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Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools. Many Americans might have assumed that the FDA already had oversight of all medical tests; it does not. However, FDA Commissioner Dr. Robert Califf said the time is now to monitor the quality of high-tech tests for cancer, heart disease and a myriad other illnesses. “A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” Califf explained in an FDA news release. “According to the Centers for Disease Control and Prevention, 70% of today’s medical decisions depend on laboratory test results,” he noted. “Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health.” A handful of corporations, including Abbott Laboratories and Quest Diagnostics, develop and sell many lab tests and now dominate the marketplace. Some more common tests — such as those used in hospitals, pharmacies or doctors’ offices to spot strep throat, COVID-19 and other conditions — are already subject to pre-marketing FDA review. But thousands of so-called “laboratory developed tests” (LDTs), analyzed at many high-tech labs, face… read on > read on >

THURSDAY, Sept. 28, 2023 (HealthDay News) – An advisory panel to the U.S. Food and Drug Administration on Wednesday voted resoundingly against recommending a stem cell-based experimental treatment for ALS. Although the FDA isn’t bound by the votes of its advisory panels, agency scientists have already penned a scathing review of the drug, called NuOwn. The application from Brainstorm, the company that developed the treatment, was “scientifically incomplete” and “grossly deficient,” FDA staff scientists wrote in the review. Meanwhile, the advisory panel voted 17-1 against the drug to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. Only a panelist representing patients voted for the medication, while one adviser abstained from voting, the Associated Press reported. “Creating false hope can be considered a moral injury and the use of statistical magic or manipulation to provide false hope is problematic,” Lisa Lee, a bioethics and research integrity expert from Virginia Tech who voted against the treatment said, the AP reported. ALS is typically fatal within three to five years of a patient’s first symptoms, as the condition destroys nerve cells in the brain and spinal cord, taking away the ability to walk, talk, swallow and breathe. The FDA agreed to convene the advisory panel in response to a 30,000-signature petition from ALS patients and advocates. But a study from Brainstorm involving 200 patients did… read on > read on >

Smoking during pregnancy is a significant risk factor for premature births, but drinking coffee is not, new research suggests. Women who smoked during pregnancy were 2.6 times more likely to give birth prematurely compared to nonsmokers, a risk that was double that of previous estimates, the University of Cambridge scientists found. “We’ve known for a long time that smoking during pregnancy is not good for the baby, but our study shows that it’s potentially much worse than previously thought. It puts the baby at risk of potentially serious complications from growing too slowly in the womb or from being born too soon,” said Gordon Smith, head of the department of obstetrics and gynecology at Cambridge, in the United Kingdom. The study also showed that with prenatal smoking, a baby was four times more likely to be small for its gestational age. This brings the risk of potentially serious complications, including breathing difficulties and infections. On the other hand, high caffeine intake from coffee or other drinks did not have the same effect, even though it’s been shown previously to be associated with lower birth weights and possibly fetal growth restriction. In this study, scientists measured levels of chemical byproducts created when substances such as tobacco and caffeine are processed in the body. The investigators recruited more than 4,200 women who attended the Rosie Hospital, part… read on > read on >

Adding 3,000 extra steps a day can help older adults with hypertension significantly lower their blood pressure. About 80% of older adults in the United States have high blood pressure. Keeping it down can help protect against heart failure, heart attacks and strokes. “We’ll all get high blood pressure if we live long enough, at least in this country,” Linda Pescatello, professor of kinesiology at the University of Connecticut, said in a university news release. “That’s how prevalent it is.” While her previous research had shown that exercise could have an immediate and long-lasting impact on blood pressure, this new study set out to learn whether moderately increasing walking — popular in this age group — could do the same. “It’s easy to do, they don’t need any equipment, they can do it anywhere at almost any time,” said co-author Duck-Chul Lee, a professor of kinesiology at Iowa State University. The researchers focused on a group of sedentary 68- to 78-year-olds who walked about 4,000 steps per day. By adding in 3,000 steps, they would log 7,000 daily steps, in line with a recommendation of the American College of Sports Medicine. Getting “3,000 steps is large enough but not too challenging to achieve for health benefits,” Lee said in the release. Participants received kits with pedometers, blood pressure monitors and step diaries to track their… read on > read on >

Ozempic, a type 2 diabetes drug that has increasingly been used to help with weight loss, will now be labeled as having the potential to block intestines. The U.S. Food and Drug Administration recently made the label update for the drug made by Novo Nordisk, without directly citing Ozempic as the cause for this condition. “Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the label reads. The side effect, known by the medical term “ileus,” is also listed on labels for the weight-loss drug Wegovy, also made by Novo Nordisk, and in the diabetes medication Mounjaro, made by Eli Lilly, CBS News reported. Both Ozempic and Wegovy are known generically as semaglutide. Among more than 8,500 reports of gastrointestinal disorders after using semaglutide medications through June 30, ileus is mentioned in 33 cases, including two deaths, CBS News reported. The two pharmaceutical companies that make these medications are both being sued for claims that the drugs can cause a similar health issue known as gastroparesis, or stomach paralysis, CBS News reported. More information The U.S. National Library of Medicine has more on ileus. SOURCE: CBS News read on >

