Tag Archives: Pharmaceuticals

Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy | Vertex Pharmaceuticals Newsroom – news.vrtx.com

  1. Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy | Vertex Pharmaceuticals Newsroom news.vrtx.com
  2. Vertex shares pop after nonopioid painkiller posts positive midstage trial results CNBC
  3. Vertex Pharmaceuticals Jumps on Pain Medication Success: How to Play It RealMoney
  4. Vertex Rallies, Flashes Bullish Signal On Phase 2 Results For Opioid Alternative Investor’s Business Daily
  5. Vertex passes neuropathic pain test, teeing up pivotal trials in pursuit of blockbuster opportunity FierceBiotech

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Recursion Pharmaceuticals soars 121% after Nvidia invests $50 million in the biotech for AI drug discovery – Yahoo Finance

  1. Recursion Pharmaceuticals soars 121% after Nvidia invests $50 million in the biotech for AI drug discovery Yahoo Finance
  2. RXRX Stock Launches Into Stratosphere On $50 Million Nvidia Investment Investor’s Business Daily
  3. Nvidia invests $50 million in biotech company Recursion for A.I. drug discovery CNBC
  4. Recursion CEO Chris Gibson: There’s real opportunity to leverage A.I. to speed up drug development CNBC Television
  5. The A.I. mania is so red hot that a small $50 million investment from Nvidia sent an obscure biotech firm’s shares up a record 78% Fortune
  6. View Full Coverage on Google News

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Weight loss surgery extends lives, study finds



CNN
 — 

Weight loss surgery reduces the risk of premature death, especially from such obesity-related conditions as cancer, diabetes and heart disease, according to a new 40-year study of nearly 22,000 people who had bariatric surgery in Utah.

Compared with those of similar weight, people who underwent one of four types of weight loss surgery were 16% less likely to die from any cause, the study found. The drop in deaths from diseases triggered by obesity, such as heart disease, cancer and diabetes, was even more dramatic.

“Deaths from cardiovascular disease decreased by 29%, while deaths from various cancers decreased by 43%, which is pretty impressive,” said lead author Ted Adams, an adjunct associate professor in nutrition and integrative physiology at the University of Utah’s School of Medicine.

“There was also a huge percentage drop — a 72% decline — in deaths related to diabetes in people who had surgery compared to those who did not,” he said. One significant downside: The study also found younger people who had the surgery were at higher risk for suicide.

The study, published Wednesday in the journal Obesity, reinforces similar findings from earlier research, including a 10-year study in Sweden that found significant reductions in premature deaths, said Dr. Eduardo Grunvald, a professor of medicine and medical director of the weight management program at the University of California San Diego Health.

The Swedish study also found a significant number of people were in remission from diabetes at both two years and 10 years after surgery.

“This new research from Utah is more evidence that people who undergo these procedures have positive, beneficial long-term outcomes,” said Grunvald, who coauthored the American Gastroenterological Association’s new guidelines on obesity treatment.

The association strongly recommends patients with obesity use recently approved weight loss medications or surgery paired with lifestyle changes.

“And the key for patients is to know that changing your diet becomes more natural, more easy to do after you have bariatric surgery or take the new weight loss medications,” said Grunvald, who was not involved in the Utah study.

“While we don’t yet fully understand why, these interventions actually change the chemistry in your brain, making it much easier to change your diet afterwards.”

Despite the benefits though, only 2% of patients who are eligible for bariatric surgery ever get it, often due to the stigma about obesity, said Dr. Caroline Apovian, a professor of medicine at Harvard Medical School and codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston. Apovian was the lead author for the Endocrine Society’s clinical practice guidelines for the pharmacological management of obesity.

Insurance carriers typically cover the cost of surgery for people over 18 with a body mass index of 40 or higher, or a BMI of 35 if the patient also has a related condition such as diabetes or high blood pressure, she said.

“I see patients with a BMI of 50, and invariably I will say, ‘You’re a candidate for everything — medication, diet, exercise and surgery.’ And many tell me, ‘Don’t talk to me about surgery. I don’t want it.’ They don’t want a surgical solution to what society has told them is a failure of willpower,” she said.

“We don’t torture people who have heart disease: ‘Oh, it’s because you ate all that fast food.’ We don’t torture people with diabetes: ‘Oh, it’s because you ate all that cake.’ We tell them they have a disease, and we treat it. Obesity is a disease, too, yet we torture people with obesity by telling them it’s their fault.”

Most of the people who choose bariatric surgery — around 80% — are women, Adams said. One of the strengths of the new study, he said, was the inclusion of men who had undergone the procedure.

