Alzheimer's drug lecanemab receives accelerated approval amid safety concerns |
Last week, the US Food and Drug Administration granted accelerated approval for the Alzheimer's disease drug lecanemab, one of the first experimental dementia drugs to appear to slow the progression of cognitive decline. Lecanemab, which will be marketed as Leqembi, is not a cure but has shown potential with slowing progression of the disease, according to clinical trial results. However, it has also raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding. The drug is a monoclonal antibody and works by binding to amyloid beta, a hallmark of Alzheimer's disease. Results from an 18-month Phase 3 clinical trial published in November showed that lecanemab "reduced markers of amyloid in early Alzheimer's disease," and it slowed the progression of cognitive decline by 27%, compared to placebo. About 6.9% of the participants given lecanemab, as an intravenous infusion, discontinued the trial due to adverse events, compared with 2.9% of those given a placebo. Overall, there were serious adverse events in 14% of the lecanemab group and 11.3% of the placebo group. The results also showed that about 0.7% of participants in the lecanemab group and 0.8% of those in the placebo group died, corresponding to six deaths in the lecanemab group and seven in the placebo group. The accelerated approval program allows for earlier approval of medications that treat serious conditions and "fill an unmet medical need" while the drugs continue to be studied in larger and longer trials. However, media reports of several deaths, including a case reported in The New England Journal of Medicine, among people using the drug outside of the initial trial have raised concerns for people using blood thinners. The drug's manufacturer, Eisai, said it did not have an official response to the case report because of patient privacy.
Lecanemab will carry a wholesale price of $26,500 per patient per year, its manufacturers announced. The wholesale cost of a drug is akin to a car's sticker price; it isn't necessarily what patients will pay after insurance or other discounts are factored in. Insurance coverage for this medication is not a given, however, given the controversy surrounding another recently approved Alzheimer's medication, Aduhelm.
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Updated obesity treatment guidelines include medications, surgery for some young people |
The American Academy of Pediatrics has updated its guidelines for the treatment of obesity in children and teens, urging prompt use of behavior therapy and lifestyle changes, and in some cases, it suggests using surgery and medications. It's the first comprehensive update to the group's obesity treatment guidelines in 15 years. They provide recommendations 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, the association 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 guidelines and vice chair of the group'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." The American Academy of Pediatrics says that 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. 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. |
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Some major pharmacies are planning to dispense abortion pills, but not in every state |
After a change to FDA rules, major pharmacy chains CVS and Walgreens say they plan to seek certification to distribute abortion pills where legally allowed. For the first time, the FDA's move allows outpatient pharmacies to dispense mifepristone, said Lewis Grossman, a professor of law at the American University Washington College of Law. In a medication abortion, mifepristone is used with another drug called misoprostol to end a pregnancy. Mifepristone blocks a hormone called progesterone that is needed for a pregnancy to continue. Misoprostol can already be distributed by pharmacies. In order to distribute the abortion pills, a pharmacy must be certified by the FDA. In a statement, Walgreens said it is "working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements and will dispense these consistent with federal and state laws." CVS said in a statement: "We plan to seek certification to dispense mifepristone where legally permissible." Honeybee Health, an online pharmacy company that had been supplying and shipping abortion medications, posted on its verified Facebook page Tuesday that it "officially became the first pharmacy certified to dispense medication abortion." In places where abortion was banned or heavily restricted before the FDA update, it remains banned or restricted, said Elizabeth Nash, a principal policy associate of state issues at the Guttmacher Institute, a reproductive-health nonprofit. "The FDA's change in allowing dispensing at pharmacies means that there are more options for access for people in states where abortion is not heavily regulated and abortion rights are protected. Where abortion has been banned, abortion remains banned," Nash said. |
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What to do if someone is in cardiac arrest |
