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U.S. Tightens Rules on Risky Virus Research
  + stars: | 2024-05-07 | by ( Carl Zimmer | Benjamin Mueller | ) www.nytimes.com   time to read: +1 min
The White House has unveiled tighter rules for research on potentially dangerous microbes and toxins, in an effort to stave off laboratory accidents that could unleash a pandemic. The new policy, published Monday evening, arrives after years of deliberations by an expert panel and a charged public debate over whether Covid arose from an animal market or a laboratory in China. But others warned against creating restrictive rules that would stifle valuable research without making people safer. The debate grew sharper during the pandemic, as politicians raised questions about the origin of Covid. Those who suggested it came from a lab raised concerns about studies that tweaked pathogens to make them more dangerous — sometimes known as “gain of function” research.
Locations: China
Federal regulators on Friday said that they had not yet discovered live bird flu virus in the first batch of retail milk samples they tested, a reassuring indication that the milk on store shelves remains safe despite an outbreak of the virus among diary cows. In an online update, the Food and Drug Administration said an initial set of tests looking for live virus, not just genetic fragments, suggested that the pasteurization process was effectively neutralizing the pathogen. “These results reaffirm our assessment that the commercial milk supply is safe,” the F.D.A. wrote in the update, adding that the testing efforts were ongoing. Officials also tested infant and toddler formula, which incorporate powdered dairy, and did not find the virus, the agency wrote.
Organizations: Food and Drug Administration, Officials
The Biden administration on Wednesday said that it would begin requiring dairy cows moving across state lines to be tested for bird flu, which has been spreading in herds for months. The new policy is part of a growing effort to stamp out the spread of a virus that federal health officials have sought to reassure Americans poses little risk to people so far. The new order, issued by the Department of Agriculture, says that lactating cows must test negative for influenza A viruses, a class that includes bird flu, before they are transported. The owners of herds with positive tests will need to provide data on the movements of the cattle to help investigators trace the disease. Since a highly contagious form of bird flu was detected in the United States in 2022, federal officials have sought to reassure Americans that the threat to the public remained low, even as the virus infected a growing number of mammals.
Persons: Biden, ” Mike Watson Organizations: Department of Agriculture, of Agriculture Locations: United States
The New York attorney general on Thursday urged the Food and Drug Administration to “take immediate action” and renew alerts to doctors and patients about the dangerous effects of Singulair for children, saying that the current warnings about the drug’s psychiatric side effects were not sufficient. In a letter, the attorney general, Letitia James, also called on the federal agency to consider discouraging the prescription of Singulair, an asthma and allergy drug, to children. Thousands of patients and parents have complained to the F.D.A. about symptoms of anxiety, rage, hallucinations and other psychiatric problems that they linked to the drug, which is also known in its generic form as montelukast. in 2020 to order its most stringent warning on instructions for the drug’s usage.
Persons: Letitia James Organizations: New, Food and Drug Administration, New York Times Locations: New York
The stomach cancer study was shot through with suspicious data. Photos of tumor-stricken mice, used to show that a drug reduced cancer growth, had been featured in two previous papers describing other treatments. The study was then wiped from the internet, leaving behind a barren web page that said nothing about the reasons for its removal. As it turned out, the flawed study was part of a pattern. A medical journal retracted one of them this month after inquiries from The New York Times.
Persons: Dr, Sam S, Yoon, Organizations: Columbia, New York Times Locations: British
How can children be exposed? It is not clear how the children at the Bronx day care might have come into contact with any drugs. But nearly all cases of children being exposed to opioids involved their ingesting the drug, a study published in The Journal of Pediatrics in 2019 found. The study looked at more than 80,000 records of children under 18 who had been exposed to drugs containing an opioid over a five-year period. The study found that roughly 99 percent of the exposures involved children orally ingesting it.
