cravings immediately and up to 30 minutes post-exercise, but not longer-term cravings,” the authors of the study, published in the Journal of Sport and Health Science, reported.

Aerobic exercise is the most effective form of exercise for reducing cravings for cigarettes, researchers found. (iStock)

The research team highlighted other key findings from their study of “exercise-based interventions for smoking cessation.”

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Exercise training made people between 15% and 21% more likely to abstain from smoking than those who didn’t exercise, the authors found.

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Researchers found that exercise curbs people’s cigarette cravings for up to 30 minutes after they stop exercising. (iStock)

Regular exercise also caused smokers to cut back by an average of two cigarettes per day.

In addition to being a free and accessible method for reducing smoking, exercise is also effective at reducing anxiety and stress, which drive many people to smoke.  

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The authors suggest that because exercise boosts feel-good hormones, such as dopamine, and reduces the stress hormone cortisol, smokers who work out feel less inclined to use nicotine as a brain reward.

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Exercise should be integrated into other smoking cessation programs to enhance quit success, the authors concluded.

Exercise releases similar feel-good brain chemicals that people get from cigarettes, researchers suggested. (iStock)

They also noted that none of the trials addressed vaping and recommended that future research target the use of electronic cigarettes.

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Hantavirus Vaccines and Treatments Are in the Pipeline

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Hantavirus Vaccines and Treatments Are in the Pipeline

The deadly hantavirus outbreak aboard the cruise ship MV Hondius has put the spotlight on a rare pathogen that typically attracts relatively little attention, even from scientists.

There are no targeted treatments for hantaviruses, which are typically carried by rodents, and no widely available vaccines. So when passengers began falling ill in the middle of the Atlantic Ocean, doctors and public health experts were limited in what they could offer.

“It’s kind of a wake-up call,” said Dr. Vaithi Arumugaswami, an infectious disease researcher at the University of California, Los Angeles. “Our tool kit is almost empty.”

That’s not for lack of trying. A handful of scientific teams around the world have been working — for decades, in some cases — to develop hantavirus treatments and vaccines. But it has not been easy to find funding or nurture commercial interest in medical interventions for a type of pathogen that does not infect humans often and does not spread easily between people.

“It’s not an airborne, highly contagious viral threat, so it hasn’t been as high a priority for groups trying to prevent pandemics,” said Jay Hooper, a virologist at the United States Army Medical Research Institute of Infectious Diseases.

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But there are promising vaccines and treatments in development. And some of them, experts said, could be moved through the pipeline rapidly if hantavirus interventions became a priority.

“I do think there are things that are sitting there on the bench that could be quickly developed,” said Dr. Ronald Nahass, the president of the Infectious Diseases Society of America. “But nothing is ready.”

There are two main types of hantaviruses: Old World viruses, which circulate primarily in Asia and Europe, and New World viruses, which are found in the Americas. The cruise ship outbreak has been linked to a New World virus known as the Andes virus, which is endemic to South America and is the only hantavirus known to spread between people.

There are vaccines that target some of the Old World viruses in Asia, but their efficacy is modest, experts said. And there are no licensed vaccines for the New World viruses, which include the Sin Nombre virus endemic to rodents in the western United States.

But there are some in development. Dr. Hooper and his colleagues have developed a DNA vaccine for the Andes virus, which proved promising in a small phase 1 trial. Under certain dosing regimens, the researchers found, more than 80 percent of participants produced neutralizing antibodies. “It’s pretty amazing,” said Dr. Hooper, who is an inventor on multiple hantavirus vaccine patents owned by the U.S. government. “Getting these kinds of neutralizing antibodies in humans is impressive.”

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There were drawbacks, including that the vaccine seemed to require at least three doses. But the vaccine is ready for further development “if there’s a need,” Dr. Hooper said. “We’ve done the science. It’s just other forces that are required to move vaccines forward — markets, government demand.”

Other teams have potential vaccines in earlier stages of development. For instance, Bryce Warner, a hantavirus researcher at the University of Saskatchewan, and his colleagues are exploring a variety of approaches, including a nasal vaccine that they hope might spark a more robust immune response in the airway.

But the research, which is being conducted in hamsters, is still in early stages, and hantavirus vaccine candidates can be challenging to move forward. Scientists lack good large-animal models for hantaviruses, Dr. Warner said, and human cases are rare enough to make trials tricky. “It’s very difficult to conduct a clinical trial when you only have a limited number of cases annually,” he said. “You don’t have the numbers of people to really show a robust effect.”

Currently, the primary treatment for hantavirus infection is supportive care, which may include supplemental oxygen or heart-lung bypass machines. Doctors also sometimes prescribe an existing antiviral drug, called ribavirin, but there is not strong evidence that it is effective for New World viruses, scientists said.

The hunt for new drugs is underway, though. At U.C.L.A., Dr. Arumugaswami and his colleagues found that favipiravir, an antiviral approved to treat influenza in Japan, inhibited the Andes virus in human cells. They also identified several compounds that had broad antiviral activity, blocking hantaviruses as well as other types of viruses, in human organoids, miniature clusters of tissue that mimic the function of organs.

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Other teams have been working to develop therapeutic antibody treatments, often working from blood samples collected from hantavirus survivors. “We were able to isolate the natural antibodies that people are making and basically winnow them down and find one that was really good,” said Kartik Chandran, a virologist at the Albert Einstein College of Medicine in New York. “We actually found several.”

When Dr. Chandran and his colleagues tested these antibodies in hamsters, one produced especially encouraging results: It seemed to work against both Old and New World hantaviruses and was effective even when given relatively late in the course of infection, Dr. Chandran said.

(Dr. Chandran is listed as an inventor on patents for hantavirus antibodies.)

Several other teams have also produced antibodies that were broadly effective in small animals, but that is where a number of potential products have stalled, experts said.

“We have a lead drug, and now what we need is someone to pay the money, which would be something like $40 million, to go the next step,” said Dr. James Crowe, director of the Vanderbilt Center for Antibody Therapeutics. “We have neither government nor foundation nor company support to do that. So we’re just waiting to find a partner.”

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(Vanderbilt University has applied for patents related to these antibodies; Dr. Crowe is listed as the inventor.)

Experts said that they hoped the current outbreak might help bring attention to a family of often-overlooked viruses.

“Certainly judging by just my inbox and text messages, there’s a renewed interest in these agents, and renewed interest in maybe at least revisiting where they are in the priority list,” Dr. Chandran said.

Whether that interest can be sustained after the virus fades from the headlines remains to be seen, experts acknowledged.

“Raising awareness never hurts,” Dr. Warner said. “We’ll see whether or not it leads to anything tangible, at least in terms of funding and resources for advancing some of these things that are lacking for hantavirus.”

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