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 >
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FDA Delays Decision on New Alzheimer’s Drug
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 >
Look to Your Parents for Your Odds of Obesity: Study
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 >
Could ‘Lazy Eye’ in Childhood Raise Risks for Adult Disease?
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 >
You Can Safely Avoid Addictive Long-Acting Opioids After Knee Replacement
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 >
Analysis Showed Maine Mass Shooter Had Blast-Related Brain Damage
The perpetrator of a mass shooting in Maine last fall had extensive brain damage from “thousands of low-level blasts” tied to his work at an Army Reserve hand grenade training range, a new report shows. On Oct. 25, Robert Card, 40, killed 18 and injured another 13 in a deadly rampage in the town of Lewiston after opening fire in a bowling alley and then a restaurant. After a two-day manhunt, Card was found dead from a self-inflicted gunshot wound. Card was a U.S. Army Reservist who had long been an instructor at the hand grenade training range, where it is believed he was exposed to constant low-level blasts on a daily basis. In a statement released Wednesday, the nonprofit Concussion Legacy Foundation said Card’s family was releasing the findings of a tissue analysis conducted on Card’s brain “in an effort to help prevent future tragedies.” The analysis had been performed at the request of the Maine Chief Medical Examiner’s office and was led by Dr. Ann McKee, of the Boston University CTE Center. “Robert Card had evidence of traumatic brain injury,” McKee said in the statement. “In the white matter, the nerve fibers that allow for communication between different areas of the brain, there was significant degeneration, axonal and myelin loss, inflammation and small blood vessel injury. There was no evidence of chronic traumatic encephalopathy [CTE].” CTE… read on > read on >
Living Near Green Spaces Could Strengthen Your Bones
Living close to trees and other greenery could be keeping your bones strong, a new 12-year study suggests. Folks whose residences were near spots deemed “green” by satellite imagery tended to have better bone density than those who lived elsewhere, Chinese researchers found. Reductions in air pollution seemed key to greenery’s benefit for bones, according to a team led by Zhengxiao Ouyang, of Central South University in Changsha. “These findings provide valuable insights into the potential of greenness in preventing the onset of osteoporosis and emphasize the significance of urban greening in developing effective prevention strategies,” Ouyang’s team said. The findings were published March 5 in the Annals of the Rheumatic Diseases. The study drew on data from over 391,000 British people whose habits and health are being tracked by the UK Biobank database. Participants averaged 56 years of age, and 53% were women. Besides recording data on each person’s bone mineral density and their genetic risk for osteoporosis, the Biobank also contained data on their diet, smoking status, income, exercise levels and other factors. The Chinese team used satellite imagery to figure out how “green” the area around each person’s residence was. Separate data was used to track local levels of air pollution. Over the 12 years included in the study, 9,307 people went on to develop a new case of osteoporosis. The study… read on > read on >
Could a Meal With Refined Carbs Make You Less Attractive?
Put down that donut and lay off the pasta: New research finds you’re less sexy after gorging on refined carbs. French researchers presented heterosexual adults with photos of an opposite-sex person who two hours earlier had eaten a breakfast rich in refined carbohydrates. Participants rated the folks in the photos as less attractive compared to people who’d eaten a healthier breakfast. “Facial attractiveness, an important factor of social interactions, seems to be impacted by immediate and chronic refined carbohydrate consumption in men and women,” concluded a team led by Amandine Visine of the University of Montpelier. Her team published its findings March 6 in the journal PLOS One. According to the researchers, “refined” carbohydrate foods are ubiquitous in the Western diet, and include highly processed fare stripped of much of its nutritional value. White flour plus refined sugar are often ingredients, and many snacks are high in refined carbohydrates. According to a news release from the journal’s publisher, “preliminary evidence has suggested that consuming high levels of refined carbohydrates might also affect non-medical traits, such as a person’s attractiveness.” To investigate further, the French team recruited 104 white male and female adults. Some were told to eat a high-glycemic breakfast loaded with refined carbs that are known to boost blood sugar levels. Others ate a low-glycemic breakfast that avoided refined carbs. All of the participants… read on > read on >
Co-founder of Company Behind Deadly 2012 Meningitis Outbreak Gets Up to 15 Years in Prison
Barry Cadden, co-founder of a specialty compounding pharmacy behind a deadly meningitis outbreak in 2012, has been handed a prison sentence of 10 to 15 years in Michigan for involuntary manslaughter. On Tuesday, Cadden pleaded no contest to the charges against him, the Associated Press reported. His sentence will be served concurrently with the 14 1/2-year sentence he is already serving under a federal conviction for fraud and other crimes. Cadden co-founded the New England Compounding Center in Massachusetts. Twelve years ago, about 100 people died and 800 in total were made ill across 20 states after receiving injections of mold-contaminated steroids sourced from the company. Most had needed the injections for back pain. Speaking in a federal court in Boston in 2017, Cadden said: “I am sorry for the whole range of suffering that resulted from my company’s drugs,” the AP reported. At the time, prosecutors said Cadden’s company failed consumers in multiple ways — cutting back on lab disinfecting, shipping products before testing they were safe and ignoring repeated warnings about the safety of methods used in the lab. All of this was done to save the company costs, prosecutors said. Cadden appeared Monday in Livingston County court, northwest of Detroit. He pleaded no contest to each of the 11 counts of involuntary manslaughter leveled against him — one for each Michigan resident… read on > read on >
Wegovy, Ozempic Use Could Complicate Your Surgery
Weight-loss drugs like Wegovy and Ozempic can increase a person’s risk of throwing up during surgery while under anesthesia, a new study reports. People are typically asked to fast prior to surgery because general anesthesia can cause nausea, and they might inhale and choke on their own vomit. Unfortunately, part of the way that these drugs, called GLP-1 receptor agonists, help prompt weight loss is by slowing the digestion process, researchers explained. That means it takes longer for food to pass through the stomach. About 56% of people on a weight-loss drug still had significant amounts of food in their stomach at the time of their surgery, as revealed by ultrasound, researchers reported March 6 in the journal JAMA Surgery. Comparatively, only 19% of people not taking a GLP-1 receptor agonist had food left over in their stomach following preoperative fasting, results showed. “More than half of the patients on a GLP-1 receptor agonist had significant gastric contents on gastric ultrasound before an elective procedure, despite adhering to preoperative fasting,” said lead researcher Dr. Sudipta Sen, an associate professor of anesthesiology with the University of Texas Health Science Center at Houston. These results jibe with guidance issued last year by the American Society of Anesthesiologists that calls for screening for weight-loss drug use before surgery, and informing patients of the risks involved, researchers said. Doctors… read on > read on >