Persons: Narcan, Dr, Sharon Levy, Levy Organizations: Boston Children’s, Pediatrics Locations: Boston
A four-line letter, signed by the attending physician of Congress and released by Senator Mitch McConnell on Thursday, suggested that his recent spells of speechlessness were linked to “occasional lightheadedness” perhaps brought on by his recovery from a concussion last winter or “dehydration.”But seven neurologists, relying on what they described as unusually revealing video of Mr. McConnell freezing up in public twice recently, said in interviews Thursday and Friday that the episodes captured in real time likely pointed to more serious medical problems afflicting the longtime Republican leader. Some of the neurologists, while cautioning that they could not diagnose the minority leader from afar, said that the letter and other comments from Mr. McConnell’s office appeared to fall short of explaining why he abruptly stopped speaking during news conferences in late July and again on Wednesday. “If I gave that tape to a medical student and that was his explanation, I’d fail him,” said Dr. Orrin Devinsky, a professor of neurology at the NYU Grossman School of Medicine, referring to the account given by the attending physician of Congress on Thursday. “Medically, these episodes need to be taken seriously.”
Persons: Mitch McConnell, McConnell, , Orrin Devinsky, Organizations: Republican, NYU Grossman School of Medicine
Representative Steve Scalise, Republican of Louisiana and the majority leader, said Tuesday he had been diagnosed with a rare form of blood cancer, but planned to return to Washington to continue working as he undergoes treatment over the next several months. Mr. Scalise, 57, said in a statement that he had begun treatment for multiple myeloma, which he described as “a very treatable blood cancer,” after feeling ill over the August congressional recess and having tests that led to his diagnosis. “I am incredibly grateful we were able to detect this early and that this cancer is treatable,” Mr. Scalise said in a statement. “I will tackle this with the same strength and energy as I have tackled past challenges.”Mr. Scalise was gravely wounded in 2017 when a gunman opened fire on members of the Republican congressional baseball team at a practice field in Alexandria, Va. Mr. Scalise was shot in the hip and underwent many surgeries to relearn how to walk.
Persons: Steve Scalise, Scalise, Mr, , ” Mr Organizations: Republican Locations: Louisiana, Washington, Alexandria, Va
One of the leading new obesity drugs, Wegovy, eased symptoms and raised the quality of life of patients with obesity and a common type of heart failure, a study funded by the drug’s maker found, adding to the evidence that the medications can produce health benefits beyond weight loss. The condition accounts for roughly half of all heart failure cases. Patients given Wegovy in the trial showed greater improvements in physical fitness and in symptoms like fatigue and shortness of breath than those administered a placebo. The study, which included 529 participants and lasted for a year, was not designed to assess cardiac emergencies, but it found that 12 patients on the placebo and only one on Wegovy were hospitalized or required an urgent medical visit for heart failure. The drug showed more pronounced relief of heart failure symptoms than other treatments, the study said.
Persons: Wegovy Organizations: The New England, of Medicine Locations: The
A new obesity drug, Wegovy, slashed the risk of serious heart problems by 20 percent in a large trial, the drug’s maker said on Tuesday, a finding that could put pressure on insurers to cover the in-demand treatment. The trial — the first to demonstrate that one of the new class of obesity drugs could also shore up patients’ heart health — reinforced the scientific consensus that obesity brings with it medical risks like heart attacks and strokes. And it bolstered the idea that those obesity drugs can deliver long-term health benefits in addition to helping patients lose weight. The drug’s maker, Novo Nordisk, reported only its top-line findings from the trial on Tuesday and not details about how Wegovy affected the risk of individual cardiovascular complications or patients’ weight. The data has not yet been published in a peer-reviewed journal.
Organizations: Novo Nordisk
Marc Tessier-Lavigne, a renowned neuroscientist, announced on Wednesday that he would step down from his position as president of Stanford University, after the release of an external review of his scientific work found fault with several high-profile journal articles published under his purview. A committee drafted the review in response to allegations that Dr. Tessier-Lavigne was involved in scientific misconduct. In its report, which focused on 12 academic papers, the committee said there was no evidence that Dr. Tessier-Lavigne had knowingly falsified data or withheld such information from the public. In response, Dr. Tessier-Lavigne vowed to retract three of the five articles, request major corrections for two and step down from his position as president. “I am gratified that the panel concluded I did not engage in any fraud or falsification of scientific data,” Dr. Tessier-Lavigne said in a statement, adding: “Although I was unaware of these issues, I want to be clear that I take responsibility for the work of my lab members.”