“For all-causes of death, the mortality was reduced by 14% for females and by 21% for males,” Adams said. In addition, deaths from related causes, such as heart attack, cancer and diabetes, was 24% lower for females and 22% lower for males who underwent surgery compared with those who did not, he said.

Four types of surgery performed between 1982 and 2018 were examined in the study: gastric bypass, gastric banding, gastric sleeve and duodenal switch.

Gastric bypass, developed in the late 1960s, creates a small pouch near the top of the stomach. A part of the small intestine is brought up and attached to that point, bypassing most of the stomach and the duodenum, the first part of the small intestine.

In gastric banding, an elastic band that can be tightened or loosened is placed around the top portion of the stomach, thus restricting the volume of food entering the stomach cavity. Because gastric banding is not as successful in creating long-term weight loss, the procedure “is not as popular today,” Adams said.

“The gastric sleeve is a procedure where essentially about two-thirds of the stomach is removed laparoscopically,” he said. “It takes less time to perform, and food still passes through the much-smaller stomach. It’s become a very popular option.”

The duodenal switch is typically reserved for patients who have a high BMI, Adams added. It’s a complicated procedure that combines a sleeve gastrectomy with an intestinal bypass, and is effective for type 2 diabetes, according to the Cleveland Clinic.

One alarming finding of the new study was a 2.4% increase in deaths by suicide, primarily among people who had bariatric surgery between the ages of 18 and 34.

“That’s because they are told that life is going to be great after surgery or medication,” said Joann Hendelman, clinical director of the National Alliance for Eating Disorders, a nonprofit advocacy group.

“All you have to do is lose weight, and people are going to want to hang out with you, people will want to be your friend, and your anxiety and depression are going to be gone,” she said. “But that’s not reality.”

In addition, there are postoperative risks and side effects associated with bariatric surgery, such as nausea, vomiting, alcoholism, a potential failure to lose weight or even weight gain, said Susan Vibbert, an advocate at Project HEAL, which provides help for people struggling with eating disorders.

“How are we defining health in these scenarios? And is there another intervention — a weight neutral intervention?” Vibbert asked.

Past research has also shown an association between suicide risk and bariatric surgery, Grunvald said, but studies on the topic are not always able to determine a patient’s mental history.

“Did the person opt for surgery because they had some unrealistic expectations or underlying psychological disorders that were not resolved after the surgery? Or is this a direct effect somehow of bariatric surgery? We can’t answer that for sure,” he said.

Intensive presurgery counseling is typically required for all who undergo the procedure, but it may not be enough, Apovian said. She lost her first bariatric surgery patient to suicide.

“She was older, in her 40s. She had surgery and lost 150 pounds. And then she put herself in front of a bus and died because she had underlying bipolar disorder she had been self-medicating with food,” Apovian said. “We as a society use a lot of food to hide trauma. What we need in this country is more psychological counseling for everybody, not just for people who undergo bariatric surgery.”

Managing weight is a unique process for each person, a mixture of genetics, culture, environment, social stigma and personal health, experts say. There is no one solution for all.

“First, we as a society must consider obesity as a disease, as a biological problem, not as a moral failing,” Grunvald said. “That’s my first piece of advice.

“And if you believe your life is going to benefit from treatment, then consider evidence-based treatment, which studies show are surgery or medications, if you haven’t been able to successfully do it with lifestyle changes alone.”

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CVS, Walmart to Cut Pharmacy Hours as Staffing Squeeze Continues

CVS, the largest U.S. drugstore chain by revenue, plans in March to cut or shift hours at about two-thirds of its roughly 9,000 U.S. locations. Walmart plans to reduce pharmacy hours by closing at 7 p.m. instead of 9 p.m. at most of its roughly 4,600 stores by March.

Walgreens Boots Alliance Inc.

previously said it was operating thousands of stores on reduced hours because of staffing shortages. Combined, the three chains operate some 24,000 retail pharmacies across the U.S. 

Walmart last year raised pay for pharmacy technicians.



Photo:

Ryan David Brown for The Wall Street Journal

Earlier in the pandemic, CVS and Walgreens struggled to meet demand for Covid shots and vaccines. The chains cut hours and, in some cases, closed pharmacies for entire weekends. Walmart, which sells a wider variety of goods, cut overall store hours, in part, to cope with Covid-related labor shortages and make time to restock empty shelves as demand for basics such as toilet paper surged.  

CVS, in a recent notice to field leaders, said most of its reduced hours will be during times when there is low patient demand or when a store has only one pharmacist on site, which the company said is a “top pain point,” for its pharmacists. 