TUESDAY, Sept. 26, 2023 (HealthDay News) – A Pfizer plant that makes vital drugs, anesthesia and hospital supplies has restarted production after a 10-week shutdown. The plant, located in Rocky Mount, N.C., sustained severe tornado damage on July 19, when roofs were ripped off and medications tossed around. “This expedited restart is a proud achievement for the Rocky Mount team; however, it is only the first step toward full recovery for the plant, as Pfizer restarts production through a phased approach, with full production across the site’s three manufacturing suites anticipated by the end of 2023,” the company said in a statement issued Monday. “Production restart has been prioritized based on patient need and inventory levels. There are approximately 13 medicines in production on the lines that have restarted, including products that are currently available through Pfizer’s emergency ordering process,” the company added. “The first shipments of these medicines to distribution centers are anticipated in the fourth quarter of 2023. While manufacturing has resumed, it is important to note that some medicines may not be back in full supply until next year.” Most of the damage happened at the plant’s storage facility rather than its medication production areas, Pfizer said. The storage area contained raw materials, finished medications and packaging supplies, CBS News reported. Established in 1968, the Rocky Mount plant has more than 3,000… read on > read on >

Kraft Heinz said it is recalling over 83,000 packs of its Kraft Singles American processed cheese slices because of a packaging defect in the plastic that wraps the cheese slices. A temporary issue developed on one of the wrapping machines, making it possible for a thin strip of individual film to stay on the cheese slice after the wrapper is removed. Having this film on the cheese could be unpleasant, the company said, and may cause gagging or be a choking hazard, according to a recall notice posted on the U.S. Food and Drug Administration website. Kraft Heinz discovered the problem after getting several consumer complaints about it. This included six complaints of customers saying they choked or gagged on the product. Still, no injuries or serious health issues have been reported. The company said it has fixed the machine with the issue and has inspected all other processing machines. Consumers should not eat the affected slices and should instead return them to the store where they were purchased for an exchange or refund. Contact Kraft Heinz from 9 a.m. to 6 p.m. ET, Monday through Friday, at 1-800-280-8252 to check on whether the cheese slices you purchased are part of the recall and to receive reimbursement. The recalled cheese packages are labeled 16 oz. Kraft Singles American Pasteurized Prepared Cheese Product with an individual… read on > read on >

A new government report finds that federal regulators need to do more to help in the battle to keep kids and teens off tobacco. Among the report’s findings were that the U.S. Food and Drug Administration needs to get tough on retailers selling tobacco to youth and should improve its oversight of online retailers. The FDA should also work with the Bureau of Alcohol, Tobacco, Firearms and Explosives to help stop online tobacco sales to children, according to the report from the Office of the Inspector General (OIG). “Responding effectively to serial violators remains a challenge for FDA,” the report stated. “The small number of retailers that repeatedly violate the Tobacco Control Act are often not subjected to more punitive actions. This risks undermining FDA’s efforts to control youth access to tobacco and enforce other restrictions on tobacco intended to safeguard public health,” according to the report. The agency needs to prioritize enforcement actions against retailers with a history of noncompliance, the OIG said. The FDA plans to discuss stricter enforcement with internal experts by November, CNN reported, and the agency agreed that inspections are a key part of keeping kids from smoking or vaping. The FDA did more than 1 million inspections between 2010 and 2020 looking for underage sales, CNN reported. The agency inspected about 74% of 360,000 stores at least once. It… read on > read on >

Highly processed packaged foods and drinks may be quick, cheap and tasty, but new research suggests they’re also likely to up your risk for depression. Among big consumers of ultra-processed foods, depression risk may rise by as much as 50%, the new study found, particularly when those foods are artificially sweetened. “Given what we know about these foods and the important role of diet in mood, we were not surprised to find this association,” said study author Dr. Andrew Chan, vice chair of gastroenterology at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School. At issue, he said, are foods that are “highly altered, often through industrial processes such as hydrogenation.” Hydrogenation is a chemical manufacturing process that significantly increases the amount of trans fat found in foods. Researchers have repeatedly linked trans fat intake to an increased risk for heart disease. The study looked at “ultra-processed” grain foods, sweet snacks, ready-to-eat meals, desserts, sauces, processed dairy products, savory snacks, processed meat, beverages, and/or artificial sweeteners. Such foods, Chan added, also “often contain additives such as dyes, stabilizers and emulsifiers. Examples include most so-called ‘fast food,’ cookies and chips.” In light of other research indicating that diet influences depression risk, Chan and his colleagues specifically set out to see what impact processed foods might have on depression risk. They looked at nearly… read on > read on >

In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. Approval of the Neffy nasal spray was widely anticipated. An FDA advisory panel voted to recommend approval of the drug for children and adults in May. While the FDA is not obligated to follow the advice of their advisory panels, it usually does. Instead, the FDA told the drug’s maker, ARS Pharmaceuticals, that it needed to conduct another study on the drug before it is approved, the company said in a statement late Tuesday night. “We are deeply disappointed that this action further delays the availability of Neffy for the millions of people who are at risk of a potentially life-threatening severe allergic reaction,” said Richard Lowenthal, co-founder, president and CEO of ARS Pharma. “We stand by the totality of the Neffy data package in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value Neffy can provide for patients, families and caregivers living daily with severe allergic reactions,” he said in a company statement, adding that his firm will aim to complete the requested trial as soon as possible. The news was unwelcome on the front lines of health care. “It’s certainly disappointing as we were hoping to have… read on > read on >