Buffalo Bills safety Damar Hamlin's collapse on the field last week in cardiac arrest reminds all of us that there are some simple steps anyone can take to help save a life. About 70% to 90% of people who go into cardiac arrest in the US die before they get to a hospital because the people around them don't always know how to help. Warning signs can include shortness of breath, a pounding heart, weakness and chest discomfort. But more often than not, cardiac arrest happens without warning. Someone who's in cardiac arrest will not have a pulse and won't respond to sound or touch. They'll either stop breathing or make gasping-like sounds, which aren't true breathing but a reflex that happens when the brain isn't getting enough oxygen. You want to get professional help there as quickly as possible, so make sure to call 911 immediately. When the heart can't pump blood to the brain and the lungs, the person may become brain-damaged or die within minutes. If someone else is around, divide the duties. One person should call 911 while the other looks for an automated external defibrillator, or AED. These devices are available in many public places like airports, office buildings and schools. When you press the power button, the AED will give you step-by-step voice instructions on where to put the electrode pads on the person's chest. Once the pads are in place, the device measures the person's heart rhythm. It won't deliver a shock if the person doesn't need one. But if they do, the AED will tell you to stand back and push a button to deliver the shock. After using the AED – or right away, if you don't have access to one – start chest compressions. Put your hands in the center of the person's chest and press hard at 100 to 120 beats per minute. It may help to hum a song with this tempo like "Stayin' Alive" by the Bee Gees, Justin Timberlake's "Can't Stop the Feeling" or Lady Gaga's "Just Dance." Locking your elbows gives you more leverage to push. With an adult, you'd typically use both hands for the chest compressions. But if you're helping a baby, use one hand. These simple steps can mean the difference of life and death. |
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| New year's resolutions shouldn't be just for you. Here are 5 resolutions to make for your dog or cat to make their year – and yours – better. |
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- When too much daydreaming becomes a disorder
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For many people, the new year means new resolutions. Among the most common: eating better. And a new study finds why that is such an important resolution to stick with. Research published in the journal JAMA Internal Medicine finds that eating better not only comes with the benefit of feeling better, it also helps you live longer. You can reduce your risk of an early death from any cause by nearly 20%, just by eating more foods from your choice of four healthy eating patterns, researchers said. People who more carefully followed any of the healthy eating patterns in the study were also less likely to die of cancer, cardiovascular illness, and respiratory and neurodegenerative disease. The study followed the eating habits of over 75,000 women and more than 44,000 men for 36 years. None of the men and women had cardiovascular disease at the start of the study, and few were smokers. All filled out eating questionnaires every four years and were scored on how closely they adhered to one of four diets: - Mediterranean diet: Stresses fruits, vegetables, whole grains, nuts, legumes, fish and a high amount of olive oil
- Healthful plant-based diet: Focuses on more plant products but gives negative points for animal products and any alcohol; frowns on unhealthy plant-based foods like potato products
- Healthy Eating Index: Tracks whether people follow basic US nutritional guidelines, which stress healthy, plant-based foods; frowns on red and processed meat; discourages added sugar, unhealthy fats and alcohol
- Alternate Healthy Eating Index: Uses "best available evidence" to include foods and nutrients most strongly associated with a lower risk of chronic disease
The study participants were divided into five groups – or quintiles – from highest to lowest adherence to one or more of the eating patterns. Those who were in the highest quintile of diet had a roughly 20% reduction in mortality compared with those in the lowest-scoring group. The study also found reductions in risk of death from certain chronic diseases if people improved their diet over time. Participants who improved the health of their diet by 25% could reduce their risk of dying from cardiovascular disease by 6% to 13% and of dying from cancer by 7% to 18%; they also had a 7% reduction in risk of death by neurodegenerative disease, such as dementia. These are all compelling reasons to start the new year right and focus on eating better – so you can chase life. |
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| When psychedelics were first studied more than 50 years ago, researchers noticed that they were useful in helping people explore a greater sense of self. Listen to our latest conversation about how scientists are now studying the potential of MDMA, psilocybin and ketamine as treatment for depression, PTSD, anxiety and other mental health conditions. |
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