CVS said in a statement it periodically reviews pharmacy operating hours as part of the normal course of business to ensure stores are open during high-demand times. “By adjusting hours in select stores this spring, we ensure our pharmacy teams are available to serve patients when they’re most needed,” the company said, adding that customers who encounter a closed pharmacy can seek help at a nearby location. 

At Walmart, the shorter hours offer pharmacy workers a better work-life balance and best serve customers in the hours they are most likely to visit the pharmacy, said a company spokeswoman. “This change is a direct result of feedback from our pharmacy associates and listening to our customers,” she said. Some Walmart pharmacies already close before 9 p.m., which will become standard across the country after the change.

An online community message board for Holliston, Mass., a small town about 30 miles outside Boston, was populated with messages last month from locals venting about the unpredictable hours of the CVS in town, said resident Audra Friend, who does digital communications for a nonprofit. Ms. Friend said she struggled for a week in November to refill a prescription for a rescue inhaler at the store because the pharmacy was sporadically closed.

“I would go in, and there was a note on the door saying, ‘Sorry, pharmacy closed,’” said Ms. Friend, who switched her prescriptions to a 24-hour CVS about 5 miles away. She said it would be better to have consistently shorter hours if that meant fewer unexpected closures. “At least that way we’re not just showing up at CVS to find out the pharmacist isn’t there,” she said.

A CVS spokeswoman said that in recent weeks the Holliston store has had no unexpected closures.

The drugstore chains have been working to stop an exodus of pharmacy staff by offering such perks as bonuses, higher pay and guaranteed lunch breaks. Pharmacists were already in short supply before the pandemic, and consumer demand for Covid-19 shots and tests put additional strains on pharmacy operations. Walgreens recently said staffing problems persist and remain a drag on revenue. 

Retail pharmacies, which benefited from a bump in sales and profits during the pandemic, are now reworking their business models as demand for Covid tests and vaccines decline and generic-drug sales generate smaller profits.

CVS and Walgreens are closing hundreds of U.S. stores and launching new healthcare offerings as they try to transform themselves into providers of a range of medical services, from diagnostic testing to primary care.  

This past summer, Walgreens was offering bonuses up to $75,000 to attract pharmacists, while CVS is working to develop a system in which pharmacists could perform more tasks remotely. The median annual pay for pharmacists was nearly $129,000 in 2021, according to Labor Department data, which also projected slower-than-average employment growth in the profession through 2031. 

In the past year, the chains have poured hundreds of millions of dollars into recruiting more pharmacists and technicians but staffing up has proven difficult. Pharmacists remain overworked, pharmacy-chain executives have acknowledged, and fewer people are attending pharmacy schools. The number of pharmacy-school applicants has dropped by more than one-third from its peak a decade ago, according to the Pharmacy College Application Service, a centralized pharmacy-school application service.

Meanwhile, many pharmacists who aren’t quitting the field are leaving drugstores to work in hospitals or with other employers. 

Walmart raised wages for U.S. pharmacy technicians in the past year, bringing average pay to more than $20 an hour. Walmart said it planned to raise the minimum wage for all U.S. hourly workers in its stores and warehouses to $14 next month, from $12.

CVS and Walgreens last year raised their minimum wages to $15 an hour.

Write to Sharon Terlep at sharon.terlep@wsj.com and Sarah Nassauer at Sarah.Nassauer@wsj.com

Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

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Rapper Young Thug, co-defendant ara accused of in-court drug transaction



CNN
 — 

Grammy-winning rapper Young Thug and a racketeering co-defendant conducted a hand-to-hand drug transaction during a court hearing, prosecutors said in a motion filed in Atlanta.

Fulton County prosecutors say the alleged exchange was captured on courtroom surveillance video Wednesday.

The rapper, whose real name is Jeffery Lamar Williams, and Kahlieff Adams are charged with conspiracy to violate the Racketeer Influenced and Corrupt Organizations Act and participation in criminal street gang activity, among other charges.

According to the motion seeking clarification of the record, Adams “stood up from his chair (…) and walked unattended” to Young Thug and gave him Percocet.

The motion said Young Thug tried to conceal his hand under the table. Sheriff’s deputies took the painkiller and searched Adams, who resisted. He was taken to Grady Memorial Hospital after “he appeared to ingest other items of contraband that he held on his person, in an effort to conceal the extent of his crimes within the courtroom.”

During the search of Adams, the deputies found Percocet, marijuana, tobacco, and other contraband, “wrapped in plastic and food seasonings to mask the odor of the marijuana,” the motion said.