Persons: Marc Tessier, Lavigne, Tessier, Randy Schekman, Shirley Tilghman, Dr . Tessier, . Tessier, , Dr, Organizations: Stanford University, Physiology, Princeton University
The vaccine, the company said, may not have gone through advanced enough testing to qualify for the new pot of U.S. funding. Federal officials, some of whom have become concerned about the leadership of the next-generation vaccine program, acknowledged that key questions remain about how the program will operate and how quickly it can deliver. Although some Biden administration officials hope to roll out new vaccine technology by fall 2024, many scientists believe doses are at least several years away. “There’s not the money, there’s not the infrastructure, there’s not the support,” John Moore, a virologist at Weill Cornell Medicine, said of the push for improved vaccines. “So I’m not expecting any next-generation major things in the near future.”
Persons: “ There’s, there’s, ” John Moore, I’m, Organizations: Biden, Weill Cornell Medicine Locations: Pennsylvania, India
When Jeffrey Vlk played running back in high school in the 1990s and then safety in college, he took and delivered countless tackles during full-contact football practices. So, starting in 2019, Vlk eliminated full-contact practices. Players wore shoulder pads once a week, on Wednesday, which he called contact day. That’s when they hit tackle bags and crash pads, and wrapped up teammates but did not throw them to the ground. Vlk said no starting player had been injured at his practices in four years.
Persons: Jeffrey Vlk, Vlk Organizations: Buffalo Grove High School Locations: Chicago
What to Know About Post-Shingles Encephalitis
  + stars: | 2023-05-18 | by ( Benjamin Mueller | ) www.nytimes.com   time to read: +1 min
Dianne Feinstein, a Democratic senator from California, returned to the Capitol last week after spending more than two months recovering from shingles. For Ms. Feinstein, 89, the virus also brought on a previously unreported case of encephalitis, a rare but potentially debilitating complication in which the brain swells. Post-shingles encephalitis can cause headache, fever, sensitivity to light, vomiting, confusion, a stiff neck or even seizures. Those include memory or language trouble, sleep disorders, mood disorders, walking difficulty and other cognitive problems. Older patients tend to have the most trouble recovering.
Five years ago, a small group of cancer scientists meeting at a restaurant in a deconsecrated church hospital in Mainz, Germany, drew up an audacious plan: They would test their novel cancer vaccine against one of the most virulent forms of the disease, a cancer notorious for roaring back even in patients whose tumors had been removed. The vaccine might not stop those relapses, some of the scientists figured. And the speed with which the disease, pancreatic cancer, often recurred could work to the scientists’ advantage: For better or worse, they would find out soon whether the vaccine helped. The vaccine provoked an immune response in half of the patients treated, and those people showed no relapse of their cancer during the course of the study, a finding that outside experts described as extremely promising. The study, published in Nature, was a landmark in the yearslong movement to make cancer vaccines tailored to the tumors of individual patients.
“I don’t think the Bloom paper changes my thinking that much.”Chinese researchers wrote about the market data last year and then made the genetic sequences available this year, allowing a team of international scientists to study them. That team wrote in a report last month that based on the data, they could not conclusively identify an animal that had passed the virus to people. Many of the earliest Covid-19 patients also worked or shopped at the market. They said the genetic data also built on other evidence, including that two early lineages of the virus had been at the market. Dr. Bloom investigated whether the amount of genetic material from the virus correlated with the amount of genetic material from susceptible animal species in the samples.
The study was cited in health warnings around the world and appeared to be a model of international collaboration in a moment of crisis. Within days, though, the researchers quietly withdrew the paper, which was replaced online by a message telling scientists not to cite it. A few observers took note of the peculiar move, but the whole episode quickly faded amid the frenzy of the coronavirus pandemic. Instead, it was withdrawn at the direction of Chinese health officials amid a crackdown on science. That effort kicked up a cloud of dust around the dates of early Covid cases, like those reported in the study.
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