Lecanemab: It’s an experimental medication that’s been shown in trials to slow cognitive decline in people with Alzheimer’s disease. It’s also up for accelerated approval by the U.S. Food and Drug Administration, with a decision expected by Jan. 6. However, the drug has also been linked to two deaths from brain bleeds among people who’ve used it in trials, so safety concerns could threaten any approval. If approved, the drug — made by Japanese pharmaceutical company Eisai — would follow the controversial drug Aduhelm to become only the second medication ever approved to slow Alzheimer’s disease. Not every patient would stand to benefit from lecanemab, stressed the Cleveland Clinic’s Dr. Babak Tousi. He led the portion of the clinical trial that was conducted at the Cleveland Clinic, in Ohio. “The trial was designed for patients in the earlier stage of Alzheimer’s disease, people with mild cognitive impairment or early stage of dementia,” Tousi noted. “If this medication gets approval, it will probably be for people who have early stage of disease, with no to minimal assistance needed for activities of daily living.” The results of the 18-month trial, which involved about 1,800 patients, gained wide attention when they were published Dec. 1 in the New England Journal of Medicine, Tousi noted. In the trial, early-stage Alzheimer’s patients who took lecanemab showed a 27% reduction in…  read on >  read on >

Children and adults with a rare type of soft tissue cancer will now have a new treatment option that could have a big impact. The U.S. Food and Drug Administration has approved the immunotherapy drug atezolizumab (Tecentriq) for use in patients with advanced alveolar soft part sarcoma (ASPS) that has spread to other parts of the body or cannot be removed by surgery. “This approval will make a huge impact in terms of a rare disease that has been particularly challenging to treat,” said Dr. Alice Chen, of the Developmental Therapeutics Clinic in the U.S. National Cancer Institute’s (NCI) Division of Cancer Treatment and Diagnosis (DCTD). This cancer begins in the soft tissue that connects and surrounds the organs and other tissues. It spreads slowly, but is typically deadly once it spreads. Chemotherapy doesn’t work against it and new targeted treatments, including drugs called tyrosine kinase inhibitors, do not have lasting effectiveness. About 80 people in the United States receive an ASPS diagnosis each year. About 50% of patients with metastatic disease are still alive after five years. The cancer mostly affects adolescents and young adults. The approval was granted following the results of a non-randomized phase 2 trial led by the NCI, part of the U.S. National Institutes of Health (NIH). The drug is approved for people aged 2 and up. About 40% of…  read on >  read on >

The U.S. Food and Drug Administration’s approval process for the controversial Alzheimer’s drug Aduhelm was “rife with irregularities,” despite lingering doubts about the power of the pricey medication to slow the disease down, a Congressional report released Thursday claims. Actions the agency took with Biogen, maker of Aduhelm, “raise serious concerns about FDA’s lapses in protocol,” the report concluded. But the 18-month investigation launched by two congressional committees also took Biogen to task for setting too high a price on the medication. Company documents showed Biogen officials settled on an annual cost of $56,000 for Aduhelm because it wanted to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found. Not only that, Biogen planned to spend up to several billion dollars on an aggressive marketing campaign to target doctors, patients, advocacy groups, insurers, policymakers and communities of color, who were drastically underrepresented in the company’s clinical trials of the drug. The controversy over Aduhelm (aducanumab) stretches back to its June 2021 approval. The Cleveland Clinic and the U.S. Department of Veterans Affairs, among others, decided not to offer Aduhelm infusions following the approval because of the drug’s questionable efficacy and risks of brain swelling and bleeding. Once Medicare sharply limited its coverage of Aduhelm, still expensive after…  read on >  read on >

If you struggle with urinary incontinence and worry that diet drinks may make matters worse, new research suggests they may not have a significant effect. “This study is important in that it may guide clinicians counseling women with urinary incontinence to focus more on behavioral modifications, such as total volume intake, rather than on the type of beverage consumed,” said Dr. Stephanie Faubion, medical director for the North American Menopause Society (NAMS). “Further, given the multiple potential adverse health effects associated with consuming sugar-containing beverages, counseling should be directed away from avoidance of artificially sweetened beverages,” Faubion added in a NAMS news release. Past research on rat models had found that artificial sweeteners enhanced contraction of the detrusor muscle, which pushes urine out of the bladder, according to the U.S. National Institutes of Health. Despite anecdotal evidence that several foods and drinks have adverse effects on the bladder and lower urinary tract, few have confirmed a link between urinary incontinence and artificial sweeteners. The new study is based on an analysis of data from the Women’s Health Initiative study and included more than 80,000 women. It aimed both to examine a potential association between artificially sweetened beverages and urinary incontinence symptoms and to identify whether stress or urge incontinence was most associated. Urinary incontinence is the loss of bladder control and the unintentional leaking of…  read on >  read on >

The Mediterranean diet delivers plenty of health dividends, and new research now discovers it may lower complications during pregnancy. Specifically, women who stuck to the diet had a 21% overall reduced risk of preeclampsia, gestational diabetes, preterm birth, delivery of a small baby and stillbirth, researchers report. “We know adverse pregnancy outcomes are becoming more common in the United States,” said lead researcher Dr. Natalie Bello, director of hypertension research at the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles. These bad outcomes can have serious consequences for mom and baby, Bello said. “While we still need more information, it seems like the adoption of a Mediterranean-type diet could be an important lifestyle approach to preventing these adverse outcomes,” she added. The Mediterranean diet is rich in vegetables, fruits, nuts, whole grains, legumes and fish, while it is low in red and processed meats and alcohol. “This diet is associated with lower blood pressure, and more favorable profiles of glucose levels, so lower sugar levels and less insulin resistance,” Bello said. Bello noted this study can’t prove that this diet caused the lower risk of complications, only that it was related to a reduced risk. “Our thoughts are that you have a healthier background going into pregnancy,” Bello said. “Pregnancy can be a stress test for the body. A lot of people who…  read on >  read on >

With flu rampant in the United States, the U.S. Food and Drug Administration is warning consumers to be wary of over-the-counter products that promise to cure you of influenza, prevent it or reduce its severity. Sellers offering these products may make claims that are not accurate or safe, the FDA cautions. “These products can be found online, including popular marketplaces, and in retail stores. They may be labeled as dietary supplements, foods, hand sanitizers, nasal sprays or devices,” according to an FDA news release. Fraudulent products also include some herbal teas, certain air filters and light therapies that claim to prevent or cure the flu, or treat symptoms, such as fever, muscle aches and congestion. Putting faith in these bogus products might cause people to delay, forgo or stop the medical treatment they need, leading to serious and life-threatening harm, the FDA warned. The ingredients could also cause side effects and interactions with other medications people may be taking. Websites selling these products may appear to be online pharmacies selling prescription drugs. Legitimate online pharmacies do exist, but so do many websites that look like safe online pharmacies and are actually fraudulent. Visit the FDA’s BeSafeRx campaign to learn how to safely buy prescription medicines online. Even homeopathic products require some caution, and none are FDA-approved. They are generally labeled as containing very small amounts…  read on >  read on >