Percocet is the brand name of a drug that mixes oxycodone, which is an opioid, and acetaminophen, which is the generic name for drugs such as Tylenol.

Keith Adams, one of Young Thug’s attorneys, told CNN on Friday, “The State is purposely misrepresenting and embellishing Wednesday’s events.”

He said Young Thug neither requested nor accepted the pill.

“As can be seen in the courtroom video footage, Mr. Williams IMMEDIATELY gave it to the courtroom deputy that was directly in front of him,” he wrote in a message.

Adams said an investigation cleared Young Thug of any wrongdoing and the responsible party was charged. He said the prosecutors’ allegations were “a blatant fabrication and disappointing.”

Teombre Calland, an attorney representing Kahlieff Adams, released a statement via text message to CNN affiliate WSB-TV saying: “On behalf of Mr. Adams, these allegations are simply that: mere statements made by the state in an effort to thwart the lengthiness of the jury selection process.”

CNN has reached out to Brian Steel, another Young Thug attorney, and Calland.

Young Thug won a Grammy Award in 2019 for his work with Childish Gambino and Ludwig Göransson on the hit song “This is America.”

The rapper was initially indicted in May on charges of conspiracy to violate the RICO Act and participation in criminal street gang activity.

A re-indictment filed on August 5 in Fulton County Superior Court accuses him of nine new charges, including participating in criminal street gang activity and violating the Georgia Controlled Substances Act.

He also was indicted on other charges of possession of a firearm during the commission of a felony and possession of a machine gun.

Jury selection is ongoing.

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First cases of gonorrhea resistant to several classes of antibiotics identified in the U.S.



CNN
 — 

Public health officials says they have found two cases of gonorrhea that appear to have reduced susceptibility to every kind of antibiotic available to treat them. It’s the first time strains of gonorrhea this resistant to antibiotics have been identified in the United States.

Increased sexual activity during the pandemic, coupled with fewer people getting routine health screenings, supercharged the spread of sexually transmitted infections around the world.

Those infections, including gonorrhea, are becoming increasingly resistant to antibiotics available to treat them, a problem that is becoming a dire threat to public health.

Globally, infections that are resistant to antibiotics kill approximately 700,000 people each year. That number is expected to rise to 10 million deaths per year by 2050 if steps aren’t taken to stop the spread of resistant organisms.

Experts say it was never a question of when this highly resistant gonorrhea strain would reach the US, but when.

“The concern is that this particular strain has been circulating around the world, so it was only a matter of time before it would hit the US,” says Dr. Jeffrey Klausner, a clinical professor of public health at the University of Southern California’s Keck School of Medicine in Los Angeles.

“It’s a reminder that gonorrhea is becoming increasingly resistant, increasingly hard to treat. We don’t have any new antibiotics. We haven’t had new antibiotics to treat gonorrhea for years and we really need a different treatment strategy,” said Klausner, who sits on the CDC workgroup for gonorrhea treatment.

Gonorrhea is sexually transmitted, and one of the most commonly diagnosed infections in the US. It is caused by the bacteria Niesseria gonorrhoeae, which can infect the mucous membranes in the genitals, rectum, throat and eyes.

People can be infected without having symptoms. Left untreated, the infection can cause pelvic pain and infertility in women and blindness in newborns.

In addition to reduced susceptibility to ceftriaxone, the strains of gonorrhea identified in Massachusetts also showed reduced susceptibility to cefixime and azithromycin; the strains were resistant to ciprofloxacin, penicillin and tetracycline, according to a clinical alert sent to physicians by the Massachusetts Department of Public Health.

The MDPH says it hasn’t yet found any connection between the two cases.

In 2021, the US Centers for Disease Control and Prevention recommended giving a double dose of the antibiotic ceftriaxone in an effort to overcome the bacteria’s building resistance to this antibiotic, and that seems to have worked in these cases, but that antibiotic is the last line of defense against this infection, and experts say a new approach is needed.

Klausner is hoping to win FDA approval for a test that would tailor antibiotic treatment to the genetic susceptibilities of the particular strain of gonorrhea that is infecting a person. This is called resistance-guided treatment, and Klausner says it works for HIV, TB and some other hospital acquired infections, but it’s never really been tried for gonorrhea.

This strain of gonorrhea has been previously seen in Asia-Pacific countries and in the United Kingdom, but not in the US. A genetic marker common to these two Massachusetts residents was also previously seen in a case in Nevada, though that strain retained sensitivity to at least one class of antibiotics.

The first symptoms of gonorrhea are often painful urination, abdominal or pelvic pain, increased vaginal discharge, or bleeding between periods, but many infections are asymptomatic, according to the CDC, making routine screenings important for catching the infection.

