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 >

Women who had diabetes during pregnancy might want to treat themselves to another cup of joe. New research shows that drinking coffee may lower their risk of type 2 diabetes. Compared to the general female population, women who had gestational diabetes may have 10 times the risk for type 2, according to researchers at the Global Centre for Asian Women’s Health (GloW) at the National University of Singapore. “The overall findings suggest that caffeinated coffee, when consumed properly [2 to 5 cups per day, without sugar and whole-fat/high-fat dairy], could be incorporated into a relatively healthy lifestyle for certain population,” GloW researcher Cuilin Zhang said in a university news release. Past studies had shown that drinking 2 to 5 cups of caffeinated or decaf coffee daily was healthier than artificially and sugar-sweetened drinks. To learn more, researchers followed more than 4,500 women who had a history of gestational diabetes over 25 years, examining long-time coffee consumption and risk. Most of the participants were white. Compared to those who drank no coffee, those who downed 4 or more cups a day after their pregnancies had a 53% lower risk of type 2 diabetes. Those who drank 2 to 3 cups lowered their risk by 17%, and those who drank 1 cup or less had a 10% lower risk, the study found. Decaf wasn’t found to have…  read on >  read on >

Call it a good idea that seems to have backfired: A tough new labeling law that requires even the smallest amount of sesame be listed on food products has instead spurred some companies to add it to their products. The new federal law goes into effect on Jan. 1, adding sesame to the list of major allergens that must appear on food labels when they are present in the product. Allergens that have appeared on labels since 2004 are milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans, the Associated Press reported. Food allergen labeling advocates have sought to add sesame to the list of major allergens for years. But the new requirements are so strict that it costs less to add sesame to food products than to try to keep it out of those aren’t meant to contain it, the AP reported. “It was really exciting as a policy advocate and a mom to get these labels,” Naomi Seiler, a consultant with the Asthma and Allergy Foundation of America whose 9-year-old daughter, Zoe, is allergic to sesame, told the AP. “Instead, companies are intentionally adding the allergen to food.” To follow the law, companies must label foods that contain sesame or follow safety measures to keep it from getting into foods through shared equipment and supplies. “It’s as if we’ve suddenly asked bakers…  read on >  read on >

Plenty of people enjoy a cup or two, or maybe three or four, of coffee every day. But new research shows that people with severe high blood pressure (“hypertension”) should steer clear of drinking too much java. The study found that for those with blood pressure of 160/100 or higher, drinking two or more cups of coffee daily was associated with a doubled risk of death from heart disease compared to those who don’t drink coffee. “We were surprised that heavy coffee consumption was associated with an increased risk of cardiovascular disease mortality among people with severe hypertension, but not in those without hypertension or with grade 1 hypertension,” said study author Dr. Masayuki Teramoto. He is with Osaka University Graduate School of Medicine in Japan and the department of epidemiology and biostatistics at the University of California, San Francisco. “In contrast, green tea consumption was not associated with an increased risk of cardiovascular disease mortality across all blood pressure categories,” Teramoto added. Why no heart harm with green tea? Researchers said polyphenols — micronutrients with anti-inflammatory and antioxidant properties — may be what’s responsible for the benefits of green tea. “These beneficial effects of green tea may partially explain why only coffee consumption was associated with an increased risk of mortality in persons with severe hypertension, despite both green tea and coffee containing caffeine,”…  read on >  read on >