Paxlovid, a medication that has helped millions of high-risk COVID patients avoid hospitalization and death since late 2021, moved one step closer to getting full approval from the U.S. Food and Drug Administration on Thursday. An FDA advisory panel voted 16-1 that the Pfizer drug remains a safe and effective treatment and should be given full approval. It has only received emergency use authorization until now, but the FDA is expected to make a final decision on full approval by May, the Associated Press reported. The vote was not a surprise, given that Paxlovid continues to be a well-used treatment while other drugs no longer work against a mutated virus. While data for healthy adults shows the drug makes no meaningful difference, it shows significant benefits for high-risk adults. Paxlovid reduces the chance of hospitalization and death by about 60% to 85% for seniors and adults who have health issues that include obesity, diabetes, lung disease and immune system disorders, the AP reported. “We still have many groups that stand to benefit from Paxlovid, including unvaccinated persons, under-vaccinated persons, the elderly and the immuno-compromised,” said Dr. Richard Murphy, of the Department of Veterans Affairs. Paxlovid could prevent 1,500 deaths and 13,000 hospitalizations each week, according to the FDA. The United States still sees about 4,000 COVID deaths and 35,000 hospitalizations weekly, according to the AP.…  read on >  read on >

Steering clear of red meat, dairy and processed foods in favor of vegetables, fruits, nuts, extra virgin olive oil and whole grains will do a woman’s heart good, a new review shows. How much good? Australian investigators concluded that women who most closely followed the Mediterranean diet — which also features legumes, fish and shellfish, and moderate amounts of wine — appeared to lower their long-term risk for heart disease and premature death by nearly 25%, compared with women who didn’t. Though not involved in the analysis, Connie Diekman, a food and nutrition consultant and former president of the Academy of Nutrition & Dietetics, said the finding “is not surprising.” For one, Diekman noted that “studies continue to demonstrate the benefit of a plant-based eating plan to reduce inflammation, a likely contributor to disease development. In addition, the limited intake of saturated fats (found predominantly in animal foods) and consumption of unsaturated fats (found in higher amounts in plants) seems to be connected to blood levels of LDL cholesterol (the ‘bad’ cholesterol) and HDL cholesterol (the ‘good’ cholesterol).” Diekman added that past research has also shown that using olive oil and nuts that are high in unsaturated fats — both key foods in the Mediterranean diet — can help lower heart disease risk. Dr. Gregg Fonarow is director of the Ahmanson-UCLA Cardiomyopathy Center, co-director of…  read on >  read on >

Americans are eating more food additives, according to a new study that found about 60% of foods they purchase contain coloring or flavoring agents, preservatives and sweeteners. That’s up by 10% from 2001. “Our research clearly shows that the proportion of ultra-processed foods with additives in Americans’ shopping carts increased significantly between 2001 and 2019,” said study leader Elizabeth Dunford, a nutrition researcher at the Gillings Global School of Public Health at the University of North Carolina at Chapel Hill (UNC). “We observed this trend across all food and additive categories.” This is important, according to the study, published recently in the Journal of the Academy of Nutrition and Dietetics, because the health consequences of food additives are not fully understood. Assessing exposure to these additives is a key to understanding any role they play in weight gain, negative changes to the gut microbiome and other adverse health outcomes that are associated with ultra-processed foods, according to researchers. More than half of the overall packaged food and beverage products bought by U.S. households contained three or more additives in 2019, according to the research. A 22% higher percentage of baby food purchases were ultra-processed and contained additives. “These findings give us reason for concern, given the growing evidence linking high consumption of processed foods with adverse health outcomes,” Dunford said in journal news release. One…  read on >  read on >

New U.S. federal regulations will require mammography facilities to tell women if they have dense breasts, a description of how the tissue looks on the X-ray. It can be more difficult to detect cancer in dense breast tissue on a mammogram. Having dense breasts is also a risk factor for developing breast cancer. The U.S. Food and Drug Administration update amends regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 (MQSA). “Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Chief Medical Officer Dr. Hilary Marston. “Since 1992, the FDA has worked to ensure patients have access to quality mammography,” she said in an FDA news release. “The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards. This means that more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.” The update also strengthens the FDA’s oversight and enforcement of facilities and helps doctors better categorize and assess mammograms. The original act was designed to ensure quality mammography, an important tool for early breast cancer detection. About half of U.S. women over 40 have dense breast tissue. The amendments…  read on >  read on >

Elderly adults who eat plenty of leafy green vegetables, fish and other healthy fare may take years off their “brain age,” a new study suggests. Researchers found that seniors with either of two healthy eating patterns — the Mediterranean and MIND diets — showed fewer brain “plaques,” abnormal protein clumps that are a hallmark of Alzheimer’s disease. In fact, people with the highest Mediterranean or MIND scores had brains that were up to 18 years younger than their counterparts with more of a burger-and-fries diet. Experts said the findings do not prove that spinach and fish will ward off dementia. But they do add to a growing body of evidence linking healthy eating to slower brain aging. Lead researcher Puja Agarwal called the results “exciting,” because they suggest that even a simple dietary change could make a substantial difference. Based on the findings, older people who eat, say, a cup of leafy greens a day could have a brain that’s four years younger, versus their peers who shun the likes of kale and spinach. The study, published March 8 in Neurology, builds on past research into diet and dementia. Both the Mediterranean and MIND diets have already been linked to slower mental decline and a lower risk of Alzheimer’s disease, the researchers said in background notes. Now the new findings connect the diets to fewer…  read on >  read on >

Pregnant women will no longer have any drug to prevent preterm birth after the maker of the only available treatment announced Tuesday that it will withdraw its product, Makena, from the market. Covis Pharma Group’s decision follows a U.S. Food and Drug Administration advisory panel vote last October that concluded the drug does not actually benefit newborns. “While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis chief innovation officer Raghav Chari said in a statement. Makena was approved 12 years ago as part of the FDA’s accelerated drug approval program after promising results from a 2011 study, The New York Times reported. A larger study in 2019 showed no benefit to pregnant women or their infants. The FDA has been proposing to remove Makena from the market since October 2020, a decision appealed by the drug maker, the Times reported. In October 2022, 15 FDA advisors voted that the study had not shown benefit. With one exception, they each voted for it to be withdrawn from the market. “I think that when we leave something on the market that hasn’t been shown to be effective, we lose out on other investigations that might be pursued,” Dr.…  read on >  read on >