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Enjoying nature may lessen need for some medications, study finds

Sign up for CNN’s Fitness, But Better newsletter series. Our seven-part guide will help you ease into a healthy routine, backed by experts.



CNN
 — 

Going for a walk in a park or along a lake or a tree-lined space may reduce the need for medication for anxiety, asthma, depression, high blood pressure or insomnia, a new study found.

“Physical activity is thought to be the key mediating factor in the health benefits of green spaces when availability or active use of green space are considered,” said study coauthor Anu Turunen, a senior researcher at the Finnish Institute for Health and Welfare in Helsinki, in an email.

The study found visiting nature three to four times a week was associated with 36% lower odds of using blood pressure pills, 33% lower odds of using mental health medications, and 26% lower odds of using asthma medications.

“The analysis can reveal key associations, but we can’t say for certain whether it was the greenspace proximity or use that led to reduced use of medications,” said Lincoln Larson, an associate professor in the College of Natural Resources at North Carolina State University in Raleigh, who was not involved in the study.

“Perhaps people who were healthier to begin with (and less likely to take prescription drugs) were more likely to get outdoors in the first place,” Larson said via email.

The study, published Monday, January 16, in the journal Occupational & Environmental Medicine, interviewed approximately 6,000 random people in three of the largest cities in Finland about their use of green and blue spaces within a kilometer of their homes.

Green spaces included forests, gardens, parks, cemeteries, moors, natural grasslands, wetlands and zoos. Blue spaces included lakes, rivers and the sea.

Prior studies have found people living near green spaces reap significant health benefits. A 2016 study compared the amount of plant life and vegetation near the homes of almost 100,000 women. After eight years, the researchers found having access to the most green space reduced the women’s death rate by 12% — and improved their mental health.

A 2019 study of green spaces around the globe found people who live near them are less likely to die prematurely. Even doctors are beginning to prescribe nature as a treatment for mental health, as CNN Chief Medical Correspondent Dr. Sanjay Gupta explored in an episode of his podcast series, Chasing Life.

The new study also investigated the impact of being able to view green or blue spaces from home on the use of medications. Observing nature while indoors didn’t appear to work.

“Just seeing nature didn’t really move the needle, but experiencing it did. Other research points to similar conclusions,” said Larson, who has studied the benefits of public parks across the United States on the well-being of urban dwellers.

“If you want to reap the full health benefits that nature can provide, you have to immerse yourself in those settings,” he said.

While research hasn’t yet been able to show a true association, Larson still believes in the benefits of seeing, as well as experiencing nature.

“If you don’t have access to those places, simply seeing green space (or perhaps even experiencing virtual nature) is better than nothing,” he added.

You might even put a plant on your desk. A 2019 study found taking care of plants in the workplace slightly reduced stress for Japanese workers — unless their plant died. On an objective measurement, 27% of the workers showed a significant decrease in their resting heart rate, according to the study.

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CDC identifies possible safety issue with Pfizer’s updated Covid-19 vaccine but says people should still get boosted



CNN
 — 

The US Centers for Disease Control and Prevention said Friday that there is a possible safety issue with the bivalent Covid-19 vaccine made by Pfizer and BioNTech but that it is unlikely to represent a true risk. The agency said it continues to recommend that people stay up-to-date with Covid-19 vaccines.

The CDC said one of its vaccine safety monitoring systems – a “near real-time surveillance system” called the Vaccine Safety Datalink – detected a possible increase in a certain kind of stroke in people 65 and older who recently got one of Pfizer’s updated booster shots.

A rapid response analysis of that signal revealed that seniors who got an bivalent booster might be more likely to have ischemic strokes within the first three weeks after their shots, compared with weeks four through six.

Ischemic strokes, the most common form, are blockages of blood to the brain. They’re usually caused by clots.

The Vaccine Safety Datalink, or VSD, is a network of large health systems across the nation that provides data about the safety and efficacy of vaccines through patients’ electronic health records. The CDC said it had identified possible confounding factors in the data coming from the VSD that may be biasing the data and need further investigation.

Of about 550,000 seniors who got Pfizer bivalent boosters and were tracked by the VSD, 130 had strokes in the three weeks after the shot, according to a CDC official who spoke to CNN on condition of anonymity because they weren’t authorized to share the data. None of the 130 people died.

The number of strokes detected is relatively small, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices’ Covid-19 Vaccine Work Group.

“These strokes are not a confirmed adverse event at the moment,” he said. “It’s like a radar system. You’re getting a blip on the radar, and you have to do further investigation to discover whether that airplane is friend or foe.”

