All Sauce from Weekly Gravy:

Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a large follow-up study, but the company stopped just short of saying it will definitely pull the drug from the market. The drug is sold as Albrioza in Canada. “Amylyx intends to share plans for Relyvrio/Albrioza in ALS, which may include voluntarily withdrawing Relyvrio/Albrioza from the market,” the company said in its statement. “At this time, Relyvrio/Albrioza and its related patient support program will continue to be available for people living with ALS. Amylyx has voluntarily decided to pause promotion of the medication during this time.” Executives added that they were “surprised and disappointed” by the results and would announce their plans for the drug in the next two months. Relyvrio was first approved by the U.S. Food and Drug Administration in September 2022, following a lengthy, impassioned campaign by patients with ALS, a fatal muscle-wasting disease. Unfortunately, the latest company study showed the drug did not slow the disease compared with a placebo treatment, and it also did not produce improvements on any secondary measures, such as muscle strength. ALS is a devastating neurological disease slowly destroys nerve cells and connections that are needed to walk, talk, speak and breathe. Most patients die…  read on >  read on >

Kids struggling with mental health problems have a tougher time recovering from a concussion, a new study finds. These troubled kids tend to have more emotional symptoms after concussion and take longer to fully recover, results show. In fact, the more mental health diagnoses a child had, the worse their emotional symptoms and the longer their recovery following a concussion, researchers reported recently in the journal Sports Health. “While research has emphasized the negative mental health effects that persist after a concussion and how they can impact development and recovery, it’s also very important to consider the burden these children and adolescents face prior to their injuries, and how their preexisting mental health status can impact recovery,” said senior researcher Dr. Matthew Grady, a pediatric sports medicine specialist at the Children’s Hospital of Philadelphia. Concussions are a common childhood injury, with about 2 million sports- and recreation-related concussions occurring each year in the United States, researchers said in background notes. These mild traumatic brain injuries can cause a variety of problems with brain function, emotions, sleep and vision, researchers said. A child’s physical health prior to concussion is known to influence their symptoms and recovery time. To see whether that held true for mental health as well, researchers analyzed data on more than 3,100 kids who had suffered a concussion. The research team checked the…  read on >  read on >

Days clogged with numerous after-school activities are detrimental to the mental health of over-scheduled high school students, a new study finds. Researchers also found that these “enrichment’ activities — tutoring, sports, school clubs and even homework — are unlikely to benefit students academically. Many folks think extra study time or tutoring will lead to better grades, but the new study shows many students are at their limit, said researcher Carolina Caetano, an assistant professor of economics with the University of Georgia College of Business. “We found that the effect of those additional activities on cognitive skills, that last hour, is basically zero,” Caetano said in a university news release. “And what’s more surprising is that the last hour doing these activities is contributing negatively to the child’s non-cognitive skills.” In other words, academic overload is causing high schoolers to lose out on social and emotional abilities — well-being, emotional control, resilience and communication, Caetano said. Caetano said it’s best to think of the relationship between enrichment activities and these social and emotional skills as a curve. For a while, an additional hour of studying, tutoring or group activities will help students improve their academic performance. But the more time a student spends on enrichment, the less time they have to relax, freely socialize or sleep – activities valuable for life skills and knowledge retention, Caetano…  read on >  read on >

Wegovy (semaglutide), the weight-loss version of blockbuster diabetes drug Ozempic, was approved on Friday by the U.S. Food and Drug Administration to help prevent heart attack, stroke and heart death. “Wegovy is now the first weight-loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders and Obesity in the FDA’s Center for Drug Evaluation and Research, said in an agency statement. “This patient population has a higher risk of cardiovascular death, heart attack and stroke,” Sharretts explained. “Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”  According to the FDA, over 70% of U.S. adults are overweight or obese, putting them at added risk for heart attack or stroke. In one multinational study involving over 17,600 people, participants received either injected Wegovy or a placebo injection. All participants also got standard-of-care management of their blood pressure and cholesterol plus counseling on exercise and healthy eating. “Wegovy significantly reduced the risk of major adverse cardiovascular events [cardiovascular death, heart attack and stroke], which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received placebo,” the FDA said. It’s thought that this expanded approval from the FDA could remove…  read on >  read on >

Instead of approving the new Alzheimer’s drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the drug’s maker said Friday. “The FDA has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design,” the company said in a statement. The move surprised the company, which had believed the agency would give its blessing to the drug during the first quarter of this year. “We were not expecting this,” Anne White, a Lilly executive vice president and president of its neuroscience division, told the Times. While independent FDA advisory committees are often called upon when the agency has questions about drugs, it was unusual to do so “at the end of the review cycle and beyond the action date that the FDA had given us,” White noted. While the FDA did not comment on the news, Lilly officials said they expected it would be a few months before the appropriate advisory committee meets to weigh the benefits of the drug, the Times reported. “The FDA did commit to us to move quickly, so we would hope that they would then take action shortly after the…  read on >  read on >