The same safety signal has not been detected with the bivalent Moderna booster, the CDC said in its notice.

The agency noted that it has looked for and failed to find the same increase in strokes in other large collections of medical records, including those maintained by Medicare, the US Department of Veterans Affairs, as well as its Vaccine Adverse Event Reporting System, known as VAERS.

Neither Pfizer nor other countries that are using the vaccine have seen any increase in this kind of stroke, the agency said, and the signal was not detected in any other databases.

The CDC says that it does not recommend any change to vaccination practices at this time and that the risks of Covid-19 for older adults continue to outweigh any possible safety issues with the vaccine.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the notice says.

“CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.”

Pfizer said in a statement Friday, “Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.

“Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine.”

The bivalent boosters from Pfizer/BioNTech and Moderna protect against the original strain of the coronavirus as well as the Omicron BA.4 and BA.5 subvariants. Only about 50 million Americans ages 5 and up have gotten them since they were authorized last fall, according to CDC data.

Schaffner said he was part of a briefing Thursday with members of the Covid-19 Vaccine Work Group. He couldn’t share specific details about the briefing but said the safety signal was discussed.

His biggest takeaway was that the safety surveillance system is working.

It’s very likely that this is a false signal, he said, but it’s being investigated, which is important.

“You want a surveillance system that occasionally sends up false signals. If you don’t get any signals, you’re worried that you’re missing stuff.”

Schaffner said he would absolutely tell people to get their Covid-19 booster if they haven’t done so yet – even those 65 and older.

“Undoubtedly, the risk of a whole series of adverse events, including hospitalization, is much, much greater with Covid-19 than it is from the vaccine,” he said.

He also said the signal – if real – may be more a factor of numbers than an indication that one manufacturer’s vaccine is riskier than the other.

Nearly two-thirds of the people in the US who’ve gotten an updated booster – 32 million – have gotten Pfizer, compared with about 18 million Moderna shots.

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Aging can be reversed in mice. Are people next?



CNN
 — 

In Boston labs, old, blind mice have regained their eyesight, developed smarter, younger brains and built healthier muscle and kidney tissue. On the flip side, young mice have prematurely aged, with devastating results to nearly every tissue in their bodies.

The experiments show aging is a reversible process, capable of being driven “forwards and backwards at will,” said anti-aging expert David Sinclair, a professor of genetics in the Blavatnik Institute at Harvard Medical School and codirector of the Paul F. Glenn Center for Biology of Aging Research.

Our bodies hold a backup copy of our youth that can be triggered to regenerate, said Sinclair, the senior author of a new paper showcasing the work of his lab and international scientists.

The combined experiments, published for the first time Thursday in the journal Cell, challenge the scientific belief aging is the result of genetic mutations that undermine our DNA, creating a junkyard of damaged cellular tissue that can lead to deterioration, disease and death.

“It’s not junk, it’s not damage that causes us to get old,” said Sinclair, who described the work last year at Life Itself, a health and wellness event presented in partnership with CNN.

“We believe it’s a loss of information — a loss in the cell’s ability to read its original DNA so it forgets how to function — in much the same way an old computer may develop corrupted software. I call it the information theory of aging.”

Jae-Hyun Yang, a genetics research fellow in the Sinclair Lab who coauthored the paper, said he expects the findings “will transform the way we view the process of aging and the way we approach the treatment of diseases associated with aging.”

While DNA can be viewed as the body’s hardware, the epigenome is the software. Epigenes are proteins and chemicals that sit like freckles on each gene, waiting to tell the gene “what to do, where to do it, and when to do it,” according to the National Human Genome Research Institute.

The epigenome literally turns genes on and off. That process can be triggered by pollution, environmental toxins and human behaviors such as smoking, eating an inflammatory diet or suffering a chronic lack of sleep. And just like a computer, the cellular process becomes corrupted as more DNA is broken or damaged, Sinclair said.

“The cell panics, and proteins that normally would control the genes get distracted by having to go and repair the DNA,” he explained. “Then they don’t all find their way back to where they started, so over time it’s like a Ping-Pong match, where the balls end up all over the floor.”

In other words, the cellular pieces lose their way home, much like a person with Alzheimer’s.

“The astonishing finding is that there’s a backup copy of the software in the body that you can reset,” Sinclair said. “We’re showing why that software gets corrupted and how we can reboot the system by tapping into a reset switch that restores the cell’s ability to read the genome correctly again, as if it was young.”