Lots of seniors are regularly taking low-dose aspirin in hopes of preventing heart attacks and strokes, even though updated guidelines often advise against it. About one in four older adults take aspirin at least three times a week, according to results from the University of Michigan’s National Poll on Health Aging. However, many seniors who take low-dose aspirin may not need to do this, researchers said. Nearly three in five (57%) of people ages 50 to 80 who take aspirin regularly don’t have a history of heart disease, poll results show. Those folks should talk with a doctor before starting or stopping aspirin use, because current guidelines mostly call for daily aspirin in people who already have heart disease or have survived a stroke or heart attack, experts said. “Aspirin is no longer a one-size-fits-all preventive tool for older adults, which for decades it was touted as,” said Dr. Jordan Schaefer, a hematologist at the University of Michigan School of Medicine. “This poll shows we have a long way to go to make sure aspirin use is consistent with current knowledge.” National guidelines for aspirin use have evolved in recent years because the over-the-counter drug can increase a person’s risk of dangerous bleeding. Experts now weigh the risk of bleeding against the benefits of preventing blood clots that can cause heart attacks and strokes. Because…  read on >  read on >

Folks worried about becoming flabby in middle age should check out what their parents looked like when they were that age, a new study says. People are six times more likely to become obese in middle age if both their parents were chubby during that time of their lives, according to research to be presented at the European Congress on Obesity in May. Further, having just one obese parent more than triples a person’s odds of middle-aged obesity, researchers found. These findings demonstrate that the established association between childhood obesity and parental weight doesn’t fade as a kid ages, said lead researcher Mari Mikkelsen, a doctoral research fellow of community medicine at the Arctic University of Norway. “Obesity in childhood, and especially in adolescence, tends to follow the individual into early adulthood, and so we suspected it would also follow them into middle age,” Mikkelsen said in a meeting news release. “We found that this is indeed the case — children whose parents lived with obesity are much more likely to be in living with obesity themselves when they are in their 40s and 50s, long after they have left home,” Mikkelsen added. For this study, researchers analyzed health data on more than 2,000 parent-offspring pairs who took both took part in an ongoing health research project called the Tromso Study.  All the offspring were…  read on >  read on >

Children with “lazy eye” are more likely to become adults facing an array of serious health problems, a new study warns. Kids diagnosed with amblyopia are more likely to develop high blood pressure, obesity and diabetes as adults, researchers found. They also face an increased risk of heart attack, according to findings published March 7 in the journal eClinicalMedicine. “Vision and the eyes are sentinels for overall health,” said lead author Dr. Siegfried Wagner, a senior research fellow with the University College London Institute of Ophthalmology.  “They are intimately linked with other organ systems. This is one of the reasons why we screen for good vision in both eyes.” Amblyopia occurs when vision in one eye doesn’t develop properly. As the brain ignores the weaker eye, that eye drifts out of position and tends to face slightly away from wherever a person is looking. As many as four in every 100 children have lazy eye, researchers said in background notes. It’s the most common vision condition in children. For this study, researcher analyzed data from more than 126,000 people ages 40 to 69 participating in the ongoing UK Biobank study. As part of their medical history, participants were asked whether they were treated for amblyopia in childhood, and whether they still had the condition in adulthood. They also were asked if they had been diagnosed with…  read on >  read on >

It’s well known that long-acting opioid meds raise the odds for addiction in users — including folks dealing with pain after an orthopedic surgery. Now, new research suggests that patients fare just as well if doctors prescribe less risky immediate-release opioids following a knee replacement surgery. Pain management was equal to that seen in patients on long-acting opioids, researchers report, and patients even had fewer bouts of medication-linked nausea. “If you can move from long-acting to immediate-release opioids without increased pain or other adverse effects, that’s a win,” said study co-author Judith Barberio, a clinical associate professor with Rutgers School of Nursing in New Jersey. “This quality improvement project suggests it’s possible to do that when recovering from a total knee replacement.” Barberio and her colleagues noted that U.S. surgeons replace about 790,000 bum knees each year. Experts have long known that the painful recovery period after joint surgery can be hazardous in terms of developing an opioid addiction. In the study, the research team took advantage of a planned switch in post-op protocol by one knee replacement surgeon: Switching patients from extended- to immediate-release opioids for pain. The study tracked outcomes for 36 patients who underwent surgeries before the change to those of 34 patients who got immediate-release opioids after the change. The result: No difference in patients’ pain scores, regardless of which type…  read on >  read on >

During the past half-century, the United States’ annual number of school shootings has increased more than twelvefold, a new study finds. What’s more, children are now four times more likely to be a school shooting victim, and the death rate from school shootings has risen more than sixfold. “Firearm violence is a public health crisis, and it needs to be addressed,” said lead researcher Dr. Louis Magnotti, a clinical professor of trauma surgery at the University of Arizona College of Medicine in Tucson. For the study, researchers analyzed 2,056 school shootings from 1970 through 2022. The incidents involved 3,083 victims, including 2,033 children ages 5 to 17 and 1,050 adults ages 18 to 74. The yearly number of school shootings has increased from 20 incidents in 1970 to 251 in 2021, researchers found. During that same period, the rate of children becoming a victim of a school shooting quadrupled, rising from 0.5 to 2.2 per 1 million population.  Deaths occurred six times as often, rising from 0.2 to 1 per 1 million population. “Not only have school shootings increased, but fatalities have increased even more than the number of shootings,” said Dr. Ronald Stewart, chair of the department of surgery at University Hospital in San Antonio, Texas. He wasn’t involved with the study. Victims and shooters were both predominantly male, 77% and 96% respectively, results…  read on >  read on >