It doesn’t matter if the body is 50 or 75, healthy or wracked with disease, Sinclair said. Once that process has been triggered, “the body will then remember how to regenerate and will be young again, even if you’re already old and have an illness. Now, what that software is, we don’t know yet. At this point, we just know that we can flip the switch.”

The hunt for the switch began when Sinclair was a graduate student, part of a team at the Massachusetts Institute of Technology that discovered the existence of genes to control aging in yeast. That gene exists in all creatures, so there should be a way to do the same in people, he surmised.

To test the theory, he began trying to fast-forward aging in mice without causing mutations or cancer.

“We started making that mouse when I was 39 years old. I’m now 53, and we’ve been studying that mouse ever since,” he said. “If the theory of information aging was wrong, then we would get either a dead mouse, a normal mouse, an aging mouse or a mouse that had cancer. We got aging.”

With the help of other scientists, Sinclair and his Harvard team have been able to age tissues in the brain, eyes, muscle, skin and kidneys of mice.

To do this, Sinclair’s team developed ICE, short for inducible changes to the epigenome. Instead of altering the coding sections of the mice’s DNA that can trigger mutations, ICE alters the way DNA is folded. The temporary, fast-healing cuts made by ICE mimic the daily damage from chemicals, sunlight and the like that contribute to aging.

ICE mice at one year looked and acted twice their age.

Now it was time to reverse the process. Sinclair Lab geneticist Yuancheng Lu created a mixture of three of four “Yamanaka factors,” human adult skin cells that have been reprogrammed to behave like embryonic or pluripotent stem cells, capable of developing into any cell in the body.

The cocktail was injected into damaged retinal ganglion cells at the back of the eyes of blind mice and switched on by feeding mice antibiotics.

“The antibiotic is just a tool. It could be any chemical really, just a way to be sure the three genes are switched on,” Sinclair told CNN previously. “Normally they are only on in very young, developing embryos and then turn off as we age.”

The mice regained most of their eyesight.

Next, the team tackled brain, muscle and kidney cells, and restored those to much younger levels, according to the study.

“One of our breakthroughs was to realize that if you use this particular set of three pluripotent stem cells, the mice don’t go back to age zero, which would cause cancer or worse,” Sinclair said. “Instead, the cells go back to between 50% and 75% of the original age, and they stop and don’t get any younger, which is lucky. How the cells know to do that, we don’t yet understand.”

Today, Sinclair’s team is trying to find a way to deliver the genetic switch evenly to each cell, thus rejuvenating the entire mouse at once.

“Delivery is a technical hurdle, but other groups seem to have done well,” Sinclair said, pointing to two unpublished studies that appear to have overcome the problem.

“One uses the same system we developed to treat very old mice, the equivalent of an 80-year-old human. And they still got the mice to live longer, which is remarkable. So they’ve kind of beaten us to the punch in that experiment,” he said.

“But that says to me the rejuvenation is not just affecting a few organs, it’s able to rejuvenate the whole mouse because they’re living longer,” he added. “The results are a gift and confirmation of what our paper is saying.”

What’s next? Billions of dollars are being poured into anti-aging, funding all sorts of methods to turn back the clock.

In his lab, Sinclair said his team has reset the cells in mice multiple times, showing that aging can be reversed more than once, and he is currently testing the genetic reset in primates. But decades could pass before any anti-aging clinical trials in humans begin, get analyzed and, if safe and successful, scaled to the mass needed for federal approval.

But just as damaging factors can disrupt the epigenome, healthy behaviors can repair it, Sinclair said.

“We know this is probably true because people who have lived a healthy lifestyle have less biological age than those who have done the opposite,” he said.

His top tips? Focus on plants for food, eat less often, get sufficient sleep, lose your breath for 10 minutes three times a week by exercising to maintain your muscle mass, don’t sweat the small stuff and have a good social group.

“The message is every day counts,” Sinclair said. “How you live your life even when you’re in your teens and 20s really matters, even decades later, because every day your clock is ticking.”

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Updated childhood obesity treatment guidelines include medications, surgery for some young people



CNN
 — 

Updated American Academy of Pediatrics guidelines for treatment of obesity urge prompt use of behavior therapy and lifestyle changes, and say surgery and medications should be used for some young people.

The guidelines, published Monday in the journal Pediatrics, are the first comprehensive update to the academy’s obesity treatment guidelines in 15 years. They provide guidance for treatment of children as young as 2 and through the teen years.

The guidelines acknowledge that obesity is complex, and tied to access to nutritious foods and health care, among other factors.

Treatment for younger children should focus on behavior and lifestyle treatment for the entire family, including nutrition support and increased physical activity. For children 12 and older, use of weight loss medications is appropriate, in addition to health behavior therapy and lifestyle treatment, AAP says. Teens 13 and older with severe obesity should be evaluated for surgery, according to the guidelines.

“There is no evidence that ‘watchful waiting’ or delayed treatment is appropriate for children with obesity,” Dr. Sandra Hassink, an author of the guideline and vice chair of AAP’s Clinical Practice Guideline Subcommittee on Obesity, said in a statement. “The goal is to help patients make changes in lifestyle, behaviors or environment in a way that is sustainable and involves families in decision-making at every step of the way.”

For children and teens, overweight is defined as a body mass index at or above the 85th percentile and below the 95th percentile; obesity is defined as a BMI at or above the 95th percentile.

Myles Faith, a psychologist at the State University of New York at Buffalo who studies childhood eating behaviors and obesity, praised the new report both for acknowledging that the causes of childhood obesity are complex and that its treatments must be a team effort.

“It’s not one cause for all kids,” he says. “There’s not been this kind of report to say that there are more options and that we shouldn’t automatically discount the possibility of medication, that we shouldn’t discount the role of surgery. For some families, it might be something to consider,” said Faith, who was not involved in the creation of the guidelines.

The new guidelines do not discuss obesity prevention; it will be addressed in another AAP policy statement to come, it says.

“These are the most comprehensive, patient-centered guidelines we have had that address overweight and obesity within childhood,” Dr. Rebecca Carter, pediatrician at the University of Maryland Children’s Hospital and assistant professor at the University of Maryland School of Medicine, said in an email Monday.

“New to these recommendations are several new medication management strategies that have proven very successful in the treatment of obesity as a chronic disease for adults, and are now being recommended for use in children and adolescents,” Carter said. “This is a major step in allowing overweight and obesity to be considered as the chronic diseases that they are.”

She added that the recommendations also are a “major step forward” in helping both parents and medical teams “take ownership” over a child’s long-term health risks related to overweight and obesity.

“They give a variety of tools to help families feel empowered that there are ways to treat these medical conditions, and that there are nuanced causes for these conditions that go beyond easy solutions and certainly take our focus away from outdated or unhealthy dieting strategies,” Carter said.

The new guidelines are designed for health care providers, but Carter said parents should talk with their children’s doctor if there are concerns about weight, and discuss strategies to optimize health and monitor changes.

“It is also appropriate to do this in a child-focused manner, taking care not to stigmatize them or make them feel bad about their body, while empowering the child to feel they have the tools needed to keep their body healthy over time.”

The new guidelines are a “much-needed advancement” to align holistic care with current science, Dr. Jennifer Woo Baidal, assistant professor of pediatrics and director of the Pediatric Obesity Initiative at Columbia University in New York City, said in a separate email Monday.

“Uptake of the new guidelines will help reverse the epidemic of childhood obesity,” she said. “More work at policy levels will be needed to mitigate policies and practices that propagate racial, ethnic, and socioeconomic disparities in obesity starting in early life. Although the guidelines support advocacy efforts of pediatricians, we as a society need to voice our support for healthful environments for the nation’s children.”

AAP says more than 14.4 million children and teens live with obesity. Children with overweight or obesity are at higher risk for asthma, sleep apnea, bone and joint problems, type 2 diabetes and heart disease, according to the US Centers for Disease Control and Prevention.

Separate research, published last month in the American Diabetes Association journal Diabetes Care, suggests that the number of young people under age 20 with type 2 diabetes in the United States may increase nearly 675% by 2060 if current trends continue.

Last month, the CDC released updated growth charts that can be used to track children and teens with severe obesity.

Growth charts are standardized tools used by health care providers to track growth from infancy through adolescence. But as obesity and severe obesity became more prevalent in the last 40 years – more than 4.5 million children and teens had severe obesity in 2017-2018, the agency says – the charts hadn’t kept up.

The growth chart in use since 2000 is based on data from 1963 to 1980 and did not extend beyond the 97th percentile, the agency said. The newly extended percentiles incorporate more recent data and provide a way to monitor and visualize very high body mass index values.

The existing growth charts for children and adolescents without obesity will not change, the CDC said, while the extended growth chart will be useful for health care providers treating patients with severe childhood obesity.

“Prior to today’s release, the growth charts did not extend high enough to plot BMI for the increasing number of children with severe obesity. The new growth charts coupled with high-quality treatment can help optimize care for children with severe obesity,” Dr. Karen Hacker, director CDC’s National Center for Chronic Disease Prevention and Health Promotion, said in a statement. “Providers can work with families on a comprehensive care plan to address childhood obesity.

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